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Background: The BioEnterics Intragastric Balloon (BIB(R), BioEnterics, Santa Barbara, CA) in association with restricted diet has been used for the treatment of obesity and morbid obesity.

Methods: Since March 1998, 322 BIB were placed in 281 obese and morbidly obese patients; 73 patients were male and 208 female; mean age was 41.6 years (21-70); mean weight was 117.4 kg (67- 229); mean BMI was 41.8 kg/m2 (29-81); % excess weight was 62% (10-216). The balloon was inserted and removed endoscopically under general anesthesia. Patients were given a balanced diet of 1000 kcal/day. Also, for 18 months we compared 42 obese patients treated only with 1000 kcal/day diet (group A) with 31 obese patients subjected to BIB for 4 months 1000 kcal/day diet (group B).

Results: After 4 months of balloon treatment, the mean weight loss was 13.9 kg and the mean reduction in BMI was 4.8. Weight loss was greater in male patients. Weight loss was accompanied by an improvement of the diseases associated with obesity, in particular diabetes. In the diet vs BIB diet study, BIB with diet produced a greater weight loss in a shorter time than diet alone.

Conclusion: The best indications for BIB were: morbidly obese opatients (BMI>40) and super-obese patients (BMI>50) in preparation for bariatric operations; obese patients with BMI 35-40 with co-morbilities in preparation for bariatric surgery; obese patients with BMI 30-35 with a chronic disease otherwise unresolved; patients with BMI <30 only in a multidisciplinary approach.

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