Advisory Panel: Lower BMI for LAP-BAND
An advisory committee to the U.S. Food and Drug Administration (FDA) took up for consideration, Dec. 3, a request by pharmaceutical company Allergan, Inc. to significantly lower how obese someone has to be to qualify for gastric banding surgery. In an 8-2 vote, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee agreed to recommend that the FDA extend the currently approved use of the LAP-BAND® system.
The LAP-BAND® was approved June 5, 2001 for weight reduction in severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions related to obesity, such as diabetes.
Allergan is requesting the FDA expand the indication for use of the LAP-BAND® device so that obese patients with a BMI of at least 35 or a BMI of at least 30 with one or more comorbid conditions qualify for the procedure. Other indications for use, Allergan says, should include obese adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs.
The Irvine, Calif. company’s LAP-BAND® adjustable banding system, which is surgically implanted (generally using a laparoscopic technique), restricts intake to the stomach. In a 12-month study sponsored by Allergan, the LAP-BAND® resulted in significant decreases in all measures of weight loss and comorbid conditions and improved quality of life, according to an FDA executive summary memorandum prepared for the Dec. 3 meeting of the Gastroenterology and Urology Devices Panel.
Federal statistics indicate that 20 percent of the adult population has a BMI of 30-35, with more than 50 percent of that population with an associated health condition. Based on this data, the number of Americans eligible for gastric banding could easily double if the FDA backs the advisory panel’s decision.