A Cautious Look at Mesotherapy
for Fat Reduction
Stephen Barrett, M.D.
Mesotherapy is a controversial technique in which substances are injected into into layers of fat and connective tissue under the skin. It was originally used for pain relief, but in recent years has been widely promoted for "rejuvenating" skin, and “melting fat” for "cellulite" reduction and other body contouring. The injected ingredients can include agents that are used to open blood vessels, nonsteroidal anti-inflammatory medications, enzymes, nutrients, antibiotics, and hormones. Treatment sessions consist of multiple small injections of a liquid formula into the area(s) of concern through a fine needle attached to a syringe or mechanical gun. The depth, amount delivered per injection, and treatment intervals vary with the condition being addressed. Searching with Google, I found fees ranging from $130 to $600 per body area per session plus an additional charge for the first consultation. Anywhere from 3 to 15 sessions may be recommended. Mesotherapy is not covered by health insurance. Most practitioners are physicians, but some are intrained laypersons.
The main ingredient in the liquid formula is phosphatidylcholine, a compound derived from soy that is a component of cell membranes in many organisms, including humans. Deoxycholate, a naturally occurring bile salt, is used to keep the phosphatidylcholine soluble in water. The ratio of the two compounds in a given formulation may differ substantially from one provider to another. Some also add small amounts of other medications, vitamins, and/or herbs. None of these agents has ever been scientifically proven safe or efficacious for fat removal.
Phosphatidylcholine, a prescription drug marketed as Lipostabil®, is licensed for intravenous use in Germany for treating blood vessel blockages by dissolving fat particles (fat embolism). It is not licensed for subcutaneous injections in cosmetic surgery, a procedure which its manufacturer, Sanofi-Aventis, warns against in its product information sheet. In the United States, where Lipostabil lacks FDA approval, providers can obtain their formulations from compounding pharmacies that mix the ingredients they request.
A laboratory study that compared the effects of phosphatidylcholine, sodium deoxycholate, and two common laboratory detergents observed that phosphatidylcholine can rupture cells. However the researchers thought that deoxycholate was more potent and said that physicians should be cautious until adequate safety data are available .
Adverse reactions to cosmetic mesotherapy have been reported. Localized adverse events have included swelling, redness, bruising, irregular contours, and tender nodules under the skin. Hives and other skin reactions to the injected medications as well as mycobacterium infections have also been reported [2-4]. Systemic side effects of phosphatidylcholine include mild transient elevations in liver function tests and rare cases of nausea and vomiting after injections of high volumes. A major British law firm is representing a young woman who is suing a surgeon who injected her with Lipostabil. The suit states that she developed an infection in both legs that required hospitalization for surgical repair, missed more than 4 months of work (because of pain), and has extensive scarring that will necessitate further surgery .
The Better Business Bureau of Eastern Missouri and Southern Illinois has rceived more than 400 complaints about FIG (d/b/a Advanced Lipo Dissolve Center), which operated clinics in Missouri and other states . Most involved failure to issue refunds, but some complainants reported that the procedure was ineffective and caused swelling and pain . FIG closed most of its clinics in December 2007 and subsequently filed for bankruptcy.
In April 2008, ABC-TV's "20/20" featured the stories of three women who developed severe complications following the Lipodissolve injections. Two were treated at FIG; the other was treated at the Pure Med Spa in St. Louis. Reporters who visited the Pure Med Spa with hidden cameras found that prospective clients were not adequately warned about complications .
Professional groups representing plastic surgeons and dermatologists in the United States have warned against mesotherapy.
- In 2005, the American Society of Plastic Surgeons' Device & Technique Assessment (DATA) Committee published a report advising patients to be wary of mesotherapy until the safety and effectiveness of the procedure are confirmed .
- In 2006, The American Society for Dermatologic Surgery concluded:
- Despite the growing popularity of mesotherapy there is a paucity of available data and no randomized, double-blinded controlled studies unequivocally establish that the procedure is safe and efficacious for medical or aesthetic conditions.
- Localized dietary and exercise resistant fat deposits can be safely improved by surgical body contouring procedures such as tumescent liposuction.
- There are many causes of aging inclusive of photodamage and chronologic changes, and currently there are many FDA approved alternatives to address the stigmata of the aging face. Mesotherapy may ultimately prove to be a viable adjunct or option for these concerns, but further study is warranted before this technique can be endorsed.
- Controlled research to determine the optimal formulation and treatment regimens as well as the safety, efficacy and further insight into the mechanism of action of this procedure is strongly encouraged .
- In 2007, the American Society for Aesthetic Plastic Surgery warned against using injection fat-loss procedures until sufficient data are available to demonstrate safety and effectivess. To help settle the issue, the Aesthetic Surgery Education and Research Foundation is sponsoring a placebo-controlled clinical trial that will follow 20 patients for 46 weeks to evaluate the efficacy of phosphatidylcholine/deoxycholate and collect data on local and systemic reactions and any long-term complications .
In 2003, the FDA warned a seller that Lipostabil was an unapproved new drug that was illegal to market without FDA approval . That same year, the Brazilian National Agency concluded that supportive scientific data were lacking and banned its use for reducing localized fat. Health Canada issued a similar warning in 2004 . The UK Medicines and Healthcare products Regulatory Agency (MHRA) has ruled that Lipostabil can not be legally imported or advertised for cosmetic purposes .
In August 2007, the Kansas State Board of Healing Arts voted to consider the use of mesotherapy for cosmetic purposes as "dishonorable conduct" unless it is part of an FDA-sanctioned clinical trial under an Investigational New Drug Application. However, FIG obtained a court order blocking the ban until the Board goes through a public comment procedure .
- Rotunda AM and others. Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatologic Surgery 30:1001-1009, 2004.
- Nagore E and others. Cutaneous infection with Mycobacterium fortuitum after localized microlipoinjections (mesotherapy) treated successfully with a triple drug regimen. Acta Dermato-Venereologic 81:29, 2001.
- Marco-Bonnet J and others. Mycobacterial bovis BCG cutaneous infections following mesotherapy: 2 cases. Annals of Dermatology and Venereology 129:728, 2002.
- Outbreak of mesotherapy-associated skin reactions—District of Columbia Area, January–February 2005
- Reaction after being injected with Lipostabil. News release, Irwin Mitchell, Nov 10, 2006.
- BBB report on FIG. Accressed April 21, 2008.
- Tabacoff H, Cohen D. Lunchtime lipo' draws concern from doctors: Women who participated in Lipodissolve injections speak out. ABC-TV 20/20, April 11, 2008
- Mesotherapy not proven as a safe alternative to liposuction. American Society of Plastic Surgeons news release, April 18, 2005.
- Technology report: Mesotherapy. American Society for Dermatologic Surgery, January 2006.
- American Society for Aesthetic Plastic Surgery warns patients to steer clear of injection fat loss treatments. American Society for Aesthetic Plastic Surgery news release, May 14, 2007.
- Woyshner JG. Warning letter to Ayoula Dublin, July 22, 2003.
- Health Canada orders doctors to stop fat burning injections. CBC News, Dec 13, 2004.
- Lipostabil not licensed for cosmetic use. MHRA press release, July 13, 2005.
- Injection lipolysis. Wikipedia, accessed Nov 29, 2007.
This article was revised on April 21, 2008.