WASHINGTON – A federal advisory panel panel Friday endorsed a company’s request that a device used for weight-loss surgery be permitted to be used on people who are slightly less obese, a crucial step toward making the already increasingly popular procedures available to many more patients.
The 10-member Food and Drug Administration advisory committee voted overwhelmingly to recommend the agency grant the request from Allergan Inc. of Irvine, Calif., to market its Lap-Band device to people with a body mass index (BMI) of between 30 and 35.
Currently, the device, which is implanted around the stomach to restrict how much food a person consumes, is only approved for use in people who have not been able to lose weight through diet and exercise and have either a BMI of 40 or above or a combination of BMI of 35 or above and at least one serious weight-related health problem. Allergan’s request was to change that to a BMI of 35 with no health problems or 30 with health problems.
In a series of votes, the committee said there was sufficient evidence that the device was safe and effective for patients with lower BMIs and any risks were outweighed by the benefits.
The agency is not bound to follow the advice of the advisory committee, but usually does. If granted, the decision would significantly increase the number of Americans eligible for the surgery.
The decision would only apply to this device, and not to another banding device sold by a division of Johnson & Johnson or to “bypass surgery” for weight loss, which is more commonly used and involves surgically reducing the size of the stomach.