The U.S. Food and Drug Administration (FDA) sent warning letters to 8 surgical centers in California and a marketing firm for misleading advertising of the weight loss device, the Lap-Band. The agency announced its action against the companies on Dec. 13.
What are FDA’s Requirements
According to the FDA announcement, the companies failed to include important and required risk information in various advertisements, including billboards.“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 FDA requires medical device companies to include information about the potential dangers and side effects associated with their products. The FDA also noted its concerns that the font size used on the Lap-Band advertising inserts may be too small for consumers to read.
What is Lap-Band
The Lap-Band is an implanted medical device used for weight loss surgery in obese adults who have failed in other attempts to lose weight. It is not intended for people under the age 18.The federal agency noted that all patients who are considering using the Lap-Band need to be aware not only of the potential risks, but also be committed to lifestyle changes such as diet changes.The FDA issued warning letters to the following companies:
- Bakersfield Surgery Institute Inc.
- Beverly Hills Surgery Center
- San Diego Ambulatory Center LLC
- Valley Surgical Center
- Top Surgeons LLC
- Palmdale Ambulatory Center
- Valencia Ambulatory Center LLC
- Cosmopolitan Plastic & Reconstructive Surgery
- 1-800-GET-THIN.
Source: FDA – http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm283455.htm
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