Allergan Seeks FDA Approval for Lap-Band for Less Obese Patients

Allergan Seeks FDA Approval for Lap-Band for Less Obese Patients
Clinical trial showed significant weight loss among Lap-Band patients with BMIs between 30 and 40.


The number of patients eligible for Lap-Band surgery could skyrocket if the Food and Drug Administration accepts Allergan's request to significantly lower how obese someone must be to qualify for the surgery.

The answer could come as soon as tomorrow, when the FDA panel on Gastroenterology and Urology Devices meets to discuss Allergan's application to expand the use of the band for those who are less obese. The panel is expected to recommend or reject the application for full FDA approval.

The Lap-Band is currently approved for weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or with a BMI of at least 35 if the patient also has one or more severe health problems.

Allergen's application comes after a clinical trial conducted on 143 less obese patients with BMIs ranging from 30 to 40. According to the study results, 80.5% of all implanted patients lost 30% of their excess weight. Nearly 66% of all the patients with the Lap-Band lost at least 50% of their excess weight. The FDA yesterday acknowledged that the patients in the study experienced "statistically significant decreases in all measures of weight loss."

Nearly 20% of the adult population has a BMI between 30 and 35, more than double the population with BMIs above 35, according to federal statistics.

The American Society for Metabolic and Bariatric Surgery says that 220,000 bariatric surgeries of all kinds were performed in the United States last year, more than twice as many as in 2003.

Dan O'Connor