5 Deaths Reported After Balloon Obesity Treatments
By Megan Brooks
Aug. 10, 2017 -- Five people who had a balloon system put into their stomach to treat obesity have died since 2016, the FDA warned Thursday.
Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert.
All five patients died within a month or less of balloon placement. Three patients died 1 to 3 days afterward. The FDA says it can't confirm the devices are responsible for the deaths.
The FDA has also received two other reports of deaths since 2016 related to potential balloon treatment problems: one case where a person got stomach hole, with the Orbera Intragastric Balloon System, and one who got an esophagus hole, with the ReShape Integrated Dual Balloon System.
The FDA is working with both companies and will track potential problems.
Also, as part of ongoing studies of these devices ordered by the FDA, the agency will measure their safety and effectiveness.
Thursday's safety alert follows an FDA alert sent to health care providers in February, when the agency said there should be close monitoring of people with liquid-filled intragastric balloon systems used to treat obesity. The agency said there could be acute pancreatitis and "spontaneous overinflation." Since then, both companies have changed their product labeling to address these risks, the FDA said.
For now, the FDA continues to recommend that doctors closely watch patients treated with these devices and report any problems.