The Food and Drug Administration is warning clinicians of potential risks associated with fluid-filled intragastric balloons to treat obesity.
Here are four things to know.
1. The agency received reports of two different adverse events associated with the devices. Some reports involved the balloon over-inflating with air or fluid in patients' stomachs, while other reports said patients developed acute pancreatitis. Both require premature removal of the device.
2. The potential safety risks apply to the The ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System, both approved in 2015.
3. The FDA is working with the manufacturers of these devices to better understand the cause of the issues.
4. The agency urges clinicians to be aware of the potential complications and act accordingly if they do arise. If clinicians remove the device due to an issue, they should report the adverse event to the FDA and follow the manufacturer's instructions for device returns or evaluations.
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