June 4, 2018
“We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients with two balloon devices used to treat obesity,” said William Maisel, M.D., director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The FDA continues to work with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices, and to ensure the product labeling adequately addresses these risks. 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.”
The FDA is alerting health care providers of five additional deaths in patients with two liquid-filled intragastric balloon systems used to treat obesity. Since 2016, a total of 12 patient deaths worldwide have been reported to the FDA involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System. The FDA approved labeling changes last week to reflect this information about deaths possibly associated with the devices. In addition to death, the FDA continues to monitor complications related to the placement and use of these devices, including perforation of the stomach wall or esophagus, inflammation of the pancreas (acute pancreatitis) and the balloon filling with air and enlarging (spontaneous hyperinflation).
The FDA continues to work with the device manufacturers, Apollo Endosurgery and ReShape Lifesciences, to better understand these issues. Health care providers are advised to closely monitor patients who have intragastric balloons for complications. Health care providers should also explain symptoms to patients that could be signs of serious or even life-threatening problems—and advise patients what to do if these symptoms happen.
The FDA issued two previous letters to health care providers concerning issues with these devices in August 2017, February 2017 and will continue to communicate publicly when significant new information or recommendations become available to share.
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..