California ads promoting Lap-Bands, used to help obese people use weight by constricting their stomachs, aren’t adequately warning people that they could cause a range of side-effects from nausea to death from surgical complications, the Food and Drug Administration said Tuesday.
The FDA said it had warned eight California surgical centers and a marketing company about their ads, mostly on billboards featuring smiling, slender models.
“The FDA issued Warning 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; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups,” the FDA said in a statement.
“It's particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices,” added the FDA’s Steve Silverman.
“If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties.”
The gastric bands can be placed using lapascopic surgery, via a small inciscion and guided by a camera. But it’s still abdominal surgery, with considerable risks, including death. Other complications include spitting up food, difficulty swallowing, gastric reflux, pain, stretching of the stomach so that the band no longer restricts food intake, and shifting of the device itself.
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