FDA Approves Expanded Use of LAP-BAND® Adjustable Gastric Banding
System for Obese Adults
The following is the press release from Allergan, Inc. regarding Lap-Band now being approved for patients with a low BMI of 30-35.
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
IRVINE, Calif.—(BUSINESS WIRE)— Allergan, Inc. (NYSE: AGN) today 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 low BMI of 30-40 and at least one comorbid condition,1,2 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.3 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.4 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.5,6
“As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success,” said Robert Michaelson, M.D., Ph.D., Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator. “These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately diet and exercise alone do not work for everyone. The LAP-BAND® System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss.”
With such a breakthrough, the next obstacle is getting major insurance carriers to acknowledge the FDA’s approval for lower or low BMI patients and authorize treatment. While we continue the fight, Sun Coast Bariatrics is pleased to offer a “Special Discount” for our Low BMI patients. For more information and qualification, please contact one of our team members or register for our free informational seminar.
Please fill out our contact us form or call us at 727-289-7137 to learn more about how SunCoast Bariatrics can help you today.