FDA LOOKS AT LOWERING BMI FOR LAPBAND SYSTEM

Panel Recommends Expanding Use of Stomach Bands
-Associated Press
-By: Matthew Perrone

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.

If approved for wider use, the Lap-Band could be available to more patients.   It will help prevent super morbid obesity with earlier intervention.  The Lap Band System or Realize System are both adjustable, restrictive, and removal devices. 

But experts stress that the Lap-Band cannot stop deeply ingrained behavior that drives people to overeat.   The procedure is a lower cost option that Roux en Y (commonly referred to as Gastric Bypass).  It is routinely performed as an outpatient.  .

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.

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