FDA reports five deaths related to weight-loss balloons

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The FDA said that it has not yet determined whether the weight loss devices or the surgery that implanted them is the cause of the deaths, but it had already issued an alert so doctors would closely monitor patients who have them.

The FDA is investigating after five people have died since 2016 following an anti-obesity procedure involving silicone balloons, the Washington Post reports.

Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due. The balloon is created to remain in place for several months.

The FDA said the deaths occurred from some time in 2016 to the present and have issued the warning as a precautionary measure, as the regulatory body has yet to directly link the intragastric balloons to the cause of death.

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

All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers.




The FDA said that they also received two other reports of fatal cases in the same period which were associated with potential complications linked to balloon treatment.

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.

Four deaths involve the Orbera® Intragastric Balloon System made by Apollo Endosurgery and 1 death involves the ReShape® Integrated Dual Balloon System manufactured by Reshape Medical. Four of the cases involved the Orbera Intragastric Balloon System by Apollo Endosurgery.

A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve USA patients.

MORE: I Swallowed a Balloon For Weight Loss and Lost 40 Lbs. Use of the device may have unwanted side effects.

In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety".

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