FDA loosens the belt on Lap-Band surgery

After rejecting the approval of three new weight-loss drugs in the past few months, the FDA on Wednesday implemented a change which represents a minor advance in the fight against the obesity epidemic: lowering the requirements for patients who wish to use Allergan’s Lap-Band stomach-restricting device. Now, people with a body mass index (BMI) of 30 and an associated obesity-related health condition, such as hypertension or diabetes, are eligible for the procedure. For those who have no obesity-related health problems, the guidelines remain unchanged and require individuals to have a BMI of at least 40. The Lap-Band, an inflatable silicone ring situated near the upper region of the stomach, promotes weight-loss by restricting how much food a person can consume, thus making them feel full faster. In a recent study, Allergan demonstrated that patients lost an average of 18 percent of their body weight a year after Lap-Band implantation.

Since the Lap-Band is only approved for use in people who have tried, but failed, to lose weight through diet, exercise and drugs, ACSH staffer Lana Spivak asks: “What drugs are they referring to? The weight-loss drugs Qnexa, Contrave and Lorcaserin were all rejected by the FDA while Meridia was pulled from the market. Though it’s good news that the FDA has expanded approval for use of the Lap-Band, it would be even better if they would approve a weight-loss drug which doesn’t require surgery.”