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Advisory Committee Recommends the FDA to Approve Label Expansion of Allergan's LAP-BAND to Include Lower Body-Mass-Indexes

Published: 12/31/10
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The LAP-BAND is a weight-loss device that is implanted around the top of the stomach using minimally invasive (laparoscopic) surgery, which effectively creates a small pouch for food at the top of the stomach and delays the passage of food into the lower part of the stomach. As the pouch in the upper part of the stomach fills, it sends signals to the brain telling it that the whole stomach is full. This in turn helps to promote fullness and satiety, with the intent of reducing hunger and food intake, and ultimately bring about weight loss. Ever since the LAP-BAND received FDA approval in 2001, the device has been approved for use in people with a BMI of 40 kg/m2 or higher, or a BMI of 35 kg/m2 or higher with the presence of one or more "serious comorbid conditions" (e.g. type 2 diabetes, high blood pressure). Earlier this month, members of the FDA Gastroenterology and Urology Advisory Committee met to consider expansion of the label for Allergan's LAP-BAND to include lower body-mass-indexes. In a move that surprised some (because the FDA has been so conservative as of late), the committee voted 8-2 in favor of expanding the LAP-BAND's label to include people with a BMI of 35 kg/m2 or higher, and people with a BMI of 30 kg/m2 or higher with at least one or more "comorbid conditions," effectively lowering the BMI requirement for use of the LAP-BAND by 5 kg/m2. Since the majority of panelists were clinicians who regularly treat obese patients, most recognized the need for more tools. However, panel members emphasized that with expansion of the label, long-term safety and efficacy of the LAP-BAND must be monitored carefully. Panel members raised concerns over the durability of the weight loss effect, potential reoperations and complications, and the lack of male and minority representation in LAP-BAND trials – all excellent points in our view. While the FDA advisory committee's vote is certainly a positive indication, the vote is only a recommendation to the FDA, albeit one that the FDA rarely goes against. We look forward to hearing the FDA's final decision shortly.  --VW

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