FDA issues another round of updates for intragastric balloon warnings in wake of deaths

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The FDA issued new updates to its warning on liquid-filled intragastric balloons used to treat obesity. (FDA)

The FDA approved updates to its warning on liquid-filled intragastric balloons used to treat obesity that includes new training and directions to physicians and patients on the use of the devices.

The new round of updates come a year after the regulatory agency issued additional directions on the devices and were formed in collaboration with the two manufacturers, Apollo Endosurgery and ReShape Medical.

”These updates provide important enhancements to our existing labeling and support our continued emphasis on patient safety,” Christopher Gostout, M.D., Apollo Endosurgery’s chief medical officer, said in a statement. “Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events.”

The FDA said that since 2016 there have been 12 reports of deaths worldwide in patients with liquid-filled intragastric balloon systems. Seven of those deaths occurred in the U.S., with four of them having been treated with the Orbera Intragastric Balloon System and three with the ReShape Integrated Dual Balloon System.

In early 2017, the FDA issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape’s devices. These are spontaneous overinflation, with liquid or gas, of the devices and acute pancreatitis. Both complications require the removal of the device.