FDA updates gastric balloon warning after 5 deaths

FDA
The FDA continues to recommend healthcare providers closely monitor patients implanted with Apollo Endosurgery and ReShape Medical's intragastric balloons.

The FDA updated its warning on liquid-filled intragastric balloons used to treat obesity after receiving five new reports of patient deaths.

Four of the patients were implanted with Apollo Endosurgery’s Orbera balloon, while the fifth was implanted with ReShape Medical’s Integrated Dual Balloon System. Intragastric balloons are designed to treat obesity by taking up room in the stomach, making patients feel full.

In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

“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 agency said.

RELATED: Allurion bumps up series C to $27M as it revs up for U.S. trial

“Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously,” said Apollo Endosurgery CEO Todd Newton in a statement. “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. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of Orbera and we will continue to do so.”

The FDA update comes six months after the agency 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. Since the February letter, both ReShape and Apollo have changed their devices’ labeling to address these risks.

Suggested Articles

Janssen is planning its first completely virtual clinical trial, using personal smartphones and wearable devices with no in-person site visits.

Sensyne Health aims to bring its AI tools to America, and it’s enlisting IT giant Cognizant and data infrastructure specialist Agorai to help.

Californian RNA biotech Arrowhead will lose its COO and R&D head from next year but is hiring a new CMO and CSO to help steady its research exec team.