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Injection lipolysis

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 breaking down fat. This practice, using drugs generally based on phosphatidylcholine
Phosphatidylcholine
Phosphatidylcholines are a class of phospholipids that incorporate choline as a headgroup.They are a major component of biological membranes and can be easily obtained from a variety of readily available sources such as egg yolk or soy beans from which they are mechanically extracted or chemically...

 and deoxycholate (PCDC), evolved from the initial intravenous use of those drug formulations to treat blood disorders.

In 1966, investigators noted that the intravenous infusion of PC-containing solutions could remove fat emboli. Later, a drug formulation called Lipostabil containing 5% PC and 4.75% deoxycholate (DC) was approved in Germany and used in the treatment of fat embolism, dyslipidemia, and alcohol-induced liver cirrhosis. The first report of Lipostabil injection for fat removal demonstrated that infra-orbital ("under the eyelid") fat could be removed by Lipostabil injection. 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. The mixture is injected directly into the subcutaneous fat through multiple microinjections administered over multiple treatment sessions. The desired end result is the removal of localized fat deposits.

Restrictive action taken by FDA against Lipodissolve


On April 7, 2010, the US Food and Drug Administration issued Warning Letter
FDA Warning Letter
The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...

s to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim 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 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207453.htm.

To see the warning letter, see http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm207642.htm.

The FDA has received reports of adverse effects in persons who have 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.

Health warnings


Three medical associations have issued health warnings cautioning against the use of injection lypolysis, including the American Society of Plastic Surgeons
American Society of Plastic Surgeons
The American Society of Plastic Surgeons is the largest plastic surgery specialty organization in the world. Founded in 1931, the society is composed of surgeons certified by the American Board of Plastic Surgery or by the Royal College of Physicians and Surgeons of Canada who perform Plastic and...

 (ASPS), the American Society for Aesthetic Plastic Surgery
American Society for Aesthetic Plastic Surgery
The American Society for Aesthetic Plastic Surgery is an organization devoted to the advancement of cosmetic surgery. It has approximately 2,400 members. U.S. members are certified by the American Board of Plastic Surgery...

 (ASAPS), and the American Society of Dermatologic Surgery (ASDS).

International regulation


The Medicines and Healthcare Products Regulatory Agency
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....

, 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
Medical Protection Society
The Medical Protection Society is a not for profit organisation which offers legal and ethical help to medical and dental professionals...

, 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.

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