07:14 PM ET Lap-Band for lower BMI safe, FDA panel says A Food and Drug Administration advisory committee on Friday

voted that the new proposed Body Mass Index requirements for Lap-Band weight

loss surgery are safe, effective, and that benefits associated with the surgery

outweigh the risks.

Now the FDA must make a final decision on whether to approve the medical

device for patients with lower BMIs than previously allowed.

Eight of the ten members of the Gastroenterology and Urology Devices

Panel cast votes saying that lowering the BMI requirement from 35 to 30 for

people with weight-related health issues would be a safe and effective means of

losing weight.

Under the new proposed guidelines, a person who is five feet, eight

inches tall would have to weigh at least 197 pounds, not 230, as was previously

the case.

"Overweight people who have a BMI of 30 to 35 have a significant burden

of medical problems associated with their obesity," says Dr. Robin Blackstone,

President-elect of the American Society of Metabolic and Bariatric Surgery. "We

really support making the band available to folks who need that kind of help."

The FDA meeting was held at the request of Allergan, Inc., the

manufacturer of the Lap-Band device. Allergan also conducted the study

presented to the advisory committee.

The panel heard from a variety of speakers, including Stephanie

Quatinetz, whose daughter Rebecca died two months after getting a Lap-Band.

Quatinetz argued that lowered BMI requirements would allow people who were not

obese enough to get the device, causing health complications that could be

fatal.

Laparoscopic Adjustable Gatric Banding, or LAGB, is the second most

common type of bariatric surgery. It's a less invasive operation compared to

gastric bypass, the most common procedure. If the proposed BMI guidelines are

approved, Allergan says more than thirty million Americans would have BMIs

within the newly eligible range. Yet the American Society of Metabolic and

Bariatric Surgery says only a fraction of overweight people actually opt for

weight loss surgery.

Dr. Karen L. Woods chaired the panel meeting. Dr. Woods is a stockholder

in Allergan, Inc. but was granted a waiver by the FDA. She did not cast a vote

on the new guidelines. In a statement regarding her waiver the FDA said, "Dr.

Woods was selected because she has expertise in therapeutic endoscopy, which is

important for the deliberations of the panel, and has experience serving as a

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