An FDA Gastroenterology and Urology Devices Advisory Panel backed the
use of the Lap-Band Adjustable Gastric Banding system in obese people with a
BMI as low as 30.
The 10-person panel voted 8-2 that the Lap-Band is safe for reducing
weight in obese patients with a BMI of at least 35 or at least 30 with one or
more comorbid conditions. In a similar vote of 8-1 with one abstention, the
panel concluded that the device is effective in this patient population.
The panel convened to discuss device marker Allergan's proposed
modified indication for patients who are less obese than for those the device
is currently indicated. The FDA first approved the Lap-Band in 2001, and is
currently indicated for patients with severe obesity, defined as a BMI of at
least 40 or at least 30 plus severe cormobidities, or for those who are 100 lb
heavier than their estimated ideal weight. Approved persons have failed more
conservative weight-reduction alternatives, such as supervised diet, exercise
and modification programs.
In a third vote, eight panelists determined that the benefits of the
Lap-Band for the stated indication outweigh the risks for purposes of approval.
"This is not a new device; it has been around, [but] in a slightly
different population," Jon C. Gould, MD, associate professor, department
of surgery, University of Wisconsin School of Medicine and Public Health, said
of his vote yes. "Although the current study is small, there is reasonable
assurance that this is an acceptable change."
Allergan presented and the FDA reviewed results of a study showing that
81% of 149 obese people with a BMI of at least 35 or at least 30 plus comorbid
conditions lost at least 30% of their excess weight, the study's primary
endpoint. In addition, there were no unexpected adverse complications, and
serious adverse events were rare.
Dissenting voters expressed concern about the length of the study.
"I don't think that a 1-year, 150-patient study should be anywhere near
satisfactory for changing the standard of care in this field," Thomas H.
Inge, MD, PhD, director of the Center for Bariatric Research and
Innovation, Cincinnati Children's Hospital Medical Center, said during the
The high number of white women included in the study was another issue
raised by the panel; nonwhite men appear to be underrepresented in the data.
The panel asked for additional data on men and other ethnic groups in addition
"I do think that the sponsor should develop a registry where every
patient who has a [Lap-Band] device is entered … I'd like to know what
happens across the national [with this device], as we do with other
operations," Walter J. Pories, MD, professor of surgery at East Carolina
University, said. Pories voted in favor of the device for the proposed
While Steven D. Schwaitsberg, MD, chief of surgery at Cambridge
Health Alliance, Boston, does not expect the experience in a less obese
population will be "radically different" than what has already been implanted
in the obese population, he said even 10 years' follow-up is not long enough
for a "lifelong implantable device.
"We should start now, and these patients should all be followed for
life," he said.
Jason T. Connor, PhD, a biostatistician at Berry Consulting, LLC,
Orlando, FL, had a unique suggestion for follow-up: "We should ask patients at
5 years, 'Would you do this again?' That seems like great information for a
surgeon to tell his or her patient."
If the proposed indication is approved by the FDA, guidelines for
obesity surgery may need to be modified. Current guidelines from leading
organizations generally recommend surgical intervention for obese people with a
BMI greater than 35. In addition, all but two panelists felt that while BMI is
a poor measure of who requires surgery for obesity, the data presented are
sufficient to suggest that current guidelines need to change. This device could
move forward lowering the threshold for BMI as an indication for the Lap-Band,
chairperson Karen L. Woods, MD, clinical associate professor of
medicine, Baylor College of Medicine, summarized.
Allergan estimates that more than 300,000 people worldwide have been
given the Lap-Band. The surgery can cost $12,000 to $20,000.
While the FDA is not required to follow the recommendations of the
advisory committee, it usually does.