Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon.

BACKGROUND: A new intragastric balloon is available for weight reduction.
METHODS: Patients consulting for a weight reduction plan and refusing any kind of actual surgery, or suffering from obesity but not meeting the IFSO standards for surgery, were offered the possibility of weight reduction by the BioEnterics intragastric balloon (BIB). A preoperative questionnaire was completed by all patients, inquiring about medical history, co-morbidity factors, dietary habits, previous treatments for weight and social, psychological, relational and economic impact of the obesity. BIB placement was done on an inpatient basis, under general anesthesia. Inflation was standardized at 500 ml saline. Intravenous antiemetic and spasmolytic drugs were given to control post-insertion nausea for 24 hours, and oral medication was administered on the patient's discharge. A standard 800 calorie diet was prescribed after dietitian's consultation. Extraction of the balloon was left to the patient's discretion at 3 or maximum 6 months after placement. Patients choosing for the maximal period received a formal invitation to extract the balloon. Evaluation of weight reduction was done at extraction and by questionnaire.
RESULTS: 126 patients (5 M, 121 F) with mean age of 35.6 years (20-62) were included after preoperative evaluation. Mean preoperative BMI was 37.7 kg/m2 (26.7-57.7 kg/m2), with a mean initial excessive weight of 35.3 kg (8.8-96.4 kg) and mean initial % excess weight of 32.2 (6.3-102). 69 patients were eligible for review; mean excess weight loss after 3 months was 48.6% and after 6 months 50.8%. Mean weight loss was 15.4 kg (0-35 kg). 76.8% of the patients (41/69) complained of severe nausea and vomiting lasting an average of 1 week (1 day-6 months), resulting in 3 patients in early removal of the balloon (at 1 day, 1 week, 1 month after placement respectively). 2 patients suffered gastric perforation presenting as acute peritonitis 3 and 4 months after placement and were operated. Extraction of the balloon was performed in 3 patients after 3 months and in 66 patients after 6 months. In 11 patients (22%), esophagitis was present (8 grade 1, 2 grade II, 1 grade III), and one patient showed diffuse gastric erosion. One patient required removal of the balloon by rigid esphagoscopy following technical failure of the endoscopic extraction device. 45 patients replied to the mailed, questionnaire; 15% (7/45) were very satisfied, 13% (6/45) satisfied, 22% (10/45) reasonably satisfied, 8.8% (4/45) unsatisfied and 40% very unsatisfied. Degree of satisfaction correlated poorly with weight loss. Results may be better with close continuous guidance by a counselor.
CONCLUSION: BIB as a means of weight reduction in the obese patient led to a 50.8% loss of excess weight after 6 months. Although severe morbidity can occur, the BIB provides a means for short-term weight reduction in conjunction with dietary measures.