Lap-Band Recommended For Less Obese Patients By FDA Panel

An FDA Advisory Panel voted 8 to 2 in favor of approving the weight-loss Lap-Band for use in less obese people than current regulations allow, the FDA (Food and Drug Administration) informs. The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee determined that the benefits outweigh the risks for less obese patients.

The Panel’s recommendation is not binding; however, the FDA usually goes along with what it says. If wider usage of the Lap-Band is approved, it would mean that millions of extra people will become eligible. Allergan, makers and marketers of the Lap-Band had sales of $182 million during the first three quarters of this year – next year’s sales would be significantly higher after approval for wider usage.

Although the general response by the FDA was positive, especially in a country where the majority of adults are overweight or obese, there was some concern regarding what the long-term (lifetime) risks of having the implant might be.

The Panel recommends that obese adults who have failed more conservative weight reduction alternatives and have a BMI (Body Mass Index) of 35 or more, or 30 or more as well as at least one comorbid condition should become eligible for Lap-Band use.

Frederick Beddingfield, M.D., Vice President of Clinical Research and Development for Allergan, Inc., said:

“We are pleased with the Committee’s decision, which reflects consensus that there is a need for additional, effective treatment options for patients who are currently obese, given the known significant health ramifications of obesity. Given the health risks of even moderate levels of obesity, it is important to have other treatment options for patients when other attempts at weight loss have proven unsuccessful.”

The Panel’s decision was based on 12-month data from a 5-year, single-arm, non-randomized trial involving 149 obese individuals. They had all been obese for an average of 17 years. They all underwent surgery to have the stomach band implanted.

Allergan says that of the 64 million obese adults in the USA today, 27 million have a BMI of 30 to 35 plus at least one comorbid condition. Obesity is the second cause of preventable premature death in America, after smoking.

Studies have shown that the majority of untreated obese people will continue being obese indefinitely, facing a significantly higher risk of developing heart disease, type 2 diabetes, some cancers, hypertension, sleep apnea and premature death.