Healthcare News

Weight Loss Balloons Now Linked To 12 Deaths

Looks like the health market on surgery is taking a hit from every angle. From implants to shots to now the balloon is being rejected by the human body. The intragastric balloon systems are weight-loss systems that function by taking up space in a patient’s stomach, according to the FDA. In a minimally invasive endoscopic procedure, the balloons are placed into the patient’s stomach through the mouth. Once in place, the balloon is filled with saline solution.

(CNN) An additional five patients have died in association with intragastric balloons for the treatment of obesity, bringing the total number of deaths to 12 worldwide since 2016, the US Food and Drug Administration said in an alert Monday.

The intragastric balloon systems are weight-loss systems that function by taking up space in a patient’s stomach, according to the FDA. In a minimally invasive endoscopic procedure, the balloons are placed into the patient’s stomach through the mouth. Once in place, the balloon is filled with saline solution.
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Four of the five new cases are related to the Orbera Intragastric Balloon system made by Apollo Endosurgery Inc. and one to the ReShape Integrated Dual Balloon System made by ReShape Lifesciences. In four of the cases, including the one for the ReShape device, death was preceded by a gastric perforation, or hole in the stomach wall, that occurred within 3½ weeks of surgical placement of the balloon, according to the FDA. The fifth death is still being investigated by Apollo Endosurgery.
“The FDA has approved new labeling for these two devices in order to adequately inform doctors and patients about the adverse events,” spokeswoman Deborah Kotz said. “We have been working with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices.”
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