The FDA has issued warning letters to eight California healthcare organizations and one marketing firm for failing to provide adequate risk information in their advertisements for an implanted gastric band.
The groups’ billboard and insert advertisements failed to include necessary warnings, precautions, potential adverse events, and contraindications associated with the Lap-Band gastric band, according to an FDA statement.
Also, the risk information included in the inserts may be too small for customers to read, the agency said.
The FDA noted that failure to correct advertising and promotion of the device could result in further action from the agency, including product seizure or civil monetary penalties.
Named in the warning letter are:
- 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
- 1-800-GET-THIN in Pasadena
The Lap-Band is indicated for obese adult patients with one or more obesity-related medical conditions, or with a body mass index of 40 or greater without an obesity-related medical condition.
Healthcare professionals that promote the gastric band must educate patients about risks associated with the device in their advertisements and promotions, the statement said. The device is not approved for patients younger than 18-years-old.
Several of the centers named in the warning are currently embroiled in a class action suit alleging that physicians at the clinics botched multiple Lap-Band surgeries on morbidly obese patients, leading to their deaths.
Allergan, which manufactures the device, is not named in the FDA warning.