Federal officials are warning health providers about weight loss balloon devices after five people died unexpectedly shortly after being treated with them.
The U.S. Food and Drug Administration (FDA) released a report which since 2016, five people died after using liquid-filled balloon weight loss system intended to treat obesity. In the procedures, patients are somewhat sedated as a deflated balloon made of silicone is inserted through the neck and to the stomach, after which it’s filled with saline to take up space in the gut. The balloon is designed to remain in place for several months. Four of those deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one happened after a patient used the ReShape Integrated Dual Balloon System, which can be made by ReShape Medical Inc.
In each case, the individual who received the weight loss balloon died within a month or less of getting the balloon placed. In three instances, the|The person died one to three days later|died.
“At this moment, we don’t know the root cause or incidence rate of individual death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices,” the FDA writes, adding that it is looking into two other deaths.
The alarm from the FDA does not necessarily mean the agency has definitively demonstrated that the balloons caused the deaths, but that they are looking into it. The agency recommends that physicians closely|doctors|physicians monitor patients that are using these devices|monitor|patients who are using these devices are closely monitored by doctors|doctors closely|doctors|physicians monitor patients who are currently using these devices|patients who are currently using these devices are closely monitored by physicians.
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