FDA: 5 deaths tied to weight-loss balloon treatments

Aurora Colorado.                       John Moore

Five people have died after have anti-obesity devices surgically inserted into their stomachs, U.S. regulators have revealed.

"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.

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

"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.

A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve USA patients. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.

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Today's FDA warning follows another alert in February 2017, after dozens of patients suffered life-threatening side effects when their balloon spontaneously over-inflated with air or fluid.

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.

All five patient deaths occurred within a month of balloon placement, and three happened just one to three days after the procedure. The exact causes in three of the deaths remained unknown.

The company said it "received no product liability-related claims in connection with these five cases" and noted that the incidence rate "remains less than 0.01%", which is in line with what it reports in the directions for use of the device.

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity.

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