Talk:Breast implant/Archive 6

This is an archive of past discussions about Breast implant. Do not edit the contents of this page. If you wish to start a new discussion or revive an old one, please do so on the current talk page.

Archive 1

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Archive 4

Links

We had come to an agreement to delete any links to websites that were paid promotional websites for specific plastic surgeons. We had also agreed to keep links only to recent summaries and research (with the exception of the Institute of Medicine report, which, although completed 8 years ago, is important enough to include). Unfortunately, someone put back some of those links. I removed them, as we had agreed. Drzuckerman 18:42, 8 December 2006 (UTC)

I agree with removing the promotional link for breastimplantsusa.com(I have no idea who put that in). However, the other two are pretty informative and interesting. The monograph by Dr. Rohrich (recent amer. society of Plastic Surgery president & editor of the world flagship plastic surgery journal)is still relevent in that many of the historical aspects of this issue are discussed (and well-referenced) and the discussion of the science is still accurate. The editorial by Marcia Angel provides excellent context for looking at this issue as it was viewed at the time by the editor of the premier world medical journal (New England Journal of medicine) and is an excellent section from her well-reviewed book about the silicone impplant crisis of the early 1990's. Droliver 22:39, 9 December 2006 (UTC)

You mean by Angel as is listed onThe Manhattan Institute website. It is well-reviewed by whom? The Manhattan Institute?Jance 00:28, 10 December 2006 (UTC)

It is important to have the most up to date info available, so I added the latest Inamed and Mentor silicone implant labeling info (from the FDA website) and an FDA consumer booklet. Marcia Angel's article was old, and she has since revised her views regarding industry-funded research -- I have met her and will ask for a more recent article. Since the best studies were conducted in the last 6 years, it's important to link to the newer articles. Brody's is apparently from last year so it should stay, but Rorick's is from 2000. Replaced with an NCI booklet for reconstruction patients. When I checked out all the links, I found another that was promotional (with ads all over the page) that I deleted. Also, there was a paper written by a law student -- obviously not a professional document, so I replaced it with a 2006 report from a legal nonprofit organization. In the spirit of compromise, the links are now devoid of promotionsal websites, balanced, and up to date. Drzuckerman 04:08, 10 December 2006 (UTC)

I reverted this to discuss a few things

1. A single link to the FDA information on breast implants is necessary as all that information is laid out there from the implant portal page. Again, this is a world-view article rather then a US-specific one & highlighting several links to what can be achieved with one seems with one belabors the point.
2. The inclusion of the political group Alliance for justice & a another self-referential document from your own organization, both of which do not demonstrably hold mainstream positions, is not appropriate.
3. The information in Rohrich's summary is still both accurate & relevent. There has in fact been little changes in the science or the interpretation of it since that work. His particular standing in Plastic Surgery makes this notable.
4. The LEDA article is about as well-referenced and thorough history on this this as I have seen and I do not think anything about it is "unprofessional". It also is about as neutral & non-judgmental as something like that can be. It is an excellent resource for someone who is unfamiliar with the silicone issue
5. Marcia Angel's book on this (from which the essay linked to was an excerpt) is a fairly substancial reference to the political environment that existed around the silicone crisis. Her position as NJOM editor gives her some standing for relevence. If you can find an update from her on this specific topic, I'd be fine with —The preceding unsigned comment was added by Droliver (talk • contribs) 19:53, 10 December 2006 (UTC).

Oliver, I have tried to work with you but this is NOT your article, this is wikipedia. There is absolutely no justification for your reverting to:

1. A website with advertising, when there are so many that don't have advertising.

2. A student paper -- that's just ridiculous.

3. You deleted a National Cancer Institute link. Why? They are the most respected cancer institute in the world.

4. You deleted an FDA link to the most recent information. Why?

5. Alliance for Justice is a very respected nonprofit organization with much more expertise on legal matters than you, me, or a law student. Every time you don't like something, you call it political, but that doesn't make it true.

Samir, I ask for your help. The article, as it is currently written, is almost entirely the product of droliver. He revereted everything to his version. Now he won't even allow an updating of links to more recent reports, even from the most indepedent sources, and insists on including reports published before ANY of the MRI rupture studies were published. And he insists of reports written by plastic surgeons while deleting those that aren't. I hope you can help, and I ask other administrators for help too. Drzuckerman 00:23, 11 December 2006 (UTC)
Dr Oliver, you don't need to revert in order "discuss a few things". That's just a ridiculous excuse for reverting. I encourage discussion of the links and the article content but you have to stop reverting other people's changes to the article. I went through several pages of the history and all you seem to be doing here is reverting changes. It is starting to look like you are asserting ownership of the article. If you cannot discuss edits without reverting, I will reprotect the article. Sarah 00:38, 11 December 2006 (UTC)

(edit conflict) Whilst I have not looked at any of the specific papers/reports being argued over. I think there is a middle ground as to what to cite. Droliver seems to looking to include initial substantive assessments, and Drzuckerman & Jance point out that the science has progressed since then and therefore so has the interpretation of the evidence. Both stances seem (from the outside of this argument) to be somewhat exclusionist. Wikipedia can report on the history within a field and need not therefore present just the "absolute current truth". I would have thought therefore that if some substantial assessment was published that had a notable effect (e.g. set out medical majority consensus or signified a change in the consensus) then the article should note that opinion (hence I would tend to feel the link (? NJOM) Droliver wishes to include is reasonable). However the article should mention any substantial non-trivial POV that arose from such a paper (citing of course from WP:Reliable sources) and if the evidence has since been improved upon, re-interpreted or re-assessed then these points also should be noted (again stating who made such an opinion and citing the sources) (hence I tend to approve of the wish of the other editors to add additional links).

NB the (italicised opinions) above are based on process rather than any judgement of the "worth" of any specific citations (the relevant paper might be brilliant or awful – I have not checked, but I am discussing general approach rather than specific facts)

Given the recent blocking of this article to bring a halt to edit warring, for Droliver to just revert that which has been discussed in the talk-pages, and which was trying to foster a wiki consensus seems disruptive to the process. I note that Sarah has therefore quite correctly restored the article back. Further edit warring has to stop, and a deterioration into revert-warring will on principle lead to extended WP:RfC, further blocks to certain editors involved and no doubt a return to article protection (this time it would no doubt be to Droliver's sense of M:The Wrong Version). Droliver you would do well at this point to apologise for your unwise revert and instead rejoin talk-page discussion :-) David Ruben ^Talk 01:13, 11 December 2006 (UTC)

--Thanks to Dr Ruben and Sarah for your help. I agree that some older reports are important, which is why I had kept in the Institute of Medicine Report and some older reports -- but didn't want most of the links to be to older reports. As an epidemiologist, my goal is to make sure the research findings reported in the paper are accurate, and that the information is NPOV, based on scientific findings. When findings are contradictory, we should say so and try to explain how different studies look at different variables and therefore have different results. Drzuckerman 05:07, 11 December 2006 (UTC)

David, I think you're going to be begging the question often of what WP:Reliable sources are with this. Are reliable sources to be the detailed reviews of multiple expert panels and the body of literature or are they alternate interpretations of these by small groups which have not been persuasive to governments and medicine at large? This contesting of every single study with "original research" is just reduplicating the hearings on these issues which have all just been repeated in the UK, Canada, & the US in the last few years. The minority view can be succinctly explained without going into the swampDroliver 16:26, 12 December 2006 (UTC)

Links in dispute

I can comment on policy in that I don't think that the LEDA project article (even if it is well written), the Manhattan Institute Article (even if it was written by Dr. Angell) and the Alliance for Justice Report can truly qualify as WP:RS. -- Samir धर्म 06:14, 11 December 2006 (UTC)

What about under WP:EL? Sarah 08:33, 11 December 2006 (UTC)

I'm not an expert on wiki policies, but #1 and #2 are based on recent research, as compiled by the US FDA, so that seems very appropriate. #4 and #5 are outdated and not of sufficient importance to include as a link since #4 is rarely if ever mentioned in other reports or published articles, and #5 never is. #8 is a website with ads, and since it overlaps with other sources, it seems expendable. I agree with Samir re #3 and #6, and I think I understand his reasoning on #7. Drzuckerman 04:59, 12 December 2006 (UTC)

1 & 2 are redundant as they both point to the FDA breast implant page, I'm advocating just linking once to the FDA breast implant portal page where this is all clearly laid out. The EQUAM report (link #4) is relevent as it is still the official E.U. position paper on this, although if you like you could exchange the 2003 STOA update to it, but the conclusions are unchanged. The point being, this is not strictly an American issue, and worldview context is important. Canada, Australia, or other countries health ministries' implant page seem more desrving then 4 internal links to the FDA. Likewise the discussion in Dr. Rohrich's paper (link 5) is still relevent, especially describing the history of the devices to that point. There has really been no science in the interim (as Dr. Zuckerman seems to be suggesting) which has affected the conclusions and accuracy of that monograph. The Marcia Angel essay (#6) is a reprint from her (still in print) book on this & I think deserves consideration giving her standing at the time of the events she was describing as NJOM editor when one of the major systemic reviews was published in her journal. I now understand DZ's issue with the "how things work" link (#8), and while it has really good content and graphics for laypeople, it does accept comercial advertisingDroliver 16:08, 12 December 2006 (UTC)

It's fine with me to delete the first FDA web page, which is merely a portal to many other articles. I think specific FDA articles are more useful than a portal, which is why I added the 2 most recent and relevant and comprehensive FDA publications. Why send readers on a fishing expedition where they have to click everything to find out what's relevant?

I completely disagree about there being no major studies in the last 6 years -- that is just not correct. There were only 17 epidemiological studies at the time of the 1999 IOM report and other reports, and almost all of them were badly designed. For example, several of the studies included less than one dozen women with implants, and one was a study of only 250 women, all of whom had implants for less than 2 years. There are now more than 100 epi studies. The IOM study is linked for historical purposes and all the other reports around that time are based on exactly the same 17 studies -- virtually the only studies of women available at the time (the other studies were of animals or cells).

In addition to being redundant to the IOM report, the EU position paper is unnecessary to show international scope because almost all the published studies cited in this wiki article were of European women and by European scientists (albeit funded by Dow Corning).

Your justification for publishing Angell's article makes no sense. The meta analysis of implant studies that was published in NEJM was not the basis of Angell's article, but was in fact based on the same 17 studies as the IOM report. And, as I previously pointed out, Dr Angell's most recent book, published last year, has a different view of industry-funded research than her older book. As I said, I will personally ask her for a more recent article. But again, the goal here is not to provide historical links, but rather a NPOV wiki article that includes a brief history but where the science is up to date.

If you want a history, rather than a history by an individual plastic surgeon who had access only to public documents, we should instead insert a link to the Congressional report, which is based on all FDA documents (official as well as internal scientific documents) and industry documents (many of which were available to Congress but not the public), fully footnoted and available through the Library of Congress. Droliver deleted that link every time it was inserted by me or anyone else. The full Congressional report is available several places on the web -- altho reports of that age are not available on government websites, you can see that these websites have the same report, and I have an official printed version which is identical to these:

http://www.transgendercare.com/surgical/brst_implants_congress102.htm

http://www.breastimplantinfo.org/what_know_3-FDA1992.html

Drzuckerman 05:49, 13 December 2006 (UTC)

So let me get this straight. Just because a 3rd party who has actively lobbied around the world on this declares all widely-accepted research and reviews on this to be either compromised or innacurate, thus it is so. You're proposing continous original re-interpretations of the body of literature in a way not consistant with how this has been evaluated, reported on, and treated by any country in the world. The hundreds (if not thousands) of panelists, researchers, and government officials who've reported/ruled on this were apparently so blinded by DOW-CORNING's subterfuge that they couldn't possibly see how the hundreds of related papers were so clearly flawed as you suggest? It's easier to just present this accurately as reported and state your case succinctly for the alternative view seperatelyDroliver 20:23, 13 December 2006 (UTC)

I do not see anywhere where Dr. Zuckerman was proposing the inclusion of original research, nor do I see in her discussion any suggestion to discount an entire "body of literature", or "hundreds of related papers". If I recall correctly, the 1999 IOM report is already included as a link, and nobody proposes removing it. It is quite appropriate to not include an additional article relying on that study - an article that was written by a doctor who may have altered her opinion since that time. Further, a congressional history is just that - a congressional history. It would be of interest to anyone wanting information on this subject. To deny it exists is revisionism. However, I am only speculating as to your objection, since your comment is a personal attack and not a statement about a specific study or article (and why it should be included or excluded). And what do you mean by calling Dr. Zuckerman a "3rd party"? Jance 22:41, 13 December 2006 (UTC)

Compromise #1

FDA 2004 Consumer Booklet on Breast Implant Complications and Reoperations keep
2006 FDA-Required Labeling Information for Silicone Breast Implants remove -- too peripheral to main topic
Harvard Law School LEDA project:The Silicone Gel-Filled Breast Implant Controversy: Testing the Bounds of Regulatory Intervention remove per argument above
European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM) consenus declaration keep as best EU consensus article
Silicone-Gel Breast Implants - a health and regulatory update by Dr. Rod Rohrich remove
Science On Trial- Medical Evidence and the Law in the Breast Implant Case by Dr. Marcia Angell remove
2006 Alliance for Justice Report on History of Silicone Breast Implants remove
How Stuff Works: Breast Implants remove

Thoughts? -- Samir धर्म 05:54, 13 December 2006 (UTC)

I haven’t visited this article for a few months, and am shocked at how biased the article now is, compared to before. It seems to be written by and for plastic surgeons, rather than having a NPOV.

As a professional working for a nonprofit health organization, I agree with Samir’s proposal above, except for the EQUAM statement. It is from 2000 and is very outdated. There just isn’t any point in including a very brief research summary with no detailed information, which is based on a summary of a small number of studies on human beings compared to the dozens of studies that have been conducted and published since then. I disagree with droliver’s remarks. He seems to think that everyone agrees with him that silicone breast implants have no risks. That may be the position of most plastic surgeons but it is not the consensus in medicine and public health. In fact, there was a presentation at the American Public Health Association annual meeting a few weeks ago that was entirely consistent with what Drzuckerman, Drcarter, and others have stated above.

I also propose we reinstate the local complications that were deleted by Droliver. These are very well-established and the plastic surgery medical associations and the implant manufacturers all agree that they are complications of all kinds of breast implants. This information should not have been deleted by droliver and suggest his POV. They include:

- ===Hematoma and Seroma===

Two known complications of breast implants include hematoma, the collection of blood inside a body cavity, and seroma, a collection of the watery portion of the blood around the implant or around healing. [1]

- A small scar can form or a rupture may occur if the implant is damaged during draining the incision. Post-operative hematoma and seroma may contribute to infection or capsular contracture.

- ===Changes in nipple and breast sensation=== - Feeling in the nipple and breast can change after implant surgery. [2] - Changes vary from intense sensitivity to no feeling in the nipple or breast after surgery. This altered sensation can be temporary or permanent and may affect sexual response or the ability to nurse a baby. - ===Extrusion=== - Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.[3] - Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.

- ===Necrosis=== - Necrosis, the death of tissue around the implant, requires surgery and may necessitate implant removal. [4] - According to studies by Inamed, necrosis occurs more frequently for silicone gel breast implants than saline implants and more frequently for reconstruction patients than augmentation patients. [http: //www.fda.gov] A permanent scar may form. GUHealth 21:49, 14 December 2006 (UTC)

I agree with GUHealth. As a public health professional working with women, the information in this section needs to be updated and accurate for the women who do not have the scientific prowess to read through scientified magazines and studies. LynnMB 20:51, 15 December 2006 (UTC)

I also concur that it's important to include the complications as listed by GUHealth. For those doing research on breast implants and, possibly, making decisions on whether they or someone that they know should have augmentation surgery, it is important that they see the major cons too. DrCarter12

I also agree with GUHealth about adding a few of those well-established complications. There are others, but these seem to be the key ones. Since that would not involve deleting anyone's work, I hope that means we can just proceed to make that addition. Sarah or Samir, will you make those additions? Drzuckerman 21:59, 15 December 2006 (UTC)

User:GUHealth, What non-profit organization exactly do you work for?
As to your concerns. Each of these complications you refer to are indeed mentioned already, most of which are not specific or unique to these devices and others are shared by any breast procedure ( be it biopsy, reduction, mastectomy, correction of inverse nipples, and others). Hematoma/Seroma is a rare event in breast augmentation. Extrusion & necrosis are exceedingly rare events in the non-cancer reconstructive groups. If your interest is in accurately presenting what is likely to be an issue, you need to look at the issues we have clearly identified. The rather unique and specific issues to implants are largely the phenomena of capsular contracture and the discussion of what factors drive reoperation rates (which is a group of factors mostly driven by capsule issues, implant/soft tissue changes over time, & size of implant/aesthetic concerns).
I also find it odd that you would dismiss the review and conclusions of EQUAM, a group representing more countries and a larger market then any such regulatory body in the world. You are unfamiliar with the literature and the subsequent updates to the 2000 report (which have been, "there's nothing new to add")if you believe that the European Union is out of date on this topic. Droliver 00:13, 16 December 2006 (UTC)

The EQUAM article is out of date because it is based on a small number of poorly designed studies (only about 20 studies of humans) that were published before 2000. There have been about 100 studies of women with implants published since then, most of them longer-term and better designed. The EU document is a very short summary, written as a policy announcement, that doesn't specifically review the research. If the EU believes their conclusions would be the same today, that does not negate the fact that the 2000 document is roughly equivalent to a 6-year old government press release. We have not linked to other government press releases from any other countries, not even more recent ones.

In contrast, the 2006 FDA articles on "labeling" links to detailed research-based documents written by the FDA for doctors and patients, based on the most up-to-date research. Even though the FDA aproved silicone implants (as the EU did), these documents are detailed summaries that include the unknown risks, complication rates specific to each companies' implants, etc. Those are very useful documents. Why are you opposed to including them oliver?

Regarding the complications that you deleted and don't want mentioned, they are not rare. For example, 6% of reconstruction patients had necrosis, according to Inamed. Necrosis, as you know, is permanent damage and 6% is a substantial number for such a serious complication. Since this article is about reconstruction as well as augmentation, that information is relevant. Drzuckerman 01:59, 17 December 2006 (UTC)

Diana, if you wish I'll change the EQUAM link to the 2006 update to it IQUAM As you can see, the conclusions have been the same over & over and this is still their position this year. The subsequent literature has done nothing but reinforce the conclusions of the EQUAM, U.K. Independent review group, the IOM, Health Canada, and the FDA. I'm not opposed to listing complications, but I am opposed to belabored descriptions of them, specifically ones that are less unique to implants. Droliver 03:12, 17 December 2006 (UTC)

Oliver, I'm glad you're not opposed to the complications, so I will put them in. But you seem to have missed my point about linking to a very short document (the equivalent to a press release) with little substantive info, most of it outdated. (The IQUAM document is 13 pages long, but less than 3 pages is for breast implants, and their claims of safety provide no details and are footnoted primarily on the 1999 IOM report, which is already in the links.) Let's use links with substantive information that is more detailed than this wiki article. And if you want to use the IQUAM document, use it as a footnote, not a link. And let's cite that interesting new information about titanium-covered implants in the IQUAM article. Drzuckerman 06:52, 17 December 2006 (UTC)

these complications are already listed in the article and do not need to be be belabored as they're somewhat generalized. I'm not sure what you're trying to prove with what you are suggesting be readded. Again, as someone who works with these devices and has these discussions with patients frequently, I can tell you the issues you seem intent on going out of you way to highlight, are not the ones you seen as an issue on a day to day patient, certainly not on elective cases. If you want to expand upon the issues involving implant-based reconstruction, the entry on breast reconstruction would seem better suited as that is the scenario and host environment where seroma or tissue loss would be more common.
The 2006 IQUAM update was only pointed to as you were implying the 2000 report no longer was accurate, which as you can clearly see is not correct. Droliver 14:25, 17 December 2006 (UTC)

Definately remove the alliance for justice which is a crass political outfit. I've provided the 2006 IQUAM update which should settle the issues with the "obsolete" 2000 refDroliver 03:29, 17 December 2006 (UTC)

Systemic Diseases

It's time to revise the systemic disease section, which is VERY pro-implant, focused on old policy statements (many of which pre-date ANY epidemiological research, and all of which pre-date most epidemiological research. If this is not a political article, it should have disease information based on research, not legal rulings. If it is going to include legal rulings, then it should include Dow Corning's $3.2 BILLION settlement which provided funds to several hundred thousand women in the US and other countries. It should also include the US government's successful settlement against several implant companies which obtained millions of dollars in compensation for women who were harmed by their silicone implants.

However, it seems much more appropriate to include research data. I suggest we include all the information that was in this article for months before droliver deleted it:

==Diseases and Systemic Illness==
Thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Although information from individual reports is considered anecdotal regardless of the numbers involved, peer-reviewed studies indicate that subjective and objective symptoms of many women with implants improve when their implants are removed. For example, in a comparison study, rheumatologists reported that women with rheumatological symptoms who had their implants removed and not replaced experienced limprovement in their health, and women whose implants were not removed or removed and replaced did not. ^[1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.
Numerous reports have reported that there is no evidence of increased mortality or classically defined autoimmune diseases among women with silicone breast implants. These include the Canadian Expert Advisory Committee review in 1992, ANDEM in France in 1996, the UK Independent Review Group 1998, and the U.S. Institute of Medicine in 1999, and the Scientific Technical Opinions Assessment (STOA) report commissioned by the European Parliament in 2001 (updated in 2003). Although these reports were independently conducted and funded, they did not conduct new studies and were instead based on the published research available at the time, most of which were funded by Dow Corning at a time that the company was being sued by women claiming illness from their breast implants.
Many of these reports are based on studies with small sample sizes that included women who had implants for just a few months or years. Years later, in 2004, the FDA pointed out that previous studies were not large enough to answer the question of whether or not breast implants increase the risk of connective tissue disease or related disorders. [5] Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. [6] Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made. ^[2] The FDA states: "When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [7]
There is no conclusive evidence linking breast implants to disease diagnosis, but as studies have followed women with implants for a longer period of time, evidence has grown regarding symptoms that are typical of autoimmune diseases. A Danish study, funded by Dow Corning and the Danish Cancer Society, reported that women who had breast implants for an average of 19 years were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population. ^[3] Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases."
Meanwhile, research on symptoms suggests that even in the short-term, women with silicone implants report more autoimmune symptoms. In data presented to the FDA, Inamed and Mentor both found that women with implants for only two years had a significant increase in auto-immune symptoms such as joint pain and nervous system symptoms. The findings remained significant when the women's age was statistically controlled. [8]
Despite these concerns, it is generally acknowledged that women undergoing breast augmentation or other plastic surgery tend to be healthier than the general population. In a study of several thousand plastic surgery patients, scientists from the National Cancer Institute found that augmented women were healthier than the general population, and yet were twice as likely to die from lung cancer or brain cancer, compared with other plastic surgery patients. ^[4] There were no reported differences in smoking habits that would explain the difference in lung cancer deaths; the authors suggested that more research was needed to determine if implants increase the risk of lung cancer or if undocumented differences in smoking were a contributing factor.
There is no evidence from the National Cancer Institute study or other studies that implant patients have a higher risk of death from breast cancer as compared with either the general population or other plastic surgery patients.
Another large study of nearly 25,000 Canadian women with implants reported lower cancer rates among augmentation patients, which the authors attributed to their higher income and better health prior to surgery. ^[5]

I ask Samir and Sarah for their help with this, and also welcome comments from other health experts. The above summary clearly shows what is known and not known about systemic illnesses, based on the most recent data. It includes the reports that droliver cited, and we can footnote them, without having so much detail on very old reports -- such as a report from the early 1990's, before ANY epidemiological studies were published. Drzuckerman 07:30, 17 December 2006 (UTC)

Absolutely wrong. There is no misinterpreting of the science on this and there's no such thing as "pro implant" data. The history of study of this is what it is. There is no medical or publich health bureau in the world who has accepted a link to systemic illness and many have come out VERY strongly dissmissing it. Attempts to frame this different are innacurate.

If you want to examine different countries' reviews & treatments here in the discussion page, I think this can be productive. Trying to spin this or reimagine the consensus is not Droliver 13:58, 17 December 2006 (UTC)

This is not an accurate portrayal of this & represents a both original research & rearguing of the issues you yourself have raised at a number of hearings both in the US & abroad. This interpretation has been soundly rejected over and over by expert panels and this is easy to show. Make the case for this succinctly rather then trying to reinterpret history. Once again you are trying to greatly expand on something that can be easily explained briefly. Droliver 14:05, 17 December 2006 (UTC)

I am surprised by droliver's comments, since the current version (which he inserted, after vandalizing what was there) is much longer and my proposed version is more succinct. My proposed language, which was in this wiki article for months before oliver deleted it, is a compromise representing a balanced presentation. Everything is footnoted and several of the statements are in quotes or close paraphrases. I can insert quotes to back up everything, just like a college term paper, but that seems unprofessional for wiki or any other encyclopedia.

I realize that one problem may be that droliver apparently does not realize that the EU standards for ALL medical devices, including all implants, is that they can be sold without any clinical trials proving safety. The fact that various countries say implants are not conclusively proven to cause specific diagnosed diseases does NOT mean that they are proven safe to never cause disease or symptoms of disease. Even the US and Canada, which require clinical trials, do not require that implants be proven safe for everyone or for long-term use. My summary is the more nuanced review: there is evidence of potential harm, but there is also evidence that implants do not cause breast cancer, that the women with implants are generally healthy, etc, all of which I included in the proposed section.

Some of this information is in the new FDA labels, which are in the form of booklets for doctors and patients. See http://www.fda.gov/cdrh/pdf2/P020056d.pdf for one example -- there are separate booklets for silicone or saline implants, made by different companies, but some of the language is identical. For example, around page 11 of all the FDA-approved booklets, it clearly states that "Safety and effectiveness [of the implants] have not been established" for women with autoimmune symptoms. The reason that they state this (in the saline labels, as well as the silicone ones) is because the implants were never tested on those women, because of concerns that the implants could harm women susceptible to those diseases (whether they already have been diagnosed or not). It is inaccurate not to mention those concerns -- and the current version does not.

Moreover, an independent Austrian study was just published in a scholarly chemistry journal last week with new evidence regarding women's autoimmune protein reactions to silicone implants. That is another example of why old reports are not appropriate to summarize research findings -- most of the old research is funded by industry, some of it is on rats, but the newer research is usually better designed and sometimes independently funded. Drzuckerman 16:29, 17 December 2006 (UTC)

Dr. Zuckerman, refighting the Health Canada & FDA hearings again is just silly and far beyond the scope of what one subsection of an overview on implants merits. The headline of a discussion on systemic disease in 2006 begins with the fact there is general international consensus that no link to this has been demonstrated. Major reviews of this were just achieved by the US & Canada. Britain & the E.U. have also (in 2006) reiterated their previous reviews. No other country has made any move over concerns on this. This is really simple to explain. There is no new major development that has come out that has changed anything despite the anti-implant movement searching desperately for one. There could in fact one day be some radical new development which causes us to completely rethink this, but that time is clearly not now.Droliver 22:34, 17 December 2006 (UTC)

We need to find a compromise between the current version and this version. Dr. Zuckerman, I agree that the opening of the systemic disease paragraph should reflect that no cause and effect relationship has been found between connective diseases and breast implants. The paragraph should, however, elaborate on the fact that there have been reports of systemic disease in women with silicone gel implants. Let's start with Dr. Zuckerman's first paragraph:

No causal relationship has been reported between silicone implants and systemic diseases, including connective tissue diseases; however, thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

Thoughts -- Samir धर्म 06:12, 18 December 2006 (UTC)

Thanks Samir, I agree with needing to acknowledge both sides. Having been asked by DrZ to comment on complications removal by DrO, I've tidied up the talk page a little and worked on the following posting to try and give some framework for co-operative improvemnt vs antagonistic arguing. Recent talk-page discussion has improved since the article was protected, but still insufficent so....

Latest spat of revert-insertion and reblanking is over some common complications. I feel no further reverting should occur until consensus is reached. Some observations to consider:

Common complications for all types of operations do not need to be discussed at length for each specific operation article. Hence I would have thought that bruising, post-op infections, surrounding numbness etc would not need to be routinely mentioned.
Likewise complications that apply generally to operations on a particular part of the body do not need to be mentioned in any great detail for each specific operation in that area (so meningitis with open cranial operations to the head does not need be repeated for pituitary surgery, surgery for epilepsy, surgical management of hydrocephalus)
But should a particular operation in an area be associated with an unusually high or low risk of a complication, then mention seems appropriate.

re Necrosis

So if risk of "necrosis occurs more frequently for silicone gel breast implants than saline implant" then this seems important to mention, and certainly is relevant in indicating that the type of implant is associated with differing risks.
The level of necrosis is described as "reconstruction patients (6% during the first three years) than augmentation patients (1% during the first three years", which leads to 2 issues as to why this seems worthy of including. Firstly as the majority of implants are/were for augmentation and for these patients the cosmetic surgery risk is clearly less than for the reconstruction plastic surgery cases. Secondly 1% risk of a non-minor problem fulfils my understanding of what would be a significant problem to specifically mentioned as part of consent for this specific procedure..

re extrusion

the risk needs be quantified - merely including because it can occur does seem to be alarmist/anti-implant POV, unless the degree of risk is specified (we don't list having a heart attack during the operation - the risk is so tiny even though it could occur I suppose as for anyone undergoing an anaesthetic).
The 2nd sentence for this risk of "Surgery needed to correct this can result in unacceptable scarring or breast tissue loss" seems subjective and personal opinion POV. Any surgery can result in what may be perceived by the patient to be unacceptable scarring. It would be more NPOV sounding, as well as briefer encyclopaedically (this is getting to be a long article) to have plainly added on to the end of the 1st sentence ", and requires further corrective surgery".

My twopence of opinion: Yes specific local complications of particular relevance to those having breast implants needs be included, but No woolly inclusion without incidence rates (to quantify low or high risk) and with just briefest of discussion.

Warning re participation

I think those editors without prior detailed knowledge of Breast Implants are finding this intense edit warring very tedious and frankly boring – it is after all just one article and there are so many more articles we can productively and non-contentiously work on. Consequently few editors are being attracted to start or continue to participate, and the small numbers hinders reaching consensus. Repeated large scale insertion & deletion of text outside of clearly discussed talk-page discussion and consensus is likely to result the article being protected, and a WP:RfC on all editors involved.

Brevity: Please therefore keep discussions brief (this is not a tribunal nor an FDA hearing)
Consensus – this means discussing, then waiting for other editors to indicate their views, editing (either way) during the wait is disruptive and just raises the heat.
Discuss the encyclopaedia entry or improvement to NPOV, not ones own POV. So each side should be able to phrase a section in NPOV terms that acknowledges minority as well as majority opinion.
- Remember Wikipedia is not a place to carryout a debate and especially not discuss the worth of one paper vs. another - for that is banned personal research, unless of course one can cite an external 3rd party source as holding that opinion of a paper.
- Also remember that wikipedia explicitly rejects the "truth" of a Scientific Point of view (WP:SPOV), but instead is reporting on currently accepted (i.e. widely held) understanding, even if is thought to be wrong. So if all the papers in favour of implants were shown to be biased, funded directly/indirectly by manufacturers, surgeons are disregarding data etc etc, yet the de facto authorities of the FDA, UK & European regulatory bodies, by extension the relevant governments and medical profession as a whole assert that (older) papers prove safety and lack of any confirmed concerns, then that is what wikipedia must report as the majority POV and also must constitute the majority of the article space (see WP:NPOV re not granting equal space to minority opinions).
- Now before anyone starts jumping over the last few sentences, I merely phrased them as I did to highlight the process of encyclopaedic development that should be occurring - namely without regard for ones own personal assessment of the various issues. Likewise before anyone suggests that I am dismissing out of hand all concerns, the de facto position is that the regulatory bodies banned/restricted implant usage.
- So whilst the "established" medical consensus is that there is no proven causation of systemic complications and this needs be clearly stated in the article, equally the quality/length of monitoring failed regulatory body requirements and the products' licenses were revoked and this too needs to be clearly stated in the article. Both aspects are de facto majority viewpoints and need be included.
- Please don't though take this needing to state what are therefore superficially black/white opposing points (we all appreciate the greys of reality, incomplete research and understanding) as an excuse to engaging in actually carrying out the real life debate. David Ruben ^Talk 06:22, 18 December 2006 (UTC)

There seems to be a misunderstanding of the general consensus re implants and systemic disease. If you look at the current reports and documents, you will see:

While there is agreement that there is no conclusive evidence that breast implants cause a UNIQUE DISEASE or a classically defined disease, there is no such agreement on systemic symptoms. On the contrary, there is clear and repeated evidence of significant increases in autoimmune symptoms, such as joint pain.
The implant manufacturers are required by regulatory agencies to warn patients that the implants are not proven safe or effective for women with autoimmune symptoms/diseases.

As for complications, a well-documented complication is loss of nipple sensation, sometimes permanently. That is different than complaints for other surgeries, at least to the women. I can add the specific statistics, all of which are now published in the FDA-required documents for patients and doctors. Drzuckerman 18:23, 18 December 2006 (UTC)

Vague symptoms do not equal disease Diane, and individual symptoms are not how auto-immune diseases are diagnosed. There has been no consistancy of patterns of symptoms in 25 years of studies on reproducing this in breast implant patients. This is echoed over & over again in each subsequent systemic review from 1990-2006. In addition the best individual long-term studies [PMID 15220596] continue to find no increases in the totals of loosely defined symptoms which can be manifestations of AI disease.

As to the warning labels, that is more a political legacy from the silicone crisis rather then some recomendation derived from evidence based medicine. It's kind of a gordian knot. That dogma is never going to be formally studied as there's little to be gained by Industry or the feds by doing so, although obviously it's clear (just on chance) that many patients with latent AI diseases have been implanted world-wide over the last 40 years. The persistance of it in the labeling really is better understand in that context rather then as some coded innuendo suggestion an issue

All the complications are already touched on already, and again nipple sensation issues are common to ALL breast surgery. With breast augmentation, it's really felt to be primarily associated with peri-areolar incisions rather then the implant itself. You almost never see it with the way more & more surgeies are being done (inframammory incision with sub muscular implant placement). A more appropriate place for that caveat would be in the incision section next to peri-arelar incisions. Droliver 04:05, 19 December 2006 (UTC)

DrOliver's comment that the labeling is only a "political legacy" seems to be WP:OR. Is it possible for me to ask DrOliver to stop making accusations that an editor is "trying to change history" etc. ? Is this helpful to any resolution of this article? Also, it would be helpful to go back to what David said about the inclusion of necrosis as a complication. Jance 19:18, 19 December 2006 (UTC)

A note on a comment earlier by Dr Oliver: You're too focused on the American process here. Regular MRI screening has been adopted by only the US & was explicitly rejected by health Canada a month prior as not being evidence based. Other countries do not endorse the FDA rec. either. While I'm fine with reference to the FDA position, it needs to be in the context of standard practices... Is it possible that the differences in policy are due to A:the higher fear of lawsuits by hospitals and physicians in the US and B:the differences in healthcare in the US vs countries with socialised or partially socialised medicine? For example, in the US a woman would likely pay for her $3000 MRI ($1500 sounds like a deal!) either out of pocket or by convincing her ins. company, whereas in Canada and the EU, the state (taxes) pay or partially pay for these tests? Having been on both sides of the pond, I've noticed Americans and Europeans (both lay people and policy-makers) have different views on drugs and medicine in general.
The second thing I want to say is, in regards to what Dr Ruben said, we don't have to be too uptight about how current research is— I mean, it's important for sure, but when current ongoing studies finish, we can always add them too; wikipedia will still be around. My €.02 Dikke poes 20:09, 19 December 2006 (UTC)

The US-FDA MRI recomendation makes no sense to anyone, especially in the first few years after implantation as we know the rupture rates hovers at < 1%. The convetional wisdom is that it was a bone thrown to the activists. They (FDA)can make this statement only because they don't have to fund it, and I think it will be largely ignored by patients. It would make more sense to do this at 8-10 years, but it just isn't a cost-effective test. When you do actuarial #'s on this (as I believe Canada & the UK have done)and compare it to the literture we have on patients with untreated rupture, it's a lot of money for little or no medical benefit. Clinical exam & ultrasound seem likely to be the more common screening modalities with MRI for confirmation (which is Canada's position) will likely be what is advised.Droliver 06:17, 20 December 2006 (UTC)

I would like to reiterate what Samir said. Let's look at a paragraph. All the speculation and generalization will only leave the article POV as desired by one editor. The idea is to come to a compromise - and no, it will not affect accuracy. The issue of implants is not black and white as DrOliver would have people believe. So why not start with the paragraph Samir suggested? It might be more difficult to make personal attacks by generalization and hyperbole, this way.

No causal relationship has been reported between silicone implants and systemic diseases, including connective tissue diseases; however, thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

Jance 01:49, 20 December 2006 (UTC)

I'd propose:

The consensus from a number of independent scientific reviews has been that there is no clear evidence of a causal link between the implantation of silicones and connective tissue disease. However, thousands of women have still claimed that they became ill from their implants, with complaints including included neurological and rheumatological problems. Some studies on explantation have suggested that subjective and objective symptoms of women may improve when their implants are removed.[1]

There is a need to emphacize the systemic reviews when this is introduced, which is why the language should be somewhat stronger like I propose and why the table summarizing these belongs in this subsection.
There are a number of papers [PMID 11886959] [PMID 15220594] (among others) which seem to disprove the assertion that AI symptoms correlate with rupture status, which is why that add-on should be dropped
Likewise, improvement after explantation does not happen predictably. I do however think it is an important concept in the case for silicone being toxic and deserves notation & reference. Calling for further research though seems like more advocacy then encylopediaDroliver 06:17, 20 December 2006 (UTC)

Oliver: do you want "connective tissue disease" in the first sentence (are the women complaining of cartilage problems? Or are you saying that's the rheumatoid connection)? (Remove second "included".) The first sentence says there's no clear evidence linking Si implants with connective-tissue disease, then the second sentence says some women claim neurological and rheumatoid problems. For this reason, even though I find your paragraph much cleaner than the ~~one above~~"Jance" version, yours is more vague when saying there is no causal relationship... then says women complain of (specifically such-and-such). If you were trying to avoid "systemic diseases," I understand, but your workaround ended up weird. And finally: in the "J" version, the pentultimate sentence says "studies suggest... that symptoms improve" and your last says "studies have suggested... that symptoms may improve" Did the studies predict the future (they may improve... implying eventually) or did they say that they improve, that some improve, or that there was uncorrelated improvement? The "some studies on explanation" is awkward. Were the studies specifically done to test whether removal of ruptured implants releived symptoms, or where these merely post-rupture studies looking at other things?

The consensus from a number of independent scientific reviews has been that there is no clear causal link between silicone breast implants and (whichever disease... if it's not AI as your links point out, what was not linked? If conn-tiss, tie in with next sentence). However, thousands (thousands?) of women have ("have still" is awkward...) claimed that they became ill from their implants, with complaints centering on (are these the majority of claims?) neurological and rheumatological problems (tie in with connective tissue??). Some studies have suggested that subjective and objective symptoms (women redundant, or use patients) may improve after the removal of their implants, but more study is needed to verify the correlation.

I bolded what I would change and italicised my questions. Dikke poes 15:10, 20 December 2006 (UTC)

Edit: The ultrasound suggestion makes more sense than the MRI for early implants, since U/S is usually cheaper. How well does it show silicone rupture? Is it the contour of the implant that changes? In any case, if the statistical relationship of rupture in the first several years is really as low as 1%, then an expensive MRI makes no sense. Has the FDA mentioned anything about regular monitoring of older implants with US? Dikke poes 15:15, 20 December 2006 (UTC)

Excuse me, but the FDA recommends MRI, not ultrasound. The MRI is 86% accurate. And there is not enough data to even get a pattern of rupture with time, which is probably why the FDA made this suggestion - in fact, the FDA specifically mentioned MRI because of its accuracy in detecting rupture. The FDA recommends an MRI three years after implantation, and then every two years. For Oliver to suggest that it was a 'carrot' to the "activists" is WP:OR and I might add, scary. To suggest that the FDA recommendation be changed to the suggestion of an editor here is WP:OR. And Dikke, I believe that paragraph was Dr. Zuckerman's not mine. I agree that there should be something cited for it.Jance 17:35, 20 December 2006 (UTC)

I'ld be a little more accepting of DrOlivers comments above as it raises some interesting issues (even if I don't fully accept his explaination) although perhaps off-topic for this particular article. NOR states "Articles may not contain any unpublished arguments, ideas, data, or theories; or any unpublished analysis or synthesis of published arguments, ideas, data, or theories that serves to advance a position." but that does not entirely hold sway for discussing artices in talkspace and raising possible issues that would need to be encyclopaedically researched into. So yes given the controversy that the subject generates, it would be interesting to compare regulation approaches for these devices around the world. From a sociological point of view, explaining why there are these differences would also be interesting although very off-topic for this specififc article. Of course, unless there can be found reliable sources to WP:Verify the particular explanation given by DrOliver, then the article can not include this. So can anyone find some WP:RS commenting of the pan-global variations of this product's licensing/restriction and why they might exist ?

Whilst the FDA may well have recomended MRIs for their 86% accuracy, that's not terribly impressive accuracy rates. Is MRI more useful at confirming non-rupture (specificity) or rupture (sensitivity) rates ? Are there coresponding figures for ultrasound option? eg I could envisage that if Ultrasound is only 90% as accurate as MRI but just 1/5 the cost, then performing ultrasound scans twice as often as MRIs might practically prove more effective and still cheeper ? David Ruben ^Talk 02:46, 21 December 2006 (UTC)

It is my understanding that the MRI is the "gold standard" for detecting rupture in silicone breast implants, and is superior to other tests. (That is from the many articles and studies I have read). However, I have not seen accuracy rates stated for ultrasound. I did not suggest that discussion on this talk page was WP:ORm, David. It was my understanding that someone suggested not including the FDA recommendation for MRIs, arguing that ultrasounds were less expensive. I presumed he was referring to the article, and not just discussing on the talk page. Certainly, a comparison wtih the recommendations of other countries can and should be included. I do not know what those are. If ultrasound were as accurate as MRIs, then I would think that should be included, while still discussing the FDA recommendation. To omit the FDA recommendation, based on one plastic surgeon's opinion that it was silly, is not appropriate. We do know that mammograms rupture implants (especially as they age). This is a fact - it is not speculation or my opinion. Given this, I have found it odd that mammogram centers only are concerned about obtaining the extra images for cancer detection, at least the one I went to, and not even asking women how old the implants are. Hopefully, that will change in time, especially since the FDA has expressly stated that mammograms can and do cause rupture.Jance 03:37, 21 December 2006 (UTC)

As to the tables, this had already been discussed months ago. The consensus then was that the table was POV. I raised, and still raise the point that the table is not only unduly repetitive, but it is selective in the summaries. I looked at every one of those studies cited. In every case, DrOliver's selections of summaries pull one line out of the whole - that which is most glowing on the safety of implants. Months ago, when I tried to add the *whole* of the conclusion (which was usually one line), he promptly deleted it. If this is not POV, then I don't know what is. It is appalling. And saying there is a need for further research, with the proper citation, is certainly not advocacy. It is a legitimate statement, if it is true and verifiable.Jance 03:44, 21 December 2006 (UTC)

David: I'm not advocating adding my extrapolative thoughts re. the MRI, that was an explanation for context to Dikke poes about how this is viewed by many who actually work with the devices. I'm not sure an extended discussion about the rest of the world is needed on imaging, other then to point out that no one else has adopted the FDA position re. scheduled MRI exams. The Health Canada panel summary discusses this issue specifically if something needs to be pointed to. MRI is clearly the preferred test, but it's not cost-effective. The Uk & Australian positions on implants in general are linked to thru the systemic review chart as is passing reference to Germany's review of this a decade prior. A number of other countries federally produced patients' handbooks (Ireland for one) can be found online and are consistant with these other countries.
The table is important for demonstrating the serial evaluation of this that began in the early 1990's and have continued thru the 2005/2006 FDA & Health Canada presentations. These aren't individual studies but a continuous reassment of the body of literture as a whole by expert review panels made of physicians and researchers from many disciplines. It is very effective for presenting an indisputable overview of the world on this and the quotations re. conclusions are self-explanatory and clearly in context.

Droliver 16:17, 21 December 2006 (UTC)

This is the same argument that DrOliver has used consistently, and it does not address the fact that it is (1) repetitive and (2) selective "cherry picking". Each one of those studies made more findings and recommendations than what Oliver picked. He only picked the most positive statement he could find in each review. The implication from his chart is that there is proof that implants do not cause problems. That is simply not true.Jance 23:50, 21 December 2006 (UTC)

Sorry, Jance, I wasn't pointing out whether that was "your" version... I tried saying, "the one above" but since both Oliver's and yours were above, I just figured for clarity it was easier to call it the "Jance" version. And yes, I was just asking Oliver about U/S. I figured he may have run across some mention of it. BTW, I consider the words "gold standard" to sound opinionated -- I'd rather, MRI is the best test available to detect rupture, with an 86%/whatever rate of detection. It's hard to make a gold standard when MRI is constantly improving, and a poor woman in Mississippi might get an old machine and a radiologist from India reading on the night shift (not to disrespect Indian radiologists), and a woman in Cape Cod may get a 7 Tesla magnet (not public yet, this is just an example) with the latest and greatest computer software and a topflight radiologist reading the film with a student going over it with him... I didn't think the U/S thing should be in the article.
For Oliver to suggest that it was a 'carrot' to the "activists" is WP:OR and I might add, scary <-- This is obviously his personal view, (that the MRI thing is a carrot to activists), but that view is NOT in the proposed paragraph. In any case, are there any more ideas/versions of this paragraph that we can use? (note, I'm going to use U/S for ultrasound so it's not confused with America in my posts)Dikke poes 17:19, 21 December 2006 (UTC)

That's ok, Dikke. I wanted to clarify. DrOliver had argued against inclusion of the FDA recommendation, and I thought that was strange. What he or his plastic surgeon friends may think about MRIs does not negate the fact that it is a recommendation. Of course, MRIs are not cost effective. They are very expensive. Unfortunately, there are no long term studies on the rate of rupture of the *new* implants (and there were none on the many old designs, either). But if I were a woman considering implants, at least in the US, I would want to know what the FDA recommendation was. Rupture is a product defect. Of course, nothing lasts forever. But how long do these last? We don't know. What are the long term effects of rutpure in the body? We don't know. (I know what happened in my own body, but I am an anecdote). If I were going to make a decision to implant, I would want to know these things. The FDA now requires manufacturers to tell women that implants do not last a lifetime. Will plastic surgeons tell women this? I suspect those who are honest will. And I suspect (and I know) that some won't, but will instead just hand women a 40 page booklet and tell them this is only a legacy of old "frivolous" lawsuits.) I only wish I had had an MRI (instead of a mammogram) five years before I did. It would be interesting to see the accuracy of an ultrasound in detecting rupture. I do not know what it is, or why the FDA recommended MRIs and not ultrasounds.Jance 23:50, 21 December 2006 (UTC)

I am not arguing about the cost or utility of MRI's, what the problem has been is the constant presentation of this from a US-centric rather then the world view. No one else has adopted the position the US-FDA took. No one. The rec. on early MRI's on devices with less then <1% failure rates during that period makes no sense to anyone. The standard recomendations in the world are for imaging to correlate with clinical findings. The "carrot" comment reflects an acknowledgement of some of the unique political considerations that have surrounded the evaluation and approval of this stateside.Droliver 19:09, 24 December 2006 (UTC)

Right. And I imagine plastic surgeons have no interest in following up once they put implants in. The FDA has stated that there is not enough data to determine rupture rate. Per your own arguments, a single study or even two short-term is hardly adequate to determine rupture rate. You think everything that remotely smacks of a "risk" is "political". Jance 23:08, 25 December 2006 (UTC)

Complications

Let's first go back to the complications section, since several important complications were deleted by droliver. It is a less complicated (no pun intended) section. Only 2 complications are currently listed, although there are many more well-established complications. And systemic disease is under that heading, whereas it should be a separate heading

I also agree with whoever said that the comments on this page are too long and it a full-time job just to read them. Let's try to be brief.

And, consistent with wiki rules, I request that droliver show more respect to people he disagrees with, stop calling me "Diane" (which is not my name and seems condescending, since nobody here calls him by his first name), stop questioning my motives, and stop misrepresenting my expertise. Let's call each other by the names we list. Drzuckerman 19:55, 20 December 2006 (UTC)

Unfortunately, I have also asked that Dr.Oliver be more respectful. I don't know how else to stop the rudeness. Also, I will note that "consensus" does not mean 100% agreement, and if consensus is accurate, then it should be acceptable to edit accordingly. Obviously, if the consensus is a false statement, etc, then it should be stopped. But that is the beauty about consensus - usually it does prevent a single editor's POV pushing. At lease, we hope it does. Jance 21:41, 20 December 2006 (UTC)

I haven't made a comment in about a week and a lot has happened. I personally believe that viewers of this page have the right to see all complications; not just rupture and capsular contracture, but they also need to know that additional surgery may be needed to fix problems, the possibility of chronic pain/necrosis, loss of sensation, etc... everday women are going to want to know about those type of complications. please include every complication in order to be neutral, yet informative. LynnMB 20:13, 20 December 2006 (UTC)

David also agreed that necrosis was a complication worth mentioning, esp if there is a difference wrt reconstruction v. augmentation. Consensus exists on this, and it should be added. DrOliver does not have to agree for there to be consensus on a legitimate edit.Jance 21:44, 20 December 2006 (UTC)

The patient handouts available on line for Inamed and Mentor silicone breast implants for primary augmentation had some glaring statistics. for Inamed 23.5% of women had reoperation within 4 years of the first breast implant surgery; for Mentor it was 15.4% within 1-3 years. Nipple complications were 4.9% for Inamed and 10.4% for Mentor. Breast pain was 8.2% for Inamed and 1.7% for Mentor (but Mentor also has a separate category labeled "breast sensation changes" that was 2.2%). Therefore I think that it is important to specify the complications with their associated rates to give women the necessary information in forming an opinion. DrCarter12

Please restore the complication information, especially if consensus exists on this topic. And if there are company-specific statistics available, such as those that DrCarter mentions, I think women have a right to see those, as well. GUHealth 22:22, 20 December 2006 (UTC)

I do not want to add it, since I have had had problems already with DrOliver. However, it is clear that there is a consensus (among doctors and non-doctors alike) and someone should add it.Jance 01:15, 21 December 2006 (UTC)

I read Dr. Ruben's page. He said, list complications if they're significantly special to the particular surgery (as all surgery working with skin has these complications to some extent). So with the statistics provided by Dr Carter (and how big are these two companies? If a significant percentage of the market, we can use them in the article), let's get the statistics for other surgeries that involve skin. Post them here in Talk. If they're like, 1-2%, then what's the deal? Only 2% of patients with (brandname) implants had post-op breast pain? Damn, I wish my oral surgeon were that good. Or are these longterm breast pain? This is important, too. If there's significant breast pain/nipple problems that go beyond post-op, then it should definitely be in the article, because it's relevent info. Just remember that any woman going under the knife is supposed to recieve info about possible complications. Sure, quacks might not, but that's what lawsuits are for :) Dikke poes 17:19, 21 December 2006 (UTC)

I do not know what causes the loss of nipple sensation. However, I would like to see a source on that, and not take the word of any one person. .Jance 23:55, 21 December 2006 (UTC)

Dikke , the common complications of this are in fact listed both in the context of breast surgery in general and those specific to implants. As David Ruben suggests, if you don't differentiate this, a relevant discussion turns into something akin to the PDR (physicians desk reference) when trying to look up something about a drug. There is so much information included of things uncommon or rare that in sources like the PDR, that it no longer becomes a useful resource for quickly figuring out what is most relevent,most often specific to that drug (or in this case device). There is a 200 page addendum on breast implants to the flagship journal of Plastic Surgery this month covering many aspects of complications & reoperations. Consistant with that, the focus is on what can be done to decrease capsular contracture and reoperation rates. Droliver 19:21, 24 December 2006 (UTC)

Right, Oliver. That was what I meant in my last sentence (that someone actually undergoing the surgery should get a booklet or something with all of the possible effects). So you're wanting main Complications section in the Wikiarticle to be 1: capsular contracture and 2: reoperation. The others want the skin/nipple stuff. So I'm asking them to add numbers here of other skin-involved surgeries and then we can see easily if there's a particular possiblity that we should add under "Complications". For instance, if probablility of nipple numbness were like 72% and for other surgeries numbness is only 20%, then it's obviously a notable complication. If however the probabilities are the same, then it's not notable-- nipples are important, sure, but so are lips. If someone having lip surgery has the same possibility of numbness, than I'd chalk it up to "Bad things that might happen from surgery" and should be left on the surgery page (I'm sure there's a wiki page on it). Dikke poes 20:48, 26 December 2006 (UTC)

Rupture

THe FDA website (2004 consumer booklet) states:

The IOM report20 stated that rupture rates reported in the medical literature across studies ranged from 0.3-77%. This large range of rupture rates is due to the different types and models of implant, varying durations of implantation, different types of groups of women studied, and other factors. The IOM report also stated that extracapsular gel (gel outside the fibrous capsule) was present in about 12-26% of gel-filled ruptures reported in the medical literature. The IOM estimated that less than 10% of modern silicone gel-filled breast implants would have ruptured by five years and that rupture rate would continue to increase over time.

These are relevant, since there is very little data on the newest "style" of implant

And,

Effects on Children

Also from the FDA There are two concerns associated with the effects on children:

the safety of the milk from mothers with breast implants for breast feeding children
the effects of silicones and other chemicals on children born of mothers with breast implants (second-generation effects).

It is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. There are no current methods for detecting silicone levels in breast milk. The IOM report49 said that there is convincing evidence that infants breast-fed by mothers with breast implants receive no higher silicon (not silicone) intakes from breast milk than infants breast-fed by mothers without breast implants. (Silicon is an element that is one component of the polymer silicone and is one of the most abundant elements on the earth. Everyone is exposed to silicon.)

Concerns have been also raised about the potential damaging effects on children born of mothers with implants. The IOM report said that the information is insufficient or flawed to draw definite conclusions about this issue. In other words, it is not known what effect breast implants may have on an unborn baby (fetus) and the nursing infant. Several studies since the IOM report have suggested that the risk of birth defects overall is not increased in children born after implant surgery.51,52 These studies are comforting, but, because they are small and of short duration, they cannot rule out a very small risk.Jance 21:06, 22 December 2006 (UTC)

Complications

-In response to the agreement and debate on this page, I have re-instated several complications with specific statistics. I did not include hematoma yet, although I would be glad to add it if there is agreement. Other possible additions include breast mass (3% for Mentor augmentation patients) and malposition (4% for Allergan augmentation patients).

In response to the questions -- the manufacturer specifies that these are all long-term serious complications, not short-term pain after surgery, etc. And Allergan/Inamed and Mentor are the 2 major manufacturers worldwide.

In response to Jance's comment, changes in nipple sensation are not specific to incisions around the nipple area (although nerve damage is believed to be more likely with those incisions). Also remember that the statistics given are for the best plastic surgeons that the implant companies could recruit. Presumably the complication rates would be higher for "average" and less experienced plastic surgeons.

With the help of the administrators, I assume that droliver will respect the wishes of the majority on these pages and not delete these well-documented complications.

I also want to remind folks to sign their comments on this page. Drzuckerman 19:41, 22 December 2006 (UTC)

Thanks for answering some of my questions :) Dikke poes 20:54, 26 December 2006 (UTC)

These complications are already in fact mentioned and referred to in both the context of breast surgery & specific to implants. The 4 year CORE data table figure summarizes these rates in a way that clearly speaks to this in a way that makes at length descriptions of less specific complications redundant. Droliver 19:26, 24 December 2006 (UTC)

Hello All, As I always state, I believe that all complications should be listed in order to best inform the women/men that read this page. I know that all surgeries have complications, but if I was considering a surgery, I would want to know specifics...so let's include the specifics. Happy Holidays. LynnMB 21:31, 22 December 2006 (UTC)

I know I'm adding this out of place, but a woman looking for surgery info should not rely on Wikipedia or ANY encyclopedia. 'Pedias describe and explain. It's a good START. But listing all complications is not our job. That is the surgeon's job. The surgeon MUST inform you that, before you get your wisdom teeth yanked for example, there's a 2% chance of infection. Is that important? Yes, of course. Does it belong in an encyclopedia? No, other than perhaps a sentence like, Like all surgeries, there is a possibility of etc etc etc'. The especialy notable complications specific to breast implants, though, DO belong here. Dikke poes 20:54, 26 December 2006 (UTC)

The allergan CORE data complication rates figure for augmentaion cases (the large majority of implants used worldwide) is now added which addresses the issue about people wishing to see data. This should be an acceptable proxy for the devices as a whole. Refs to several of the general complication issues are now attached adjacent to their mention. This would seem to accomplish the agenda without expanding the section to unwieldy lengths for the specific complications that need less expanding.Droliver 18:57, 24 December 2006 (UTC)

Yes, and necrosis was not mentioned in your edit, although several here (including David) thought it was significant enough to mention. There is nothing "unwieldy" about a short discussion of the complications. There is far more unnecessary detail in the generations of implants, for example, or the specfic techniques. And certainly, what you had previously with multiple charts was far more unwieldy than a couple of paragraphs, and was also redundant. Jance 01:08, 25 December 2006 (UTC)

As per your request, necrosis is incorporated in the context of reconstructive/reoperative surgery.Droliver 20:49, 25 December 2006 (UTC)

I changed back to what a consensus had been on complications. I also removed the unwieldy charts.Jance 23:05, 25 December 2006 (UTC)

Actually, you just reverted back what was an attempt to address the issue of both relevence & brevity to the complications area while incorporating some of your concerns about more serious local complications that primarily involve reconstructive surgery. The list of independent reviews of the literature is also important to communicate the continual & ongoing reevaluation of the literature of this topic & it puts in context the contention that a paucity of study has been done or that there has been much in the way of inconsistancy of the literature. If you can find such systemic reviews that have been overlooked, please bring it to attentionDroliver 16:26, 26 December 2006 (UTC)

I like how the narrative for complications is now displayed. However I am curious as to why the Inamed table is included? Why was this one chosen and not Mentor also? I even feel that the table does not add a great deal to the information. It can always be referred to via a refernce link. DrCarter12 16:46, 26 December 2006 (UTC)

Other changes

I would like others to look at the section on "Systemic Illness" and let us know if it is inaccurate, not mainstream, or any other problem that would warrant major change. I welcome other MDs opinions on this paragraph. Please tell me what, in this paragraph, is inaccurate or even misleading.Jance 02:19, 26 December 2006 (UTC)

I note that rather discuss this, as I requested, DrOliver deleted it and inserted a totally different version. He did not even discuss why he thought what was there was incorrect, or misleading (it wasn't). The "current version" is what DrOliver substituted, and it includes unwieldy tables that are redundant, and the comments are selectively chosen. Jance 18:42, 26 December 2006 (UTC)

current version reads: Droliver 16:39, 26 December 2006 (UTC)

Since the early 1990s, a number of comprehensive (systemic) reviews have been commissioned by various countries to examine the literature and science concerning links between silicone gel breast implants and systemic diseases. A consensus has emerged from these independent reviews that there is no clear evidence of a causal link between the implantation of silicone breast implants and connective tissue disease. The conclusions of these reviews are summarized:

SYSTEMIC REVIEW TABLE SUMMARY (here)

Thousands of women have still claimed that they have become ill from their implants. Complaints include neurological and rheumatological problems. Critics have pointed to the difficulty of effectively studying rare autoimmune diseases (which may take years to develop) and potential conflicts of interest with industry-funded research as reasons to be skeptical of studies finding no correlation to diseases they believe are caused by silicone or saline breast implants.

As studies have followed women with implants for a longer period of time, more information has been made available to assess some of these issues. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of classic rheumatic symptoms then control groups.^[3]

A large study of Sweedish plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery, which the authors attributed to possible differences in smoking rates. ^[6]''::Another large 2006 study with long-term follow-up of nearly 25,000 Canadian women with implants reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind.^[5]

A 2001 study on silicone gel breast implants reported an increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. ^[7]. This association has not repeated in a number of studies^[8], and the US-FDA concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants." ^[9]

''

Droliver, your systemic disease section has errors. I included Samir's paragraph and corrected your incorrect description of the Breiting and Brinton articles. Drzuckerman 16:48, 26 December 2006 (UTC)

This is the version that is current (now):

No conclusive causal relationship has been established between silicone implants and classic connective tissue diseases; however, tens of thousands of women have claimed that they became ill from their implants, and an international settlement by six implant manufacturers totalled more than $3 billion for patients who were able to prove they were harmed by their implants. Complaints include neurological and rheumatological problems, particularly associated with ruptured implants. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [46] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

A 2001 study on silicone gel breast implants reported an increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule. [47]. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population. [48] Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases", thus distinguishing between symptoms and classically defined diseases. Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. [15] According to the US FDA, "When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. Researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." [16]

Several studies have established that women who undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. A large study of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled, but the authors speculated that there could potentially be differences in smoking that were not evaluated.[49] Another large study of nearly 25,000 Canadian women with implants recently reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind. The study reported a high incidence of breast pain, and higher suicide rates in implant patients. [50]

Hopefully a compromise can be reached.Jance 18:39, 26 December 2006 (UTC)

DZ, you are attempting original research reinterpretations of this study, ignoring the authors their report & conclusions. Please describe exactly what you submit is innacurately charcterized. You seem to be merely pushing the same interpretation of this and other papers which has been argued to & not endorsed by a number of the review and safety panels.Droliver 18:22, 27 December 2006 (UTC)

Once again, Samir's suggestion, as a paragraph to discuss

We need to find a compromise between the current version and this version. Dr. Zuckerman, I agree that the opening of the systemic disease paragraph should reflect that no cause and effect relationship has been found between connective diseases and breast implants. The paragraph should, however, elaborate on the fact that there have been reports of systemic disease in women with silicone gel implants. Let's start with Dr. Zuckerman's first paragraph:

No causal relationship has been reported between silicone implants and systemic diseases, including connective tissue diseases; however, thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [1] More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms. Thoughts -- Samir धर्म 06:12, 18 December 2006 (UTC) == It is my understanding that actually 200,000 women were involved in the lawsuit so, if anything, Dr. Zuckerman's estimate was very conservative. I also believe that to specifically cite numbers represents a NPOV versus making generalizations as do Samir's suggestions for changing the first paragraph. I think the first paragraph by Dr. Zuckerman should not be altered at all.DrCarter12 19:38, 26 December 2006 (UTC)

What would you propose? My objection was what Droliver had stated, "a number of" - 200,000 plus (many more than that, since many never registered for the class action) is hardly "a number of. "A number of" implies a few. Jance 01:31, 27 December 2006 (UTC)

The paragraph on this is explicitly NPOV & goes out of it's way to try and touch on the alternative view (which in fact has little standing iin the literature). The section indeed specifically mentions that there have been claims of said association and mentions the overview arguments for distrusting previous work. The number of participants in the DOW settlement is not reflective of people with symptoms but included anyone with implants, symptomatic or not who filed for monetary claims. This unique American settlement is an example of our tort problems stateside where the issue got ahead of the science by a number of years and companies made a decision after being strong-armed via class-action suits on liability at the time. You can find any number revisitations of that. It is clear that such a settlement would not be offered in 2006 by DOW with the overwhelming subsequent research on this Droliver 18:33, 27 December 2006 (UTC)
- I think the following points need to be addressed in any systemic illness section:
  - No causal relationship exists between silicone breast implant rupture and connective tissue disease
  - Systemic reviews have been conducted to back this up
  - Thousands of women have claimed they have become ill because of breast implant ruptures and that various nonspecific neurological and rheumatologic complaints are common
- The DOW settlement should not be used as evidence of of causality between rupture and systemic disease. Also, there is no need to make a table of the systemic reviews conducted and quote the findings of each -- Samir धर्म 20:48, 27 December 2006 (UTC)

Yes, although I think it necessary to say there is no evidence of.. (instead of a categorical statement). Other than that, I agree completely. (My issue still is the rupture rate and effects of rupture, which for all these many studies, still do not study.)Jance 01:10, 28 December 2006 (UTC)

Who reverted the complications? See article for more Info on autoimmune symptoms too

Who deleted all the agreed-upon information about complications?

In addition, Droliver you have repeatedly misrepresented the Breiting et al article. If you have the article, I suggest you read it. Although funded by Dow Corning, they reported significant increases in auto-immune symptoms as well as complications. Re complications, they stated "breast pain was reported nearly three times as frequently among women with breast implants than among women with breast reduction" "and 67% of all women with implants reported moderate or severe breast hardness." (pages 220-221). Re autoimmune symptoms, they stated "Compared with general population controls, women with implants reported significant exceeses of fatigue (odds ratio, 2.6), Raynaud-like symptoms (white fingers and toes on cold exposure (odds ratio 2.4) and cognitive symptoms (impaired memory, problems with traffic orientation, difficulties in adding numbers) (odds ratio, 1.9)" (pages 221). They also reported between a "five fold and seven-fold" increase in the use of antidepressants among women with implants (page 221). They found no significant increase in autoimmune diagnosis, but symptoms can be an early sign of disease, as you know.

Describing these autoimmune symptoms is not "original research" -- its in the published article. So if you want to quote the article, it should be NPOV and accurate: no increase in diseases, but significant increases in autoimmune symptoms, use of antidepressants, and two complication (chronic breast pain and breast hardness). Samir, I am happy to try to work with you on the systemic disease section. I don't care whether we mention the law suit or not here-- I only mentioned it because it provides a specific number that seemed NPOV because it is a fact.

But meanwhile, I asked you to restore the complications that were deleted recently, but several hours passed and I figured out how to do it and restored them myself. Please note: EVERYONE agreed to these complications, but droliver removed them without trying for any consensus. Drzuckerman 00:18, 28 December 2006 (UTC) --Thousands of women have not only complained of symptoms with silicone breast implants but many of these women, who have had the implants removed, noted an improvement of said symptoms. I agree with Dr. Zuckerman that to be neutral in this article requires just stating the facts and not deriving conclusions. DrCarter12 21:38, 27 December 2006 (UTC)

I do not think the lawsuit should be mentioned. In fact, we are not sure whether all of those women were ill, or just preserving their rights in a settlement...do we? I can also testify that many more women never registered for the lawsuit but have had ruptures, become ill with autoimmune disease and filed 'late claims'. This, of course, is still occurring, since there are many many women that have implants from 15, 20 or more years ago. No research on the rupture rates and effects of migration on these women, but hey, that's not important! The only issue doctors seem to be concerned about is the widespread use that new and improved implants "enjoy". Regardless, the lawsuit should not be raised. If you want to say "hundreds of thousands", fine by me. I said "thousands" which is minimizing. Droliver said "a number" which is um...well, not the case. Jance 01:13, 28 December 2006 (UTC)

DZ, Individual symptoms do not equal disease and the study is important in that no increase in # of vague symptoms existed. That's what it finds in black & white. It is in fact more evidence to refute what you're trying to imply. You are trying to turn the results and conclusion of that study 180 degrees on it's head implying something that is not consistant with the decription of that particular study and many others. That is indeed original research on your part. In addition, the complication section was reverted to the previous version rather then the changed one. Both the numerical data and mention of the more severe complications you wished addressed were added with reference. I'm not exactly sure what you're trying to demonstrate? Droliver 00:08, 29 December 2006 (UTC)

Oliver, it might be helpful if you would stop twisting what others say. Jance 05:30, 29 December 2006 (UTC)

--droliver, everyone else agrees that the complications should be listed, except you. If you continue to delete the well-referenced, widely established information about complications, you risk having this entire article deleted because of an editing war. On the complications issue, your view is contradictory to Dr Carter, Samir, Sarah (administrator), Jance, the GW University person, the MPH person, and me. If you want others to work with you on, you need to be more reasonable and stop deleting.

As an epidemiologist, I am certainly aware of the difference between symptoms and disease, but most autoimmune diseases first show up as symptoms. If you are not aware of that fact, then read up about those diseases. You are incorrect about the Breiting article -- I quoted their findings directly, but I am happy to fax the entire article to you if you'd like. I also offer it to Samir, Dr Ruben, or anyone else.

I added the language re systemic disease that Samir had previously approved. I kept the first paragraph as Samir suggested, as a compromise and show of good faith, deleting information about symptoms. I respectfully suggest that droliver review the peer-reviewed published articles in full (not just the abstracts) to see how the government documents are specific to diseases, whereas the studies (by implant makers as well as government researchers) find significant increases in auto-immune symptoms when age and other confounding variables are controlled.

It is time to discuss the newly proposed language that several health professionals have agreed to, as well as Samir, rather than continuing to have droliver delete and replace this. We are willing to be reasonable, droliver, so I hope you'll work with us. Drzuckerman 06:00, 29 December 2006 (UTC) re

I sorry Diana, but you keep ignoring the fact that the complications you refer to are in fact already mentioned with numbers adjavent. You seek to achieve an exagerated edit of that in a way that is not reflective of the way this is seen in clinical practice. Please refer to recent vintage Plastic Surgery journals or meetings if you want to see what what in fact the true concerns with in re. to complications. It is not tissue loss or scarring with primary cases, but addressing capsular contraction & reoperation rates which is why those topics deserve expansion. Excess scarring & tissue loss discussions are really focused on breast reduction/mastopexy & reconstructive patients, which is made clear in this entry.

The systemic review introduction is clearly consistant with Samir's proposal and is now minus the table. There is no ambiguity in the world view in assessing this.

Your concerns re. Breiting study seem to be in highlighting elements of the data out of context with the study and the way AI diseases are diagnosed. Symptoms don't equal disease. The number of vague symptoms in this and many other studies predictably is consistant with control groups. That is what was demonstrated there again with better/longer follow up then most. Again, you're getting off into the orignal research reinterpretation with this on what is universally agreed to be grade A data further dismissing concerns over systemic illness.Droliver 17:11, 30 December 2006 (UTC)

Compromise?

I too would like to see a compromise struck so that this article can be in a version that everyone can live with. We need to remember that many women and their families will look to this article in guiding their decision regarding breast implants and reconstruction. I feel that the version for complications and systemic disease is well researched and cited. However, I would suggest that the location of the section on "systemic illness" follow "complications". I also disagree with droliver's assertion that DrZ is linking causality to having breast implants and systmic systems. When I read the section it just demonstates that women have complained and they also have breast implants. I have had the occasion to treat 2 women with silicone breast implants and rheumatic complaints. This dilemma is real to me and those 2 patients. DrCarter12 20:04, 29 December 2006 (UTC)

I agree with DrCarter. It is important to be extremely careful with the language of this article and to not imply support for the idea of cause and effect between silicone implants and certain illnesses where there is no scientific evidence supporting such a linkage. --Curtis Bledsoe 00:22, 31 December 2006 (UTC)

Agreed. It is easy to quickly survey the consensus on this & just as easy to describe it in brief. Wikipedia is not the place to rehear at length the failed arguments on this. That's been done systematically for the last 15 years. As Curtis points out, there is deliberate language implying and suggesting conclusions that are not supported by either the data or general international consensusDroliver 10:30, 31 December 2006 (UTC)

I will note that Curtis Bledsoe is making purely malicious edits, after having followed me here. He has already been warned on this type of conduct.Jance 00:11, 31 December 2006 (UTC)

And I will note that your allegations are completely unfounded. My edits are not "malicious" but rather they are both valid and supported by my comments. I haven't "followed" you here, despite your apparent need to believe this. And I'm curious what exactly I've been "warned on" (sic). --Curtis Bledsoe 00:20, 31 December 2006 (UTC)

We need an admin to look at the violations by this user. There are many. Although he is new, he has been warned. He is a SPEJance 00:26, 31 December 2006 (UTC)

Advisory comments by one user to another is surely the preferred method of informing a user of policies, and pointing out guidelines that they might inadvertently (remembering to Assume good faith) be at risk of breaching - such comments I agree already made to both editors. If this results in a positive change to generally accepted collaborative contributing, then no retrospective further action would seem required. However if further disruption then continues, article talk pages is not the place to seek higher level of action, instead follow dispute resolution processes and use WP:3RR or WP:AN/I to set out details of specific breaches.

That all said both Curtis Bledsoe and Jance have engaged in repeat revert warring with 9 reverts over 12 edits between 00:51 and 04:35, 31 December 2006 (no single point reverted more than twice I agree), this seems overall to be disruptive to the wiki process and thus admin opinions sought. David Ruben ^Talk 04:49, 31 December 2006 (UTC)

I would hope that others can see what he has done to NCAHF, that brought him here. I have already opened an An/I. Jance 08:27, 31 December 2006 (UTC)

David's "help" here is not of much help. I don't know what else I should have expected.Jance 09:05, 31 December 2006 (UTC)

Previous "off-line" version moved

Previously I had created subpages to act for editors to use as an "off-line" version. I don't think this has been much used as of late and Sarah recently posted to me a problem with this approach and that she has kindly moved and preserved the page under her userspace as a result:David Ruben ^Talk 04:57, 31 December 2006 (UTC)

The other night I was poking around in the mainspace and I discovered a page you started earlier in the year at Breast implant/Risks and debate. It was labelled as a sub-page and I just wanted to let you know that you can't make sub-pages of mainspace articles. There's some feature in the software that prevents it and if you try to make a subpage, it actually makes it as an article (see WP:SP). So when searching "breast implants," the page "Breast implant/Risks and debate" came up as its own article. I moved the page to my userspace, User talk:Sarah/Breast implant risks and debate, for now in case it was worth keeping but I just thought I should let you know. Sarah 08:22, 28 December 2006 (UTC)

David, there's another companion to that scratchpad still lingering as breast implant controversy that needs to be put out of its misery Droliver 10:21, 31 December 2006 (UTC)

If you want that one "put out of its misery," you'll have to take it to AFD.Sarah 16:23, 31 December 2006 (UTC)

Protection

The article seems to have descended back into edit warring. I have protected it again. Guy (Help!) 17:47, 31 December 2006 (UTC)

I think the crux of the matter here is the statement "Thousands of women still claim that they have become ill after getting their implants" in the "Systemic illness and disease" section. The problem is that is completely unsupported. The statement may well be true, but there's no citation to support it. A statement like that should contain some supporting citation. However, it is better than the previous version that read "Thousands of women still claim that they have become ill from their implants". It is important to carefully parse such statements. The old way, the implication is created that the women are claiming that the implants caused their illnesses. That requires an entirely different level of supporting documentation. We then have to talk about who these women are and what authority or expertise they have to make such a statement. It is better to say that the illnesses occurred *after* the implants and rely on whatever scientific evidence exists to provide the cause/effect linkage - or, in this case, the lack of it. --Curtis Bledsoe 18:33, 31 December 2006 (UTC)

Actually, hundreds of thousands of women, not thousands, have claimed breast implants caused their illness., SO yes, it is true. We could cite the lawsuits. We could cite that thousands of documents. Which would you prefer, Curtis?Jance 20:24, 31 December 2006 (UTC)

You can cite anything you like so long as it is relevant and verifiable. However, as to the claim that the implants caused the illness, you'll also have to provide scientific evidence to support the claim. But since there is no scientific evidence to support a causual link between implants and various illnesses, you're going to have difficulty doing that. --Curtis Bledsoe 20:39, 31 December 2006 (UTC)

Curtis does not seem to understand the comment he removed. The statement was "hundreds of thousands of women, not thousands, have claimed breast implants caused their illness."

That is a true statement. Also, it is not true to say there is no scientifice evidence to support a causal link. Even Oliver would not say that. I think you need to stop wikistalking.Jance 00:44, 1 January 2007 (UTC)

"Hundreds of thousands" is overstating it and confuses women claiming money in a class action settlement with women who actually had symptoms. The secondary gain involved has made any useful analysis impossible. I think more telling is how that issue played out singularly in the USA with our class-action lawsuit system, but that's neither here nor there.
I agree with Jance that is incorrect to say there is no evidence re possible illness. More accurate (I would submit) would be there is little evidence, and when studied rigorously there has consistantly been a lack of a pattern of symptoms or disease when compared to control groups. This has been validated over and over again world-wide. As it's impossible to prove a negative, that's about as definative as we can can declare on this. One day we may make some discovery which in fact does identify some very small subgroup of women with some genetic predisposition to AI phenomena to explain what Jance & Dr. Zuckerman believe, but no such information currently exists (and may never). Droliver 04:46, 1 January 2007 (UTC)

I actually agree with Droliver, on most of this. "No clear evidence" is more accurate. Also, for the reasons I already stated in this talk page, "hundreds of thousands" or citing the lawsuit is probably not a good claim. There may be hundreds of thousands, I don't know. We all agree that there were 'thousands.' Off topic but interesting is that both asbestos and BI litigation had claimants (or litigants) who were attempting to preserve their rights in a lawsuit before either SOL ran or the settlement, and were not necessarily ill. In both cases, some may never become ill. That was the problem with both class actions, imho. (Let's not debate the 'science' which could go on forever). The ABA has addressed the asbestos issue. The BI class action settlement will soon be ending, and I am glad of that. My hope is that more research will be done on rupture, and its effects - there is little evidence one way or the other on this. Most of the many many studies that do exist do not look at these issues. So of course we do not have clear evidence. I personally do not believe we have all the answers. And, we may never. Jance 20:15, 1 January 2007 (UTC)

So truthfully, what source gives us this "thousands of women" or "hundreds of thousands?" Yes, I saw the earlier remark on the 200,000 involved in the class-action lawsuit, but as some here have already said, there is a problem with using that number... so where else do we find them? C'mon, I'm sure that like, TIME or someone has done stories on Breast implants during the whole disease-claim rage during the 90's, and have a number from some expert here or there that we can use. I don't agree with Mr Curtis' removal of the sentence, but I've been bothered by the source for the number for a while now. Comments? Dikke poes 14:10, 3 January 2007 (UTC)

Editors guilty of continued reversions

I would like to see something said to Droliver for his reversion here, and to Curtis for his continued reversions, sarcasm and abusiveness on NCAHF. Jance 20:23, 31 December 2006 (UTC)

Do you mean the one revert by DrOliver on 29th and this sequence the previous day ? Yes Jance I would agree that following previous edit warring, page protection and advice to discuss here on talk pages, to reach consensus and only then to implement changes to the articles, yes this was not a constructive approach. That said, following your raising of concerns for this article, another admin had now protected again and this will force all editors to return to talk page discussion.

CB has had various comments posted on their talk page. NCAHF is off-topic for here, but I see you have already raised this at AN/I and action has been taken.

For what it is not worth, my personal view is that the raised concerns for BI have been previously under commented upon in this article, but equally the scientific proof to confirm the concerns seems currently lacking and both are valid notable points that should be mentioned. That places me I think on neither side, and I generally find myself seeming to agree with DrZ's various comments above. This article does not attract a lot of interest (as measured by number of different editors) and this makes reaching a widely-based consensus harder (vs just a few individuals on either side), so trying to keep cool, being super-civil is really important - an edit war looks bad for all involved parties and is nasty (to both article development and for the wikistress to the involved parties). I hope all editors are able to restart what had seemed more promising discussion and return to Image:wikistress1.png. Have a peaceful New Year David Ruben ^Talk 03:02, 1 January 2007 (UTC)

Thank you. The disruption was a result of a wikistalker. And, I might add, the latest revert was by Droliver. Jance 20:09, 1 January 2007 (UTC)

Balanced Article

The currently protected version is not a balanced article. The section on complications that was agreed to by everyone except droliver, a plastic surgeon who says clearly that he believes that implants have no worrisome risks, has been deleted by him. Instead there is a chart that needs a magnifying glass to be read, and is only based on one of the 6 major populations that were studies in prospective clinical trials. The version that droliver deleted included a range of complication rates based on those 6 major study populations.

The section on systemic diseases that I had carefully revised started with a summary paragraph proposed by Samir and agreed to by DrCarter, the GU editor, and the public health person. It was deleted, apparently by droliver. The current (protected) version includes several errors which I had previously corrected. The corrected version was supported by DrCarter and others (Dr Ruben?). But it is now not possible to restore those corrections because the article is protected.

Droliver, we all know from your writings that you believe that implants are safe. You are entitled to your own opinion, but the facts are the facts. This article should have the facts, not your opinion. When a regulatory agency or research center says that there is no conclusive evidence that implants cause specific diseases, that does not mean that there is NO evidence that implants cause ANY systemic illnesses, symptoms, or diseases, and it doesn't mean that there is conclusive evidence that implants DON'T cause disease. As the scientists repeatedly explain, the absence of proof is not the proof of absence.

Remember that the same National Academy of Sciences/Institute of Medicine that wrote one report on breast implants also wrote 3 widely publicized reports on Agent Orange and dioxin stating that there was no clear evidence that Agent Orange or dioxin caused disease -- until a few years later, when they wrote a report saying that "now there is such evidence." Interestingly, if you look at the Agent Orange article on wiki, the previous reports saying there was no association between dioxin and disease aren't even mentioned. Drzuckerman 23:27, 1 January 2007 (UTC)

Droliver made the last revert, to Curtis' version that included Curtis' edits. To be fair, Droliver has stated here that he does not agree with Curtis' edit. Of course, Droliver did not correct it in the article when he reverted to a version that he liked, which was not discussed on this talk page. Jance 00:58, 2 January 2007 (UTC)

Why has the article been reverted back to the previous version. I thought that discussion was being done to reach an editorial compromise. Instead one or some of the authors has deleted the version prior to New Year's that I, and a couple of other commentators, felt represented a NPOV (ie DrZ's version). DrCarter12 16:54, 2 January 2007 (UTC)

Editorial suggestions

Um, minor changes, really:
disease.[8][9][10][11][12] .[13] I'd move the period from between link 12 and 13
Thousands of women still claim that they have become ill after getting their implants. Complaints include neurological and rheumatological problems. Critics of silicone implant use have pointed to the difficulty of effectively studying rare autoimmune diseases (which may take years to develop) and potential conflicts of interest with industry-funded research as reasons to be skeptical of studies finding no correlation to diseases they believe are caused by silicone or saline breast implants. They point to studies which have identified increased self reported rheumatologic symptoms and others that suggested that the subjective and objective symptoms of women with implants may improve when their implants are removed [19]. I'd move the period to before the link. Generally, this paragraph version seems more speculative than previous ones we've had on this talk page. I (personally) think that if "potential conflicts of interest" and other newer add's are left, there should be more sources (as in, who makes these claims that industry studies are biased?) Sure, it's logical, but because this is an encyclopedia, I think this phrase needs more documented support...
As studies have followed women with implants for a longer period of time, more information has been made available to assess some of these issues. A 2004 Danish study, I'd remove this comma reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of classic rheumatic symptoms then THAN control groups.[20] A large study of Swedish plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery, which the authors attributed to possible differences in smoking rates. [21][22] Another large study with long-term follow-up of nearly 25,000 Canadian women with implants reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind. [23] I'd also remove the spaces between the ends of sentences and links. Plus, question: are these studies ALL implants, or just the suspected silicon gel ones?
In 2001 a study reported an increase in fibromyalgia among women with extracapsular implant rupture. [24]. Remove space and extra period This association has not been observed in a number of related studies[25] , Remove space between sentence and comma and the US-FDA hyphen? concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants." [26] Again, space between end of sentence and link. Also, I asked a question on Dr Ruben's page, but I don't think he saw it :) Are we okay to mention the FDA, or is it US-centrism as Dr Oliver believes? Though I think I'd (personally) leave it in, as the US has a lot of influence on the world (for better or worse). My two cents, and if the paragraph is otherwise kept, I hope my copyedits remain... Dikke poes 12:25, 3 January 2007 (UTC)

EDIT oops, I thought the version to comment on was the current one. Ignore my comments above. The only change I would make to the Zuckerman version is, there is a mention of "CTD" but I didn't see it explained in earlier paragraphs (maybe I missed it); so could the first mention be, CTD (connective-tissue disease) and maybe a link if this is first mention? Since a reader might not necessarily know CTD is referring to rheumatological disorders, etc. Again sorry... maybe I should strike-through my comments above... Dikke poes 13:04, 3 January 2007 (UTC)

<After an edit conflict>:Hey Dikke, thank you for your input and suggestions. You're actually a step ahead of us. :) At the moment, the article is fully protected. When articles are protected, we usually use the time to try to reach a consensus on the version to use as a starting base, then we will go through the article and address content and stylistic issues, such as those raised by yourself. The version we're selecting won't be the final "locked-in" version; it is just the base to build on. I was wondering if you think Dr Zuckerman's version [9] of the article would be a satisfactory starting base? Sarah 13:10, 3 January 2007 (UTC) No need to apologise or strike through your comments; you're just ahead of your times. :) Sarah 13:10, 3 January 2007 (UTC)

No, Sarah, my EDIT oops statement is now referring to the link up above described as "Zuckerman's version" (and it looks like the same one you just now linked to). Yeah, I know the article's protected, I just didn't read the way-above comments where it clearly has a diff to the version to be commented on... I just didn't see it and looked at the locked page instead (the struck-through part) :) So my comments in EDIT oops are indeed my view of Zuckerman's version (It looks to me like the one posted earlier where many editors seem to have liked it). I'm not a doctor or a person with really any experience with implants, and I've made no edits to the page at all ever... actually, I saw this article listed in the "Needs copyediting" wiki page, but when I got here it had a different tag, so came directly to the talk page. :)

But also, I heard this is a 4-day vote, but I think we should wait for input from Mr Curtis and Dr Oliver, since they're often on the other side of the debate. I mean, (geez, how do I say this without looking like an asshole?) many of the editors who've voted haven't edited anything except the BI talk page. I'm not saying they're not real editors or anything, just that in my very personal opinion, their votes maybe should be looked at differently than Dr Zuckerman's, Jance's, or Oliver's. Maybe even mine, since I haven't edited anything medical before. But in any case, with my note on the mention of CTD, I'll add my vote to the top. Cheers, Dikke poes 14:26, 3 January 2007 (UTC)

Dikke, I believe the term you're looking for in re. to the "unusual" pattern of participation is meat puppet[10]
Dr. Zuckerman's proposal is not an accurate reflection of how you would discuss this and extends a generalized discussion on general complications of any breast surgery into a segment now many pargraphs long. As has been pointed out, every complication is already mentioned (with some FDA data on augmentation patients attached) with expansion of the areas that are truly unique to implants so I'm not sure what the agenda is. Is it to represent how this is discussed on an everyday basis, or is it to reflect an exagerated emphasis on somewhat uncommon complications?
The version that exists is both a concise and accurate representation of this as would be discussed in either a professional meeting or when going over issues with patients preoperatively. There are many,many sources of series of long-term follow ups of breast implant patients discussing complication and the common denominators are capsule issues and reoperations. One of the article referenced (" Decision and Management Algorithms to Address Patient and Food and Drug Administration Concerns Regarding Breast Augmentation and Implants." Plastic & Reconstructive Surgery. 114(5):1252-1257, October 2004)

specifically address the concerns re. complications the FDA asked of surgeons and industry during the pre market approval period. Droliver 14:46, 3 January 2007 (UTC)

To answer Dikke's question, the stats include saline implants too. Although I share his concern that the article not be too US-centric, the FDA data are based on studies done by the two largest implant companies in the world (and they sell all over the world). The FDA is one of the few countries that required safety studies be done (the EU does not require clinical trials for medical implants) and the only one to make the data public and require it to be available for patients. So, it's a good source of info.

I don't know what a meatpuppet is, but I assume it is not a compliment. However, I think health experts who have been commented on the implant page should be taken seriously, whether or not they spend much time on other pages. Many of us who are editors started on one page and then moved to others. I've now edited about 6-8 articles, and would like to do more but this one is so time-consuming it's difficult to get involved in others. For the time I have spent on this one, I could have published a few additional articles in medical journals, and that has a big advantage: nobody can delete my work just because they disagree. I'm sure that most doctors and public health folks feel the same way about wikipedia, and if we want their input on wiki we shouldn't make it so difficult for them to participate.

And, to respond briefly to droliver, I have already said that your table is too small to read, and apparently (altho I can't see it) too specific to one company and to one study population. Why have one microscopic table on complications when there are so many less important details in this article? Here's an idea: let's put the detailed technical information on incisions etc (which is really for doctors only) in a microscopic size table instead, and keep the info of more general interest in a font size that people can read. 72.75.6.148 16:00, 3 January 2007 (UTC)

I am PERSONALLY insulted by the term "meatpuppet!!" To make an assumption based on the mere fact that someone performed a search to see where else I have chosen to comment on Wik articles and discussions is not constructive. Could it ever have been supposed that I have a major interest in this topic. Or that I personally feel strongly about this topic. Or that maybe I felt that too few medical professionals have represented the patients' concerns and confusion regarding this topic. I am a pretty busy person with doing a day job during the week, working in urgent care on weekends, and attending school during evenings ( I am getting a master's degree). Therefore, I am unable to write voluminous articles on Wik as many of you are. But when I have an opinion, I wish to present it without being challenged on my reputation and motives. Thank you. PS. I have written a short section on asthma if you were curious about what other subject matter I find interesting. DrCarter12 17:12, 3 January 2007 (UTC)

Dr. Carter, I am sorry about this disparagement. Wikipedia is like anything else, I guess...it takes all kinds. The term "meatpuppet" should not be directed at new users, but at people who are deliberately disruptive -- which you are not. No one editor owns Wikipedia, and we were all new at some point.Jance 17:58, 3 January 2007 (UTC)

Oh man, I knew I'd sound stupid. Just like in real life :) I apologise to anyone who thought I was calling anyone a meat or whatever puppet. I am at fault since I mentioned the numbers, and I really should listen more to that little voice that says "This will make you sound like an asshole." I regularly click on people's names out of curiosity, to see where their interests are etc (and I note that my own record makes me look like I actually own a TV :). Maybe I worried that this was some kind of vote using raw numbers, but Sarah has corrected me on this. Again, to Dr Carter and anyone else I've insulted, I'm really sorry. Dikke poes 14:57, 6 January 2007 (UTC)

Can someone add a link to http://www.newimage.com/cosmetic-plastic-surgery/breast/augmentation-overview.aspx ? The page is very relevant as an external link to this page because it gives a great overivew of the precedure, facts, and myths. Including risks. Regards, (Srikarna 14:41, 14 August 2007 (UTC))

links to commercial portals like that are best avoided. Droliver 01:25, 15 August 2007 (UTC)

Moving forward

I've archived everything up until the straw poll. If we need any of those comments, we can restore them later. For now, I want to resolve this issue, so we can move forward and start editing.

There are some new rules on this page and I'm very serious about enforcing them. I don't want anyone making personal comments about other editors, speculating about their motives or making accusations. I don't want any such comments here on this talk page, I don't want them on my talk page (or anyone else's) and I don't want to be emailed with a run-down of information on other editors and their backgrounds and alleged motives. This kind of behaviour is entirely inappropriate and I'm starting to see it as an attempt to paralyse this article in certain forms. Well, that's just not going to work anymore. We are going to decide on a version of the article to start editing and then we are going to start editing it. We aren't aiming for a promotional brochure for patients or an article biased in the other direction. What we are aiming for is a balanced and honest article. I hope you all will stick around and help build that, but if it doesn't interest you, please feel free to bow out. This article is currently ranked at number 3 in "Breast implant" g-searches and so I think that is reason enough to ensure this article is an unbiased, honest article.

Like Dikke,I am not a doctor (or a scientist or an academic).I can follow this material, but others with both medical and non-medical backgrounds have said that they find these arguments and rants tedious and they give up on trying to help. I don't want that to happen anymore. I don't care about people's educational and career backgrounds. I don't care if people are high school students, doctors, campaigners or forum leaders or whatever. All I care about is writing a decent, accurate and balanced article. Please, when you can, try to be concise on this talk page because needlessly engaging in long academic rants is academically exclusive and not what Wiki is about. Sarah 18:12, 3 January 2007 (UTC)

It was protected in the wrong version after an edit war between Jance and someone who hadn't edited here before. For the record, I would like to know which version of the article editors support as the base to move forward from here. If there is consensus, I will change it. Please sign under your preferred heading. Sarah 17:20, 2 January 2007 (UTC)

Thank you, Sarah. I promise to comply.Jance 22:10, 3 January 2007 (UTC)

Expression of opinions seems to be progressing smoothly and civily. In particular a larger number of opinions being expressed than we have previously seen discussing this article. I hope this helps both with current option being considered and then for the furture taking the article forward (eg the sourcing number of women who have complained below).

Given the previous prolonged dispute over this article, I think it is important to obtain as large a number of editor opinions as possible before an admin closes and enacts decission - the current page protection "tranquility" is conducive to encouraging other editors to this discussion. I have put an open invitation to participate at Wikipedia_talk:WikiProject Clinical medicine#Breast implants (so that those with a general interest in medical topics may be encourged to help participate here) and would suggest that discussion be left open for a few more days yet.

I've tried to stay neutral in previous dicussions, so I'ld rather see additional editor opinions posted than perhaps add my own posting and thus exclude myself from helping Sarah conclude this discussion or then help enact the consensus/page protection :-) David Ruben ^Talk 03:19, 6 January 2007 (UTC)

Oh, David, I'm sorry. I didn't see your message here until just now. I've already restored the Dr Zuckerman version...I'm leaving the page protected, though, so if anyone wants to comment in the next few days, I consider the poll still open and we can just revert it again. But I would like to try to move forward soon. I am not happy seeing the article paralysed or either side of this dispute being beneficiaries of an unfortunate edit war. I am hoping that if both sides are willing to give an inch we will end up on common ground with an article that might not be what they consider their ideal article but something both find acceptable. Thanks for mentioning on CLINMED. The poll is not closed; if anyone would like to particpate they are most welcome. Sarah 11:43, 6 January 2007 (UTC)

(moved my comments here after re-reading what Sarah said): Since the early 1990s, a number of systemic reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. Does "systemic reviews" mean a way of reviewing the data, or reviews of "systemic illness-reports"?

Thousands of women still claim that they have become ill from their implants. Can we add Dr Carter's source here? Complaints include neurological and rheumatological problems. Peer-reviewed studies suggest that subjective and objective symptoms of many women with implants improve when their implants are removed. [18] Space between fullstop and link remove

As studies have followed women with implants for a longer period of time, more data are available... I know data can be both plural and singular, but don't we normally say "data is"? Just wondering, I wouldn't change it unless someone agreed. "Data are" sounds rare/older style to me though.
...but were "significantly more likely" to report "fatigue", "Raynaud-like symptoms... even though there's a brief expl, I wouldn't mind a link to Raynaud's just out of interest.

Note, I just looked back at an old history, and I like Dr Oliver's chart, it's a quick and easy skim (if it were readable). Charts are supposed to show "redundant" info, info that's already in paragraph from somewhere else. If Dr Oliver could make this a .png instead of a .jpg (apparently you can resize .png's because they're vectored?), could it go back into the article (I dunno the correctness of the numbers, and it's only one manufacturer, but I thought it's nice to have a list of probability of complications and which type somewhere in the article). Dikke poes 15:02, 6 January 2007 (UTC)

The chart to which you refer is very long, and biased. The summaries are cherry-picked, without information about the whole summaries included in the reports and studies. The consensus (twice) was to delete it. Jance 22:37, 6 January 2007 (UTC)

And the correct grammar is "data are". "Datum" is the singular.Jance 01:37, 7 January 2007 (UTC)

Straw poll

The last version by User:71.8.78.88 [11]

In no way does that version reflect a truly accurate discussion. There has yet to be a case made that the current verion hasn't already addressed the complications accurately and attempts at original research reimaginations of the literature in particular are innacurate & not representativeDroliver 14:53, 3 January 2007 (UTC)

I think you posted in the wrong section, Oliver. And again, Dr Zuckerman's version is both accurate and representative - as a woman, I surely would want to know this information!Jance 15:59, 3 January 2007 (UTC)

The last version by Dr Zuckerman on December 28 [12]

Yes, please. This seems to be the most neutral, yet informative posting for women. LynnMB 21:34, 2 January 2007 (UTC)
I vote for this version, because I believe that it provides the most neutral point of view. GUHealth 21:50, 2 January 2007 (UTC)
I vote that Wik keeps this version too. DrCarter12 22:04, 2 January 2007 (UTC)
I also think this is the more accurate and neutral version.Jance 23:44, 2 January 2007 (UTC)
This is a nice surprise. Of course, I also support my last version as the one to be protected, so that we can work together toward compromise. Thanks to Sarah for asking for this straw poll. Drzuckerman 01:23, 3 January 2007 (UTC)
As a plastic surgeon who specializes in removal of implants, and not wishing to get into another ridiculous debate, I would strongly support Dr Zuckermans' version which seems to be the most balanced. Dr Melmed —Preceding unsigned comment added by 68.95.131.197 (talk) 04:24, 3 January 2007
My comments below (starting with "EDIT oops") withstanding, I do find the Zuckerman version an acceptable base. Dikke poes 14:27, 3 January 2007 (UTC)
I just read the current article and also think it's one-sided. The Zuckerman version appears much more balanced and accurate. OBOS Editor 21:02, 3 January 2007 (UTC)
I also find this version much more fair. Owen 19:12, 6 January 2007 (UTC)

A different version (please specify)

The last version by Nakamomita [13]

I had made adjustments to the structure of the article which I would like to see implemented (which was reverted because I didn't see I needed to get a straw vote before making changes. I apologize for that). I think that "Procedure" and "Recovery" should be part of the article. In addition, "Incision type", "Type of Implants", and "Implant Pocket Placement" are variables that should be listed under "Procedures". The current structure lists "Incision Type" and "Implant Pocket Placement" under "Systemic illness and disease" which is very odd. I would like to make those changes without affecting other parts of the article--hopefully avoiding any controversy while improving the structure. Thank you. Nakomomita 07:25, 27 February 2007 (UTC)

Content issues

Please add to this list and we can start trying to resolve them.

What is the source for thousands of women?

I suspect that the existing editors thought it was common knowledge (the actual number is probably higher than 'thousands'). I am sure someone can find a source, however, and it is reasonable to ask. Jance 22:10, 3 January 2007 (UTC)

Jance, this item may be helpful in answering your question. I also provided my source for the information. Between Jan. 1, 1985, and Sept. 17, 1996, FDA received 103,343 adverse reaction reports associated with silicone breast implants and 23,454 reports involving the saline implants. Because these figures come from all databases, there may be a few duplicate reports. The reports included risks clearly associated with the devices, as well as adverse effects attributed to the implants, but not proved to be linked to them. Therefore it was reasonable to generalize the figure to "tens of thousands." Source: A Status Report on Breast Implant Safety, by the US FDA: http://www.fda.gov/fdac/features/995_implants.html Thanks. DrCarter12 21:05, 4 January 2007 (UTC)

Thank you, DrCarter. This should be a good resource. Jance 22:33, 4 January 2007 (UTC)

Awesome++, Dr Carter. This is exactly what we needed! Dikke poes 14:35, 6 January 2007 (UTC)

Thanks Dr Carter - good catch for the reference and I agree with the conclusion of the likely number of events reported. However your markup above needs tweaking, in as much that the last sentance in bold is not in that article, but instead was your sensible comment on the quote (it should be in plain text and after the sourcing information) :-) With the article currently protected, I'll await further comment before transfering over the full citation template markup:

Segal M (March 1997). "A Status Report on Breast Implant Safety". FDA. Retrieved 2007-01-07.

Although stating the obvious, I am fine with it.Jance 01:35, 7 January 2007 (UTC)

Straw poll

I've restored Dr Zuckerman's last edit as a result of the above straw poll. I just want to say something about the poll and how I have viewed it. There have been allegations made here on the talk page of meatpuppetry, and privately concerns of sockpuppetry were raised with me. I never saw this as a vote and anyone running sockpuppets has wasted their time. I considered the polled in terms of an AFD and looked at actual comments and credibility, rather than pure numbers. I won't point out specific accounts that I discounted, but there were some who I completely ignored. If someone had made a cogent argument against either version, that would have held far more weight than people who just signed their names. Also, this is not an endorsement of the Dr Zuckerman version. This is just a starting base. Now it's time to move forward with editing and I encourage people to start nominating under the "Content issues" section above issues they have with the actual content, including information that may need to be added, merged, removed, edited, verified etc. Sarah 11:31, 6 January 2007 (UTC)

Addit: The straw poll is still open. If people wish to comment in general or in support of a particular version, they are most welcome. Sarah 11:47, 6 January 2007 (UTC)

Small Revisions to the systemic disease section

1. In response to Dikke's suggestion, I agree that we need to explain CTD (connective tissue disease) when it is first used in the systemic disease section. A good way to do this is to insert in the previous paragraph on fibromyalgia that the study found a significant increase in "fibromyalgia and several other autoimmune and connective tissue diseases (CTDs)" That is an accurate statement and kills 2 birds with one stone by explaining the overlap between CTDs and autoimmune diseases, which is good since both terms have been used in the article.

2. And, in response to Dr Carter's suggestion, and Dikke's concurrence, I would support Sarah inserting the article that Dr Carter cited as a reference for "Tens of thousands of women" claim that they have become ill from their implants." The source is: A Status Report on Breast Implant Safety, by the US FDA: http://www.fda.gov/fdac/features/995_implants.html

3. It looks like Sarah fixed most of the typos that Dikke suggested, and his major substantive change in this section. Thanks to Sarah and everyone for working together on this. Drzuckerman 20:23, 7 January 2007 (UTC)

Hi, I voted earlier but I should probably introduce myself. I am one of the editors of Our Bodies Ourselves, a book on women's health issues that has been translated into 19 languages and is currently in its 8th printing. Breast implants is one of the topics in our book. I agree with Dr Zuckerman's comments above for the systemic disease section:

1. I agree that it should be added that "fibroymyalgia and several other autoimmune and connective tissue diseases (CTDs)"
2. Changing "Thousands of women still claim..." to "Tens of thousands of women claim that they have become ill from their implants" and then use the citation that Dr Carter gave above. (A Status Report on Breast Implant Safety, by the US FDA: http://www.fda.gov/fdac/features/995_implants.html)
OBOS Editor 16:17, 11 January 2007 (UTC)

This article needs pictures.

systemic disease section

The references to recent studies were worded to accurately reflect the conclusions of those studies, in particular the Danish long-term follow up studies [PMID 14676691] & [PMID 15220596] which clearly concluded the opposite of what was impliedDroliver 04:21, 11 February 2007 (UTC)

Huh? Can you rephrase that? Dikke poes 18:25, 11 February 2007 (UTC)

It seems what Dr Oliver wants to do is make sure the Wikipedia article correctly cites the conclusions of the papers in question. It would be wrong to take the paper's data and draw conclusions from it that the paper itself does not draw. That would be tantamount to original research and prohibited by Wikipedia policy.

May I suggest that the references are actually cited with their full academic references rather than just by PubMed URL. This makes it easier to see who the authors are, when it was published, and in which journal. JFW | T@lk 21:55, 11 February 2007 (UTC)

JFD, the oft cited pair of articles & their Medline synopsis are linked up to their PMID's to review what the papers actually conclude. There is little ambiguity I'd submit as compared to what was being suggested prior:

"Self-reported musculoskeletal symptoms among Danish women with cosmetic breast implant." Kjoller K, et al Ann Plast Surg. 2004 Jan;52(1):1-7 [PMID 14676691]

"Long-term health status of Danish women with silicone breast implants." Breiting VB, et al Plast Reconstr Surg. 2004 Jul;114(1):217-26 [PMID 15220596]

Droliver 00:01, 13 February 2007 (UTC)

I did not write that particular section, but I did read the studies. The section was correct as written, and the article was not misquoted or misrepresented. A number of editors have read the article and agreed with the way it was described. The full academic reference is important to cite. Droliver has continuously claimed misrepresentation and it is getting old. And Dikke poes, I urge you to read the article, and then ask if it is incorrectly represented. I disagree wtih the assessment that Oliver wants to make sure the articles are correctly cited. I have found way to many instances of "mistakes" to accept that. Jance 07:08, 13 February 2007 (UTC)

Jance, sure, I'll give it a look (give me a few days, I hope to have it done by weekend). BTW, you removed a pic of a three table-sitting silicone implants because they were in the saline section (in History I can see they were originally called saline implants, which may be why the pic was there). Can you re-add that, but put it under the into for silicone? (Or even top paragraph of article.) No, I don't mean the other one you deleted :) That one was ew. Dikke poes 06:50, 14 February 2007 (UTC)

Dikke, would you mind? I will, but am rushing right now. Am swamped. But it's fine with me. The other one is back, and shouldn't be. I have to run now....Jance 21:40, 15 February 2007 (UTC)

I'm not a doctor and not a medical expert. But I would like to give my impressions. The second paragraph begins with, "Thousands of women still claim that they have become ill from their implants."

This sentence is presenting a POV. It is implying, "Although the reviews found nothing wrong, these women still say that implants are causing disease." I think the word "still" should be removed as it implies that "even though they are wrong", they still say so. Fanra 21:37, 9 June 2007 (UTC)

The fourth paragraph, that begins, "Several studies have established that women who undergo breast augmentation..." seems poorly written and misleading. It says the women are richer and healthier and then adds that it was true both before and after surgery. Strange as it may seem, simply changing the word "undergo" with "elect to undergo" might help make it clearer, at least to me. This removes the implication that the surgery itself has some effect.

Next the last line in that paragraph should be removed or rewritten. First you say that the women are not the same as the general population in the first sentence, and then you compare them in the last sentence to the general population. Therefore, the Canadian study, while it might have some value, must be clearly prefaced with the statement that since it doesn't compare equivalent populations, that it is (at least it seems to me) really pretty useless. If it isn't useless, then someone needs to explain how comparing two different groups is valid. Perhaps there are some things in the study that make it valid that are not explained, they need to be explained if so. Fanra 22:01, 9 June 2007 (UTC)

I'm not sure I understand your point re "equivalent populations" as the equivalency here is the sex of the study group and the differentiator between groups is the presence or abscence of implants. The Canadian study, it's relevence, and it's conclusions are pretty self-explanatory. Droliver 20:43, 10 June 2007 (UTC)

I thought that I was clear but I guess I wasn't. First sentence says that women who elect to get breast implants are "healthier and more affluent than the general population". Then the Canadian study compares that group to the general population and says that they have less cancer. So did the Canadian study compare women of the same age, income, general health, weight, genetic risks and other factors or was it just women with implants vs. all other women? Studies can show you any results you want them to, so unless you carefully match as many of the possible risk factors, the study is meaningless. Fanra 13:25, 11 June 2007 (UTC)

The first sentence describes general demogaphic characteristics which have been observed over a number of papers. The Canadian paper uses a large age-matched peer group from their national health system and doesn't use weight, income, etc... as data points (nor would you expect it to). You can follow the PMID link if you wish to learn more about it. "Meaningless" is a little flip in re. to such a large, long-term outcome study that is one of the benchmark papers for these patients. It's very important data along with the swedish/scandanavian papersDroliver 15:23, 11 June 2007 (UTC)

In the past, I've found that I've been unable to follow PMID links to the actual text of studies as the web site didn't provide any, however this time I was to do so. Examining the study, I see it was an examination of 24,558 women with breast implants and 15,893 women who underwent other plastic surgery. It concluded that "Overall mortality was lower among women who received breast implants relative to the general population" and "higher suicide rates were observed in both the implant...and other plastic surgery...patients" The most important part was this, "No differences in mortality were found between the implant and other surgeries group for any of the 20 causes of death examined."

Therefore, the study results do not say anything about breast implants, per se, rather it says something about women who undergo plastic surgery. The study appears to have been cherry picked and the line placed in this article to imply that women who get breast implants will get less cancer. Secondly, even if it is true that these women have gotten less cancer, the study actually doesn't say that, it says less women have DIED from cancer, not that less have contracted it, a subtle but important difference. Thirdly, the study itself says, "Self-selection is a likely explanation for lower mortality rates because women who choose to undergo an invasive cosmetic procedure are likely to be, on average, in better health than those in the general population."

All in all, I find it shocking that such careless and misleading information is in an article that has been reviewed by several doctors, people who are supposed to be exact and scientific. Fanra 18:00, 11 June 2007 (UTC)

Fanra, while I think it's more a distinction without a difference for this, I changed the label of cancer rates to cancer-related mortality in the main entry. I'd agree that this study says nothing about breast implants, it say's what they are not. It is the largest epidemiologic "snapshot" of this group of patients we have to date and is notable for information on oncologic risk and suicide rates that had been a source of controversy in years prior. What is says about breast implants per se is that there appears to be no propensity for cancer clusters (as proxied by cancer death rates)in recipients and that when you compare apples-to-apples (plastic surgery patients) for suicide rates, the causal relationship does not materialize. Droliver 19:09, 13 June 2007 (UTC)
You are avoiding the real issues. What does the study show? It shows that mortality of breast implant patients is the same as other plastic surgery patients, therefore "proving" that breast implants do not cause more mortality. Anything beyond that is cherry picking and not supported by the study. The way the results of the study were placed in this article, they were placed in a way that implies that breast implants will lead to less cancer. ~~You can play all the games you want to but that is what was done.~~ Remove the study or put in that the study only proves that breast implants do not increase mortality. Any attempts to use this study to "prove" that women with breast implants will get less cancer than women who don't (the other plastic surgery group) is wrong and misleading.

"distinction without a difference for this,", ~~really please~~. I didn't go into it because I thought it was obvious but if you can't ~~(or refuse)~~ to see it I will. Women with breast implants are far more likely to get breast exams and mammograms than the general population. Therefore, of course they have fewer breast cancer deaths. It is a fact that early detection leads to better survival rates. Also note that since women who get plastic surgery are healthier and wealthier than the general population, their cancer survival rate is also higher. Cancer survival rates do relate to wealth and general health. ~~So please try to overlook your desire to prove that implants are the greatest thing since sliced bread and~~ lets put in what the study really proves, which is that breast implants do not increase mortality. Since they don't reduce cancer deaths (at least that's what the study shows), let's not imply they do, ok? What does the study prove? The study itself says, "Findings suggest that breast implants do not directly increase mortality in women.", anything else you cherry pick from it is wrong and POV.

As for suicide rates, please note that I did not ask for this article to include that breast implant women have a higher suicide rate than the general population. Had I been interested in promoting a POV, I would have but since I was only trying to have this article be truthful about what the study says, I didn't. Even though the study reported higher suicide rates than the general population, the study also cautioned that further work is needed to evaluate risk factors. Be aware that I could add to the article, "Women who received breast implants have been shown in four separate studies to have a 130% higher suicide rate than the general population." and I would be factually correct. The study itself noted, this very study you say is such a great study, shows a 73% higher suicide rate than the general population.

Please be aware that you are promoting a double standard here. First you say that cancer should be compared to the general population, rather than the plastic surgery group, then you turn around and say suicide should not be compared to the general population but to the plastic surgery group. Again, I could play games and add in the suicide rate but since suicide is dependent on so many factors (like cancer deaths are) that would be cherry picking and using a study that is designed for one purpose (to determine if implants cause more deaths) for another (like to show they get less cancer). Fanra 10:59, 14 June 2007 (UTC)

I put a strikethrough on some lines that I should not have written. Please disregard them. Sorry. Fanra 20:31, 14 June 2007 (UTC)

Fanra, I think you are somewhat unfamiliar with the context of this literature and the history of claims made in the media and class-action lawsuits a generation ago. It was claimed for years in lawsuits that breast implants caused cancer and it's taken a number of these large population studies to refute that notion. (There is till this vague "collective memory" among patients about this whole issue that I constantly have to go over with them when considering these operations). That disconnect about cancer risk is what is demonstrated by such stark differences in breast (and other) cancer rates in these studies, and it is not suggested per se that breast implants are protective against cancer. Again, this study we're discussing is more about what implants are not. For oncologic purposes, the general population of aged matched women would be the standard blunt control group for which to compare against. The dozen or so other variables you suggest are not collected in large-scale databases that are commonly used for such case-control retrospective population studies. For suicide, where you try to account for markers of psychopathology we know exist, the cohort of other cosmetic surgery patients is clearly the appropriate one as touched in the discussion of related papers on the subject.Droliver 22:00, 18 June 2007 (UTC)

I understand what you are saying here. I have no problem if you wish to insert, "The study showed the same levels of cancer mortality between the implant and the control group." or any other way you might wish to show that implants do not cause cancer. But again, you have to compare the implant and the control group to each other, not the implant group to the general population, since the study was not designed to examine that issue. And while it might be a small point, it is necessary to only state mortality, since the study did not get any figures whatsoever on contracting cancer, only deaths.

I feel it would be a good thing to dispel the myth of implants causing cancer and I support your efforts on this issue. However, we have to stick with the facts and not imply that implants reduce cancer. How you present the facts is just as important as the facts themselves. You might have noticed that I changed it to say, "Findings suggest that breast implants do not directly increase mortality in women." which is exactly what the study writers wrote. If you feel we need to more directly deal with the myth of implants causing cancer, we can add the line I suggested above or any other line you wish, as long as it reflects the entire study and not just grabbing some figures out of context. Thank you. Fanra 03:03, 20 June 2007 (UTC)

Balance needs to be restored

I had taken a few weeks off this page and was sorry to see that the language that Samir and numerous other administrators and health experts had agreed to had been changed. The article is noticeably less balanced as a result.

Most notably, in the systemic disease section, even the Danish studies paid for by Dow Corning concluded that there were significant increases in auto-immune SYMPTOMS for women with implants. There were no significant increases in diseases, however. Both symptoms and diseases are important issues and that information should not have been deleted. Several editors and administrators had agreed to that compromise language. So, I restored it and will ask the administrators for help. It should not be changed again until we hear from the many editors who have read the research literature on this.

The section on the benefits of augmentation surgery had also been edited in a way that was not reflective of the most recent studies. If one reads Dr David Sarwer's research (which is widely quoted by plastic surgeons) one sees his greater concern and data supporting an increase in body dysmorphic disorder among patients, rather than other problems such low self-esteem that were emphasized in this article. So, I added that information, as well as his study showing that the benefits are quite specific to the breasts, and not to improvements in general self-confidence or self-esteem.

The longest-term studies on self-esteem etc, which are 3-4-year studies, clearly show a no improvement on most mental health and quality of life measures, and Inamed even reported a decreased confidence on a well-established self-concept scale. So, obviously this article should reflect those better designed studies. There can be no accusation of bias against implants in these findings, since the companies include the information in their patient booklets (see "Important Information for Women About Breast Augmentation with Inamed Silicone Gel-Filled Implants." Available at http://www.fda.gov/cdrh/pdf2/P020056d.pdf ) Drzuckerman 16:21, 15 February 2007 (UTC)

I have been away from the site for a while. Many unfortunate changes have ensued. For example, the new picture at the start of the article, what scientific purpose does it serve? Secondly, the article now appears to be less evidence based (with scholarly references) and less neutral. I too thought, along with Dr. Zuckerman, that we were not going to make such generalized deletions. I was under the impression that we agreed to let the editors do their job in a step wise, consensus provoking matter. DrCarter12 19:16, 15 February 2007 (UTC)

I'm an editor for the women's health reference book, "Our Bodies, Ourselves" (often called the "bible" of women's health), and my organization has been following breast implant research studies and findings for years. I agree that Dr. Zuckerman’s explanations of systemic diseases and benefits are more neutral and balanced than the previous version. OBOS Editor 16:19, 21 February 2007 (UTC)

- Please point to any major health organization in the world suggesting associations of silicone implants to systemic disease. There aren't any. Four of the standard textbooks in Plastic Surgery published 2006 editions, each of which summarized this issue similarly. The positions of every health ministry in the world are similar and easy to demonstrate. Likewise every large study published in the literature has demonstrated similar findings. If we're to have an accurate portrayal of this topic it starts and ends with what we actually know about this. There have been position papers in 2006 from Canada, the US-FDA, and the UK/E.U reaffirming the same view as well. Still maintaining that accuracy/neutrality is lacking flies in the face of this broad consensus. Droliver 03:25, 22 February 2007 (UTC)

- I remind Droliver and other editors that changes must be voted on in this discusion page. You can't just change things because you disagree. Dr Carter and several other editors have agreed with the revisons I had made, and also have pointed out that there are other major sources of medical information that are considered less biased than plastic surgery textbooks. I just talked to an editor of JAMA about this, and he agreed that studies that include women with implants (of any type) for "at least one day" or "at least one month" are not appropriately designed to determine safety. Drzuckerman

I think you misunderstand the process Diane. Accuracy, particularly in medicine/science entry isn't something "voted" upon, particularly by a number of anonymous single-issue editors. You can make your contrarian arguments, but at the end of the day an encylopedia is not an advocate, but rather a reflection. There is not one health ministry, professional organization, or medical textbook supporting the implications you keep pushing about this topic. It's beyond ridiculous of you to suggest that every current plastic surgery textbook is biased de novo when that is the logical starting point for review of any subject. Droliver 21:17, 24 February 2007 (UTC)

Single Studies are not conclusive

Dr Oliver has pointed out that if one study shows a significant relationship between breast implants and health problems, such as the Brown study of rupture and fibromyalgia, that doesn't prove that implants cause problems. Similarly, it is not appropriate to quote single studies suggesting various cures for capsular contracture when there is no general agreement on prevention or treatment because there are no conclusive studies. I deleted a few of the most egregious examples that had been inserted without consensus on this page. I seek comments about some of the other ones in the capsular contracture section. Do these articles represent any kind of scientific consensus? And if so, why aren't all plastic surgeons following their advice? Drzuckerman 04:57, 24 February 2007 (UTC)

I'm curious re. your issue with the capsular contracture section. It is reflective of many of the techniques and ideas re. both pathophysiology and treatment that we commonly discuss in our literature and professional meetings. As someone who actually treats this, I can tell you that your off base with your implication re. the relevence
In point of fact re. the Brown study you mention suggested a protective effect from intracapsular rupture and when the study is grouped appropriately, no difference is found. Brown suggested an implausible conclusion based on their own data & this is pointed out in a number of articles that subsequently look at this issue. At least half a dozen large series have also not substantiated the Brown findings and the FDA implant homepage specifically mentions it as not being corroborated as well.Droliver 21:17, 24 February 2007 (UTC)

Single studies may not be worthwhile including, but that depends on the individual merits of that study. On pulmonary embolism I've just included the one study that investigated thrombolysis in haemodynamically unstable pulmonary embolism, even though it included only 8 patients and has not been replicated (PMID 10608028). That is because that study is widely regarded as the evidence base for a life-saving treatment. Conversely, if particular studies on capsular contracture are small/non-replicated but are heavily cited, regarded as important and reliable by the field etc then there should be no grounds to delete it from the article. JFW | T@lk 10:21, 25 February 2007 (UTC)

Question...

I know it doesnt relate much to the article, I will try my best to make sure it does. I dont know where else to ask! Can short/petite women get breast implants? I am short and I was wondering if it will be possible for me to get the size of implants I want. I'm around 5'0 tall, an inch or two shorter. Maybe this could possibly be added to the article? If not, I guess I just wanted to know since I dont know where else to ask. --67.185.26.89 08:19, 25 February 2007 (UTC)

Why would that be a problem? This should only really be added to the article if there is a documented record of shorter women having problems finding a suitable surgeon/implant. JFW | T@lk 10:21, 25 February 2007 (UTC)

Curbside consult here: There's a school of thought re. implant sizing that the base-width of your breast (plus analyzing soft tissue coverage)is the proper way to size implants. This tends to use smaller implants then many patients think they would want but clearly looks like it can reduce reoperations, mostly due to not putting as heavy an implant in. This was particularly true with bigger saline implants (which are heavier per volume unit then silicone) which "bottom out" with regularity. Bigger implants will also end up being wider which can leave a bulging breast lateral to your chest wall which is not very aesthetic. Smaller implants will serve you better with longer lasting results which is what I think should be the endpoint. I touched on this a year ago in my blog if you're interested [14]

Droliver 19:14, 25 February 2007 (UTC)

Ok, because I had heard from SEVERAL people (not surgeons or anything) that because small people have smaller bodies and less room, they cant get big implants. --67.185.26.89 21:47, 27 February 2007 (UTC)

Again, respecting your existing anatomy is important to minimizing uneccessary reoperations. Large implants do not hold up well over time.Droliver 23:30, 1 March 2007 (UTC)

I'm curious. Dr Oliver, is this a very common question from patients/interested people? Do you think body-size should be mentioned in the article? Dikke poes 15:16, 28 February 2007 (UTC)

no, I don't think body-size is really something that is of much importance to an overview entry. We discuss things like that a great deal during in professional discussions, but it's a little too much "inside baseball" for thisDroliver 23:30, 1 March 2007 (UTC)

This is not the place for medical advice

This is NOT the place for plastic surgery advice to potential patients, either in the article or in the discussion section

Drzuckerman

1)I definitely agree that this is not the place to give people personal advice regarding surgical options. 2)I know that there is no causal evidence that links silicone breast implants with collagen vascular disease. But how do we explain how patients generally feel better after having their implants removed? I think there are a lot of questions still needing to be answered Dr. Oliver before you can just write this occurrence off as not having any possible association. DrCarter12 16:09, 26 February 2007 (UTC)

Dr Zuckerman: this is in reference to a general enquiry. Obviously specific advice was not given; Dr Oliver was explaining what his professional approach would be to smaller people. Are you enraged that he is doing that? Who says this anonymous user is a "potential patient"? It is correct that Wikipedia is not for personal medical advice, and people soliciting this should be referred to their own physicians.

DrCarter12: obviously, if someone attributes being ill to having breast implants then removing these will have a substantial placebo effect. The problem is that neither "feeling ill" nor recovering from this is measurable objectively like urea & creatinine are in renal failure. If the Institute of Medicine in a 560 page report cannot give this answer, it would be ludicrous to expect an individual plastic surgeon to provide this. By the way, I see that most of your work on Wikipedia is on this very talkpage. Have you got any other clinical interests? JFW | T@lk 18:19, 26 February 2007 (UTC)

I did write some material on exercise induced asthma- but it was edited out because someone felt that the information was covered under another heading. I have not had the opportunity to read the article again to see where I may contribute. DrCarter12 17:24, 28 February 2007 (UTC)

I am a communications professional who has worked with health and women’s issues, and I have been following this discussion for a while now. This is my first time weighing in. It’s clear that Dr. Oliver is a plastic surgeon with a positive POV about breast implants. He seems to delete a lot of things from the entry -- even solid scientific research -- that would make a reader think hard or even twice about the advisability of the procedure as a cosmetic enhancement. Now, a random question has been entered by a potential breast-implant recipient who basically asks, because of her small size, whether or not she could get the procedure, and if so, whether it could be done with bigger rather than smaller implants. Dr. Oliver skips over the first question and answers the second in a very reassuring way, with the subtext being, “Yes, get implants.” I don’t know if his response could be considered a “curbside consult,” since it basically encourages the woman to pursue her desire without any caution about potential risks, which responsible doctors do. But “curbside consult” or not, his answer is inherently biased, so it has no place in this discussion, which, anyway, is about the breast implants ENTRY. In the future, such random questions should be ignored or, at the very most, the questioner directed to a physician who could review her medical history. WrdFox 00:18, 27 February 2007 (UTC) WrdFox

What a strange way to interpret the question & my response to it. While the discussion page of wikipedia is not a way I'd encourage getting personalized medical advice, a generalized mention of the single most effective way to avoid complications from elective breast augmentation (if you choose to have it) is pretty much a non-issue. My POV with this sticks to what is mainstream and broadly agreed upon international treatment of this topicDroliver 23:38, 1 March 2007 (UTC)

Ok. You have it ALL wrong. First off, I realize my question was a little off-topic, but where else was I supposed to ask it? I figured if someone felt they could answer it and help me, great, if not, they could simply ignore it. I also thought people wouldnt make such a big deal over it and just delete it after I got help. Not fuss over it!

I was also thinking that if small people could not get large implants, this would be a reasonable add to the article. Why not TELL small people that bigger implants wont last longer for them? I STILL, as of right now, DONT have an answer as to whether or not small people CAN, or can NOT, get large implants. And if they can NOT, I personally think this should be put in the article. I wasnt creating any controversy over this. Or at least I didnt mean to. I thought people would, you know, answer if they wanted to or ignore it, not create an argument about the one person who answered, regardless of whether or not it was a helpful answer--which it wasnt, really...but oh well. And oh yeah, I forgot--I was NOT asking for medical advice! Advice is a recommendation. I was asking if something was POSSIBLE, not 'should I do this'. I'm getting implants whether the world likes it or not, but I was ASKING if it is POSSIBLE to go up to the size I want--a C or D cup. Not SHOULD I, CAN I. There IS a difference. I'm not trying to sound rude, please believe me, I just dont want you all thinking I came to cause trouble. =)--67.185.26.89 06:26, 10 March 2007 (UTC)

Your question was more like, can grandma dye her hair hot pink? Well, technically, sure. But it doesn't look very good :) Dikke poes 10:42, 29 April 2007 (UTC)

This is the place for straw polls BEFORE changes to the article

And, the 2 administrators, Dr Ruben and Sarah , both warned that no changes should be made to the article without a straw poll. DrOliver, you should not be changing the article when your changes are specifically opposed by other editors (see above).

Lastly, does anyone think the intro to this article should say that using breast implants to enlarge the breasts is called "breast enlargement"? One would think that is obvious, therefore it was deleted. Why was it put back in?

I added "breast enlargement" several days ago. Unlike merely descriptive terms like "making the breast larger" or "breast enhancement", the phrase "breast enlargement" is terminology that is often times used instead of "breast augmentation". Likewise, it would also be considered "obvious" then to say that breast implants used to augment the breast is called "breast augmentation". I think it should be put back in. Nakomomita 07:12, 27 February 2007 (UTC)

I just noticed that the talk page already shows what I mean. On this talk page, Ty580 has a post "Stem cell breast enlargement treatment." Nakomomita 07:30, 27 February 2007 (UTC)

I agree that the treatment of capsular contracture is relevant, but we should not be adding information that is not fully supported by research. I agree with JFW that there are situations where a small clnical trial is very important. However, the capsular contracture articles that had been cited were "studies" of one or a few doctors' experiences -- they were not clinical trials. The gold standard treatment for capsular contracture is still removal of the capsule.

In our previous discussion, Droliver has said that the Brown et al study (paid for by the FDA and conducted by researchers at FDA and several medical schools) is just a single study (which happens to show that women with extracapsular silicone leakage are significantly more likely to have several autoimmune diseases)and therefore not worthy of inclusion. The Brown study is a peer-reviewed study that is unique because it is independent (no financial ties to implant makers or plastic surgeons), included women with implants for a very long period of time, and measured extracapsular silicone leakage with MRIs that were read by several experts. There are no other studies of autoimmune diseases that have those methodological strengths.Drzuckerman 19:41, 25 February 2007 (UTC)

If the Brown study has not been replicated by other investigators then it may not be notable individually. If no other work has been done at all (which would surprise me), then the Brown study could be presented as a puzzle. If its design is unique from all other trials then its results may not be generalisable and a larger trial along the same lines may be required to settle the issue.

I disagree that Dr Oliver is not allowed to make edits at all, even if they are slightly controversial. The straw poll was quite specific in its conclusion, and not all his edits have been in contradiction to this conclusion. JFW | T@lk 18:23, 26 February 2007 (UTC)

JFW, The Brown study was/is notable but has indeed not been duplicated in a number of much larger related studies. When you actually look at that study, what you see is both an usual way of grouping patients (intact/intracapsular rupture vs extracapsular, rather then 3 groups) that exagerated rates of fibromyalgia and the implausible suggestion that women with intracapsular rupture had fibromyalgia rates substantially lower (8.0%) than women with intact implants (14.8%). These irregularities have been discussed in several subsequent papers and commented upon by the FDA in it's consumer handbook. A 2004 review of the literature of the papers up to that point by Lipworth,et al [PMID 15156983] comments on a number of these which I can email to you if you like. Additionally an updated long term Danish study that is most comprehensive in follow up going to print this month confirms findings reported in 2001 re lack of correlation to [PMID 17321754]Droliver 00:30, 2 March 2007 (UTC)

JFK, who determines how controversial a potential edit is? What is non-controversial to one side could be totally beyond belief for the other. The bottom line is, this entry has been so contentious that it had to be locked. Obviously, both sides are ultra-sensitive about the biases of the other side. That’s why, to maintain a level of stability in this entry (so that is can serve in some capacity as a reference for the general public), ground rules are important. If one of the ground rules is to submit potential changes to a straw poll, then it should be followed to the letter. WrdFox 00:21, 27 February 2007 (UTC) WrdFox

WrdFox, with due respect, I'm a bit hesitant to enter into a long discussion with a new editor who has immediately come to this page to choose sides. Have you been asked by anyone to do this? JFW | T@lk 07:15, 2 March 2007 (UTC)

What I see is, when everyone did the poll, Dr Oliver didn't say anything. He clearly disagreed with the result, though. So far, nothing on the talk page has been study-specific. Maybe that's what we need. Dr Wolff seems to be the only one really getting into what the studies actually say. That seems to be Dr oliver's contentious point. So we need to show 1)whether there are more implant/rheumatoid linkage studies besides Brown, and what were the results 2)what exactly Brown and the other 2 studies (reff'd further up the talk page here) actually say in their conclusions.

I'd promised jance I'd take a look myself, but work started to really steal time (computer time). I still hope to try.

And do we really need a "straw poll" before every edit? I'd rather the facts of the aformentioned studies get sorted out here before more edits that touch on them, but hey, I did a bunch of edits a while back and didn't straw any polls.

Also, I don't see Oliver saying small women shouldn't get huge new boobs as "medical advice." It's not like it's on the Wikipedia article page anyway. Dikke poes 15:28, 28 February 2007 (UTC)

Dikke, I and Dr Z have made references to various studies on the talk page.DrCarter12 17:26, 28 February 2007 (UTC)

Dikke, for the people with casual experience with this topic who are trying to make sense of this I would suggest asking several things.

1 - What have the major international reviews of silicone implants concluded?
2 - What do contemporary medical & plastic surgery texts say about breast implants?
3 - How are these devices treated by different countries' health ministries?
4 - What topics and issues are being discussed in professional meetings?

The answers to the first three are pretty easy to demonstrate in print & having sat all morning in one of the major surgery symposiums today on this, I can tell you the answer to the last agrees with the others. Breast implants have been called by US-FDA officials as the most scrutinized medical device in history and there is a large body of work to point to. A number of sequential expert panels have periodically reviewed this literature en bloc and have repeatedly failed to confirm some of the implications that continue to be highlighted here by several editors. Repeating such a "science trial" in the talk page of Wikipedia is beyond the scope of what's practical, which is again why I refer people to the mainstream of medical/scientific/governemental positions. Droliver 00:09, 2 March 2007 (UTC)

We cannot deny that the allegation has been made. My solution for the whole problem is:

List the initial reports that led to the banning of silicon implants.
List the IOM/other reports that have unnerved these allegations.
List which organisations are nevertheless of the opinion that there is a problem. If these views are not backed by organisations, they probably fall below the notability horizon. JFW | T@lk 07:15, 2 March 2007 (UTC)

Stem cell breast enlargement treatment

"Stem cell technique helps women grow their own implants", the Daily Mail, 12th February 2007. --Ty580 15:48, 26 February 2007 (UTC)

This isn't really ready for prime time yet & premature to include in an encyclopedic entry IMODroliver 01:56, 2 March 2007 (UTC)

Standards for wikipedia

My entries directly quote from the peer-reviewed literature as well as government regulatory agencies. I have repeatedly balanced the article with all sides of the controversy. In contrast, droliver's revisions only focus on the most "pro-implant" statements, which generally point to the lack of conclusive evidence for specific systemic diseases. However, the same people and agencies that droliver likes to use as experts ALSO clearly state that there are high complication rates and problems associated with breast implants.

The versions of this article that I have supported tell both sides of the story. The versions that droliver prefers are one-sided POV of plastic surgeons. Numerous other editors, including physicians, an editor of an international health reference book, and others have agreed with me, disagreed with droliver, but he just ignores them.

I am directly quoting many of the same references that droliver uses, but if I use quotes that he disagrees with, he deletes them. The issue is not who we are quoting, but whether we include both sides of the controversy. I'd be glad to show exactly what I mean if JFW or dikke are interested. Drzuckerman 16:33, 3 March 2007 (UTC)

Straw Poll for Changes

As requested by Administrators, we will once again do a straw poll.

Systemic Diseases

We already did one on the section on systemic diseases, and droliver's version was rejected just a few weeks ago, and again about a week ago. So, neither droliver nor JGWolff should be reverting to that version, unless they can muster enough votes from regular editors to this article to support such a change. Drzuckerman 05:34, 6 March 2007 (UTC)

Patient Characteristics

droliver's version of the "Patient Characteristics" section is not accurate. For example, Dr. David Sarwer is cited in a 2003 article, but his more recent articles specify that women undergoing breast augmentation are similar to other women in terms of self-esteem, depression, etc. There is no evidence that they are more likely to kill themselves before they had surgery.

There is only one study showing women choosing augmentation were more likely to have a psychiatric history. That was in a country where women could get free augmentation surgery if they had a medical history showing they needed augmentation for psychiatric reasons. So -- surprise!! -- the women got the psychiatric history they needed to get free augmentation.

There is a growing body of literature indicating that when objective pre/post measures are used, breast augmentation does not improve self-esteem or quality of life, even in the short-term. I have cited those articles and can cite more if anyone thinks that is necessary. Meanwhile, I welcome your votes on this issue. Drzuckerman MRIs

droliver's statement about MRIs not being required in other countries is misleading. He cites a 2005 article. However, the implant manufacturers did not specify the need for MRIs until 2006. That is now in the implant companies' official labels. Votes welcome on whether a 2006 decision by the implant companies to warn women that they need MRIs trumps an older summary article. Drzuckerman

You cannot possibly revert on the basis of a new straw poll that nobody has yet voted in, as you have done today! The previous straw poll was a while ago and cannot inform your recent actions. You are simply asking for an RFC.

My advice, Drzuckerman, consists of the following. Please disagree with it as you wish, but I've dealt with these situations before.

Stop reverting. If you don't like particular content, remove it in individual edits given ample reasons. Just stating that Droliver makes "POV edits" is not a valid reason; every edit needs to be challenged individually.
Start discussing. If you want other editors to support you in your quest to make this article WP:NPOV and WP:ATT, please make it your habit to precede every planned major edit with a post on the talkpage. It may actually be wise to wait for other editors to support you (or disagree with you).
Accept that other editors will have an alternative viewpoint from you, and that you need their support if you ever want this article to reflect all views.

Let me make this clear: your serial reverting is not the way forward. JFW | T@lk 21:06, 6 March 2007 (UTC)

Dr. Zuckerman, as you know there is a well & often cited establish body of literature in re. to issues about patient charcteristics and the like. You seem to be trying to reinvent this in a way not consistent with how this is treated by mainstream reference sources. We have data (of varying quality) which has been fairly consistant in characterizing cosmetic surgery patients (as a cohort) as having higher psychopathologic rates as well as a number of surveys on patients specific to breast surgery. I'm not sure what exactly you're trying to achieve with your edits?Droliver 17:41, 7 March 2007 (UTC)

Getting back to the point above, Dr Zuckerman is asking for a straw poll vote, which is what the administrators requested. So in respects to that, I do think that her version is more accurate. OBOS Editor 20:53, 8 March 2007 (UTC)

Also, I believe that Dr Oliver's section on systemic diseases is biased--note that he deleted direct quotations indicating statistically significant increases in autoimmune symptoms even from the EXACT SAME authors he cited. In other words, if an article showed an increase in symptoms but not in diagnosis, he cites the part about diagnosis but NOT the part about the significant increase in symptoms. Since symptoms often precede diagnoses, this is biased. There isn't a reason to delete this (that is, unless you want to make it sound like implants are safer than they are). 71.124.137.236 21:01, 8 March 2007 (UTC) --(Whoops, that was me)OBOS Editor 21:03, 8 March 2007 (UTC)

Which administrator asked for a straw poll? I am an administrator, and I think Drzuckerman should follow my advice above. There are no "good and bad versions". There are versions that need work. JFW | T@lk 23:27, 8 March 2007 (UTC)

Why is the section biased? Would you say the Institute of Medicine is biased? The whole reason they were asked to comment is because they are not biased. JFW | T@lk 23:28, 8 March 2007 (UTC)

And what on earth are "autoimmune symptoms"? JFW | T@lk 23:31, 8 March 2007 (UTC)

When you speak of administrators requesting or "demanding", as some people have said, a straw poll, if you are refering to me, you are mistaken. I have not requested any straw polls other than the one I conducted myself and I have no opinion regarding the straw poll currently being requested. I also want to note that I endorse Dr Wolff's comment that serial reverting is not acceptable and it needs to stop immediately. I support discussion of edits and examination of the literature but I certainly do not support edit warring from either side or the use of straw polls to retard development of this article. Sarah 09:59, 10 March 2007 (UTC)

JFD,I agree. The whole notion that some international conspiracy exists that has co-opted the body of literature ans surgery journals, the medical textbook industry, multiple independent systemic review panels, and the health ministries of every industrialized nation on earth relating to this is ridiculous. The argument supporting links to illness at this time is a distinct "counter-culture" movement & is worthy of mention, but clearly in the context of how widely embraced it is. I think the current descriptor in the article is fair
OBOS,the several dozen subjective symptoms that fall under the grab-bag of rheumatologic indicators are not diseases in and of themselves. What we've seen over and over again is the distinct lack of any identifiable pattern or increased frequency re. these symptoms which is what the long-term Scandanavian studies again reported. This conclusion is echoed in each and every major review of this topic. To suggest that these papers and the related literature in fact support what you're implying is wholesale reinterpretation of those papers as well as misunderstanding rheumatology diagnosis and disease.Droliver 01:43, 9 March 2007 (UTC)

DrCarter speaks

I voiced this opinion before about the picture of breasts that had undergone augmetation in the front of the article. I am still wondering what purpose it serves other than the obvious. However, I don't believe that the picture adds to the discussion. There is a concern that women who are going for any plastic surgery may have psychiatric issues before undergoing the procedure. PMID 16777929

I vote for the serial MRIs. Whether there is evidence that links silicone breast implant leakage to CTDs. The seepage of silicone into the body does cause local inflammation and pain. It is also dificult to remove from tissue once the leak has occurred. This leakage is not clinically detectable so can go on for years until symptoms encourage diagnostic studies. Possibly with performing regular MRIs we can diagnose this potential problem early.DrCarter12 16:34, 6 March 2007 (UTC)

Is that supported by evidence, guidelines? JFW | T@lk 21:06, 6 March 2007 (UTC)

JFW, routine serial MRI's have been endorsed by no one except the USFDA. Health Canada specifically mentioned they felt it was not evidence based medicine just one month prior to American approval, a reflection of the unique American political history with these devices. Standard recomendations for the rest of the world would be along the lines of screening on a clinical exam basis and doing ultrasound prior to MRI if rupture is suspectedDroliver 02:27, 7 March 2007 (UTC)

Misunderstandings

I am very concerned by some apparent misunderstandings and misrepresentations of what I and other administrators have said.

"And, the 2 administrators, Dr Ruben and Sarah, both warned that no changes should be made to the article without a straw poll."

I have never said that no changes should be made without a straw poll. That is certainly not my position, it never has been and while I do not wish to speak for Dr Ruben, I do not believe it has ever been his position either. As I said at the time of the straw poll, I was looking for a version to use as a starting base to move forward with editing in order to stop the edit warring that was occurring between the two versions of the article. I thought I was quite clear that I did not intend the article to become locked down in that version, it was not an endorsement of that version and I certainly did not intend for that straw poll to lead to an ongoing editing process that involved straw polls for any and every change. That is not the way Wikipedia works and I believe that it is a violation of policy and Jimbo's foundation principles which mandate open editing. The straw poll was a once-off process to try to avert the edit warring. If other people wish to propose other straw polls, that is fine, but straw polls are not to be used as a strategy to prevent an editor, or a group of editors, from making edits.

I am not sure why there is some sort of suggestion that Dr Oliver is not welcome to edit or not welcome to edit controversially. I am not aware of any grounds for imposing editing restrictions on Dr Oliver and anyone who wants to impose such restrictions needs to either propose community sanctions at the noticeboard or they need to request the arbitration committee impose editing restrictions. The only things I have asked Dr Oliver to do is to respect Dr Zuckerman's request that he not refer to her by her first name and that he refrain from injecting invective into discussion. I certainly do not and have never supported editing restrictions on Dr Oliver or any other editors here. I believe his input is valuable, as is the input of editors on the opposing side, and that the most well-rounded article probably lies somewhere in the middle of both points of view.

I am currently on a wiki-break but I was very concerned that my opinions and statements are being mistakenly misrepresented. Reverting on the basis that a straw poll is needed before changes are made to the article is not acceptable. Please do not do this. Thanks, Sarah 09:47, 10 March 2007 (UTC)

Hi, I'm on a bit of a wikibreak currently, but would largely agree with Sarah. Certainly I would hope that any past comments of mine are not taken to mean that a straw poll has to be undertaken before any editing takes place (clearly silly at the level of spelling corrections). Editors are free to edit the article as they see fit - it is nolonger protected. Admins carry no real special weight in content disputes (vs perhaps how editors behave in such content disputes) other than perhaps a level of experience over a number of topics (and other disputes) that the various parties might choose to listen too (or not). All editors are free to edit this article, if an editor is thought problematic then raise a WP:RFC to discuss the perceived problems to try and reach understanding (or at least an appreciation of views). However the previous edit warring was most unpleasant and care needs be taken by everyone to try and prevent a return to mutiple sequential edits or revert-warring. So, no straw polls absolutely required, but it would seem sensible for editors to voluntarily try to discuss proposed major changes or altering tone/POV/NPOV or at least agreeing how to disagree, before rekindling the flames :-) That said there is no requirement in content discussion for straw polls, Wikipedia is not a democracy (one can be bold) likewise it is not a bureaucracy, but nor is it an anarchy :-) David Ruben ^Talk 20:31, 12 March 2007 (UTC)

Changes for accuracy

I'm truly sorry that I misunderstood the previous statements made asking for a straw poll. Nevertheless, several editors have agreed with my concerns about droliver's and jwolff's revisions, and more important, it is not appropriate for anyone to keep reverting to inaccurate information.

The revisions made by Jwolff and droliver regarding the mental health benefits of implants are inaccurate. The data clearly show that for all plastic surgery, including breast augmentation, the benefits are specific to the body part that has been changed, but not to mental health or self esteem. In fact, the most recent studies indicate that women and men with body dysmorphic disorder, many of whom undergo cosmetic surgery, do not benefit at all. Those well documented facts should not be deleted.

Similarly, there was general agreement about the risk information, and the only disagreements came from droliver, and perhaps jwolff. They are entitled to their opinions, and the current version includes much of their content, but let's make sure the article is accurate and balanced. Drzuckerman 02:50, 11 March 2007 (UTC)

I'd submit that you are somewhat incorrect with your characterization of the research on psychosocial aspects cosmetic surgery. There are a great many papers pertaining to this, many of which have been referred to as index papers for nearly 3 decades. The tools and methods used have gotten more refined, but it doesn't really overturn a great deal of information that existed previously. Your associate colleague (Dr. David Sarwer) at the University of Pennsylvania Medical School reported only 5 years ago that their study [PMID 1178684] and that of Rankin [PMID 9811016] provide growing evidence to suggest that cosmetic surgery leads to improvements in at least 3 areas of psychological functioning: body image, quality of life and depressive symptoms. There are similar papers still going to print even more recently [PMID 16181718] and a host of related outcomes data from other plastic surgery procedures generally report similar findings. I think this is summarized fairly accurately as the paragraph concludes mentioning that some of the improvements that have been reported may in fact be transitory (at least as reflected in the USFDA implant adjuct studies). Droliver 19:19, 11 March 2007 (UTC)

Dr Oliver, I think the last paper there (PMID 16181718) hurts the case. Only 25 patients, all having cosmetic surgery, given questionaires, the last being only 4 months after the surgeries. I personally would prefer a battery of psychologocal tests a year or two after surg, with like 1000 people or so :) And you've got something wrong with the Sarwer number, it leads to mice inhaling benzine or something evil like that. The Rankin one is better. Dikke poes 15:47, 20 March 2007 (UTC)

Sorry for the PMID error, the correct one for Dr. Sarwer's article is [PMID 11786842] (which you isn't summarized for you on pubmed). The French article with 'only' 25 patients was mentioned only to illustrate the fact there continue to be similar reports to what's been reported for nearly 50 years re. psychological aspects of breast augmentation procedures. I can point you to this continuem of papers if you're interested, but it's really beating a dead horse. There's also a whole other line of research on psychologic endpoints re. breast reconstruction & reduction patients which tend to imply many of these same outcomes. Again, my takehome point is that there is a long track record of attributing positive attributes, some of which may have been overstated. I think that's communicated in the entryDroliver 02:02, 22 March 2007 (UTC)

Let's discuss compromises and avoid a edit war

JFW, I'd like to talk to you about the edits you want, and hope we can compromise. Let's discuss one at a time. For example, there is a large new literature on the association between cosmetic surgery and body dysmorphic disorder, so why do you want to delete it?

Similarly, did you want to add that women getting breast augmentation are more likely to be married with children? You listed the Brinton study, but I believe that was based on marital status an average of 12 years AFTER surgery, not at the time of surgery. If I'm wrong, and there is good data to support that addition, it's fine with me. Drzuckerman 03:21, 11 March 2007 (UTC)

You left this posting only 16 minutes before reverting again to your preferred version, insisting you had a mandate from a straw poll several weeks ago! I am not endorsing either version, but neither do I support large reversions on insufficient basis. In fact, I aim to facilitate here rather than actually choose sides. I state from the outset that while I'm probably not 100% neutral, I am one of the few remaining administrators who is committed to taking this article forward.

I was one of the editors who was supportive of inclusion of material on BDD. I support the addition of 2-3 references to large, well-constructed studies. I do not want a proliferation of 50 references on something that is rare in absolute terms.

I did not list the Brinton study, and with no access to the fulltext I cannot comment on the marital status issue. However, if the authors draw a conclusion but you disagree with that on methodological grounds, you should be writing to Plast Reconstr Surg rather than bring out this point here. This should remain strictly objective, rather than trying to characterise the recipients of breast implants (1) as nutcases, (2) as vulnerable people preyed on by a cynical industry. JFW | T@lk 08:05, 11 March 2007 (UTC)

If breast implants are succesful in getting their recipients married over a 12-year timeframe, that can surely be presented as a favourable consequence :-)? JFW | T@lk 08:07, 11 March 2007 (UTC)

A more then passing tangent on BDD is not really specific to an entry on breast implants and is really lumped in with all other psychopathology (depression, etc..)when this has been addressed in the breast implant literature. It's more appropriately included in an entry on cosmetic plastic surgery (as a whole)where it's been estimated to exist in 10-15% of all comers. I think the take-home point re. this is well-characterized in the existing entry. Droliver 19:35, 11 March 2007 (UTC)

Wow Jfdwolf, I hope that comment about breast implants increasing the likelihood of women marrying was just a touch of sarcasm and not your interpretation of the Brinton article. I have also recently read the article. It is difficult to draw any temporal conclusions because there is no association between when women had their implants and when they were married. I don't think Dr. Zuckerman has a problem with the article but with your interpretation of the results. I find your comments off the mark as well. Also you must keep in mind that the comparison group was other plastic surgery recipients (not having breast implants) and the actual numbers of those married or common law were 62.7% with breast implants and 56.1% with other plastic surgery. The adjusted odds raito was even 1.00 not making it any different than chance. I believe that Dr. Z presents a more thoughtful discussion of the literature. I hope that a compromise can be reached that is not representative of one view over another. DrCarter12 00:03, 12 March 2007 (UTC)

- I thought the smiley was sufficient indication that my comment was whimsical. JFW | T@lk 15:32, 12 March 2007 (UTC)

Thanks Dr Carter, you are right about the Brinton article. It is an excellent article, but misquoted on this wiki article until I changed it. JFW, to respond to your earlier comment about the Institute of Medicine report: it was written in 1999, and only a few epidemiological studies were published at that time. Dozens have been published since, and most are longer-term and better designed than the studies quoted by IOM. However, I have quoted them on complications, and droliver has repeatedly deleted that.

Also, JFW, if you did not read the article on marital status, then why did you revert to a version that recently added that quote about their marital status?

I repeat my interest in a compromise article, discussing one revision at a time. It sounds like we have dealt with the marital status issue above, so here's a simple one.

Doesn't it seem silly to start the article with a statement that enlarging the breast is called breast enlargement? First of all, it seems silly because it is obvious. Second because the more common terms are breast augmentation and breast enhancement. I have heard from women all over the world with implants, and they all call it ba or breast augmentation.

WordFox's comments seem helpful and I don't understand why JFW dismissed them. New editors should be welcomed, let's not insult them. And, I also agree with Dikke's comments that we should go back to discussing the specific publications that support various points of view. Droliver likes to quote the "international literature" but in fact he is quoting government political/regulatory reports, not scientific or medical ones. The standards are different. In the EU, devices are approved without clinical trials and taken off the market later if conclusively shown to cause serious harm. That does not mean that they are proven safe. If we are discussing science and medicine, let's stick with peer-reviewed research findings. And discuss each revision, one by one before making it.

Any comments on the "breast enlargement" issue I raised above or any more on the marital status issue? Drzuckerman 14:04, 12 March 2007 (UTC)

I reverted because this is not a "battle of versions". I have stated that I do not aim to endorse either viewpoint at this stage but to stop the revert warring. You have been encouraged to make piecemeal changes after they have been adequately discussed and consensus has been reached.

The marital status issue will not be resolved unless you can achieve consensus. I have stated that I cannot comment either way without the fulltext. You seem to have DrCarter12 on your side, so let's see what Droliver thinks of this, and OBOS if she is around.

I do not support the removal of "breast enlargement" as a synonym. We use plenty of obvious synonyms, and this term is very popular here in the UK.

You did the same thing today - just revert because the present "version" is not satisfactory to you. This is not acceptable, and has in the past led to people being blocked from Wikipedia. Any further reverts along the same lines will be met with a request for comments. JFW | T@lk 15:32, 12 March 2007 (UTC)

I'd also submit breast enlargement is fairly commonly used synonym as well for breast augmentation/implantation surgery
There are a number of sources re. social & health characteristic of patients with implants, some of which specifically address the changes observed with current patients as compared to patient's having the surgery 20-30 years prior. I've never seen one that doesn't mention the marriage rate as being higher presently when it's been indexed, although I think this is a fairly marginal aspect of this entry to begin with. Droliver 17:28, 13 March 2007 (UTC)

•Dr Z mentioned getting a "compromise article" produced. She posed a couple of options that neither Jfdwolff or Droliver want to alter their position on. Perhaps one of you should suggest a place in the article where a consensus can be reached.DrCarter12 03:21, 15 March 2007 (UTC) Even though it sounds redundant, I don't see reason to take "enlargement" out. I find it more specific than "augmentation" which only means change (breast reduction is also augmentation). "Enhancement" sounds POV to me because it means to make something Better-- but if it's in medical liturature then I wouldn't argue against it, but of course again enhancement doesn't always mean enlargement. For that Punky Brewster chick, her enhancement was a reduction.
Re marriage, sounds kinda trivial. Linking the two would be difficult. Perhaps women who seek implants are more traditional-minded and are more likely to marry than co-habitate? I don't see how you could find a cause-and-effect with this one, and if the numbers are trivial, I wouldn't even add it. Dikke poes 15:37, 20 March 2007 (UTC)

Compromises: #1 augment

Let me clarify what I meant about the first sentence of this article. It currently says:

A breast implant is a prosthesis used to enlarge the size of a woman's breasts(known as breast augmentation or breast enlargement).

Even though the dictionary definition of augment is to "make larger" I think the problem with the sentence is that it says that enlarging the size of a woman's breasts is known as breast enlargement. That is redundant. Breast augmentation means the same thing but at least it uses a different word.

I agree with Dikke Poes that breast reduction could be enhancement. And I also agree with Dikke Poes that enhancement certainly implies improvement, so augmentation or enlargement is a more NPOV term. The first sentence could instead say: A breast implant is a prosthesis used to increase the size of a woman's breasts (known as breast augmentation or breast enlargement).

Is there any opposition? I will wait a few days for feedback before revising it, to make sure that JFW does not object.

I also agree about the marriage issue -- I will defer to Dr Carter, who mentioned that the study did not find a significant increase in married status. Drzuckerman

Agree with version containing all synonyms. Most breast enlargements are with the use of implants. JFW | T@lk 07:06, 26 March 2007 (UTC)

Compromises # 2: Symptoms can increase even if diagnoses haven't

As several of us previously stated, the 2004 Danish study by Brieting et al specified statistically significant increases in several important autoimmune symptoms, including the unusual symptoms of Raynaud's disease. It is important to distingush between symptoms and diagnosis, because much longer term studies are needed to determine diagnoses. Symptoms can change significantly first. So that change has been made. Drzuckerman

Could you please wait until we're done discussing this?

Inserting the phrase "More research is needed" is editorialising and fails WP:NPOV.

Why are the reviews quoted "government" reviews, rather than "independent systemic (comprehensive)"? You haven't explained.

There's no such thing as "autoimmune symptoms". There are symptoms, and there's autoimmune disease. Hepatitis B and osteoarthritis are not autoimmune, yet both can cause joint pains. JFW | T@lk 07:06, 26 March 2007 (UTC)

I agree completely with JFW. Aside from this particular study there are an avalanche of other large studies & reviews concluding the same thing (ie. no increase in AI disease). Reinterpreting the conclusion of these to imply otherwise is inconsistant with current widespread international consensus and wikipedia's no original research recomendations. Editorializing "More research is needed" and muddying the water over how AI diseases are in fact diagnosed is clearly too much innuendo. The positions of international medical,scientific, and regulatory organizations are VERY clear where they come down on this and are what should ostensibly be represented in an encyclopedic view of this.Droliver 02:33, 27 March 2007 (UTC)

Why does DrOliver not feel that a fuller description of symptomology is valid when referring to the Danish Study? Though their diagnosis of autoimmune disorders were not more prevalent, associated symptoms as Dr. Z mentioned were. I believe that is an important thing to include in the article.DrCarter12 16:22, 28 March 2007 (UTC)
- What you propose is in fact an end-run reinterpretation of the conclusions of this paper by tossing out an out of context part of the data. In the larger picture, the idea you're pushing is not currently accepted by any federal or medical organization in the worldDroliver 01:47, 29 March 2007 (UTC)

"Associated symptoms" is a very vague term that is best avoided. As I stated, every so-called "autoimmune symptom" has a long differential diagnosis. As stated, joint pains may be due to a large number of non-autoimmune conditions (I'll add Lyme disease, tuberculosis and infectious endocarditis for good measure).

DrCarter12, could you please start using edit summaries when editing? Your edit today may have its merits, but you should summarise what you've done, preferably without making personal attacks at other editors (as often happens in edit wars). JFW | T@lk 18:01, 28 March 2007 (UTC)

Sorry about that- will do.DrCarter12 03:06, 29 March 2007 (UTC)

I've corrected the description of the 2004 Danish study. It is important to say that there were significant increases in symptoms of Raynauds disease, as well as fatigue, memory loss, and other autoimmune diseases, even though there was no increase in diagnoses of diseases. As we all know, symptoms tend to be noticed years before these diseases are diagnosed. Dr. Oliver’s edits make this section NPOV. OBOS Editor 19:27, 28 March 2007 (UTC)

You have a misunderstanding of this paper and how population-based studies on rheumatology are performed and interpreted. You're trying to infer something (a relationship to disease) that is in fact not demonstrated in this paper or any of the other major popultaion study papers or comprehensive reviews. I would again point you to any number of 3rd party sources of authority which have uniformly rejected this. Droliver 01:47, 29 March 2007 (UTC)

--The OBOS editor is correct. I am an epidemiologist and I concur completely. Our Bodies Ourselves (OBOS) is a internationally cited book on women's health, translated into many languages. The OBOS editor is quoting a study funded by implant manufacturers that droliver also cited. She didn't infer causation, she merely listed statistically significant increases in symptoms that may be a sign of a causal relationship since all the other variables were statistically controlled. It's all in quotes, and droliver has repeatedly removed it. The "third party" sources mentioned by droliver are all very brief summaries of data on diagnosis of systemic disease, but they are not saying there is no evidence of symptoms -- as several of us (including Dr Carter) have stated before, that is an important distinction. 3 of us agree (a physician, women's health editor, and epidemiologist), and droliver (a plastic surgeon) disagrees. JFW I hope we can count on your help so that a compromise article can move forward. In recent weeks, droliver's changes have been kept and most other changes have been deleted. Drzuckerman

OBOS is a book which makes no bones about its feminist political leanings in the treatment of many health related topics. It is not a reference medical textbook despite the fact that some of it's chapters individually are quite good. It's chapters on implants and cosmetic surgery are not one of those, and the content and editorial POV is distinctly out of step with the international consensus and the medical literature. That's all well and good, but it does not carry much weight if you're pointing towards it in the way a medical topic should be presented when there are a dozen or more current medical textbooks which do in fact address this quite clearly. The conclusion of the study in question speaks for itself as do the related work - there is no predictable or identifiable pattern of symptoms or disease which is the observation of every large study going on two decades. What you seek to highlight is clearly intended to imply something completely contrary to the study result itself. As has been pointed this is both innacurate and falls into the "original research" trap.

Droliver 14:28, 29 March 2007 (UTC)

--Just because OBOS is feminist does not mean it is not scientific. In fact, OBOS is written by many physicians from major medical schools. Droliver, your bias is showing.Drzuckerman 16:16, 29 March 2007 (UTC)

If bias is insisting upon reflecting this in the way that standard reference textbooks, the medical literature, & the regulatory agencies around the world treat it, then yes I am biased toward that. Droliver 22:04, 1 April 2007 (UTC)

More revisions

I was surprised to see DrCarter's comments about "revert" regarding her edits, but realized she didn't revert the entire article but only revised one small section on patients. She did a great job of clarifying the data on patient characteristics. JFW or Dikke had asked for more info on the marital status data. DrCarter, can you provide that? I think that would help everyone, since that keeps getting changed back despite the lack of data to support it Drzuckerman

--JWolff, do I understand correctly that you will always revert to droliver's version of this article, no matter who or how many editors disagree and no matter what evidence we provide that droliver's version has inaccurate representations? Drzuckerman

This is not about versions anymore. I have already explained that I will revert if edits are not sufficiently discussed and explained. I can't help the fact that Droliver seems to be largely playing things by the book.

What concerns me more is the fact that there are so many editors (Drzuckerman, DrCarter12, OBOS editor etc) all having empty userpages, all editing this article alone, and occasionally doing things rather similarly (e.g. using HTML markup when this is not strictly necessary). I have tried to assume good faith, but occasionally I wonder whether all those voices could all be coming from the same person. In other words, whether there is sock puppetry going on here. I will not make this point again, but if there are ongoing concerns I will have to request that identities are verified. Undeclared sock puppetry is a bannable offence. JFW | T@lk 07:48, 2 April 2007 (UTC)

As regards to the "Patient Characteristics" section changes- I only edited this section because I thought it would not be a contestable section to proceed with - it appears that I was wrong. Some things that I mentioned in my version were pretty much echoed by DrOliver's version. However he appears to see his version as the only way to describe the section. Is there a way that the 2 versions be blended?

As regards to Dikke's comment regarding the triviality with the married statistics between breast implant and other plastic surgery patients is valid. The adjusted odds ratio for the married and common law groups were no different from chance. This was also seen in the separated and divorce groups. The never married groups did have a larger representation in the other plastic surgery group- not breast implant. However the Brinton study was done to just prove that when comparing statistics of breast implant patients, a contol group consisting of women witih other plastic surgeries was more appropriate than comparing them to the general popluation. The authors did not provide any causality to these differences. They did agree that more research needs to be done to answer many of those questions.DrCarter12 16:52, 30 March 2007 (UTC)

I think this is a somewhat esoteric and relatively unimportant thing to get into in the first place, but the Brinton paper (by a 62.7% vs. 56.1 margin of its subjects, though the CI disappears when you play with the numbers to adjust for differences in age) and several other related papers all do have this difference in marriage rates. There's another upublished survery of implant patients that was sponsored by the Aesthetic Society's research foundation (ASERF) a few years ago which also had substancially higher rates of marriage among respondents as compared to US census data. Whether or not a more appropriate group for comparison is other plastic surgery patients or the general population seems irrelevent to these observations. Is your concern with this that there is some implication that implants increase your chances of getting married? Droliver 22:36, 1 April 2007 (UTC)

Revision of the "Capsular contracture" section ONLY

Let's try to reach a concensus this way. Below is a suggested revision of the capsular contraction section only. I thought that we could discuss my proposed changes and then hopefully come to a final product that everyone can agree with. Thanks.

“Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma.Capsular contracture may happen again after this additional surgery.

Correction of capsular contracture may require surgical removal or release of the capsule or removal (and possible replacement) of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), was once a common maneuver for treating hard capsules; implant makers now warn against the procedure because it can cause implant rupture. Although there is no agreement on effectiveness, nonsurgical methods of treating capsules include external ultrasound{Planas J.Five-year experience on ultrasonic treatment of breast contractures.Aesthetic Plast Surg.2001.25(2):p89-93},treatment with leukotriene pathway inhibitors (Accolate, Singulair){Schlesinger SL, et al.Zafirlukast (Accolate): A new treatment for capsular contracture. Aesthetic Plast Surg.2002.22(4):329-336},and pulsed electromagnetic field therapy{Silver H. Reduction of capsular contracture with two-stage augmentation mammaplasty and pulsed electromagnetic energy (Diapulse therapy).Plast Reconstr Surg.1982. 69(5):802-8}.”DrCarter12 23:56, 30 March 2007 (UTC)

What exactly is in this that is substancially different from the existing version?Droliver 22:00, 1 April 2007 (UTC)
The last sentence of the first paragraph is a fragment and doesn't make sense. Also is the first sentence correct: is the capsule an immune response - there is no inflammation to see on histology. Will TALK 13:27, 22 April 2007 (UTC)

Removed the "prevention" methods section and concentrated more on treatment. Will, the last sentence is not a fragment (may be throwing you off because of the citations). also agree inflammatory cells are not found in the capsule but it is the product of an inflammatory response to the implant itself. DrCarter12 00:40, 23 May 2007 (UTC)

In point of fact, prevention is discussed in the literature at least as much as treatment

Droliver 15:22, 24 May 2007 (UTC)

Article Picture

I know there was some debate about this before, but if a fair use picture is going to be shown of a completed breast augmentation that didn't work, shouldn't one also be shown of one that did work? Showing neither or showing both seems fair, but showing an image of only one possible result seems like weasel wording the article only with images not words. [2007-05-12 T 23:06 UTC]

At some point I've been planning on making a gallery for a handful preop/postop pictures of sterotypical cases and results for augmentation, augmentation/lift case, and reconstructive patients. I just haven't gotten around to looking thru pictures I have with consents for releaseDroliver 02:47, 15 May 2007 (UTC)

I finally got around to it. 2 cases with average candidates & representative results are depicted.Droliver 21:22, 10 June 2007 (UTC)

Rupture

The fourth paragraph ends, "MRI data from the US-FDA required "core" studies of contemporary implants has demonstrated low rupture rates ("

Is anyone able to fix this? It seems there is something missing at the end. Thank you. Fanra 22:08, 9 June 2007 (UTC)

Repair or revision surgery

It seems the word "revision" is in question here. Let's look at the line: "Most common indications for re-operations have included major or minor cosmetic revisions, capsular contracture treatment, and replacement of ruptured/deflated implants."

Now let us look at the citation for that line: http://www.fda.gov/cdrh/breastimplants/handbook2004/localcomplications.html

According to the citation, it does not give actually figures for what are the most common indications for re-operations, however, it does state (without giving numbers) that "You are likely to have the implants removed, with or without replacement, because of one or more complications over the course of your life." The citation goes on to state the various reasons that women will have to get re-operations.

The word "revision" is used twice. Once in the section heading, where it states, "Key points to consider whether you are undergoing breast augmentation, reconstruction, or revision:", and again, where it discusses type of surgical procedure(s), "scar or wound revision (e.g., surgical removal of excess scar tissue)". The word "revision" is not the most common word used to describe the reasons for re-operation, the word used is "complications". Indeed, while "revision" is used 2 times, "complication" is used 19 times.

When it was changed back from "repairs", which I put in, back to "revisions", it was said that the common medical term is "revisions", not "repairs". If that is true, then it needs a citation. Since the citation used was the FDA article, using the word "revision" is wrong, since it is a incorrect citation. According to the article cited, the word used should be "complications". If there is a feeling that the word "revisions" should be used instead, then we need to see some citations that support it. Remember that Wikipedia is all about referenced sources, not what we might think (or know) is correct but what the sources say.

I will give people time to respond to this before I change it to match the source cited. Fanra 11:19, 14 June 2007 (UTC)

"Revision" is the term used for any surgery that needs to be re-done. That applies to hip replacements as much as it does to breast implants. On the whole, references are not needed to support the use of terminology. JFW | T@lk 22:32, 28 June 2007 (UTC)

Your statement might be true. However, Wikipedia is not written for doctors but for the lay public. Therefore, any terms used should be those that are clear to the general public. The word "revision" in general implies either a change of mind, or correction, or both. The sentence says, "Most common indications": Is the most common reasons for revision surgery a change of mind or a correction? The answer is correction. Therefore, I believe we should use a word that is clear about that rather than one which, while it might be crystal clear to the medical community, is ambiguous to the general public.

I originally used the word "repairs". I am open to another word besides complications as long as it is unambiguous. Since the FDA uses "complications", that is what I went with. I felt (correctly or incorrectly) that the FDA consulted both doctors and public relations experts in deciding to use that term as the clearest for the general public. Fanra 23:34, 28 June 2007 (UTC)

^ Vasey FB, Zarabadi SA, Seleznick M, Ricca L (2003). "Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined". J Rheumatol. 30 (10): 2092–4. PMID 14528500.{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ Zuckerman D (2006). "Breast Implants: Making an Informed Decision". Johns Hopkins Advanced Studies in Medicine. 6 (9): 547–9. {{cite journal}}: Cite has empty unknown parameter: |1= (help)
^ ^a ^b Breiting VB, Holmich LR, Brandt B (2004). "Long-term health status of Danish women with silicone breast implants". Plastic and Reconstructive Surgery. 114: 217–226. {{cite journal}}: Cite has empty unknown parameter: |1= (help)CS1 maint: multiple names: authors list (link) Cite error: The named reference "Breiting2004" was defined multiple times with different content (see the help page).
^ Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN (2006). "Mortality rates among augmentation mammoplasty patients: an update". Epidemiology. 17 (2): 162–9. PMID 16477256.{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ ^a ^b Villenueve PJ; et al. (2006). "Mortality among Canadian Women with Cosmetic Breast Implants". Am J Epidemiol. PMID 16777929. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)
^ McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O (2006). "Long-term cancer risk among Swedish women with cosmetic breast implants: an update of a nationwide study". J Natl Cancer Inst. 98 (8): 557–60. PMID 16622125.{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS (2001). "Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women". J Rheumatol. 28 (5): 996–1003. PMID 11361228 FDA Summary.{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ Lipworth L, Tarone RE, McLaughlin JK. (2004). "Breast implants and fibromyalgia: a review of the epidemiologic evidence". Ann Plast Surg. 52 (3): 284–7. PMID 15156983.{{cite journal}}: CS1 maint: multiple names: authors list (link)
^ [15]

[Vasey2003-1] Vasey FB, Zarabadi SA, Seleznick M, Ricca L (2003). "Where there's smoke there's fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined". J Rheumatol. 30 (10): 2092–4. PMID 14528500.{{cite journal}}: CS1 maint: multiple names: authors list (link)

[Zuckerman2006-2] Zuckerman D (2006). "Breast Implants: Making an Informed Decision". Johns Hopkins Advanced Studies in Medicine. 6 (9): 547–9. {{cite journal}}: Cite has empty unknown parameter: |1= (help)

[Breiting2004-3] Breiting VB, Holmich LR, Brandt B (2004). "Long-term health status of Danish women with silicone breast implants". Plastic and Reconstructive Surgery. 114: 217–226. {{cite journal}}: Cite has empty unknown parameter: |1= (help)CS1 maint: multiple names: authors list (link) Cite error: The named reference "Breiting2004" was defined multiple times with different content (see the help page).

[Brinton2006-4] Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN (2006). "Mortality rates among augmentation mammoplasty patients: an update". Epidemiology. 17 (2): 162–9. PMID 16477256.{{cite journal}}: CS1 maint: multiple names: authors list (link)

[Villenueve2006-5] Villenueve PJ; et al. (2006). "Mortality among Canadian Women with Cosmetic Breast Implants". Am J Epidemiol. PMID 16777929. {{cite journal}}: Explicit use of et al. in: |author= (help); Unknown parameter |month= ignored (help)

[Mclaughlin2006-6] McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O (2006). "Long-term cancer risk among Swedish women with cosmetic breast implants: an update of a nationwide study". J Natl Cancer Inst. 98 (8): 557–60. PMID 16622125.{{cite journal}}: CS1 maint: multiple names: authors list (link)

[Brown2001-7] Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS (2001). "Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women". J Rheumatol. 28 (5): 996–1003. PMID 11361228 FDA Summary.{{cite journal}}: CS1 maint: multiple names: authors list (link)

[Lipworth-8] Lipworth L, Tarone RE, McLaughlin JK. (2004). "Breast implants and fibromyalgia: a review of the epidemiologic evidence". Ann Plast Surg. 52 (3): 284–7. PMID 15156983.{{cite journal}}: CS1 maint: multiple names: authors list (link)

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