Is plastic surgery becoming the new Wild West?
Has the mind set of plastic surgeons changed to an "anything goes" mentality?
The FDA recently accused six U.S. spas and a Brazilian company of making false and misleading claims about fat-melting injections known as mesotherapy, lipodissolve, lipozap, lipotherapy, or injection lipolysis. The action comes as no surprise to anyone who has followed the procedures in question.
“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. “[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.
However, Ms. Anderson continues, the FDA is "really concerned" by reports of complications and the absence of data showing that the procedures are even effective, let alone safe. Reported side effects include permanent scarring and deep, painful knots under the skin in areas where the lipodissolve cocktail has been injected.
Lipodissolve, or mesotherapy, entails delivery of a series of injections of medications purported to melt away localized fat deposits. The chemicals injected ran the gamut from vitamins to minerals to herbal extracts to who-knows-what. The drugs used most commonly include phosphatidylcholine and deoxycholate, even though phosphatidylcholine is not approved for injection.
There is no evidence that this procedure works. “The FDA is not aware of any credible evidence to support these claims,” Ms. Anderson says.
According to Dr. Felmont Eaves, a plastic surgeon and president-elect of the American Society of Aesthetic Plastic Surgery, the FDA warnings reflect a much wider problem in the cosmetic surgery industry.
“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,” Dr. Eaves told 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.”
APSG Comment: "Ask someone qualified"? Like who? Could Dr. Eaves mean, perhaps, someone like your plastic surgeon? Companies may indeed push a new treatment or device, but it takes a licensed practitioner to deliver actual care.
Despite the small numbers of spas that received this warning, use of lipodissolve and similar mesotherapy treatments is widespread in both the East Asia and West. Many board-certified plastic surgeons actively promote lipodissolve in their practices despite heavy scepticism from authorities.
Sadly, this limited FDA action highlights only a single symptom of a more serious underlying disease.
From shameless stem cell claims to hawking "minimally invasive" sham treatments to advertising unproven invasive techniques, more than a few cosmetic surgeons seem to be evolving into hucksters. Whether driven by the global oversupply of surgeons or the economic downturn, this "anything goes" mentality now seems to pervade plastic surgery.