Patient Deaths and Liquid-filled Intragastric Balloon Systems

Santa Clara, CA: Following five reports of patient deaths that occurred within a month or less of placement of liquid-filled intragastric balloon systems the US Food and Drug Administration (FDA) has issued an updated alert.

The agency states that the five unanticipated deaths occurred from 2016 to present day 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 Inc.

In three reports, the patients died within one to three days after balloon placement.

Further, the FDA has received two additional 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).

The FDA said in a statement that it does not currently know the root cause or incidence rate of patient death, nor have they been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).

In February 2017, the FDA issued a letter to health care providers to recommend close monitoring of patients with liquid-filled intragastric balloon systems used to treat obesity for the potential risks of acute pancreatitis and spontaneous over-inflation.

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Last updated on Aug-10-17