Adjustable Gastric Band Providers Warned By FDA For Misleading Advertising
Adjustable gastric band providers have been issued with warnings by the FDA for misleading advertising, the agency announced today.
The FDA said it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, PR Newswire reports.
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 omitted information includes warnings, precautions, possible side effects and contraindications.
The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers, PR Newswire reports.