The increase of fat-destroying injections—touted as nonsurgical alternatives to liposuction—is spurring warnings from physicians.
The treatment, called lipodissolve or medical lipolysis, involves a series of tiny injections that melt fat deposits in various parts of the body. The problem is that the concoctions that are being injected are not FDA-approved.
As the popularity of the injections has increased, so have the complaints. Last month, ASAPS warned that the shots are “scientifically unproven, lacking any objective data on safety and efficacy.”
Physicians who offer lipodissolve say that the injections can be effective when administered by a skilled professional.
A 2006 study published in the Aesthetic Surgery Journal includes statistics based on data submitted by 75 physicians in 17 countries who performed lipodissolve treatments on more than 17,000 patients. The study shows that 12% of patients expressed disappointment with the aesthetic result, and they experienced complications such as temporary hyperpigmentation, pain, and allergic reactions.
One fact that is not in dispute is that there are no fat-busting injectables approved by the FDA. Practitioners use different recipes that are prepared by a compounding pharmacy. Such custom mixes, using ingredients approved for other uses, fall into a regulatory gray area.
One combination used by many practitioners is phosphatidylcholine, a soybean-derived ingredient in food supplements, and sodium deoxycholate, an emulsifier derived from cattle bile. Lipodissolve uses additional ingredients, including herbs.
According to representatives of clinics that administer lipodissolve injections, their concoctions are legal because states regulate pharmacy practice, including compounded drugs.
The FDA says that in virtually all cases, it regards compounded drugs as unapproved drugs. The agency says that it is currently evaluating lipodissolve and it will not discuss pending investigations or enforcement matters until a resolution is met.
[online.wsj.com, June 12, 2007]