FDA Advisory Committee Recommends Approval to Expand Use of LAP-BAND® Adjustable Gastric Banding System for Obese Adults
"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
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.12 In addition, obesity is the
second-leading cause of preventable death in
The LAP-BAND® System study, initiated by
The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month timepoint, where clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL). Percent excess weight loss (%EWL) is defined as the percent of "excess weight" — i.e., the weight above ideal weight — that is lost. Results from the 12-month dataset demonstrate clinically significant weight loss in this patient group with a low risk of serious complications. Specifically, 83.9% of the patients lost at least 30% of their EWL at the one-year timepoint, more than twice the percentage required for success. More than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study. This level of weight loss exceeds what is typically seen with more conservative treatment, such as diet and exercise.
The secondary endpoints for the trial were improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension and improvement in Quality of Life (QoL). Eighty five percent of subjects in the trial had at least one comorbid condition. In terms of improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension, 22-33% of patients with those conditions, their conditions resolved after one year. In addition, approximately 60% of patients, who had a comorbidity at baseline, had improvement of at least one comorbid condition by month 12. Also, there was a statistically significant improvement in QoL at months six and 12.
During the 12-month study period, the types of Adverse Events (AEs) reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease (GERD). Most AEs were mild to moderate in severity and resolved in less than 4 weeks.
The LAP-BAND® System was originally approved by the
Important LAP-BAND® Safety Information
Indications: The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient's ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.
CAUTION: Rx only.
This press release contains "forward-looking statements," including the
statements by Dr. Beddingfield, and other statements regarding the
safety, effectiveness, adverse reactions, product availability and
market potential of the LAP-BAND® System. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from
1 Flegal KM,
2 2009 CDC Behavioral Risk Factor Surveillance System (BRFSS) annual data.
3 Jia H, Lubetkin E. Trends in quality-adjusted life-years lost contributed by smoking and obesity. Am J Prev Med 2010;38:138-44.
4 Kuczmarski MD, Prevalence of Overweight and Weight Gain in
5 Kraschnewski, JL et al. Long-term weight loss maintenance
6 Sacks FM, et al, Comparison of Weight-Loss Diets with Different Composition of Fat, Protein, and Carbohydrates. NEJM 2009; 360:859-73.
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