FDA links intragastric balloons to 5 more deaths, bringing total to 12 since 2016

pharmafile | June 5, 2018 | News story | Manufacturing and Production, Sales and Marketing FDA, gastric balloon, pharma 

Five more deaths have been reported to the FDA in patients using intragastric balloon systems, meaning that 12 total deaths have been linked to the use of the devices since 2016.

An intragastric balloon is an inflatable, saline-filled medical device inserted into the patient’s body through the mouth as a treatment for obesity, which then works by occupying space in the stomach and reducing appetite.

The specific iterations of the technology associated with these most recent deaths were manufactured by ReShape Lifesciences and Apollo Endosurgery, according to the US regulator, both of whose stocks fell by around 10% on the news. In four out of five cases, gastric perforation occurred before death and within 31.5 weeks from the original implantation procedure.

Apollo confirmed that four patients had died while using its Orbera Intragastric Balloon device since August 2017, when the FDA issued its previous warning letter alerting healthcare providers to seven deaths linked to the technology. ReShape too said that there had been one reported death of a patient using its ReShape Balloon device since that time, and three since August 2015.

Apollo added that the rate of spontaneous hyperinflation of its implanted devices is just 0.07%, with the rate of gastric perforation even lower at 0.01%, meaning mortality rates were even lower than this.

The FDA has issued a new letter to flag the issues to healthcare providers. FDA spokesperson Deborah Kotz remarked: “The FDA has approved new labeling for these two devices in order to adequately inform doctors and patients about the adverse events. We have been working with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices.” However, she added that the agency still considers the devices “an appropriate treatment option” for obesity in some cases.

Matt Fellows

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