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Gastric Balloon-Makers Respond To US FDA Warning

 
• By Elizabeth Orr

Apollo Endosurgery and Reshape Medical are both defending their products’ safety in the wake of a US FDA letter warning of five deaths tied to the companies' intragastric balloon devices.

Vintage inscription made by old typewriter, warning

Manufacturers of gastric balloons used to treat obesity are defending their products’ safety in the wake of an Aug. 10 FDA letter informing providers that multiple deaths had been linked to the products.

FDA is still investigating the exact causes of the deaths, the letter said. The letter primarily cites five deaths that...

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