Background: Since March 1998, 143 BioEnterics(R) Intragastric Balloons (BIB) were placed in 132 obese and morbidly obese patients, to study the clinical possibilities of a new system, both from the point of view of the materials used and the application method. Methods: 36 patients were male and 96 female; mean age was 43 years (21-70); mean weight was 115.4 kg (67-229), and mean BMI was 41.0 (29-81). 8 patients were affected by severe respiratory insufficiency. We placed and removed the balloon endoscopically under conscious sedation or general anesthesia. BIB was removed in the majority of patients 4 months after insertion. The patients were given a balanced diet of 800-1000 kcal/day; follow-up involved a monthly check-up (routine blood tests, weight control) and a visit every 15 days with the dietitian. Results: Mean weight loss was 14.4 kg; mean reduction in BMI was 5.2. Weight loss was much better in males. The weight loss produced an improvement of the complications associated with the obesity. Complications observed were: balloon intolerance (9 early removals), 1 balloon deflated and passed, 2 cases of gastric ulcer at balloon removal. Conclusions: The most correct indications for BIB should be: extremely obese patients (BMI>40) in preparation for a bariatric operation; obese patients with BMI 30-35 with a chronic disease otherwise unresolved; patients with BMI < 30 in a multidisciplinary approach.