The U.S. Food and Drug Administration announced today that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN, for misleading ads for Lap-Band, a surgically implanted gastric band for weight loss.

Lap-Band is for obese adults who have a body mass index (BMI) of 30 to 40, with one or more obesity-related medical conditions (such as type 2 diabetes and hypertension), or for patients with a BMI of 40 or over with or without an obesity-related medical condition, according to the FDA.

We’ve recently reported on the considerable risks of the procedure, and the difficulty of recovery.

The FDA said that it sent warning letters to the surgical centers and marketing firm because Lap-Band is a restricted medical device that is being misbranded as a result of misleading advertising. The letters stated that billboards and ad inserts fail to provide required risk information, including warnings, precautions, possible side effects and contraindications, and that the font size of information related to the risks on the advertising inserts is too small to be read.

The FDA is ready to take further action, (product seizure or civil money penalties) if the companies do not address its concerns over the misleading advertisements.

According to the FDA, gastric banding is supposed to be 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.

The Lap-Band has not been approved for children or teens younger than 18. The FDA says that only those who are able to follow dietary and other health and lifestyle recommendations should consider the procedure, and that it’s important to be 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.

In addition to 1-800-GET-THIN, the surgical centers that the FDA sent letters to included Bakersfield Surgery Institute, Beverly Hills Surgery Center, Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons, Valencia Ambulatory Center, Cosmopolitan Plastic & Reconstructive Surgery, and San Diego Ambulatory Center.

Our previous coverage of some of the issues concerning gastric banding were covered in Bariatric surgery: A personal perspective, and Think twice about lap-band surgery for weight loss.

FDA issues Warning Letters for misleading advertising of Lap-Band [FDA]