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
"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®
Obesity is the second-leading cause of preventable death in
"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
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. Following approval, the
patients in the trial will continue to be followed for a total of five
years. In addition, there will be an analysis of the outcomes of
patients with BMI of 30 to 40 recorded in the Bariatric Outcomes
Longitudinal DatabaseSM (BOLDSM). Established in
2007 by the
About the LBMI-001 Clinical Study
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 excess weight 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 obesity related 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, saw 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 four weeks.
About the LAP-BAND® System
The LAP-BAND® System was originally approved by the
Important LAP-BAND® Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
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, but
not limited to, the statements by Dr. Beddingfield and Dr. Michaelson,
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, Prevelance 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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