WebMD Medical News
Laura J. Martin, MD
April 7, 2010 -- The FDA today scolded six U.S. spas and one Brazilian
company for making false and misleading claims about fat-melting injections
known as mesotherapy, lipodissolve, lipozap, lipotherapy, or injection
“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
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:
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.
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
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
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
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.”
SOURCES:Kathleen Anderson, deputy director, Division of New Drugs and Labeling
Compliance, FDA, Silver Spring, Md.FDA news conference, April 7, 2010.News release, FDA.Renato Saltz, MD, president, American Society for Aesthetic Plastic Surgery;
plastic surgeon, Salt Lake City.Felmont F. Eaves III, MD, president-elect, American Society for Aesthetic
Plastic Surgery; plastic surgeon, Charlotte, N.C.
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