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 Dr. Simpson, or call Allergan Product Support at 1-800-624-4261.

Please note that this is not a full discussion of risks and potential complications of the band- for those you will be discussing at length with Dr. Simpson

CAUTION: Rx only.

References:

1. Needleman Bradley, Happel Lynn. Bariatric Surgery: Choosing the Optimal Procedure. Surgical Clinics of North America. 2008.
2. The LAP-BAND® System Surgical Aid in the Treatment of Obesity (PSI). Allergan, Inc. Irvine, CA. 02/11.
3. Hutter Matthew, et al. First Report from the American College of Surgeons Bariatric Surgery Center Network: Laparoscopic Sleeve Gastrectomy has Morbidity and Effectiveness Positioned Between the Band and the Bypass. September 2001.
4. DeMaria Eric, Pate Virginia, Warthen Michael, Winegar Deborah. Baseline data from American Society for Metabolic and Bariatric Surgery-designated Bariatric Surgery Centers of Excellence using the Bariatric Outcomes Longitudinal Database. Surgery for Obesity and Related Diseases 6. 2010.
5. The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Perioperative Safety in the Longitudinal Assessment of Bariatric Surgery. The New England Journal of Medicine Vol. 361 No. 5. July 30, 2009.
6. Directions For Use (DFU). LAP-BAND AP® Adjustable Gastric Banding System with OMNIFORM® Design. Allergan, Inc. Irvine, CA. 02/11