Objective To evaluate the use of a low-pressure gastric band in the treatment of severe obesity in a prospective study. Summary Background Data Gastric banding for severe obesity has been associated with erosion and perforation of the stomach. The Swedish adjust able gastric band (SAGB) has been proposed as a low-pressure device. Methods From January 1998 to October 2001, 625 patients underwent laparoscopic SAGB. Median age was 36 years, and 80.4% Of patients were female. Median preoperative body mass index (BMI) was 40. Previous upper abdominal surgery was reported in 36 (6%) patients. A five-trocar technique was used without a calibration balloon. Results Median follow-up was 19.5 months. All patients were treated laparoscopically with a median operating time of 80 minutes. Conversion was necessary in two patients (0.3%): one trocar injury of the mesentery and one esophageal perforation. Median hospital stay was 3 days; there were no 30-day deaths. Early morbidity was present in 27 patients (4.3%). Late band reoperation was necessary in 49 patients (7.8%). Indications for reoperation were band slippage or pouch dilation, acute total dysphagia, and band leakage or malfunction. Median excess weight loss was 45.8%, 49.9%, and 47.4% after 1, 2, and 3 years, respectively, with a measurable beneficial effect on arterial hypertension, sleep apnea syndrome, and diabetes control. Conclusions SAGB is a safe and effective new method in the management of severe obesity. Long-term follow-up (>3 years) is necessary to confirm its effectiveness and safety.