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Gastric Balloon Labeling Updated After Patient Deaths

 
• By Elizabeth Orr

US FDA has approved updated labeling for Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System in the wake of five more patient deaths.

Stomach surgery puzzle concept (3d rendering). Hands of surgeon with surgical tools perform stomach surgery as a result of gastric ulcer, peritonitis, gastric erosion, stomach bleeding, obesity, tumor

Five additional patient deaths have been tied to liquid-filled intragastric balloons used to treat obesity, bringing the total to 12 deaths since 2016. US FDA announced June 4 that it has approved updated labeling to update the risks statement.

The revisions include new mortality statistics, as well as more information on how to manage patients experiencing side effects. FDA...

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