A Food and Drug Administration (FDA) advisory panel voted 8 to 2 on Friday in favor of a request from Allergan — the maker of the Lap-Band silicone ring used in gastric-banding surgery — to expand the eligible patient population for the weight-loss procedure.
Allergan has proposed lowering the threshold of obesity that patients must meet in order to qualify for the surgery. The Lap-Band device is currently approved for people with a body mass index (BMI) of 40 or higher, or 35 or higher with a related medical problem like diabetes or high blood pressure. Allergan is requesting expansion of approval for people with a BMI of 35 or higher, or 30 with related health problems. (More on Time.com: What’s the Ideal BMI for Longevity?)
The FDA panel agreed that the benefits of the surgery outweighs its risks in less obese patients, after having reviewed available data, including new clinical trial results presented by Allergan. Healthland reported on Thursday:
In support of its request, Allergan (better known as the maker of Botox) recently released the results of a clinical trial it supported that demonstrated the benefit of Lap-Band surgery on the less obese. The trial followed 143 patients with BMIs between 30 and 40; 80.5% of them had lost 30% of their body mass one year after surgery.
The Associated Press is reporting that the number of eligible patients for Lap-Band surgery will move from 15 million to 27 million, if the FDA decides to follow the panel’s recommendation.
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