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 inability 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 malnutrition, anemia, or other 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 or call 1-800-624-4261. CAUTION: This device is restricted to sale by or on the order of a physician.
References: 1 Choban P et al. Bariatric surgery for morbid obesity: why, who, when, how, where, and then what? Cleveland Clinic Journal of Medicine. 2002. 69(11):897-903. 2 Weight-control Information Nehvork (VIN), an information service of the National Institute of Diabetes and Digestive and Gdney Diseases (NIDDG. Active at My Size. October 2006.
Available at:
http://win.niddk.nih.govipublicationstactNe.htm. Accessed October 7, 2008. 3 O'Brien PE, et al. tap-Band: Outcomes and Results. 1 Laparoendosc Adv Surg Tech A. 2003;13(4): 265.270.