FDA: 5 deaths tied to weight-loss balloon treatments

FDA: 5 deaths tied to weight-loss balloon treatments

All five patients died within a month or less of balloon placement.

Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food. The balloons are left in the stomach for up to six months with the idea being they leave less room for food.

In its statement released on August 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon.

But three of the five patients died within three days of their supposedly low-risk operation.

The FDA says it doesn't know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them. "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 agency, however, cautioned that it has yet to determine whether the devices or the way in which they were placed in the stomachs directly caused those deaths.

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"The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc.to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation", the agency said. Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery.

More than 180,000 of Apollo Endo-Surgery's Orbera balloons have been placed in patients since the product was approved by the FDA in 2015.

It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device.

Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon.

Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients. Use of the device may have unwanted side effects.

Endoscopic placement of the balloon is temporary and reversible without surgical incisions.

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