FDA: Intragastric Balloons Associated With Five Deaths

August 14, 2017

The FDA has issued an update warning that intragastric balloons by Apollo Endo Surgery and ReShape Medical are tied to five deaths.

The reports all suggested the deaths occurred within a month or less of balloon placements, with three occurring within three days of placement. The agency cannot yet identify the root cause or positively attribute the deaths to the devices or their insertion procedures.

The FDA said it will continue its collaboration with the two companies to resolve the issue.

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