1-800-Get-Thin Accused of Misleading Patients

Federal health officials today warned eight surgical centers and a marketing firm in California that they have 15 days to correct misleading advertisements promoting the Lap-Band, a stomach-restricting device used to treat obesity, or face product seizure and fines.

The Food and Drug Administration said advertisements by the centers and a marketing firm, 1-800-GET-THIN, leave out facts about the risks and side effects of Lap-Band implantation. The stomach-restricting band is made by Irvine-based Allergan.

The FDA sent letters to Bakersfield Surgery Institute, Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons LLC, Valencia Ambulatory Center LLC, Cosmopolitan Plastic & Reconstructive Surgery, San Diego Ambulatory Center LLC and 1-800-GET-THIN LLC.

In a news release, the FDA warns that billboards and advertising inserts  promoting the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the printed information related to risks on the advertising inserts is too small to be read by consumers.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”

Deaths and injuries have led to wrongful-death and injury lawsuits against 1-800-GET-THIN, its affiliated surgery centers and doctors who performed the procedures. Allergan is not affiliated with 1-800-GET-THIN.

If you suspect a problem with a gastric banding device, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.