Advertisers that omit the risks and exaggerate the benefits of Lap-Band surgery could find themselves in a federal beef, according to an FDA warning to surgical centers and marketing firms.
The federal watchdog agency issued warning letters to 8 California surgical centers and the marketing firm 1-800-GET-THIN, citing them for running misleading Lap-Band ads without required risk information.
"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings," the federal watchdog agency’s Steve Silverman said in prepared remarks. "It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices."
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The FDA issued warning letters to the Bakersfield Surgery Institute, Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons, Valencia Ambulatory Center, Cosmopolital Plastic & Reconstructive Surgery, San Diego Ambulatory Center, and to 1-800-GET-THIN.
The agency warned the recipients that billboards and advertisements promoting the Lap-Band procedure failed to include risk information such as warnings, side effects and contraindications.
If recipients do not correct their promotional strategies, they’ll face product seizure and fines, according to the letter.
The Lap-Band is approved by the FDA for weight loss in obese adults. The device is implanted during surgery and uses an adjustable silicon ring to constrict the upper portion of the stomach.
Gastric banding was first approved by the federal watchdog agency in 2001 for use in patients categorized as "severely obese" with a Body mass index over 40, but last year, the FDA approved Lap-Band surgery for patients over 18 who have an obesity related medical condition and a BMI of 30 to 40.
"The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider," Kimber Richter, deputy director for medical affairs in the FDA’s center for devices & radiological health said in prepared remarks. "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."
More than 500,000 patients have been implanted with Irvine, Calif.-based Allergan’s (NYSE:AGN) Lap-Band device, according to the company.
