The Food and Drugs Administration (FDA) has come out with 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 agency said Tuesday that ad claims such as, “I lost 90 pounds with the Lap-Band!” or “Ready to be the next weight-loss success story?” leave out mandatory information about the risks and side effects of Lap-Band implantation.
The FDA issued warning letters to 1-800-GET-THIN LLC, 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.
Gastric banding operations are provided in morbidly obese patients. It 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. The stomach-restricting band - made by Allergan Inc. - limits food intake, but can also cause infection, nausea, vomiting, and irritation of the esophagus.
The 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. The FDA added that the risk information included in the inserts may be too small for customers to read. 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.
In February the agency expanded Lap-Band's approval to an additional 26 million American patients with a body mass index (BMI) between 30 and 40 and one weight-related medical condition, such as diabetes or high blood pressure. That's up from the 15 million patients who were eligible under the previous criteria: BMI of 40 or higher, or 35 and higher with weight-related complications.
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.
The companies have 15 business days to respond and lay out plans to correct the advertisements.
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