FDA WARNING_LETTER - Beverly Hills Surgery Center, LLC

The FDA issued a Warning Letter to Beverly Hills Surgery Center, LLC, regarding the marketing of the LapBand gastric banding system, a restricted device. The FDA determined that the center, through entities like 1-800-GET-THIN, misbranded the LapBand in violation of sections 502(q), 502(r), and 201(n) of the Federal Food, Drug, and Cosmetic Act.

The LapBand is a prescription-only device. The violations stem from advertising that is false or misleading, fails to reveal material facts, and does not adequately include required information on intended uses, warnings, precautions, side effects, and contraindications. Examples cited include billboards and advertising inserts that promote weight loss with the LapBand, often featuring testimonials, but fail to disclose crucial risk information, age/qualifying requirements, and the need for ongoing dietary changes. The letter notes that risk information, when present, is often in illegibly small font.

The FDA demands that Beverly Hills Surgery Center, LLC, immediately cease marketing the LapBand with violative advertising and take prompt corrective action. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties. The firm must respond in writing within fifteen working days, detailing corrective steps and preventative measures, including documentation.