Expanded Use of LAP BAND for Obese Adults is Approved by FDA
On February 16, 2011, Allergan, Inc. announced that the United States Food and Drug Administration (FDA) approved the LAP-BAND® System for use on a wider range of adults, including those whose Body Mass Index or BMI fell between 30 and 40 and had at least 1 weight-related health condition. (1)
According to Allergan’s Vice President of Clinical Research and Development Frederick Beddingfield, M.D., “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.”
Obesity is second to smoking when it comes to preventable death in the U.S. (2) and has been linked to such life-threatening conditions as cardiovascular disease, Type 2 diabetes, stroke, and premature death. Most long-term treatments to lose weight have been proven ineffective, according to the published literature and research, with as many as 80 to 85% of patients regaining lost weight within 12 months. (3, 4)
Robert Michaelson, M.D., Ph.D., Clinical Trial Investigator and bariatric surgeon at Northwestern Surgical Weight Loss Surgery, Everett, Washington, stated that: “The LAP-BAND® System meets an unmet clinical need, as it provides an effective treatment option …”
The FDA’s approval of the LAP-BAND® System’s expanded use came after a review of the data from a prospective, non-randomized, multi-center five year study.
Study participants were an average 63 pounds overweight and were obese for an average of 17 years. After undergoing the LAP-BAND® procedure, 83.9% of study participants had lost as much as 30% of the excess weight by the 1 year point, and nearly 2/3 of them were no longer considered obese.
Of the study participants suffering from co-morbid health conditions, 22-33% saw a resolution of their obesity-related health conditions, including high cholesterol, high blood pressure and type 2 diabetes. Approximately 60% who suffered from at least one co-morbid health condition saw statistically significant improvement a year after the LAP-BAND® procedure. Their quality of life had also been improved. Participants maintained their weight loss throughout the study’s second year.
Study-related surgical adverse events were typical for the LAP-BAND® device and included GERD, vomiting, and difficulty swallowing. Most study participants that experienced adverse events were of mild or moderate significance and many were resolved within a 4 week period.
The LAP-BAND® System is the only weight loss device that has been approved for bariatric surgery by the Food and Drug Administration. Allergan’s LAP-BAND® procedures have been performed more than 650,000 times over the past 18 years, and the LAP-BAND® System has had an exceptional record for safety and effectiveness during that time period.
Information about Allergan can be found by visiting allergan.com or by calling (714) 246-4636.
1. Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and Trends in Obesity Among US Adults, 1999-2008. JAMA: The Journal of the American Medical Association 2010;303:235-41.
2. Jia H, Lubetkin E. Trends in quality-adjusted life-years lost contributed by smoking and obesity. Am J Prev Med 2010;38:138-44.
3. Kuczmarski MD, Prevelance of Overweight and Weight Gain in the United States. Am J Clin Nutr 1992; 55:495S-502S.
4. Kraschnewski, JL et al. Long-term weight loss maintenance in the United States.International Journal of Obesity 2010
