Liquid-filled intragastric balloons are used for the treatment of obesity and this trend has surfaced rapidly during recent years. However, starting from 2016, there have been five reports of unanticipated deaths among individuals who were using the intragastric balloon systems. Four reports were related to the use of Orbera Intragastric Balloon System, whereas one was about ReShape Integrated Dual Balloon System.
All patient deaths occurred within one month of intragastric balloon placement; three of them within three days of placement. So far, the root cause of deaths remains unidentified. Potential complications may include flaws in insertion procedures, intestinal obstruction and esophageal performation etc.
FDA is working in collaboration with the manufacturers to better understand the issue and to find an appropriate solution for it. Meanwhile, FDA has advised the physicians to monitor closely the users of such devices for any possible complications. The manufacturers have revised their product labeling accordingly.