FDA Continues to Allow Sale of Unapproved Medical Device

Note: This press release was updated on Aug. 21, 2012

July 18, 2012

FDA Continues to Allow Sale of Unapproved Medical Device

Regulator Should Halt Distribution of the LipoTron and Investigate Apparent Illegal Marketing Campaign

WASHINGTON, D.C. – The Food and Drug Administration (FDA) should act immediately to end the distribution, sale and promotion of an unapproved medical device that could pose a risk of harm to patients, Public Citizen said in a letter sent today to the FDA.

The FDA has been aware for several years of the apparent illegal sale and promotion since 2007 of the LipoTron medical device — manufactured by RevecoMED International in Fullerton, Calif., and intended for use in removing subcutaneous and visceral fat, and sometimes sold as the major component of a weight loss program called Lipo-Ex — without the approval or clearance of the FDA, the letter said.

After learning of this situation from a July 11 story published in FairWarning, Public Citizen obtained documents from one of the whistleblowers who was referenced in the story and who originally brought this matter to the attention of the FDA.

According to information provided to Public Citizen by the whistleblower, in approximately 2007, and again in approximately 2009, RevecoMED International sought clearance from the FDA for marketing the LipoTron. In both instances, the FDA did not grant clearance, instead requesting additional information from the company. Despite this lack of clearance, RevecoMED International continued to market the device.

The device, which is being promoted as a treatment to “melt” fat, poses a risk of burns.

According to documents  provided by the whistleblower, the FDA’s Office of Criminal Investigations was initially presented with allegations, along with supporting evidence, of illegal marketing of the LipoTron by RevecoMED and its distributor (Advanced Aesthetic Concepts) in January 2010. A series of subsequent emails from an FDA criminal investigator appears to confirm that RevecoMED and its distributor have been illegally marketing the LipoTron.

“The emails provided to us by the whistleblower demonstrate that multiple FDA officials have been aware of these apparently illegal activities related to marketing of the LipoTron for several years,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “By not removing these devices from the market and clinical practice, these officials have recklessly failed to protect patients.”
 
In the letter, Public Citizen called on the FDA to:

(1) Immediately seize all LipoTron devices that have been manufactured by RevecoMED and either (a) are being held in inventory by the manufacturer in the U.S. or (b) have been sold and distributed to user facilities in the U.S.

(2) Immediately order RevecoMED and any distributors of the LipoTron device to cease and desist all activities involving the distribution, sale and promotion of the LipoTron device.

(3) Expeditiously complete its criminal investigation of the distribution, sale and promotion of the LipoTron, and take appropriate legal action against those individuals, companies and user facilities that are found by the agency to have engaged in any illegal marketing or promotion of this device.

“The failure of the FDA to take appropriate action to end these apparently illegal activities after they were brought to the attention of the agency’s Office of Criminal Investigations more than two and half years ago is disturbing and inexplicable,” said Carome. “The agency’s failure to act has allowed numerous patients throughout the U.S. to be exposed to a potentially harmful medical device with unproven effectiveness.”

Read the letter.