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.
The 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.