Devices

Safety Update on Obesity Gastric Balloons

FDA has issued a letter to health care providers that updates risk information for gastric balloon devices used for weight loss. Results from two FDA-required post-approval studies provide updated information on two specific risks — device over-inflation or spontaneous hyperinflation, and sudden pancreas inflammation (acute pancreatitis). “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,” a safety notice says. “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.”

In the Orbera post-approval study, six out of 258 patients (2.3%) experienced balloon hyperinflation, FDA says. No events of hyperinflation were reported in the ReShape post-approval study. In the ReShape post-approval study, two out of 159 patients (1.3%) experienced acute pancreatitis. There were no events of acute pancreatitis reported in the Orbera post-approval study. There were no events of balloon hyperinflation or acute pancreatitis reported in the studies the companies used in their premarket approval applications submitted to the FDA. No deaths were reported in the post-approval studies, FDA says, noting that it has received reports for a total of 18 deaths worldwide since Orbera and ReShape were approved in 2015.

FDA says it will continue to work with Apollo Endosurgery to ensure that the Orbera product labeling includes the post-approval study findings. In 2019, Apollo stopped selling and distributing the ReShape Balloon.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome