Tolerance and efficacy of an air-filled balloon in non-morbidly obese patients: results of a prospective multicenter study.

BACKGROUND

Intragastric balloons have been proposed to induce body weight loss in obese subjects. Most studies were performed using liquid-filled balloons. Air-filled balloons may increase digestive tolerance. Our goal was to study the tolerance and efficacy of a new air-filled intragastric balloon in nonmorbidly obese patients.

METHODS

32 patients were included, with a mean BMI of 35.0 (range 30.1-40.0). The balloon was inserted under general anaesthesia, inflated with 800 ml of air, and removed 4 months later. Tolerance and body weight were monitored until 12 months after removal. Ghrelin levels were measured before balloon insertion, 1 and 4 weeks after, and before removal.

RESULTS

Weight loss was significant at 1, 2 and 4 months after balloon insertion (6, 7 and 10 kg, respectively, P<0.001). Early removal of the balloon occurred in 3 cases. 28 patients were contacted 12 months after balloon removal: 2 had undergone gastric banding; among the 26 remaining, the mean weight loss was 7 kg. 9 patients (30%) remained with a weight loss >10%, and satisfaction with the method was 87% for these 9 patients, and 22% for the other patients who had weight loss <10% (P<0.04). Fasting plasma ghrelin levels increased at week 1 and 4 after balloon insertion, and decreased at week 16 (P<0.001). CONCLUSIONS. The air-filled intragastric balloon was safe. Its effect on weight loss appeared equivalent to other balloons. 12 months after balloon removal, 30% of the patients maintained a weight loss >10%.