Lap-Band Weight-Loss Surgery Risks Not Fully Disclosed in Ads: FDA

Federal health regulators are warning surgical centers and a marketing company to stop posting misleading advertisements for gastric lap band procedures, which often herald the weight loss results of the medical implant without warning consumers about the serious risk of health problems and complications, which could include death. 

The FDA issued warning letters to eight surgical centers in California and the marketing firm 1-800-GET-THIN LLC, for misleading lap band advertisements on Monday.

Surgical centers that received the warning letters include 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; and San Diego Ambulatory Center LLC.

The agency claims that all of the companies splashed California with billboards and eye-catching ads featuring slim people and touting the incredible weight loss potential if consumers undergo Lap-Band implant surgery. However, the ads fail to give adequate warnings about the Lap-Band weight-loss surgery risks, as required by federal law.

When the risks are included in the ads, the FDA indicates that the print is often far too small to actually be read by consumers.

The companies have 15 days to respond to the letters, telling the FDA how they intend to immediately correct their misleading ads. If they fail to do so, or fail to take action, they could face FDA penalties that could include product seizure or fines.

The Lap-Band, or laparoscopic adjustable gastric banding, is a band placed around the upper part of the stomach that creates a small pouch which quickly fills with food. The band causes the person to feel full quickly, which may result in weight loss. However, the Lap-Band is linked to a number of complications, including erosion of the band through the stomach wall, the band moving out of position, nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD), abdominal pain, and leaking of the gastric band. In addition, recipients must change their eating habits, as they are unable to eat large meals and must eat a series of smaller meals throughout the day for the rest of their lives or until they have the band removed.

A recent study found that 60% of people who undergo gastric Lap-Band surgery could experience complications that require additional surgery and nearly half will eventually require the Lap-Band’s removal. Nearly a third discover that their bands have eroded the wall of their stomach over time, according to the study by Belgian researchers.