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From the Food and Drug Administration
August 1, 2001

New Weight-Reduction System

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JAMA. 2001;286(5):527. doi:10.1001/jama.286.5.527-JFD10007-3-1

The FDA has approved the Lap-Band Adjustable Gastric Banding System (BioEnterics Corp, Carpinteria, Calif) for use in weight reduction for severely obese patients. The approved indication is limited to patients with a body mass index (BMI) of at least 40 kg/m2; with a BMI of at least 35 kg/m2 with one or more severe conditions, such as hypertension or gallstone disease; or who weigh at least 100 lb more than their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables. The system is indicated for use only in adult patients in whom more conservative weight-reduction alternatives have failed and who make a commitment to accept significant changes in their lifestyle, such as reduced food consumption and daily exercise.

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