Several surgical centers in California were issued warning letters by the U.S. Food and Drug Administration today for featuring misleading advertisements for the Lap-Band, a weight-loss device.
Among the offending advertisements: billboards that do not list the device's risks and side effects.
"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings," Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said in a statement. "It's particularly troublesome when advertisements don't communicate the serious risks associated with medical devices."
In the letters, the FDA warns that the billboards and advertising inserts used by the offending companies promote the Lap-Band procedure without providing required risk information, including warnings, precautions, possible side effects and contraindications. The agency also said it was concerned that the information related to risks is printed on the advertising inserts in a font size too small to be read by consumers.
The organizations that received letters were: 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; San Diego Ambulatory Center LLC; and 1-800-GET-THIN.
If the affected companies do not change the advertising-and-promotion strategies to address the concerns raised by the FDA, the agency said it is prepared to take further action, which could include product seizure or civil money penalties.
The Lap-Band is a gastric band, a device implanted surgically that restricts the amount of food the stomach can hold. Patients eligible for the procedure are obese adults who have a body mass index (BMI) of 30 to 40, with one or more obesity-related medical conditions (such as Type 2 diabetes and hypertension). Patients with a BMI of 40 or over with or without an obesity-related medical condition can also receive the device.
Gastric banding is used when nonsurgical weight-loss methods (such as supervised diet, exercise and behavior modification) have not been successful, the FDA says. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle.
“It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health-care provider to be sure the procedure is appropriate for the patient," said Dr. Kimber Richter, deputy director for medical affairs in the FDA’s Center for Devices and Radiological Health.
Complications after gastric-banding surgery include: difficulty swallowing, abdominal pain, leaking of the gastric band, erosion of the band through the stomach wall and a shift in orientation of the band, which requires additional surgery to reposition, according to the FDA.
Health-care providers who choose to promote the gastric-banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials, the FDA says. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.