06-08-2010, 03:26 PM
Part of an ongoing series looking at the reality behind health claims.
The claim: Lipodissolve, a series of drug injections, can dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.
Reality: Though it's easier than eating right and exercising, the products used to perform the procedure are not approved by the U.S. Food and Drug Administration for fat removal and the agency has issued a consumer warning about false and misleading claims, said Dr. Janet Woodcock director of FDA’s Center for Drug Evaluation and Research.
Moreover, the FDA says it's "not aware" of clinical studies showing lipodissolve is effective or safe. Unexpected side effects include permanent scarring, skin deformation, and deep, painful knots under the skin in areas where the lipodissolve treatments were injected according to the FDA.
The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine (PC) and deoxycholate (DC). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.
Earlier this week, the FDA announced it had sent warning lettersto six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure. For example, some of the companies have made claims that lipodissolve is superior to liposuction or that it 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 following U.S. companies received warning letters:
* Monarch Med Spa, 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, Fla.
* All About You Med Spa, Madison, Ind.
T
The Brazilian firm getting a warning letter marketed lipodissolve products on two no-longer functioning Web sites: zipmed.net and mesoone.com.
To report a side effect, go to the FDA's MedWatch Adverse Event Reporting Program