FDA In Brief: Postmarket Update on Liquid-filled Intragastric Balloons | FDA

FDA In Brief: Postmarket Update on Liquid-filled Intragastric Balloons | FDA

FDA In Brief: Postmarket Update on Liquid-filled Intragastric Balloons

The following quote is attributed to Benjamin Fisher, Ph.D., director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health:

“As a condition of device premarket approval, the FDA requires the manufacturers of gastric balloon devices used for weight loss to conduct studies assessing the devices’ performance after they are approved, known as post-approval studies. This is one important way the FDA continues to assess the safety and effectiveness of these medical devices. “Today, the results from two of those post-approval studies tell us more information about two specific risks—over-inflation of the device, or spontaneous hyperinflation, and sudden inflammation of the pancreas, or acute pancreatitis—which the FDA first communicated about in 2017. The FDA wants to ensure health care professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment. While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them.”

Additional Information: Today the U.S. Food and Drug Administration issued a Letter to Health Care Providers to provide details about the completed post-approval studies for the Orbera and ReShape liquid-filled intragastric balloons. In the Orbera post-approval study, 6 out of 258 patients (2.3%) experienced balloon hyperinflation. No events of hyperinflation were reported from the ReShape post-approval study. In the ReShape post-approval study, two out of ...

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