Lap-Band Device Gets Wider Indication: FDA Lowers BMI Requirements for Weight-Loss Surgery

February 22, 2011

February 22, 2011 (Irvine, California) — Less obese individuals are now candidates for laparoscopic gastric banding surgery, with the Food and Drug Administration (FDA) lowering the body-mass index (BMI) requirements for those eligible to undergo surgery using the Lap-Band Adjustable Gastric Banding System (Allergan, Irvine, CA) [1].

The FDA approved the expanded use of the gastric band for obese adults who have failed to lose weight with diet, exercise, and pharmacotherapy and who have a BMI of 30 to 40 kg/m2and one additional obesity-related comorbid condition, such as diabetes or hypertension.

The expanded approval is based on a December 2010 advisory panel hearing in which committee members vote 8 to 2 in favor of widening the pool of patients eligible for the banding surgery. Previously, the gastric surgery was indicated only for patients with a BMI >35 kg/m2and additional risk factors or >40 kg/m2in those without any other conditions. 

According to the Los Angeles Times, reporters citing company officials say the expanded indication means that approximately 25 million more Americans would be eligible for the Lap-Band surgery, with roughly 45 million Americans, or one in seven, now eligible for the weight-loss procedure [2].

During the surgery, a band is placed around the upper part of the stomach, and this creates a small pouch that holds only a small amount of food. As a result of the narrowed opening, food passes slowly from the pouch to the rest of the stomach, helping the patient eat less and increasing the amount of time needed for digestion.

Just a couple of weeks ago, the FDA rejected the diet drug Contrave, the third weight-loss drug to be turned away by the agency in the past year. The agency was concerned about blood-pressure and heart-rate changes with Contrave, a combination of naltrexone and bupropion HCL--specifically, that most patients who lost weight with the drug failed to see significant improvements in blood pressure. As heartwire reported recently, clinicians who treat obesity were disappointed by the FDA decision.


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