Contamination of single fluid-filled intragastric balloons with orogastric fluid is not associated with hyperinflation: an ex-vivo study and systematic review of literature

Fadi Hawa,Eric J Vargas,Alison Mcrae,Andres Acosta,Barham K Abu Dayyeh,Fateh Bazerbachi

doi:10.1186/s12876-021-01863-w

Fadi Hawa, Eric J Vargas + Show 4 more

Open Access

https://doi.org/10.1186/s12876-021-01863-w

Copy DOI

Abstract

BackgroundSpontaneous hyperinflation is reported to the Food and Drug Administration as a complication of intragastric balloons. It is postulated that orogastric contamination of the intragastric balloon may cause this phenomenon. We sought to investigate the effects of intentional balloon contamination with gastric contents on intragastric balloon perimeter and contents, whether methylene blue plays a role in preventing spontaneous hyperinflation, and review the available literature on spontaneous hyperinflation.MethodsFour pairs of balloons with different combinations of sterile saline, orogastric contaminants, and methylene blue were incubated in a 37 °C water bath for six months to simulate physiological conditions with serial measurements of balloon perimeter. Our findings were compared against a systematic review across multiple databases to summarize the available literature.ResultsBalloon mean perimeter decreased from 33.5 cm ± 0.53 cm to 28.5 cm ± 0.46 cm (p < 0.0001). No significant differences were seen with the methylene blue group. Only 11 cases were found reported in the literature.ConclusionsDespite contaminating intragastric balloons with gastric aspirates, hyperinflation did not occur, and other factors may be in play to account for this phenomenon, when observed. Rates of hyperinflation remain under-reported in the literature. Further controlled experiments are needed.

Highlights

Spontaneous hyperinflation is reported to the Food and Drug Administration as a complication of intragastric balloons
The onset of symptoms can be as early as seven days and up to 23 weeks after balloon placement. The mechanism behind this adverse events (AEs) remains unclear, with reports postulating that orogastric (OG) contamination with microorganisms during intragastric balloon (IGB) insertion is the likely culprit [15, 16]. In this ex-vivo study, we investigate the effects of intentional contamination of the single fluidfilled IGBs with OG contents on balloon perimeter and contents and whether methylene blue (MB) plays a role in preventing spontaneous hyperinflation
Results of the ex‐vivo study Eight IGBs were used in the ex-vivo study, and serial measurements of the perimeter of the balloon were documented over 165 days

Summary

Introduction

Spontaneous hyperinflation is reported to the Food and Drug Administration as a complication of intragastric balloons. Traditional obesity management techniques, such as lifestyle interventions (e.g., diet and physical activity), which remain the foundation of any weight loss program, are often. In this context, endoscopic bariatric therapies (EBTs) emerged as an effective and less-invasive alternative to surgery [4]. Endoscopic bariatric therapies (EBTs) emerged as an effective and less-invasive alternative to surgery [4] This field has the potential to bridge the gap in patients who fail lifestyle interventions or who are intolerant to weight loss pharmacotherapy and are not surgical candidates. The most commonly reported adverse events (AEs) associated with this device are mild accommodative gastrointestinal symptoms, while serious AEs occur in < 1% of cases (e.g., perforation, prosthesis migration) [11,12,13]

Objectives

Methods

Results

Discussion

Conclusion