Five Die While Using Obesity Devices, FDA Says

Aurora Colorado. John Moore

Aurora Colorado. John Moore

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. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit.

The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight.

Four of the deaths are being investigated in connection with the Orbera Intragastic Balloon System by Apollo Endosurgery; the fifth death is in connection to the ReShape Integrated Dual Balloon System by ReShape Medical Inc., CNN reports.

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. Three of them died within the first three days, the administration said.

The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.

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"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program", FDA said.

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.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States.

The symptoms of balloon over-inflation or pancreatitis include severe abdominal or back pain, abdominal swelling, trouble breathing, fever or vomiting.

They said that from January 2006 to March 2017, 21 patients using the Orbera device died.

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