April 27, 2020
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.”
- 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 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. The FDA has received reports for a total of 18 deaths worldwide since Orbera and ReShape were approved in 2015, of which eight were patients in the U.S. (five with Orbera and three with ReShape).
- The FDA continues to work with the manufacturers of gastric balloons to monitor and evaluate reported deaths and adverse events, and to implement potential mitigation strategies. Since 2017, the FDA has worked with the manufacturers of all available intragastric balloons in the U.S. to update their labeling with more information about possible risks associated with use of their devices including death, acute pancreatitis and hyperinflation.
- The FDA will continue to work with Apollo Endosurgery to ensure that the Orbera product labeling includes the post-approval study findings. As of January 1, 2019, Apollo Endosurgery stopped selling and distributing the ReShape Balloon.
- The FDA first communicated on the potential risk of hyperinflation and acute pancreatitis with liquid-filled intragastric balloons in February 2017. Since then, the FDA provided updates in August 2017 and June 2018 about the potential risk of death with liquid-filled intragastric balloons, and in December 2019 announced the availability of the final data summary for the Reshape balloon post-approval study.
- On September 5, 2019, the FDA published a discussion paper, Consideration of Benefit-Risk Approaches for Weight-Loss Devices, which describes a concept the agency is considering to assess the safety and effectiveness of weight-loss devices, including gastric balloons, and highlights areas where the FDA sought input from stakeholders
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.