Balloon obesity devices linked to 5 patient deaths, says FDA

Tabitha Dunn
August 13, 2017

Federal officials are warning health providers about weight loss balloon devices after five people died unexpectedly shortly after being treated with them.

Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.

The liquid-filled intragastric balloon systems have been used as a treatment for obesity, said the FDA alert issued on Thursday. Three patients died 1 to 3 days afterward. The FDA is also looking into two additional deaths that could possibly be related to "complications associated with the balloon treatment"-one from each company".

"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. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc. Four of those deaths involved the Orbera Intragastric Balloon System, and one involved the ReShape Integrated Dual Balloon System, the FDA says. "Patients must be monitored closely during the entire term of treatment to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms".

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More than 180,000 of Apollo Endo-Surgery's Orbera balloons have been placed in patients since the product was approved by the FDA in 2015.

"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement.

'The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity'.

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