The Food and Drug Administration on Thursday reported five deaths in patients using fluid-filled intragastric balloons to treat obesity.
Here are four things to know.
- Four deaths occurred among patients implanted with the Apollo Endo Surgery's Orbera Intragastric Balloon System, one of which involving a patient in the U.S. The fifth case involved ReShape Medical's ReShape Integrated Dual Balloon System.
- The weight loss system, which the FDA first issued a safety warning for in February, involves the inflation of balloons in patients' stomachs via a micro-catheter. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.
- All five patient deaths occurred within a month of balloon placement, and three happened just one to three days after the procedure.
- The FDA has not identified a root cause for the patient deaths and cannot "definitively attribute the deaths to the devices or the insertion procedures for these devices," according to an agency notice.
"The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation," the agency said.
5. Apollo Endo Surgery issued a statement August 10 in response to the FDA's safety notice.
"The FDA’s letter to [healthcare providers] does not indicate that the patient deaths were related to the Orbera device or the insertion procedures," the company wrote. "While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device."
Editor's note: This article was updated Aug 16.
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