Brazilian Multicenter Study of the Intragastric Balloon

Background: Intragastric balloons have been used in obese patients to provide early satiety and thereby induce weight loss. Several studies have reported promising results with a new balloon (BIB^®) designed to overcome some of the technical pitfalls of earlier devices. We assessed both safety and effectiveness of the BIB^®. Method: From November 2000 to February 2004, 483 overweight and obese patients were treated with the BIB^®. 323 patients completed a 6-month follow-up, and 85 of them completed a 1-year follow-up. All patients took part in a multidisciplinary program involving clinical, psychiatric, physical training, and dietary approaches. Results: Compared to baseline values, after a 6-month follow-up subjects showed significant reductions in weight (15.2 ± 10.5 kg), percent excess weight loss (48.3 ± 28.1), and BMI (-5.3 ± 3.4 kg/m²) (P < 0.000). At 1-year follow-up, 85 patients have maintained more than 90% of their BMI reduction. The main side-effects were nausea/vomiting (40%), and epigastric pain (20%), requiring removal of the BIB ® in 11 patients (3.4%). Minor complications were reflux esophagitis (12%) and symptomatic gastric stasis (9%). Balloon impaction occurred in 2 cases (0.6%), and in 1 patient (0.3%) there was spontaneous deflation of the balloon leading to a small-bowel obstruction solved by a surgical approach. Conclusion: The BIB^® has been effective to temporarily control obesity, inducing an excess weight loss of approximately 48%. It was not associated with mortality and showed minimal risk of major complications.