St. Louis Bariatric Surgeon Excited Over New FDA Changes
FDA Approves Expanded Use Of LAP-BAND® Adjustable Gastric Banding System For Obese Adults
Obese Adults with a BMI of 30-40 with at Least One Obesity Related Comorbid Condition Now Qualify for LAP-BAND® System Procedure When All Other Conservative Weight-loss Therapies Have Failed
Recently Allergan, Inc. (NYSE: AGN) announced the U.S. Food and Drug Administration (FDA) approved the expanded use of the LAP-BAND® System, Allergan’s gastric band, for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. Currently, approximately 37 million Americans have a BMI of 30-40 and at least one comorbid condition underscoring obesity as a growing health epidemic in the United States and the need for additional effective treatment options.
“Given the proven and significant health ramifications of obesity, we are pleased with the FDA’s decision to expand the use of the LAP-BAND® System,” said Frederick Beddingfield, M.D., Allergan’s Vice President of Clinical Research and Development. “Although this label expansion represents a significant advancement in obesity treatment, the LAP-BAND® System is not intended for everyone. The LAP-BAND® System does represent a potential treatment option for those patients with obesity and a related health condition, who have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option.”
Obesity is the second-leading cause of preventable death in the United States, second only to smoking. Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese. However, not all weight-loss treatments are effective over the long term – as a preponderance of data, published literature and scientific research have found that diet and exercise is unsuccessful in 80-85% of patients at one year.
“The recent approval by the FDA for Lap Band surgery with a BMI of 30 or greater is exciting news for the Bariatric world. This opens the door to those individuals who are not morbidly obese but are overweight and are struggling with being able to have surgery to help them with their weight loss program,” said Richard O. Follwell, D.O., Bariatric Surgeon
The approval to expand the use of the LAP-BAND® Adjustable Gastric Banding System is based on a review of full 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multi-center five year-study and the more than 17-year safety and effectiveness record of the LAP-BAND® System.
For more information please contact Dr. Richard Follwell at 636-698-6033
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