FDA Issues Warning of Gastric Balloon-Related Deaths
The FDA has recommended that health care providers closely monitor patients with liquid-filled intragastric balloon systems for the treatment of obesity.
The update comes following 5 unanticipated deaths reported from 2016 to the present in patients treated with the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System.
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In all 5 cases, death occurred within 1 month of balloon placement, with death occurring within 1-3 days after placement in 3 cases. At this time, the FDA is not sure of the root cause of the deaths and are not able to definitively attribute the deaths to these devices.
The FDA requests that health care providers report any adverse events related to intragastric balloon systems.
—Michael Potts
Reference:
Liquid-filled intragastric balloon systems: letter to healthcare providers - potential risks. FDA. August 10, 2017. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570916.htm.