FDA issues Warning Letters for Misleading Advertising of Lap-Band

The FDA issued warning letters for misleading Lap-Band advertising which the Agency states lacks information on the risks of gastric banding. A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the FDA’s position on a issue but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions. (Click here to read the full press release).

The Warning Letters were issued against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.

The FDA issued Warning Letters 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; and
1-800-GET-THIN

because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. Misbranding under the Food Drug and Cosmetic Act (FDCA) includes misleading or false labeling/advertising or failing to prominately display required wording (see FDCA section 502).

In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts 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.”

If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the Agency indicated it is prepared to take further action, which could include product seizure or civil money penalties.

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 (such as type II diabetes and 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 (such as supervised diet, exercise and behavior modification) have not been successful. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle. To learn more click here.

“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.”

The Lap-Band has not been approved for use in children younger than 18. Only those who are able and willing to follow dietary and other health and lifestyle recommendations should consider the procedure. It’s important that patients and their physicians are aware of and understand the limitations of gastric banding.

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. 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.

If you suspect a problem with a gastric banding device, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

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FDA issues Warning Letters for Misleading Advertising of Lap-Band

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