The US Food and Drug Administration (FDA)said today that it has received five reports of unanticipated deaths that occurred from 2016 to the present in patients who received a liquid-filled intragastric balloon system to treat obesity.
Four reports involve the Orbera Intragastric Balloon System (Apollo Endosurgery) and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert.
All five patients died within 1 month or less of balloon placement. Three patients died 1 to 3 days after the balloon was placed.
“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction),” the FDA said.
The FDA has also received two additional reports of deaths from 2016 to the present related to potential complications associated with balloon treatment: one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System.
The FDA is working with both companies to better understand the issue of unanticipated death and to monitor the potential complications of acute pancreatitis and spontaneous overinflation.
Additionally, as part of the ongoing, FDA-mandated postapproval studies for these devices, the FDA will obtain more information to help assess the continued safety and effectiveness of these approved medical devices.
Today’s safety alert follows an FDA alert sent to healthcare providers in February, in which the agency recommended close monitoring of patients with liquid-filled intragastric balloon systems used to treat obesity for the potential risks of acute pancreatitis and spontaneous overinflation. Since then, both companies have revised their product labeling to address these risks, the FDA said.
For now, the FDA continues to recommend that healthcare providers closely monitor patients treated with these devices for complications and report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.