Popular Fat Reduction Device Has Yet To Be Approved By The FDA

Having been touted as the next generation in non-invasive weight reduction, the LipoTron 3000 has established itself as the most effective, non-surgical way for patients to rid themselves of unwanted fat. Subsequently, testimonials praising the device have translated into millions of dollars in sales for physicians, medical spas and the device’s manufacturer, RevecoMED International of Fullerton, Calif. Of significant concern, however, is a distinct lack of U.S. Food and Drug Administration (FDA) approval. The LipoTron 3000 has yet to be cleared or approved by the FDA, which means the device is in direct violation of federal law.

Developed by RevecoMED International, the LipoTron 3000 has been referred to as “the most innovative, effective, and technologically advanced” non-surgical method of removing fat. In doing so, this device destroys undesirable fat cells by emitting several radio-frequency waves throughout the target area. According to the device’s manufacturer, these procedures are specifically designed to target subcutaneous fat, located just below the skin’s surface. However, the searing radio-frequency waves are also able to target and destroy visceral fat surrounding the body’s vital organs. Physicians and medical spas typically recommend six to eight treatments for about $400 each.

While doctors and medical spas around the country have been using this device to eradicate fat for several years, it has yet to receive approval from the FDA. According to an investigation headed by the watchdog group FairWarning, the FDA has been aware of the device’s current uses since at least January of 2010. However, regulatory officials will not say if their is currently an investigation underway.

The FDA was made aware of the transgressions committed by RevecoMED when two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator. Paige Peterson, a former LipoTron distributor, and Belinda W. Worley, a marketing consultant who worked with her, agreed to meet with criminal investigator Evan Rae. Peterson then acknowledged that she gave Rae a detailed statement, a computer flash drive and copies of records, including emails, memos and invoices pertaining to the sales of LipoTron 3000 devices.

Complicating the volatile situation, were comments made by RevecoMED’s President, James S. Rosen. According to Rosen, Peterson had gone over to “the dark side.”

“She’s a person that’s vindictive,” he said. “She’s doing it out of spite.”

Rosen also acknowledged that the FDA has not contacted him or his company. He asserted that, “As of today, we are compliant with the FDA.”

In response to the FDA’s neglect for the situation, the Texas Department of State Health Services issued a warning letter last September to a Fort Worth distributor for marketing the LipoTron 3000 without FDA clearance. According to an agency report, Mark Durante, managing partner of Advanced Aesthetic Concepts, told state investigators that the LipoTron 3000 had been cleared by the FDA. However, he was later forced to correct himself once it was obvious that the device had not received the appropriate clearance.

In response to the warning letter, Durante had his practice change the verbiage used in LipoTron 3000 promotional ads on their website. However, a spokeswoman for the Texas agency said it recently opened a second complaint investigation of Advanced Aesthetic Concepts.

In their first attempt to gain approval from the FDA, RevecoMED International sought to have the LipoTron 3000 administered under the market clearance approval process in 2007. In order for RevecoMED International to have gained approval for their device, all they would have needed to do was to prove that it was similar in both safety and effectiveness to products that were already on the market. However, Reveco’s bid failed. The company’s initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data.

While having been turned down by the FDA, LipoTron 3000 sales continued despite not having gained legal access to the U.S. market. According to Sarah Clark-Lynn, an FDA spokeswoman, “a physician should not have been able to obtain it, much less use it on a patient.”

While there have been scattered incidents of patients receiving minor shocks and burns from LipoTron 3000 treatments, there are currently no known reports acknowledging serious injury. The real problem, regarding the sales of these devices, is the manufacturer’s direct disregard for federal law and the FDA’s lack of action.

Do I Have a LipoTron 3000 Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in LipoTron 3000 lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured after receiving LipoTron 3000 treatment, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.