Legal news for product liability attorneys. The FDA is going after spas and suppliers who sell or use lipodissolve, which is an unapproved treatment.
Product liability attorneys alert- The FDA has issued warning letter regarding the lipodissolve treatment.
Washington, D.C.—The U.S. Food and Drug Administration (FDA) http://www.fda.gov/ is going after spas and suppliers who are selling and/or giving the unapproved “fat-melting” injections across the U.S. The FDA says the injections have not been proven to be safe, which are used to dissolve fat in localized areas, as reported by Business Week.
The lipodissolve injections, also known as mesotherapy, lipozap, lipotherapy, or injection lipolysis are now a popular non-surgical alternative to liposuction. The injections are used to dissolve small fat deposits around the legs, arms and belly region. The drug, which has yet to be cleared by scientists, usually are combinations of phosphatidylcholine and deoxycholate.
The FDA issued warning letters to about a half-dozen spas that offer the procedure, stating they are making unsubstantiated claims about lipodissolve therapy. The letter sent to All About You Medspa in Madison, Ind. read, “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience.” Other spas that were cited include, Pure Med Spa of Boca Raton, Fla., Monarch Med Spa of King of Prussia, Pa., in addition to three others. A Brizillian company that sells the lipodissolve product on two Web sites : zipmed.com and mesone.com, has also been issued a warning letter.
One spa’s Web site, the Monarch Med Spa, claimed, “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.” The FDA says they have received reports of permanent scarring; hard lumps on patients’ skin and skin deformities after having the therapy.
Legal News Reporter: Nicole Howley-Legal news for product liability lawyers.