Lap Band Clinic Gets FDA Warning Letter Over Marketing Claims

Allegedly misleading advertising statements about the risks and benefits of Lap-Band weight loss surgery has led the FDA to send a warning letter to a Los Angeles clinic, as the agency continues to ratchet down on what are often seen as fly-by-night surgical centers that promote the procedure as a quick fix, without disclosing the potential health risks. 

The FDA warning letter was sent to Lap-Band VIP on June 25 and released to the public this week, referring to the clinic’s commercials and billboards as false and misleading.

The text of two commercials and two billboards are highlighted in the letter, none of which provide any information about the potential health risks. There is no mention that there could be surgical complications and the advertisements do not tell the consumers that the Lap-Band requires a drastic change in eating habits, according to the federal regulatory agency.

The FDA has requested that the clinic immediately stop marketing the Lap-Band in advertisements that violate federal regulations and indicated that the clinic could be subject to potential regulatory action if it does not comply. The FDA warned that it could seize the company’s assets, get an injunction against its operation or pursue monetary fines if it failed to comply.

The Lap-Band, also known as the laparoscopic adjustable gastric banding, is a loop of material placed around the upper part of the stomach, creating a small pouch which quickly fills with food. People with the band feel full after eating small amounts, which promotes weight loss.

Although the Lap Band can be effective, there are a number of potential complications associated with the weight loss surgery, 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.

The Lap-Band forces recipients to 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.

Recent studies have suggested that 40% of patients implanted with the weight loss device may suffer serious complications and problems following Lap-Band procedures. 

In December, the FDA raised concerns about many clinics that were not fully disclosing the risks associated with Lap-Band procedures in direct-to-consumer advertisements. The agency has focused on several Lap-Band clinics in recent months, particularly in the L.A. area.