FDA Reports That 5 People Have Died After Weight Loss Balloon Treatments

FDA Five deaths reported while using weight loss balloon treatment

Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full.

Apollo Endo-Surgery said, per NBC News, that worldwide sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include US patients.

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.

The FDA also warned that several patients developed acute pancreatitis (pancreas inflammation) because the fluid-filled balloons compressed their internal organs. Four of the patients received an Orbera Intragastric Balloon System made by Apollo Endosurgery; while one of the patients received a ReShape Integrated Dual Balloon System developed by ReShape Medical Inc.

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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. Then saline is used to fill the balloons.

The balloons are put inside patients' stomachs and inflated to help people feel full and eat less.

The agency recommends that doctors closely monitor patients who are using these devices. Use of the device may have unwanted side effects. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017. ReShape is committed to supporting the continued safe and effective use of the dual balloon and is proactively communicating with physicians about this FDA update. The FDA says it can't confirm the devices are responsible for the deaths.

"All five reports indicate that patient deaths occurred within a month or less of balloon placement", the FDA said in a statement cited by NBC.

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