The Food and Drug Administration issued a warning Friday to medical providers to closely monitor patients undergoing a specific gastric-bypass procedure, following the deaths of five people shortly after they underwent the operation.
At least three patients died within one to three days following a procedure for a liquid-filled intragastric balloon system. Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food.
The other two deaths occurred within a month or less of having the procedure.
The FDA said the deaths occurred from some time in 2016 to the present and have issued the warning as a precautionary measure, as the regulatory body has yet to directly link the intragastric balloons to the cause of death.
Four of the reported deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one other death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc., the FDA said in a press release.
The FDA recommends health providers monitor patients closely for pancreatitis — inflammation of the pancreas — and spontaneous overinflation of the inserted bag. In February, the FDA had issued a preliminary warning to medical providers to carefully monitor such reactions.
• Laura Kelly can be reached at lkelly@washingtontimes.com.
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