US Food and Drug Administration (FDA) has issued a warning to 8 surgical centers (Bakersfield Surgery Institute, Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center in West Hills, Top Surgeons LLC in Beverly Hills, Valencia Ambulatory Center, Cosmopolitan Plastic & Reconstructive Surgery in Beverly Hills, San Diego Ambulatory Center in Pasadena) and 1 marketing firm in California for misleading advertisements promoting the gastric band, a stomach-restricting device used to treat obesity.
The warning was issued as the advertisements failed to include necessary warnings, precautions, potential adverse events and contraindications associated with the Lap-Band gastric band.
AdvertisementThe Lap-Band is indicated for obese patients above 18-years of age or with a body mass index (BMI) between 30-40 with one or more obesity-related medical conditions, like diabetes or high blood pressure. It limits food intake, but can also cause irritation of the esophagus, infection, nausea and vomiting in some cases.
The prime targets of the Lap-Band advertisements are people who have tried other weight-loss methods and are now being led to believe that surgery is an easy option. The FDA action is aimed at the portal through which such vulnerable subjects may be tempted to make unwise and uninformed choices about their healthcare.
Failure to correct the advertisements could result in further action from the agency, including product seizure or civil monetary penalties.
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