WASHINGTON - About 12 million more obese Americans could soon qualify for surgery to implant a small, flexible stomach band designed to help them lose weight by dramatically limiting their food intake.
The Food and Drug Administration will make a final decision on the Lap-Band in the coming months.
The device from Allergan Inc. is currently implanted in roughly 100,000 people each year and usually helps patients lose 50 pounds or more. Under federal guidelines, it has been limited to patients who are morbidly obese.
On Friday, a panel of FDA advisers recommended expanding use of the device to include patients who are less obese. The panel voted 8-2 that the benefits of broader approval outweighed the risks.
But experts stress that the Lap-Band cannot stop deeply ingrained behavior that drives people to overeat. And the cost of the procedure will remain a barrier for many potential patients.
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The procedure's costs can range from $14,000 to $20,000. The device itself costs $3,000.
Susquehanna International analyst Gary Nachman says both insurers and patients are often reluctant to pay.
More than a third of all American adults are obese. About 15 million of them meet criteria for gastric banding surgery under existing guidelines, which say a person should have a body mass index of 40 or higher, or a BMI of 35 or higher if the person suffers from a weight-related medical problem such as diabetes or high blood pressure.
If adopted, the proposal would lower the Lap-Band requirement to a BMI of 35 or higher, or as low as 30 with one related health problem.
Doing so would increase the number of eligible patients to 27 million, according to federal health data.
Dr. Jack Ditslear said broader approval could help people with lower BMIs avoid dangerous complications down the road.
The adjustable band has been available in the U.S. since 2001 but far longer in Europe and Australia, where it is dominant. A ring is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.
The device was developed as an alternative to gastric bypass surgery, a permanent procedure in which food is rerouted from a pouch in the stomach to the small intestine.
