Contamination of Single Fluid-Filled Intragastric Balloons with Orogastric Fluid is not Associated with Hyperinflation: An Ex-vivo Study and Systematic Review of Literature

Abstract

Background Spontaneous 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 diameter and contents, whether methylene blue plays a role in preventing spontaneous hyperinflation, and review the available literature on spontaneous hyperinflation. Methods Four pairs of balloons with different combinations of sterile saline, contaminants, and methylene blue were incubated in a 37° Celsius water bath for 6 months to simulate physiological conditions with serial measurements of balloon diameter. Our findings were compared against a systematic review across multiple databases to summarize the available literature. Results Balloon mean diameter 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. Conclusions Despite 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.