Alert

Following Reported Deaths, FDA Issues Alert on Intragastric Balloons

By MedTech Intelligence Staff
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Alert

The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.

Between 2016 and present time, there have been five reports of unanticipated deaths related to the placement of liquid-filled intragastric balloons to treat obesity. According to a healthcare provider alert issued through the agency’s MedWatch program, the deaths occurred within a month or less of placing the device in the body (three deaths occurred in just one to three days following balloon placement). Four of the reports involve Apollo Endo Surgery’s Orbera Intragastric Balloon System and one report involves ReShape Medical, Inc.’s ReShape Integrated Dual Balloon System.

In addition, FDA received two more reports of death that are related to complications associated with the balloon treatment—one occurred as a result of gastric perforation and the other esophageal perforation.

“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. Additionally, as part of the ongoing, FDA-mandated post-approval studies for these devices, we will obtain more information to help assess the continued safety and effectiveness of these approved medical devices.” – FDA

Earlier this year, FDA sent a letter to healthcare providers, recommending they closely monitor patients who have liquid-filled intragastric balloons to treat obesity due to the risk of acute pancreatitis and spontaneous over-inflation. Since the agency issued this letter, Apollo Endo-Surgery and ReShape Medical revised product labeling related to these risks.

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