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
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
"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
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