Alert

Five More Deaths, FDA Alerts on Liquid-Filled Intragastric Balloons

By MedTech Intelligence Staff
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Alert

This is the second alert the agency has issued in less than one year.

Five more deaths have been reported in patients where liquid-filled intragastric balloon systems were used to treat obesity. That brings the total number of deaths to 12 patients worldwide since 2012.

MedTech Intelligence last reported on this issue in August 2017, with the cases involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System.

Last week the FDA approved labeling changes that indicated deaths could be associated with the above-mentioned devices. The agency is also monitoring complications associated with device placement and use, which includes perforation of the stomach wall or esophagus, acute pancreatitis, and spontaneous hyperinflation. Healthcare providers have also been advised to monitor patients who have these balloons for complications.

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