FDA warns firms of misleading Lap-Band ads

WASHINGTON, Dec. 13 (UPI) -- The U.S. Food and Drug Administration said Tuesday it warned eight California surgical centers their ads for the Lap-Band weight-loss device were misleading.

The FDA said it sent letters to Bakersfield Surgery Institute Inc., Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons LLC, Valencia Ambulatory Center LLC, Cosmopolitan Plastic & Reconstructive Surgery and San Diego Ambulatory Center LLC, telling them their advertising for the Lap-Band failed to provide required risk information, including warnings, precautions, possible side effects and contraindications. A marketing firm, 1-800-GET-THIN, also got a warning letter, the FDA said.

The Lap-Band is a gastric band, is a medical device implanted surgically around the top of the stomach to produce weight loss in obese adults.

The letter also said advertising inserts used by the eight surgical centers and the marketing firm to promote the Lap-Band procedure had risk warnings printed in type size too small to be read by consumers.

"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings," Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said in a statement.

"It's particularly troublesome when advertisements don't communicate the serious risks associated with medical devices."

If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency said it is prepared to take further action, which could include product seizure or civil money penalties.