FDA: LipoDissolve Procedure Too Good To Be True
The US Food and Drug Administration has issued warning letters to six US based medical spas and a Brazilian company for making false or misleading statements about drugs that they claim will eliminate fat. Lipodissolve products and procedures have not been evaluated or approved by the FDA, although the marketing claims may lead some consumers to believe that they have.
Lipodissolve is a procedure that involves a series of injections, using drugs such as phosphatidylcholine and deoxycholate, which claims to zero in and permanently remove small pockets of fat from the body. It may also be called mesotherapy, lipozap, lipotherapy, or injection lipolysis.
The warning letters were issued to the following U.S. companies: Monarch Medspa (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), and All About You Med Spa (Madison, Ind). The Brazilian company receiving a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com.
Each of the companies has made unsupported claims that the products have “an outstanding safety record and are superior to other fat loss procedures, including liposuction.” Some of the companies have also made claims that the products can treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities.
“They make it sound so good and so safe,” said Kathleen Anderson, deputy director of the FDA's Division of New Drugs and Labeling Compliance. “[They claim] it dissolves fat -- melts it away with no side effects -- and they have done thousands of procedures, and it really sells well. We are really concerned because we have had reports of complications, and we have no good data that say this is safe and this is effective.”
Complications from the lipodissolve procedure include permanent scarring, skin deformation, and deep painful knots at the injection sites. Anyone with serious side effects from the procedure should contact their health care provider and the FDA MedWatch Adverse Event Reporting program (see below).
The American Society for Aesthetic Plastic Surgery (ASAPS) is conducting a study of lipodissolve and preliminary results will be presented at the annual meeting later this month. Renato Saltz MD, president of the ASAPS says, “At this point, there is no indication for this procedure based on what we know today. We are working on the science and perhaps we will find some application for lipodissolve or mesotherapy in the future.”
The US companies have 15 business days from the date of the receipt of the warning letter to state how they will correct the violations and prevent similar incidences from occurring in the future. Failure to comply may result in legal action. The agency has also issued an import alert against the products of the Brazilian company and has alerted the appropriate regulatory authorities in Brazil.