Yesterday Allergan, Inc. publicly admitted that the company has received a subpoena from the Department of Health and Human Services in connection with its gastric banding device, Lap-Band.
Simply put, a gastric banding device is designed to help overweight individuals lose weight. An adjustable silicone band is invasively implanted around the patient’s stomach and tightened to reduce its size.
The U.S. Food and Drug Administration (“FDA”) approved the gastric banding device in 2001 for patients who were at least 100 pounds overweight, had a body mass index (“BMI”) of 40 or higher, or a BMI of at least 35 accompanied by additional obesity-related conditions or diseases. Subsequently, in February, 2011, the FDA approved Allergan’s request to expand the device’s marketing to those with a lower BMI and at least one obesity-related condition.
However, just this past January Democratic lawmakers in Washington called for hearings regarding the efficacy and safety of gastric banding devices, including the Lap-Band. House representatives were motivated by a recent Archives of Surgery study, which found that almost 50% of gastric band patients enjoyed no appreciable weight loss—and sometimes needed the device removed—six years after undergoing the procedure. Additionally, over 40% of gastric banding patients suffered long-term health complications attributed to the surgery.