Five more patient deaths have been linked to two liquid-filled intragastric balloon systems designed to treat obesity, bringing the worldwide total to 12 deaths since 2016.
According to an FDA alert sent to healthcare providers June 4, four of the new deaths reported since August 2017 occurred following gastric perforation from one day to 3.5 weeks after balloon implantation.
Three of these fatalities occurred with the Orbera Intragastric Balloon System (Apollo Endosurgery) and the other came with the ReShape Integrated Dual Balloon System (ReShape Lifesciences). The fifth death was also with the Orbera device, but the manufacturer is still investigating the cause of that incident, according to the FDA.
U.S. patients have accounted for seven of the 12 deaths reported since 2016—four with the Orbera system and three with the ReShape system. The FDA said it has approved new U.S. labeling with more information about the possible death risk associated with the devices.
“The FDA will continue to monitor the safety and effectiveness of these approved devices by working with the manufacturers to monitor death reports, assess possible risk factors and mitigations, and ensure that the products' labeling addresses these risks,” the agency’s letter stated. “The FDA will keep the public informed as significant new information or recommendations become available.”
In the meantime, the FDA recommended providers inform patients of the symptoms of life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration and gastric and esophageal perforation; monitor patients closely during the entire term of treatment; and report any adverse events related to the systems through its MedWatch program.
Both manufacturers released statements in response to the FDA’s letter, citing their devices’ low global event rates and expressing a willingness to work with the agency on reporting adverse events and labeling their products appropriately. ReShape Lifesciences’ statement is available here, while Apollo Endosurgery’s response can be found here.