People Who Weigh Less Now Qualify for Gastric Device
THURSDAY Feb. 17, 2011 -- The Lap-Band gastric banding device has been approved by the U.S. Food and Drug Administration for people who are less obese than previous candidates, device maker Allergan said.
Under the expanded approval, people may now qualify for the stomach-restricting device if they have failed other weight-loss regimens and have a body mass index (BMI) of 30 to 40. Some 37 million Americans have a BMI in that range, along with at least one coexisting condition such as heart disease, type 2 diabetes, high blood pressure or sleep apnea, the company said in a news release.
Previously, the device -- a silicone band placed around the upper stomach -- had been restricted to people with a BMI of at least 35 if they had a related chronic health condition or 40 if they had no such problem, The New York Times reported.
Under the initial approval, a person 5-feet, 6 inches tall with diabetes would have to weigh 216 pounds to be a candidate for the device. Under the new rules, that person would have to weigh 186 pounds, the newspaper said.
Obesity is the second-highest cause of preventable death in the United States, next to smoking, Allergan said. The company is based in Irvine, Calif.
The FDA has more about the Lap-Band device.
Posted: February 2011