The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS).
The additional deaths bring the total number of deaths worldwide from the Orbera intragastric balloon and ReShape integrated dual balloon system up to 12 since 2016, the agency said.
The federal watchdog said that it continues to monitor complications related to the placement and use of the devices, which include perforation of the stomach wall or esophagus, inflammation of the pancreas and the balloon filling with air and enlarging.
The FDA said it is continuing to work with the device makers as it tries to better understand the issues, and advised healthcare providers to closely monitor patients with intragastric balloons for complications and inform them of signs of serious or life-threatening problems and what to do if they occur.
“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. 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,” FDA Center for Devices and Radiological Health Office of Device Evaluation director Dr. William Maisel said in a prepared statement.
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By: Fink Densford
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