[author: Aaron Kase]
When is a massager more than a massager? When it’s sold and used to melt fat, contrary to its FDA registration.
An investigative story by public-interest journal Fairwarning lays out the story of the LipoTron 3000 device, which is being advertised and used nationwide as a fat-reduction tool, frequently and falsely touted as “FDA approved.” According to RevecoMED International, the manufacturer, the device uses radio frequency to literally melt the fat away, without disrupting other internal organs.
Unfortunately, the FDA never approved the device for fat reduction. Documents reviewed by Fairwarning showed that the company twice applied for clearance to market the device, but was denied both times. Finally, in 2011 the company registered Lipotron as a “Class 1″ massager, a less rigorous process that doesn’t require any testing or approval from the FDA.
Nevertheless, critics say, Lipotron continues to be marketed and used to fight fat, in violation of FDA rules.
“In this case, where the product was only approved for sale as a simple massager, the manufacturer cannot represent that the product has other medical benefits such as the ability to melt fat and promote weight loss,” says Anthony T. DiPietro, a medical malpractice trial lawyer from New York City who has teamed up with the law firm of Slater Slater Schulman to handle pharmaceutical litigation and defective drug cases, as well as product liability lawsuits for people who have been injured by dangerous and defective products.
An internet archive of the manufacturer’s website from 2010 clearly advertises LipoTron for fat reduction: “LipoTron uses radio frequency to specifically target fat cells,” it reads, with a description of how the fat will be dissolved and subsequently eliminated by the body. The webpage has since been deleted.
RevecoMED President James S. Rosen told Fairwarning, “As of today, we are compliant with the FDA.”
Never Obtained Approval
Anthony T. DiPietro
Consumer watchdog group Public Citizen has written a letter to the FDA urging them to take action and issue a recall for the LipoTron device, as well as asking individual state agencies to investigate. The group estimates that several hundred of the devices are in use around the nation.
“It never obtained approval,” says Dr. Michael A. Carome, deputy director of Public Citizen’s Health Research Group. “It’s been marketed since at least 2007, if not earlier.”
LipoTron’s approval as a massager, Carome says, is not carte blanche for it to be marketed and used to burn fat. “The way it’s being used by multiple physicians and multiple health spas around the country, it clearly is not a massager,” the doctor says.
Without proper testing, the device could potentially hold danger for consumers. The Fairwarning story reports scattered incidents of minor shocks and burns but no serious injuries reported. No known lawsuits have yet been filed against the manufacturer or any doctor or health spa that uses it, but should someone get hurt a number of parties could be liable.
“A person who is injured by a non-FDA approved medical device has several options,” DiPietro explains. “The patient can sue the doctor or facility where the injury occurred in order to obtain compensation for his or her injuries. It is important to note that doctors are not allowed to represent to their patients that the use of such non-FDA approved devices are safe or effective for the patient. This is especially true where the device has already been rejected by the FDA for that particular use.”
The manufacturer could also be liable, DiPietro notes.
As far as unregulated medical devices go, LipoTron could just be the tip of the iceberg, according to Public Citizen. Due to the lack of rigor needed for manufacturers to obtain a Class 1 clearance from the FDA, there could be many more out there posing unknown dangers to patients.
“Hundreds of thousands of devices are registered through that pathway every year, and it’s unclear what if any review the FDA does to confirm registration of such Class 1 applications,” says Carome. After LipoTron’s application for approval as a fat reduction device was denied, he says, “it’s astonishing that the FDA subsequently allowed it to be classified as a level 1 device and that it’s remained on the market.”
The FDA did not respond to request for comment.