Lipodissolve injections, a popular nonsurgical alternative to liposuction, are used to dissolve small fat deposits around the legs, arms and belly. The FDA said Wednesday the drugs have not been cleared by federal scientists, as required by law.
The agency issued warning letters to a half-dozen spas in America that offer the injections, citing them for making unsubstantiated claims about lipodissolve therapy.
“The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” states a letter to All About You Medspa in Madison, Ind.
Other spas cited by the FDA included: Pure Med Spa of Boca Raton, Fla., Monarch Med Spa of King of Prussia, Pa., and three others.
The Web site for Monarch Med Spa claims that, “Rather than go through the pain and discomfort associated with liposuction, patients now have the option of a series of injections with very minimal discomfort.”
Calls to Monarch Med Spa were not immediately returned Wednesday.
FDA regulators called on the spas to stop using such claims and notify the agency within 15 working days of steps they are taking to correct the violations.
“FDA is not aware of any credible scientific evidence to support these claims,” said Kathleen Anderson, an FDA deputy director, on a call with reporters.
Spas that offer the injections say they are safe and effective. But public safety advocates have called for proof and urge patients to think twice before paying thousands of dollars for an unproven procedure.
FDA said it has received reports of permanent scarring, hard lumps and dark spots on their skin after receiving the therapy.
The FDA also issued a warning to a Brazilian company that sells lipodissolve treatments on two Web sites: zipmed.net and mesoone.com.
Lipodissolve and similar treatments use two chemicals, phosphatidylcholine, or PC, and sodium dioxycholate, or DC. Other ingredients in the cocktails include the drug Infasurf, which is used to treat respiratory problems in premature infants, according to the FDA.
Lipodissolve formulations are usually mixed at medical spas through via a process called compounding, in which a pharmacist combines multiple drugs to create a new formulation. The FDA does not regulate the practice of medicine and declined to discuss drug compounding.
“We’re not aware of where these spas are getting their drugs, therefore we cannot comment on the issue of compounding this product,” said FDA pharmacist Suda Shukla.
Copyright 2010 The Associated Press.