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]

In 1966, investigators noted that the intravenous infusion of PC-containing solutions could remove fat emboli.[3] 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,[4][5] dyslipidemia,[6] and alcohol-induced liver cirrhosis.[7] The first report of Lipostabil injection for fat removal demonstrated that infra-orbital ("under the eyelid") fat could be removed by Lipostabil injection.[8] 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][9][10][11][12][13][14][15][16] 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.[2]

Restrictive action taken by FDA against Lipodissolve[edit]

On April 7, 2010, the US Food and Drug Administration issued Warning Letters 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 [1].

To see the warning letter, see [2].

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: and

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[edit]

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[17]

International regulation[edit]

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.[18]
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[19]. 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.


In this area, we can indicate three different possibilities, which in themselves are already a reflection of the current discussion. These are either DOC (deoxycholate) by itself, or else a combination of PPC (polyenylphosphatdylcholine) and DOC in pure form, or the same combination but with the PPC/DOC diluted with NACL (1 : 1) and the addition of a vitamin B complex. This last variant has become known as the NETWORK Compound(NC) and is used by most physicians.

The approval of Kybella™ in the USA[edit]

The current discussion is being stimulated by the approval of KybellaTM, a drug for the treatment of double chin, in the USA. The active substance in KybellaTM is deoxycholic acid. The question is being raised as to whether, and to what extent, the second active ingredient, PPC, has any additional effect at all or whether DOC is not sufficient on its own, seeing that it has been shown to be able to destroy the cell membranes of the adipocytes by itself. A number of published studies indicate that it remains preferable to continue adding PPC as a second active ingredient to the injectable. The main question in this context is what happens to the fat cells after they have been destroyed and to what extent PPC fosters the metabolization of the fat that has been released, thus also improving the result. The mechanism by which PPC acts can be described as follows:
• PPC diminishes the aggressiveness of the DOC
• PPC diminishes the toxicity of the DOC
• PPC stimulates fat-reducing enzymes such as lipase
• PPC acts as an emulsifier for the fat that is released
• PPC increases the absorption capacity and fosters transport of the cholesterol esther to the liver
• As well as destruction of the cell membrane (necrosis), PPC also causes apoptosis (Peckitt[20], Lee[21]) and thus further contributes to improving the long-term results[22]


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External links[edit]