Lipodissolve Fat-Melting Injections Under Investigation by the FDA

The FDA is cracking down on several medical spas across the U.S. that offer Lipodissolve (also referred to as Mesotherapy), stating that these spas are offering a health treatment that has not been officially investigated and approved for public use by federal officials (1). By law, a medical therapy or treatment must be supported by substantial clinical and scientific evidence and then undergo a series of test trials before being approved by the FDA.

Lipodissolve is touted as a safe and cost-effective alternative to liposuction for small body fat deposits. Lipodissolve involves the injection of two chemicals, namely phosphatidylcholine (PC) and sodium dioxycholate (DC), into specific fatty areas of the body (2). PC is a vital fatty acid that is found in many animal and plant tissues, including those of the human body. DC is a bile acid byproduct of intestinal bacteria and helps the body absorb fat.

Preliminary studies performed by medical spas on test subjects who received PC/DC chemical injections indicated a reduction in targeted body fat deposits (3). The tissue that was examined did reveal areas of cell and fatty tissue death. Most of the "before" and "after" photos taken of individual patients indicated some fatty area reduction and tightening.

Lipodissolve proponents claim that the chemicals used for the treatment occur naturally in the body. However, those opposed to the procedure state that just because the chemicals are normally present, that does not make them safe to use in extracted and concentrated form. Additionally, PC and DC are often mixed with other ingredients, such as Infasurf (a drug used to treat respiratory problems in premature babies), or other vitamins and herbs.

The FDA has begun cracking down on medical spas offering Lipodissolve treatment due to reports of patients who underwent the therapy and then had issues with scars, hard lumps and nodules, and dark spots around the injection sites. Other side effects included post-procedure dizziness, nausea, tenderness or pain in the injection sites, bruising, infection, and skin deformation (4). There has so far been no reasonable explanation offered for the majority of these side effects.

Lipodissolve treatment, while not as expensive as Liposuction, can still end up costing thousands of dollars for the patient. Lipodissolve treatment on the stomach costs from $300-$800. Injections to the arms run from $300-$600, while injections to the back run from $300-$800 (3). Patient health insurance plans rarely, if ever, cover such cosmetic procedures.

The FDA has requested that the targeted medical spas send written responses within 15 business days explaining how they intend to correct these violations. The FDA is threatening the spas with legal action if they do not respond.

References:

1. FDA Cracking Down on Fat-Melting Injections http://www.foxnews.com/story/0,2933,590533,00.html
2. FDA Warns of Lipodissolve & Mesotherapy Procedures Serious Side Effects http://www.phillipswebster.com/blog/2010/04/fda-warns-of-lipodissolve-mesotherapy-procedures-serious-side-effects/
3. Losing Fat with Lipodissolve: Is it Safe and Effective? http://www.associatedcontent.com/article/1308657/losing_fat_with_lipodissolve_is_it.html?cat=69
4. FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207453.htm