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Injection lipolysis

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Injection lipolysis is a controversial cosmetic procedure in which drug mixtures are injected into patients with the goal of destroying fat cells. This practice, using drugs generally based on phosphatidylcholine and deoxycholate (PCDC), evolved from the initial intravenous use of those drug formulations to treat blood disorders.[1][2]

While no placebo-controlled studies have demonstrated the safety or efficacy of this therapy, numerous retrospective studies of Lipostabil injections have reported the efficacy of this practice.[2][3][4][5][6][7][8][9][10] The mixture is injected directly into the subcutaneous fat through multiple microinjections administered over multiple treatment sessions. The desired result is the removal of localized fat deposits.[2]

History

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In 1966, investigators noted that the intravenous infusion of PC-containing solutions could remove fat emboli.[11] Later, a drug formulation called Lipostabil containing 5% PC and 2.5% deoxycholate (DC) was approved in Germany and used in the treatment of fat embolism,[12][13] dyslipidemia,[14] and alcohol-induced liver cirrhosis.[15] The first report of Lipostabil injection for fat removal demonstrated that infra-orbital ("under the eyelid") fat could be removed by Lipostabil injection.[16]

Kybella

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In 2015, the US Food and Drug Administration approved deoxycholic acid (branded as Kybella) for use as an injection lipolysis product when used to reduce moderate to severe submental fullness (double chin).[17][18][19] While the procedure is generally considered safe when performed by a qualified healthcare professional, potential side effects may include swelling, bruising, numbness, and rarely, nerve injury in the treated area.[17][18][20]

Health warnings

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Three medical associations have issued health warnings cautioning against the use of injection lypolysis, including the American Society of Plastic Surgeons (ASPS), the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society of Dermatologic Surgery (ASDS).The Aesthetic Surgery Education and Research Foundation has funded on behalf of the American Society for Aesthetic Plastic Surgery a half side comparison study with interesting results[21]

Restrictive action taken by FDA against Lipodissolve

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On April 7, 2010, the US Food and Drug Administration issued Warning Letters to six U.S. based medspas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claimed will eliminate fat in a procedure called "lipodissolve", or for otherwise misbranding lipodissolve products. "We are concerned that these companies are misleading consumers", said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal".

For the complete FDA statement, see here [1]. To see the warning letter, see [2].

The FDA received reports of adverse effects in persons who had the procedure using these drugs, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the lipodissolve products have been injected. The warning letters were issued to the following U.S. companies: Monarch Medspa, King of Prussia, Pa; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn PURE Med Spa, Boca Raton, Fl.; and All About You Med Spa, Madison, Ind. The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.

The FDA is requesting a written response from the U.S. companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future. Each U.S. company has been informed in its warning letter that failure to promptly correct the violations may result in legal action. Each of the companies involved has been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction. Additionally some of the letters indicate that the companies have made claim that lipodissolve products can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities. The FDA is not aware of clinical evidence to support any of these claims.[citation needed]

International regulation

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The Medicines and Healthcare products Regulatory Agency, the governmental body regulating the manufacture and commercialization of drugs in the United Kingdom, issued a similar warning to physicians considering the use of these substances for cosmetic purposes, stating these drugs "are being unlawfully advertised in the UK as a cosmetic product for the reduction of fat." The MHRA also pointed out that considerable safety concerns remain because these agents have not been tested in controlled clinical trials. While British physicians can still inject Lipodissolve for fat removal, the drug cannot be promoted as a drug for that purpose. As of July, 2005, The Medical Protection Society, the organization that provides British doctors with legal advice and coverage against litigation costs and damages, ceased offering malpractice insurance for use of Lipodissolve because of safety concerns.[22]
On the other hand, the therapy is very often administered especially in German speaking countries because the drug Lipostabil N has been approved in Germany for more than 40 years. A physicians' network, the NETWORK-Lipolysis with 3,000 members worldwide amongst them 1,000 alone in German speaking countries has collected safety data. The latest published so-called Lipolysis Report 2015 has been published in 2016.[23] 4% of the members have answered the survey. 29,889 patient results have been collected with in total ca. 76,000 treatment sessions. Nowadays the composition is compounded by pharmacies in Germany and Switzerland.[citation needed]

References

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  1. ^ Matarasso, A.; Pfeifer, T.M. (2005). "Mesotherapy for body contouring". Plast Reconstr Surg. 115 (Pt 5): 1420–4. doi:10.1097/01.PRS.0000162227.94032.ED. PMID 15809611. S2CID 38159936.
  2. ^ a b c Duncan, D.I.; Hasengschwandtner, F (2005). "Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction". Aesthet Surg J. 25 (Pt 5): 530–543. doi:10.1016/j.asj.2005.07.009. PMID 19338857.
  3. ^ Rotunda, A.M., M.M. Avram, and Avram, A.S. (2005). "Cellulite: Is there a role for injectables?". Journal of Cosmetic and Laser Therapy. 7 (3–4): 147–54. doi:10.1080/14764170500430234. PMID 16414902. S2CID 40625377.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  4. ^ Ablon G, Rotunda, AM. (2004). "Treatment of lower eyelid fat pads using phosphatidylcholine: clinical trial and review". Dermatologic Surgery. 30 (3): 422–7. doi:10.1097/00042728-200403000-00020. PMID 15008874.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  5. ^ Hexsel, D., Serra, M., Mazzuco, R. (2003). "Phosphatidylcholine in the treatment of localized fat". Journal of Drugs in Dermatology. 2 (5): 511–8. PMID 14558399.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  6. ^ Rotunda, A.M., G. Ablon, and M.S. Kolodney (2005). "Lipomas treated with subcutaneous deoxycholate injections". Journal of the American Academy of Dermatology. 53 (6): 973–8. doi:10.1016/j.jaad.2005.07.068. PMID 16310057.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  7. ^ Rotunda, A.M.; M.S. Kolodney (2006). "Mesotherapy and Phosphatidylcholine Injections: Historical Clarification and Review". Dermatologic Surgery. 32 (4): 465–480. CiteSeerX 10.1.1.506.2372. doi:10.1111/j.1524-4725.2006.32100.x. PMID 16681654. S2CID 9994696.
  8. ^ Bechara, F.G., Sand, M., Hoffmann, K., Sand, D., Altmeyer, P., and Stucker, M. (2007). "Fat tissue after lipolysis of lipomas: a histopathological and immunohistochemical study". Journal of Cutaneous Pathology. 34 (7): 552–7. doi:10.1111/j.1600-0560.2006.00651.x. PMID 17576334. S2CID 39429064.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  9. ^ Bechara, F.G., Sand, M., Altmeyer, P., and Hoffmann, K. (2006). "Intralesional lipolysis with phosphatidylcholine for the treatment of lipomas: pilot study". Arch Dermatol. 142 (8): 1069–70. doi:10.1001/archderm.142.8.1069-b. PMID 16924064.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  10. ^ Bechara, F.G., Sand, M., Sand, D., Rotterdam, S., Stucker, M., Altmeyer, P., and Hoffmann, K. (2006). "Lipolysis of lipomas in patients with familial multiple lipomatosis: an ultrasonography-controlled trial". Journal of Cutaneous Medicine and Surgery. 10 (4): 155–9. doi:10.2310/7750.2006.00040. PMID 17234112. S2CID 45970041.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  11. ^ Kroupa, J. (1966). "Lipostabil in the prevention of fat embolism. (Experimental study)". Rozhl Chir. 45 (Pt 7): 444–452. PMID 5924189.
  12. ^ Schroder, D., Buttenschon, K., Herrmann, F., Brede, S. (1991). "Is there a drug treatment approach for prevention and therapy of fat embolism syndrome?". Klin Wochenschr. 69 (Pt 26): 229–233.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  13. ^ Stohlmacher, P., Haferland, W., and Gottschall, S. (1975). "Diffuse foam cell pneumonia following fatty embolism treated with lipostabil. A contribution to the pathology of therapy". Z Arztl Fortbild (Jena). 69 (5): 237–239. PMID 1226856.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  14. ^ Klimov, A.N., Konstantinov, V.O., Lipovetsky, B.M., Kuznetsov, A.S., Lozovsky, V.T., Trufanov, V.F., Plavinsky, S.L., Gundermann, K.J., and Schumacher. R.. (1995). ""Essential" phospholipids versus nicotinic acid in the treatment of patients with type IIb hyperlipoproteinemia and ischemic heart disease". Cardiovascular Drugs and Therapy. 9 (6): 779–784. doi:10.1007/bf00879871. PMID 8850382. S2CID 21578474.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  15. ^ Lieber, C.S., Weiss, D.G., Groszmann, R., Paronetto, F., Schenker, S. (2003). "For the Veterans Affairs Cooperative Study 391 Group., II. Veterans Affairs Cooperative Study of polyenylphosphatidylcholine in alcoholic liver disease". Alcohol Clin Exp Res. 27 (11): 1765–1772. doi:10.1097/01.alc.0000093743.03049.80. PMID 14634492.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  16. ^ Rittes, P.G. (2001). "The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads". Dermatologic Surgery. 27 (4): 391–2. doi:10.1097/00042728-200104000-00014. PMID 11298713.
  17. ^ a b Liu M, Chesnut C, Lask G (June 2019). "Overview of Kybella (Deoxycholic Acid Injection) as a Fat Resorption Product for Submental Fat". Facial Plastic Surgery. 35 (3): 274–277. doi:10.1055/s-0039-1688943. PMID 31189201.
  18. ^ a b Farina GA, Cherubini K, de Figueiredo MA, Salum FG (October 2020). "Deoxycholic acid in the submental fat reduction: A review of properties, adverse effects, and complications". Journal of Cosmetic Dermatology. 19 (10): 2497–2504. doi:10.1111/jocd.13619. hdl:10923/18644. PMID 32654409.
  19. ^ "FDA approves treatment for fat below the chin". Food and Drug Administration. April 29, 2015. Archived from the original on May 1, 2015. Retrieved December 16, 2019.
  20. ^ Murdock, Joshua (3 May 2022). "The 10 Kybella Side Effects: What to Expect". GoodRx. Retrieved 1 June 2024.
  21. ^ Dominic N. Reeds, B. Selma Mohammed, Samuel Klein, Craig Brian Boswell and V. Leroy Young (2013), "Metabolic and Structural Effects of Phosphatidylcholine and Deoxycholate Injections on Subcutaneous Fat: A Randomized, Controlled Trial", Aesthetic Surgery Journal., vol. 33, no. 3, pp. 400–408, doi:10.1177/1090820X13478630, PMC 3667691, PMID 23439063{{citation}}: CS1 maint: multiple names: authors list (link)
  22. ^ Lister, Sam (July 18, 2005). "Youre on your own if you give flab jab insurers warn doctors". The Times. London. Retrieved May 5, 2010.[dead link]
  23. ^ Weidmann M, Lettko M, Prantl L (2016), "Injektionslipolyse", J Ästhet Chir. (in German), vol. 9, no. 4, pp. 158–167, doi:10.1007/s12631-016-0047-2{{citation}}: CS1 maint: multiple names: authors list (link)
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  • (April 7, 2010): [3]
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