Recalled breathing assistance devices from Philips Respironics have been linked to 561 deaths, federal regulators said Wednesday.
The death toll is an update to the U.S. Food and Drug Administration's 2021 recall of Philips' ventilators, BiPAP and CPAP machines. The recall stated the polyester-based polyurethane (PE-PUR) foam used to reduce sound and vibration in the devices could unknowingly be breaking down with use and absorbed into the user's body, potentially leading to health injuries.
And Thursday, the FDA put a number to those injuries, saying it's received more than 116,000 reports on the medical devices — including the 561 ending in death — associated with the PE-PUR foam breakdown, or suspected breakdown, since April 2021, when Philips first notified the FDA it was looking into the potential issue.
The other figures in the tally, which include mandatory reports from Philips and voluntary reports from consumers and health professionals, detail reports of cancer, pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules and chest pain from the PE-PUR foam breakdown.
Following initial recall, reworked sleep apnea machines are recalled
Reworked Respironics DreamStation CPAP, BiPAP machines, made by Phillips, are being recalled because they may not work.
The FDA issued its recall of the Philips devices in June 2021, saying the PE-PUR sound abatement foam breakdown could send black debris or other particles into a user's air pathway. This included about 15 million products manufactured between 2009 to 2021, and after repairs failed to properly fix the foam issue, caused a worldwide shortage of similar devices, leaving people with sleep apnea or breathing issues at a loss for a solution.
On Monday, Philips announced it would completely stop selling breathing machines in the U.S. until it meets a list of conditions laid out in its settlement with the FDA, which has yet to be finalized in court. It's not clear what those conditions are, but it's likely the plan to resolve the issues, and therefore sell the devices again, will take at least a year.
Philips agreed in December to pay nearly $480 million to users of its affected devices, but it's still facing thousands of lawsuits claiming the devices consumers needed to promote their health did just the opposite.
