The Food and Drug Administration officially approved use of gastric bands, also known as Lap-Bands, for people with a BMI of 30 or higher and have an obesity-related health problem. The previous regulations only approved the device for people with a BMI of 40 and no additional health problems or a BMI of 35 with health complications. The new regulation is in accordance with recommendations made by an FDA panel in December.
Allergan, the maker of the Lap-Band, originally applied to lower the threshold to anyone with a BMI of 35, regardless of other health complications. However, the new provision only includes people with conditions such as diabetes or hypertension, the threshold for otherwise healthy people remains at a BMI of 40. “In order to target this therapy to patients who will benefit the most, the approved indication is limited to patients at the highest risk of obesity-related complications,” said Karen Riley, a spokeswoman for the FDA. According to The New York Times, an estimated 26 million Americans are now eligible for the surgery.
The Lap-Band is a silicone ring that is placed around the upper part of the stomach. It effectively decreased the size of the stomach, helping patients feel full sooner and eat less. Researchers found that on average, people who underwent the surgery lost 18 percent of their body weight after a year. Allegran has agreed to follow patients involved in initial studies for another five years.
February 17th, 2011