Texas Lipotron 3000 Lawyer

July 20, 2012 — The LipoTron 3000 (also referred to as the Lipo-Ex) is a medical device that is promoted as Radio Frequency (RF) Lipoplasty. Manufacturers and plastic surgeons claim that it uses high-frequency radio waves to heat subcutaneous fat, convincing their users that 3 months to 1 year of treatment can melt fat away without pain, surgery, or recovery time. However, critics and whistleblowers are concerned that the device has never been approved by the U.S. Food and Drug Administration (FDA). Furthermore, the FDA does not appear to be taking action.

 

Back in 2010, manufacturers attempted to approve the Lipotron 3000 under the FDA’s 510(k) clearance system, which allows the fast-track approval of new medical devices so long as they are “substantially similar” to an existing device. The FDA rejected the application, so the manufacturers returned with an application that claims the Lipotron 3000 is a massager. Massagers can be sold without gaining FDA approval.

Technically, once a device is legally on the market for a medical purpose, doctors are allowed to use it “off-label” for another purpose. Some customers who purchased the $85,000 device say they were told that FDA approval was imminent, but after waiting years, the approval never occurred.

Plastic surgeons and spas do not usually promote the Lipotron 3000 as a massager, but rather as a way to reduce subcutaneous fat or tighten skin. Dr. Sherwood Baxt, a New Jersey plastic surgeon who appeared in promotional videos for the Lipotron 3000 and uses it on his patients, says that he no longer uses it for fat reduction because “it wasn’t as effective as I thought it was going to be.” He now uses it for “skin-tightening” and recommends 3-12 months of treatment.

Fortunately, there have been no reports of serious injury linked to the device. However, some people have reported minor burns and shocks when undergoing treatment. Manufacturers claim that the radio waves target subcutaneous fat and visceral fat around internal organs, while avoiding the organs themselves.

The FDA has never vetted these claims. The agency will not comment on whether they are currently investigating the manufacturers of the Lipotron 3000 or the retailers who sell treatments with the device. FDA spokeswoman Sarah Clark-Lynn said that if there were illegally-marketed devices on the market, “a physcian should not have been able to obtain it, much less use it on a patient.”

In 2011, the Texas Department of State Health Services sent a warning letter to one distributor located in Fort Worth. The distributor responded to the letter by claiming that the device was approved by the FDA. However, the distributor later corrected the statement to say that the application had only been submitted.

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