FDA Warns: Fat-Dissolving Spa Claims Are Unfounded

If you've heard the come-on that a spa treatment could melt your fat away, don't buy it.

The Food and Drug Administration said today it has warned six spas they have been making false and misleading claims about a procedure often called lipodissolve.

But you might also hear it referred to as lipozap, lipotherapy, injection lipolysis or mesotherapy.

In no uncertain terms, FDA told the spa operators to zip their lips on lipozap and all the rest. "They make it sound so good and so safe —where they say 'It dissolves fat,' 'It melts it away,' 'There's no side effect,' 'We've done thousands procedures,' " FDA's Kathleen Anderson said in a conference call with reporters. "It really sells very well, and we're really, really concerned. We have no good data that this is safe or effective. That's what we want consumers to know."

 

The procedure, touted as an alternative to liposuction, involves a series of drug injections purported to dissolve fat. The medications inside the syringes vary from from spa to spa, but usually include phosphatidylcholine and deoxycholate. For now, you can check out the description on the Web site of one of the companies that was warned here.

The FDA says that none of the drugs used in lipodissolve have passed muster with the agency for this procedure. "There is no FDA-approved injectable product that is phosphatidylcholine," Anderson noted. "I mean, there just isn't."

The risks also aren't understood. Pain at the injection site, knots under the skin and permanent scarring have been reported. But there have been no definitive studies of side effects.

Beyond the six spas that were issued warning letters, the FDA noted that many others market the procedure.

Back in 2006, the American Society for Aesthetic Plastic Surgery (ASAPS) said it was funding a study of lipodissolve. This afternoon, ASAPS President-Elect Dr. Felmont Eaves told Shots that the results are expected to be presented in about two weeks at the group's next national meeting. He acknowledged, however, that the study was small and " doesn't really have the statistical power to answer all the questions we may have."

For now, Eaves said, there's simply no proof for lipodissolve. "There's this Wild West mentality [with new aesthetic procedures] that you go out there and claim whatever you want and patients are drawn in," he said. "So it's good the FDA is saying 'No, you need to have proof.' "

Eaves added, "We're saying that the data is incomplete. We don't know whether it works and if it's safe or not until we have more data."