Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting

Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting

“…22,25 The recently published postmarket approval study for the FF-IGB showed slightly higher weight loss at IGB system removal than in our retrospective analysis, but the same 12-month weight loss. 26 These data support the findings in this study that there is no difference in clinical weight loss between the GF-IGB and FF-IGB at balloon system removal or 6 months after balloon system removal.…”

“…The early removal rate seen in this study was also slightly higher than in the multicenter registry study with 321 patients reported by Vargas et al (23.3% vs. 16.6%), 25 but was closer to both the US randomized controlled trial and the US postmarket approval study which showed an early removal rate of 18%. 10,26 Although confidence intervals for early removals were not reported in either of these studies, it is likely that our early removal rate would fall within the confidence interval for early removals for both of the FF-IGB US randomized controlled trial and US postmarket approval study. The early removal rate due to symptoms for GF-IGB in our study was 5.3%, which was slightly lower than the 10% early removal rate reported in Moore et al 22 ; however, it is unclear if all removals in the Moore registry were due to intolerance or if some patients had balloons removed due to relocation.…”

Six intragastric balloons: Which to choose?

“…Thus, IGB insertion represents a generally safe, easy to perform, adjustable, reversible, and reproducible endoscopic gastric restriction procedure, successfully applied for weight loss over the last 30 years. It covers a broad spectrum of indications from the overweight to the obese individual who does not fulfill the criteria for bariatric surgery, up to the morbidly obese, who qualifies for bariatric surgery but has uncontrolled co-morbidities causing her/him to be of high-risk for anesthesia and surgery or denied anesthesia and/or surgery, or its use as a bridge to bariatric surgery, and, finally, to anyone who just needs to achieve limited weight reduction, either prior to surgery of whatever kind and for whatever reason or merely for aesthetic purposes[ 51 , 82 , 83 ]. Generally speaking, the specific indications for balloon implantation for each candidate for such treatment must be built on the absolute judgment of the treating physician or the multidisciplinary working team; however, the positive response, that is the weight loss, is due exclusively to the responsibility of the patient to strictly adhere to a diet/exercise program and follow-up sessions throughout the treatment period, whatever type of balloon has been used.…”

“…The ReShape Duo balloon, FDA-approved system is inserted transorally and advanced into the stomach by means of an endoscopic guidewire. Each is filled separately with up to 450 mL of saline (maximum total volume 900 mL), although a smaller volume is recommended for individuals less than 64.5 inches in height[ 47 - 51 ]. When inflated, it occupies a significant portion of the stomach (900 mL), while maintaining the natural gastric anatomy.…”

“…This chapter aims to show in numbers - through meta-analysis and large series - studies published in recent years - the effectiveness in weight loss of the IGBs now in use in clinical practice. For comparison and homogeneity of expression the parameters of percentage total body weight loss (%TBWL), percentage excess weight loss (%EWL) and BMI are used[ 51 , 61 ] (Table 2 ).…”