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“They make it sound so good and so safe,” said Kathleen Anderson, the deputy director of the FDA’s Division of New Drugs and Labeling Compliance, during a news conference. “[They claim] it dissolves fat — melts it away with no side effects — and they have done thousands of procedures, and it really sells well,” she says. “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.”
Side effects reported to the FDA include permanent scarring and deep, painful knots under the skin in areas where the lipodissolve cocktail has been injected, she says.
The new warning went out to six U.S companies:
*Monarch Medspa in King of Prussia, PA
*Spa 35 in Boise, Idaho
*Medical Cosmetic Enhancements in Chevy Chase, MD
*Innovative Directions in Health in Edina, Minn
*PURE Med Spa in Boca Raton, Fla
*All About You Med Spa in Madison, Ind
The FDA also admonished a Brazilian company for hawking lipodissolve products on two web sites: zipmed.net and mesoone.com. The agency has issued an import alert to prevent the importation and distribution of unapproved lipodissolve drug products into the United States.
The hope is that the new warning will have a chilling effect on other medical spas and web sites that may also be guilty of touting the benefits of this unproven treatment. “If other firms that didn’t get letters are making false and misleading claims, they should also stop doing it,” she says.
If the companies do not take steps to correct the violations within 15 days, the FDA can seize the products or order an injunction to legally stop the company from continuing to make these false and misleading claims.
What Is Lipodissolve?
Lipodissolve or mesotherapy involves a series of injections of medications that are purported to melt away localized fat deposits. The drugs most regularly used in are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other drugs or products such as vitamins, minerals, and herbal extracts may also be used. Phosphatidylcholine is not approved for injection.
There is no evidence that this procedure works despite the claims made by the medical spas cited by the FDA. Some even claim that lipodissolve can treat male breast enlargement, benign fatty growths (lipomas), excess fat deposits, and surgical deformities. “The FDA is not aware of any credible evidence to support these claims,” Anderson says.
“This is a great day for patient safety. The FDA is sending a strong message,” says Renato Saltz, MD, president of the American Society for Aesthetic Plastic Surgery (ASAPS) and a plastic surgeon in Salt Lake City.
Saltz tells WebMD that he has seen some bad complications in people who have tried the procedure.
The ASAPS is conducting a study of lipodissolve, the preliminary results of which are slated to be presented at the annual ASAPS meeting in Washington, D.C., later this month.
“At this point, there is no indication for this procedure based on what we know today,” Saltz says. “We are working on the science and perhaps we will find some application for lipodissolve or mesotherapy in the future.”
This issue highlighted by the new FDA warnings is part of a larger problem in cosmetic surgery, says Felmont F. Eaves III, MD, the ASAPS president-elect and a plastic surgeon in Charlotte, N.C.
“Right now, a lot of companies are pushing treatments with no data and no proof of safety, and devices approved by FDA are being used for other things. It’s a Wild West out there,” he tells WebMD. “Don’t be lured by fancy marketing, have a big dose of skepticism when you see ads, and ask someone qualified what the real scoop is.”