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# FDA Alert on Obesity Balloon Devices After 5 Deaths
- URL: https://www.fdaweb.com/fda-alert-on-obesity-balloon-devices-after-5-deaths/
- Published: 2017-08-10T12:00:00.000Z
- Updated: 2026-09-14T22:40:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139352

FDA has issued a [safety alert update](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570916.htm?ref=fdaweb.com) based on receiving five reports of unanticipated deaths since 2016 in patients with liquid-filled intragastric balloon systems used to treat obesity. “Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical,” the alert says. The five reports show that the deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement, the agency says.

  
FDA says that currently there is no identified root cause or incidence rate of patient deaths, and causality has not been attributed to the devices or the insertion procedures for the devices (e.g., gastric and esophageal perforation, or intestinal obstruction). The agency says it also received two reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System).