A federal advisory panel Friday endorsed an expansion of the use of Allergan‘s Lap-Band stomach-restricting device to patients who are less than severely obese.
The vote could pave the way to double the number of Americans who qualify for weight-loss surgery. And it could eventually lead to making other types of weight-loss surgery available to those who are not quite as heavy.
“I see this as the first step in the march toward changing the standard of care,” E. Francine Stokes McElveen, the consumer representative on the committee, said during the meeting in Gaithersburg, Md.
The advisory committee to the Food and Drug Administration voted 8 to 2 that the benefits of Lap-Band surgery exceeded the risks for patients in the lower range of obesity. It voted 8 to 2 that the device was safe, and 8 to 1, with one abstention, that the device was effective.
The F.D.A. usually agrees with its advisory committees, but it was not clear when a decision would be made.
Current guidelines say weight-loss surgery is appropriate for people who have failed to lose weight through diet and exercise and have a body mass index of 40 and above – or 35 and above if they have diabetes, hypertension or another severe health problem associated with diabetes.
Allergan wants to lower the threshold to a B.M.I. of 35 for people without health complications, and to 30 for people with health problems, which also would no longer have to be severe.
A person who is 5 feet, 5 inches with hypertension must weigh at least 210 pounds to qualify for surgery now. Under the proposal endorsed by the committee, that person would have to weigh only 180 pounds.
An Allergan executive said at the meeting that 27 million Americans had a B.M.I. between 30 and 35 and at least one associated health condition. […]
In her testimony, Diana Zuckerman of the National Research Center for Women and Families urged the committee to vote against approval, saying there was not enough long-term data. “We need that information before approval is expanded to include such a very large number of adults,” she said. […]
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