
Lap-Band maker Allergan (NYSE:AGN) received a subpoena this month from the Office of the Inspector General for the Dept. of Health & Human Services, the company revealed in an SEC filing.
The troubled weight-loss device has been the subject of federal scrutiny following an FDA statement issued late last year warning advertisers to steer clear of exaggerated and false promises in their ads for Lap-Band.
The latest investigation involved a request for documents relate to production of the device, according to the regulatory filing.
Lap-Band is approved by the FDA for weight loss in obese adults. The device is implanted during surgery and uses an adjustable silicon ring to constrict the upper portion of the stomach.
In December 2011 the FDA issued warning letters to 8 California surgical centers and the marketing firm 1-800-GET-THIN, citing them for running misleading Lap-Band ads without required risk information.
In January House Democrats called for a probe into weight-loss devices following a study concluding that nearly half of all patients who received weight-loss implants, including the Lap-Band device, and no weight loss at 6 years and that more than 40% had long-term complications, Bloomberg reported.
In February a pair of outpatient clinics in Los Angeles stopped offering weight-loss surgeries using the Lap-Band gastrointestinal device amid the ongoing controversy over marketing campaigns and Allergan announced that it would stop selling the device to companies affiliated with the 1-800-GET THIN campaign
The FDA is scheduled to meet over 2 days this week to consider the safety profile of medical technologies intended to help obese patients lose weight, evaluating the merits of endoscopic and laparoscopic weight-loss devices, such as balloons, sutures and bands, versus surgical approaches.
More than 500,000 patients have been implanted with Irvine, Calif.-based Allergan’s Lap-Band device, according to the company.