Intragastric balloon for "non-morbid" obesity: a retrospective evaluation of tolerance and efficacy.

ABSTRACT

BACKGROUND: One potential indication for intra-gastric balloon is weight reduction for mild to moderate obesity. The authors evaluated retrospectively the tolerance and efficacy of the BioEnterics intragastric balloon (BIB). METHODS: From February 1998 to July 2001, an intragastric balloon was placed under endoscopic control in 176 patients (mean BMI 31 kg/m(2)). It was filled with 500 ml saline in the first 142 patients and with 600 ml in the last 34. Removal was proposed between 4 and 6 months after balloon insertion. RESULTS: Balloon placement was uneventful. 13 patients were lost of follow-up (7.4%). Removal was performed endoscopically in 113 patients (64.2%), with 1 case of tracheal aspiration. Balloon evacuation was spontaneous in 49 cases. 1 BIB was removed at laparoscopic surgery for small bowel obstruction. Side-effects were vomiting during the first week (90%), occasional vomiting for >3 weeks (18%), hypokalemia (8.5%), functional renal failure (1.1%), abdominal pain (12.5%), gastro-esophageal reflux (11.5%). There were 2 gastric ulcers, 1 sub-occlusion treated endoscopically and the 1 small bowel obstruction treated surgically, occurring after the theoretical date of removal in all cases. Mean excess weight loss was 38 +/- 28.5 % (35.4 +/- 27.3 % for 500-ml balloons and 48.8 +/- 31.0 % for 600-ml balloons (P <0.02)). CONCLUSIONS: The BIB appears to be safe provided that it is removed within the period specified by the manufacturer. Its efficacy to reduce weight in patients with non-morbid obesity may depend in part on the filling volume.