FDA WARNING_LETTER - Palmdale Ambulatory Surgery Center

The FDA issued a Warning Letter to Michael Omidi, President of Bakersfield Surgery Institute, Inc., and associated entities (Palmdale Ambulatory Surgery Center, Valley Surgical Center, Top Surgeons, LLC, Cosmopolitan Plastic & Reconstructive Surgery), regarding the marketing of the LapBand gastric banding system. The FDA determined that the firms, through means including 1-800-GET-THIN, are marketing the LapBand in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The LapBand is a restricted device, approved by the FDA with the condition that it only be sold and distributed under prescription. The firms' promotion of the LapBand misbrands the device under sections 502(q), 502(r), and 201(n) of the Act.

Specific violations include: 1. **Misleading Advertising (Section 502(q) and 201(n)):** Advertisements, including billboards and inserts, fail to reveal material facts such as relevant risk information, age and other qualifying requirements for the procedure, and the need for ongoing modification of eating habits, as provided in the approved LapBand labeling. Examples cited include billboards stating "SAFE 1 HOUR" and inserts with large testimonials and calls to action, while critical disclaimers are in very small print. 2. **Inadequate Risk Disclosure (Section 502(r)):** Advertisements