This article is a collaboration between MedPage Today® and: Medpage Today
The FDA sent a letter to healthcare providers warning of reports of seven deaths with liquid-filled intragastric balloon systems used to treat obesity.
In five cases, the cause of death was unclear, but all occurred within a month or less of balloon placement, the agency said. In three of those cases, the patient died within one to three days of having the balloon inserted.
Four of these reports involved the Orbera Intragastric Balloon System from Apollo Endo Surgery, and one involved the ReShape Integrated Dual Balloon System by ReShape Medical.
