“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."

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," said Frederick Beddingfield, M.D., Vice President of Clinical Research and Development for Allergan, Inc. "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 Committee's decision followed a review of the currently unmet clinical needs among the obese patient population, as well as 12-month data from a prospective, single-arm, non-randomized, multi-center five-year study involving 149 obese patients, who on average had been obese for 17 years, treated with the LAP-BAND® System, numerous publications, and the more than 17-year safety and effectiveness record of the LAP-BAND® System.

Currently, over 64 million Americans are obese, and of those Americans, approximately 27 million of them have a BMI of 30-35 and at least one comorbid condition.