An FDA advisory panel has voted 8 to 2 in favor of approving an expanded indication for an implantable adjustable gastric band (Lap-Band Adjustable Gastric Banding System) to be used for weight reduction in patients with a body mass index (BMI) of at least 30 kg/m2 and less than 40 kg/m2.
The device is currently indicated for patients with severe obesity (BMI of at least 40 kg/m2 or BMI of at least 35 kg/m2 with 1 or more severe comorbid conditions) or for those who are at least 100 pounds heavier than their estimated ideal body weight.
"Patients with a BMI of less than 35 kg/m2 (even with a comorbid condition) are usually not considered appropriate for bariatric surgery," notes the manufacturers in a report prepared for the FDA. "Expansion of the indication to include lower BMI patients would change the current practice of medicine with respect to bariatric surgery."
The Gastroenterology and Urology Devices Advisory Committee voted on the expanded indication on December 3.