FDA safety alert on unanticipated deaths with intragastric balloons


FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc. All five reports indicate that patient deaths occurred within a month or less of b…

Read more at Medical Dialogues: FDA safety alert on unanticipated deaths with intragastric balloons http://speciality.medicaldialogues.in/fda-safety-alert-on-unanticipated-deaths-with-intragastric-balloons/

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