A letter was released by the FDA alerting health care providers of seven deaths involving patients implanted with liquid-filled intragastric balloon systems, including Apollo Endo Surgery's Orbera Intragastric Balloon System and ReShape Medical's ReShape Integrated Dual Balloon System, for obesity treatment. The FDA seeks to continue its collaboration with the device makers to track possible complications, including spontaneous overinflation and acute pancreatitis, and determine the cause of deaths.
Warning on deaths after intragastric balloons implantation issued by FDA
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