FDA Issues Strong Warnings over 1-800-Get Thin Lap-Band

Los Angeles, CA: The Food and Drug Administration (FDA) recently stated that the 1-800-GET-THIN marketing company uses misleading advertising to promote the company's Lap-Band weight-loss surgery. The FDA says that the billboard, radio and television ads underplay serious risks to patient health.

In the FDA news release of December 11, 2011, the agency stated they had 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 to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups.

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 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. But Lap-Band surgery can also cause infection, nausea, vomiting and irritation of the esophagus.

"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' 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."

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Published on Dec-28-11