April 7, 2010 — The FDA today scolded six U.S. spas and one Braziliancompany for making false and misleading claims about fat-melting injectionsknown as mesotherapy, lipodissolve, lipozap, lipotherapy, or injectionlipolysis.
“They make it sound so good and so safe,” said Kathleen Anderson, the deputydirector of the FDA’s Division of New Drugs and Labeling Compliance, during anews conference. “[They claim] it dissolves fat — melts it away with noside effects — and they have done thousands of procedures, and it really sellswell,” she says. “We are really concerned because we have had reports ofcomplications, and we have no good data that say this is safe and this iseffective.”
Side effects reported to the FDA include permanent scarring and deep,painful knots under the skin in areas where the lipodissolve cocktail has beeninjected, 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 lipodissolveproducts on two web sites: zipmed.net and mesoone.com. The agency has issued animport alert to prevent the importation and distribution of unapprovedlipodissolve drug products into the United States.
The hope is that the new warning will have a chilling effect on othermedical spas and web sites that may also be guilty of touting the benefits ofthis unproven treatment. “If other firms that didn’t get letters are makingfalse 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 thecompany from continuing to make these false and misleading claims.
What Is Lipodissolve?
Lipodissolve or mesotherapy involves a series of injections of medicationsthat are purported to melt away localized fat deposits. The drugs mostregularly used in are phosphatidylcholine and deoxycholate (commonly called PCand DC, respectively). Other drugs or products such as vitamins, minerals, andherbal extracts may also be used. Phosphatidylcholine is not approved forinjection.
There is no evidence that this procedure works despite the claims made bythe medical spas cited by the FDA. Some even claim that lipodissolve can treatmale breast enlargement, benign fatty growths (lipomas), excess fat deposits,and surgical deformities. “The FDA is not aware of any credible evidence tosupport these claims,” Anderson says.
“This is a great day for patient safety. The FDA is sending a strongmessage,” says Renato Saltz, MD, president of the American Society forAesthetic Plastic Surgery (ASAPS) and a plastic surgeon in Salt LakeCity.
Saltz tells WebMD that he has seen some bad complications in people who havetried the procedure.
The ASAPS is conducting a study of lipodissolve, the preliminary results ofwhich 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 basedon what we know today,” Saltz says. “We are working on the science andperhaps we will find some application for lipodissolve or mesotherapy in thefuture.”
This issue highlighted by the new FDA warnings is part of a larger problemin cosmetic surgery, says Felmont F. Eaves III, MD, the ASAPS president-electand a plastic surgeon in Charlotte, N.C.
“Right now, a lot of companies are pushing treatments with no data and noproof 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 fancymarketing, have a big dose of skepticism when you see ads, and ask someonequalified what the real scoop is.”