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FDA: 5 deaths tied to weight-loss balloon treatments

13 August 2017

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. The five people died with a month of getting the balloons inserted into their bodies, and three of them died within just three days.

The company has not received product-liability claims as a result of any of the deaths, it said.

The full statement from the FDA follows below.

The U.S. Food and Drug Administration (FDA) released a report that since 2016, five people died after using liquid-filled balloon weight loss system meant to treat obesity.

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Four deaths occurred among patients implanted with the Apollo Endo Surgery's Orbera Intragastric Balloon System, and one involved ReShape Medical's ReShape Integrated Dual Balloon System.

"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 wrote.

The intragastric balloon systems work by placing one or two deflated balloons into a person's stomach by way of an endoscope that goes through the mouth.

Also, as part of ongoing studies of these devices ordered by the FDA, the agency will measure their safety and effectiveness.

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The FDA will keep the public informed as significant new information becomes available.

Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons. Since issuing this letter, both companies have revised their product labeling to address these risks. "Patients must be monitored closely during the entire term of treatment to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms".

A typical stomach has a gastric volume of 900 ml, and the inflated balloon occupies a volume around 700 ml.

The products and procedures are approved by the FDA. Use of the device may have unwanted side effects. This can be done in an outpatient setting under sedation.

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One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery. Thus, the space for food is reduced, tending to a loss of weight. After a maximum of up to six months, the device is removed using endoscopy again.

FDA: 5 deaths tied to weight-loss balloon treatments