Lap-Band safe and effective in less obese, FDA advisors vote
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 meeting.
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 to Caucasian.
"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 population.
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.
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