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Breast Implant Illness

Breast implant illness (BII) is a collection of negative symptoms, such as fatigue, rheumatoid arthritis, joint pain, and memory loss, that have affected patients who have undergone a breast augmentation with implants. Though breast implant illness is not an official medical diagnosis, it is a rising medical concern and an issue in the community of people who have undergone a breast augmentation.

There are no known causes as to why breast implant illness occurs nor have their been any studies that directly links the illness with saline or silicone breast implants. Additionally, there is no direct timeline of when the constellation of symptoms may affect women. Patient advocacy through social media has brought recognition and attention to this new medical matter.

Symptoms

For those that have undergone cosmetic augmentation with implants, symptoms can begin to show either months after the implants have been inserted or years after the breast augmentation. It all depends on the person and their immunological responses.

Rheumatoid arthritis, inflammation of the joint(s), is one of the symptoms of breast implant illness

Signs & symptoms includes, but are not limited to, the following:

• Fatigue
• Joint pain
• Memory loss
• Hair loss
• Dry Skin, eyes, hair, and mouth
• Weight Fluctuations
• Shortness of breath
• Depression, anxiety, panic attacks
• Rashes
• Temperature intolerance
• Fevers, night sweats, heat intolerance
• Low libido
• Insomnia
• Dizziness, vertigo
• Decline in vision
• Headaches, migraines
• Ear ringing
• Easy bruising
• Blood pressure issues
• Changes in heart, heart palpitations, heart pain
• Inflammation
• Nausea
• Reflux, GERD
• Hypothyroid
• Parathyroid issues
• Liver problems
• Kidney problems
• Swollen and tender lymph nodes of breast and underarm areas
• Pain or burning sensation around the implant
• Numbness and tingling in limbs
• Bouts of dehydration for no reason
• Frequent urination

Background

Breast Implant Illness History

As this "illness" has not been officially recognized by the medical community, there have been no medically documented reports of cases nor has there been any studies conducted to evaluate breast implant illness in women. Additionally, there is no definitive timeline as to when women start to experience issues with their implants and can categorize it as breast implant illness because not only do BII symptoms vary with people but also because there are no diagnostic criteria of BII.

People that have undergone breast augmentation with implants and experienced BII symptoms typically discover that they have breast implant illness through online communities and forums such as the Facebook group Breast Implant Illness and Healing by Nicole, which has about 110,820 members and focuses on promoting and advancing consumers' knowledge of breast implants and the symptoms that may come with it. It is a community where women of all backgrounds share before and after pictures of their breast implants, stories of how breast implants have affected them in their daily lives, and how they are treating the issues and dealing with symptoms. Patient advocacy and communication through various social platforms have allowed women to openly discuss and shine a light on how they are feeling after having a breast augmentation with implants.

FDA, breast implant regulation & safety

On March 25th and 26th of 2019, the Food and Drug Administration held a public advisory committee meeting that consisted of "researchers, patient advocacy groups, and manufacturers." The purpose of the 2-day conference was to not only review breast implant illness and the debilitating immune disorders that may come with it but also to re-examine implant safety as well as implant medical devices. The 40 and counting breast implant patients recounted stories of how their debilitating saline and silicone implants have impacted their lives. The FDA panel was asked to hold breast implant manufacturers more liable for the health, safety, and well-being of a patient and to better inform patients on the negative side effects of breast augmentation with implants.

U.S. Food and Drug Administration Logo

Additionally, in March 2019, the Food and Drug Administration issued "warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements." Mentor World LLC. received a noticed from the FDA for "poor follow-up rates with patients in the study" as well as "significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data." Sientra also received a warning due to its "poor follow-up rates with patients" (only 61%) and its "failure to address these concerns and comply with its post-approval study requirements is a violation of the firm's pre-market approval order." Back in 1992-2006, silicone implants were only made available to patients for "reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants"; however, in November of 2006, the FDA approved the selling of silicone breast implants for breast reconstruction and for breast augmentation for women at least 22 years old from the manufacturers Inamed Aesthetics, now known as Allergan, Inc., and Mentor Worldwide LLC. Mentor was supposed to follow up to around 40,000 women for 10 years to see the long term effects and safety of these implant devices; however, the company failed to address concerns and meet the case-study requirements. On May of 2019, Jeff Shuren, M.D.,J.D., the director of the FDA's Center for Devices and Radiological Health, and Amy Abernethy, M.D., Ph.D., the FDA Principal Deputy Commissioner, issued a public statement acknowledging breast implant illness and declaring that more research would be done on implants to better ensure women's health. However, this does not mean a ban was placed on breast implants. See the following paragraph below for the FDA's recognition of breast implant illness:

"And we have heard from patients concerned that their implants may be connected to health conditions involving their immune system’s response to these devices, resulting in a variety of symptoms like chronic fatigue, cognitive issues, joint and muscle pain. While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness. We believe women considering a breast implant should be aware of these risks. As we describe below, we are taking steps to better characterize the condition and its risk factors, and are considering ways to help to ensure women have all of the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms."

As of October of 2019, the FDA has suggested breast implant manufacturers to start labeling their products with a boxed warning, the most stringent form of warning, in order to "spell out the risks of implants, including that they are not lifetime devices and that the chances of complications increase over time. The warning also would list the devices’ association with a rare form of lymphoma and say some patients have reported fatigue, muscle aches and joint pain." According to the FDA, these warnings were necessary because some patients were not understanding the consequences and effects that saline and silicone gel-filled devices may have. Labeling recommendations were created not only to improve a patient's understanding of the content inside the implants but also to overall improve "patient communication."

Explant (1/2): Implants that were in a woman's body from October 2016-March 2020.

Treatment

With medical professionals that have recognized breast implant illness, they recommend patients experiencing symptoms to have a breast explant surgery, in particular, an en bloc capsuloctemy, which is the removal of the implant and the scar tissue capsule as one piece. This method prevents any bacteria, biofilm, or other foreign objects from escaping into different parts of the body. Additionally, there is no scientific evidence which "specifically show which symptoms may or may not improve with implant removal with or without capsulectomy." Another implant removal method is a total capsuloctemy which still removes the implant and the scar tissue capsule; however, the breast implant is removed first and then the capsule. Patients should also check in with their doctor before requesting removal of their breast implants because the symptoms related to BII could be due to "menopause, thyroid problems, and autoimmune diseases" and not related to their breast implants.

Since so little is known about breast implant illness and because it could be attributed to numerous factors, such as a family history of autoimmune disease or allergies, there have been patients that have sought treatment by "switching from a textured silicone gel-filled implant to a smooth saline-filled implant. This approach may improve BII symptoms but may also carry a greater risk that symptoms will return again over time."

Explant (2/2): Allergen Silicone 525 in L & R

Note that the illness is not subjective to just one certain type of implant because it "can occur with any type of breast implant, including

silicone gel-filled, saline-filled, smooth surface, textured surface, round, or teardrop-shaped."

Treatment Factors

Psychological Factors

In 2018, 313,735 women in the U.S. underwent a breast augmentation (Augmentation mammaplasty) surgery and for a variety of reason, such as for cosmetic reasons to enhance appearance or for reconstruction purposes after a mastectomy. The surgery is intended to boost a person's confidence and self-esteem so when a woman undergoes breast implant removal in an attempt to try to resolve BII symptoms, she may feel unsatisfied with her body at first due to deflation and wrinkled skin. Since women tend to have their implants for years in their bodies, it may be hard and take them some time to adjust to their original, smaller chest size. However, there have been reports that "Many women ultimately find comfort in their reduced chests."

Financial Factors

In an American Society of Plastic Surgeons 2018 statistic, the average cost of breast implant removal is around $2,566; however, this is only the surgeon's fee. The total cost of breast implants may range from anywhere from $5,000-$8,000, which include the cost of anesthesia, prescriptions, post-operation check-ups, and medical tests. Some women opt to remove their implants and then replace them with new ones, which would cost an additional $2,500-$3,500. The total cost may fluctuate depending on your location and the hospital or clinic that the surgery is conducted at. All these fees may add up and be a financial burden on women.

Three programs that aim to ease the financial burdens of explant surgery are The Explant Financial Assistance Program the Women's Health and Cancer Rights Act of 1998 (WHCRA), and the National Center for Health Research. The Explant Financial Assistance Program is an initiative started by the Common Benefit Trust that aids women in medical and financial need by covering the financial costs of implant removal surgery. If applicants meet the eight requirements of the program, women are eligible to receive up to $5,000 in financial assistance. Since starting in 2015, the program has had a number of applicants in need of financial aid and was renewed till 2018. As of April 2019, the program has been suspended and is not accepting any new applications.

Anaplastic large cell lymphoma

The Women's Health and Cancer Right Act of 1998 is a federal law created to assist breast cancer patients that "choose to have their breasts rebuilt (reconstructed) after a mastectomy." It is a law that "requires almost all insurers to cover breast cancer related surgeries, including explant and flat plastics closure..." Though this law is not applicable under Medicare and Medicaid, "Medicare covers breast reconstruction if you had a mastectomy because of breast cancer. Medicaid coverage varies in each state."

The National Center for Health Research (NCHR) is a nonprofit and nonpartisan organization that is "focused on research that can improve the health of adults and children." Depending on their policies, insurance companies may not cover breast implant removal surgery unless it is "medically necessary", which includes, but is not limited to, the following criteria: ruptured silicone implants, severe capsular contracture, infections, chronic breast pain, and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In addition, insurance companies will not cover a silicone-filled implant removal surgery due to autoimmune or connective tissue disorders because there have been no studies linking silicone implants to these disorders. The organization started a program in 2015 that has assisted more than 6,000 women in navigating "their health insurance policies so that they can get coverage when the removal of breast implants is medically necessary."

Ruptured silicone implant

Looking Ahead

To prevent any rupture or migration of the implant or because of infection, the American Society of Plastic Surgeons do recommend that patients replace their implants around every 10 years. Additionally, it is recommended by the FDA that "people with silicone breast implants receive MRI screening for 'silent rupture' 3 years after the initial implant surgery and every 2 years after that." Patients with silicone implants need an MRI more than a patient with saline implant due to silicone ruptures being less noticeable and gradual compared to a tear in a saline implant. If saline implants do rupture, the saltwater will be reabsorbed by the body.

The month of March is considered to be National Breast Implant Awareness Month. In particular, March 8th is Breast Implant Awareness Day. Recognition of these dates are two initiatives centered around promoting breast implants knowledge, benefits and risks of surgery, and making sure manufacturers are transparent and responsible.

See also

• Breast
• Breast implant
• Breast augmentation (Augmentation mammoplasty)
• Mammoplasty
• Mastopexy (breast lift)
• Anaplastic large-cell lymphoma
• Breast reconstruction
• Breast reduction plasty