5 Deaths After Using Weight Loss Balloon Device: FDA

At least five people have died since 2016 after using a balloon device used to treat obesity that is placed inside patients' stomachs, according to the FDA.

The FDA on Thursday issued an update to alert health care providers of the five reports of "unanticipated deaths." Four of the reports involved the Orbera Intragastric Balloon System and one report involved the ReShape Integrated Dual Balloon System.

According to the FDA, all five deaths occurred within a month or less of the balloon being placed, and three of the deaths occurred as soon as one to three days after the placement.

"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 statement. The FDA said it has received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.

The FDA said it is working with both companies to better understand the issue of unanticipated death and to monitor potential complications of acute pancreatitis and spontaneous over-inflation.

"Additionally, as part of the ongoing, FDA-mandated post-approval studies for these devices, we will obtain more information to help assess the continued safety and effectiveness of these approved medical devices," the FDA said.

The FDA recommends that health care providers closely monitor patients treated with these devices for complications.

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