Evidence-based Review of the Bioenterics Intragastric Balloon for Weight Loss

Abstract

We reviewed clinical studies performed with the Bioenterics intragastric balloon (BIB) to promote weight loss. Thirty studies were included [18 prospective (5 randomized), 12 retrospective], totaling 4,877 patients. Only one of three sham-controlled trials found a significantly higher weight loss with the BIB vs the sham procedure plus exhaustive follow-up. In nonrandomized studies, weight loss with the BIB averaged 17.8 kg (range, 4.9-28.5), corresponding to BMI changes of 4.0-9.0 kg/m(2). Comorbidities resolved or improved in 52-100% of patients. Best short-term results were observed in patients devoid of binge eating disorder with a BMI in the 30.0-40.0 kg/m(2) range; the BIB also helped to prepare superobese patients for bariatric surgery. Severe complications were exceptional (gastric perforation and intestinal obstruction; 0.2% each); digestive intolerance prompted early BIB removal in 2.5% of patients. Long-term (>or=2 years) results are awaited, as well as well-designed studies to define the best indications for this therapy.

Usefulness of an intra-gastric balloon before bariatric surgery

“…Even though there is a low rate of complications with IGBs, there have been reports of deaths due to gastric perforation (24,38,39) or during the balloon removal procedure, additional to the risks inherent to general anesthesia in this type of patients (7).…”

Protocol for: The Use of Intra-Gastric Balloons as an Adjunct to a Lifestyle Support Programme to Promote Weight Loss in Severely Obese Adolescents

“…weeks [16][17][18][19][20][21][22][23][24] The researchers will facilitate a discussion asking the young person /family to consider their environment and identify strategies to help remind them to perform their desired behaviour. E.g.…”

“…This reluctance to perform bariatric surgery more frequently in adolescents is reinforced by, current UK clinical guidelines that specify adolescent bariatric surgery should only be considered in exceptional individual circumstances [9]. Yet there is strong recognition that novel, less invasive, whilst equally effective treatment strategies tailored to the needs of severely obese adolescents [20,21] are warranted. One such approach, which is proposed here, is the use of intra gastric balloons as a potential, reversible, intervention for adolescent obesity.…”

“…Since then, Bioenterics fluid-filled balloons (BIB) have been sited endoscopically into the stomach typically for six months, to induce satiety by reducing the stomach capacity, thereby reducing food intake and encouraging weight loss amongst obese populations [23,24]. A systematic review by Dumonceau (2008) of BIB treatments reported a mean weight loss of 17.8 kg, ranging from 4.9 kg -28.5 kg [21]. Imaz (2008) reported a weight loss of 14.7 kg at 6 months representing a 32.1% loss of excess weight and a BMI change of 5.7 [22].…”

Multicenter study on the safety of bariatric endoscopy

“…Initially, these techniques have seemingly shown fairly promising efficacy results (5)(6)(7)(8)(9)(10)(11)(12), with better outcomes when compared to diet alone (13). Furthermore, a priori they are more cost-effective and less invasive than surgery, hence a lower complication rate and higher safety should be expected.…”