On Aug. 10, the FDA released a safety alert about the potential risks of liquid-filled intragastric balloon systems used to treat obesity.
In a letter to clinicians, the agency noted five reports of unanticipated deaths that occurred from 2016 to the present in patients treated with these systems. Four reports involve the Orbera Intragastric Balloon System, and one involves the ReShape Integrated Dual Balloon System.
In three reports, patients died as soon as one to three days after balloon placement, and all deaths occurred within the first month. The root cause of the deaths is unknown, although the systems carry potential risks of acute pancreatitis and spontaneous overinflation.