The U.S. Food & Drug Administration (FDA) has issued risk alert after receiving five reports of unanticipated deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.
All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement.
At this time, the deaths have also not been directly attributed to the devices or the insertion procedures for these devices.
The FDA recommends that health care providers closely monitor patients treated with these devices for complications and that you promptly report any adverse events related to intragastric balloon systems.
More information, including how to report an adverse event, is available on the FDA website