Intragastric balloon for obesity: a retrospective evaluation of tolerance and efficacy.

BACKGROUND: The intragastric balloon may be used for weight reduction for mild or moderate obesity, or for preoperative weight loss for super-obesity. The authors retrospectively evaluated the tolerance and efficacy of the BioEnterics Intragastric Balloon (BIB).
METHODS: From October 2002 to July 2004, intragastric balloons were placed, under endoscopic control, in 44 patients (mean BMI 45 kg/m2 , mean age 31 years). The balloons were filled with 500-600 mL of normal saline. Removal was recommended for 6 months after balloon insertion.
RESULTS: 6 patients (13.6%) were lost to follow-up, 7 super-obese patients underwent LAGB at our hospital, and 2 patients had the BIB procedure performed twice. Balloon placement was uneventful. Removal was performed endoscopically in 38 patients under conscious sedation with anesthesiological assistance (2 patients had the BIB removed under general anesthesia). No cases of tracheal aspiration or spontaneous balloon evacuation were encountered. Sideeffects were vomiting during the 1st week (77.2%), occasional vomiting for >3 weeks (11.3%), hypokalemia (6.8%), functional renal insufficiency (4.5%), abdominal pain (15.9%), and gastroesophageal reflux (6.8%). There was 1 gastric perforation (treated laparoscopically after removal of the BIB), 1 gastric ulcer, 4 cases of intolerance (1 of these elected to have LAGB), and 1 died (from other medical conditions). Mean excess weight loss was 13 kg (33 kg in the super-obese).
CONCLUSIONS: The BIB appears to be safe provided that it is removed within the specified 6 months. Surveillance is necessary. It was efficient in reducing weight in patients with mild or moderate obesity and as preoperative treatment for super-obese patients to reduce the surgical risk before LAGB.