Adjustable Gastric Band Providers Warned By FDA For Misleading Advertising

This week, the Food and Drug Administration (FDA) sent a warning letter to the Southern California marketing company 1-800-GET-THIN for using misleading advertising to promote Lap-Band weight-loss surgery.


The agency says the company’s numerous billboards feature thin models and enticing slogans like “Let Your New Life Begin!” but fail to convey the serious risks carried by weight-loss surgery. The warnings are there, but in font so small as to be illegible, the agency says. The FDA also took issue with 1-800-GET-THIN’s other marketing materials, which similarly do not inform patients about the risks.


The FDA letters — sent to 1-800-GET-THIN and eight other affiliated surgery centers — give the outfits 15 days to figure out how to correct their misleading ads. The agency’s move comes in response to complaints from Los Angeles County’s public health agency and even from Allergan, which manufactures the Lap-Band device used in the gastric banding surgery, saying the risks of the surgery are not properly communicated.


The device, designed for weight loss in obese adults, had been approved by the FDA, which has now issued Warning Letters to the centers.


The clinics include 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.


The federal health agency said the Lap-Band is a restricted medical device that has been misbranded as a result of misleading advertising by these groups, reports PR Newswire.


In the letters, the FDA warns that billboards and advertising inserts used by the clinics to promote the Lap-Band fail to provide required risk information.


The FDA announced today that it had issued its warning letters to 1-800-Get-Thin and the surgical centers earlier this month. In those letters, the FDA complains that the Lap-Band advertising omits warnings, precautions, contraindications, and possible side effects of the procedure. The warnings in some of those ads that instruct would-be patients to consult their physicians about risks and to read online safety information "may be so small as to render the information illegible," the agency added.


The risks of the surgery, which include death, are heightened for obese individuals, according to the FDA. Risks after the Lap-Band procedure include nausea and vomiting, difficulty swallowing, gastroesophageal reflux disease, stretching of the stomach pouch, and the need for further surgery when the band shifts position or erodes into the stomach.


"FDA's concern is that these ads glamorize the Lap-Band without communicating any of the risks," Steven Silverman, director of the Office of Compliance in the agency's Center for Devices and Radiological Health, said in a press release.


The warning letters instruct and the 8 surgery centers to immediately cease marketing the Lap-Band with "misleading" ads. If they fail to comply, the agency said it may resort to "product seizure" and civil penalties.


An attorney for 1-800-Get-Thin did not respond to a request to comment on the warning letter as of press time.


Allergan, the maker of the Lap-Band system, did not receive an FDA warning letter. Company spokesperson Caroline Van Hove told Medscape Medical News that Allergan has no financial ties to 1-800-Get-Thin and no control over how Allergan customers — namely bariatric surgeons — promote Lap-Band surgery.