Story highlights FDA: Root cause of the five deaths not known yet

All five had gotten liquid-filled balloons placed in stomach to aid weight loss

Five people who were using an obesity treatment that places balloons inside their stomachs have died since 2016, according to the US Food and Drug Administration.

Four of the deaths involved people using the Orbera Intragastric Balloon System and one involved ReShape Integrated Dual Balloon System, the agency said.

"At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices," the FDA said in a safety alert issued Thursday.

The five people died within a month or less of having the balloons inserted. Three died one to three days after the balloon placement.

The agency is also reviewing two additional deaths, one from each company, that could be related to "potential complications associated with balloon treatment." One was a stomach perforation and the other was a perforation in the esophagus, according to the FDA.

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