Federal officials are warning health providers around weight loss balloon apparatus after five people died unexpectedly after being treated together.
The U.S. Food and Drug Administration (FDA) released a report on Thursday that because 2016 five individuals died after using liquid-filled balloon weight loss systems intended to treat obesity. Four of the deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery. 1 report entails ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.
In each instance, the person who obtained the weight loss balloon–patients are somewhat sedated as the balloon is inserted through the throat and into the stomach–died within a month or less of getting the balloon put. In three instances, the|The person died one to three days afterward|died.
“At this time, we do not know the root cause or incidence rate of individual death, nor have we been able to definitively attribute the deaths to the apparatus or the insertion procedures for these devices,” the FDA writes, adding that it is looking into two additional deaths.
The alarm from the FDA does not mean the agency has definitively demonstrated that the balloons caused the deaths, but that they are looking into it. The agency recommends that doctors closely|doctors|physicians monitor patients that are using these devices|monitor|patients which are using these devices are closely monitored by physicians|physicians closely|doctors|physicians monitor patients that are currently using these devices|patients which are currently using these devices are closely monitored by physicians.
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