Posted August 17, 2012 in Uncategorized
The LipoTron 3000, a popular aesthetic device touted for its ability to “eliminate fat”, is gaining popularity in some physicians’ offices around the country, but the product hasn’t been cleared by federal authorities.
Medical spas in Chicago and Florida call the LipoTron 3000 “innovative” and “effective,” but the device hasn’t achieved clearance by the Food and Drug Administration. The device, also known as Lipo-Ex, is manufactured by RevecoMED and has been falsely advertised by some practitioners as being FDA-approved, according to the Florida Center for Investigative Reporting.
According to the FCIR, the federal agency won’t say whether it is investigating RevecoMED, citing a policy not to discuss investigations or acknowledge if there is one.
RevecoMED President James S. Rosen said the government agency hasn’t contacted his company.
“As of today, we are compliant with the FDA,” Mr. Rosen told the FCIR.
The Texas Department of State Health Services issued a warning letter to a Fort Worth distributor in September 2011 regarding the company’s marketing of LipoTron without FDA clearance, FCIR reports.
Another day, another sketchy medical device:
But there’s a problem: The LipoTron, which targets fat with radiofrequency waves, has never been cleared or approved by the U.S. Food and Drug Administration, which would make it illegal under federal law to sell or promote it for weight loss.
The FDA is aware of the activity. But an investigation by FairWarning found that the agency has not taken enforcement action – even though it has known about the situation at least since January 2010. At that time, two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator.
The LipoTron isn’t FDA-approved, though some spas that offer the treatment falsely claim that it is. This isn’t some harmless butt massager, this is potentially serious:*
Selling for as much as $85,000, the LipoTron passes radiofrequency waves through the body to heat, and destroy fat cells. According to Reveco, the procedure targets subcutaneous fat, which is just below the skin, as well as visceral fat surrounding the vital organs, but without harming adjacent tissues. Spas typically recommend six to eight treatments for about $400 each.
The FDA is aware the un-approved fat-zapper, but it hasn’t moved to shut down the company that makes it.
*Assuming it works as advertised, which it may not.
Unlike the LipoTron, Liposonix is FDA approved. The treatment safety of the Liposonix system was assessed through 24 weeks post-treatment. Safety was evaluated by monitoring adverse events, results from a pre-specified battery of blood tests and physical examinations. The adverse events resulting from treatment with the Liposonix during this study included procedural pain, post-procedural pain, bruising and swelling. These were mostly mild, short-lived in duration and resolved without incident. No serious adverse events or unanticipated adverse device effects were shown to be related to treatment with the investigational device.
Call Concannon Plastic Surgery and Medical Spa today at 573-449-5000 and schedule your free Liposonix consultation!