The U.S. Food & Drug Administration (FDA) just issued a warning to California surgery centers over Lap-Band ads because the ads lack information on risks of gastric banding
The FDA announced that it has taken action against eight California surgical centers and the marketing firm 1.800.GET.THIN LLC, for misleading advertising of the Lap-Band. Lap-Band is an FDA-approved restricted medical device used for weight loss in obese adults and is, said the FDA, being misbranded as a result of misleading advertising by these groups. The FDA Warning Letters were issued to:
• 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
In the letters, the FDA warned that billboards and advertising inserts used by these firms to promote the Lap-Band procedure fail to provide required risk information that include warnings, precautions, possible side effects, and contraindications. The FDA said it is concerned that the font size used in the ads for risks is too small to be read by consumers.
“The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”
The agency said it is prepared to take further action, such as product seizure or civil monetary penalties, if these firms do not change the advertising and promotion strategies to address the FDA’s concerns.
The Lap-Band is a gastric band—an implanted medical device—used in a surgical procedure for weight loss in obese adults who have a body mass index (BMI) of 30-40, with one or more obesity-related medical conditions (Type II diabetes, hypertension), or in patients with a BMI of 40 or over with or without an obesity-related medical condition.
Gastric banding is used when non-surgical weight loss methods (supervised diet, exercise, and behavior modification) have not resulted in desired weight loss. Patients considering gastric banding must also make significant changes to how they eat and live.
“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “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.”
Health care providers promoting the gastric band procedure must educate patients about the risks involved, which must also be indicated in advertising and promotional materials, which patients should read and should receive from their physician, said the FDA.