In the wake of the announcement earlier this week that Philips and the FDA have agreed to the terms of a consent decree related to Philips’ recall of millions of respiratory support devices, the FDA has once again updated its tally of complaints received related to the recall.
The latest update spans the third quarter of 2023, during which the FDA received more than 7,000 medical device reports (MDRs) associated with the recall, including 111 new reports of patient deaths.
That brings the total number of reports received since April 2021 to more than 116,000, with 561 deaths reported, per the FDA’s notice.
Amid the FDA’s regular updates of the MDR count, both the regulator and Philips have repeatedly reminded onlookers that the MDR submission system is a passive one, meaning the reports—which come from healthcare providers, patients and caregivers—have not been confirmed to be accurate or specifically linked to Philips’ devices.
Philips began the recall in June 2021 after discovering that the polyester-based polyurethane (PE-PUR) foam used to muffle sound and vibrations in many of its respiratory devices could break down over time, potentially sending chemicals and debris into a user’s airflow. The foam was used in many of Philips’ CPAP and BiPAP machines and ventilators, prompting the company to recall around 5.5 million devices around the world.
According to the FDA, swallowing or inhaling pieces of the foam could cause internal and external irritation, asthma or headache, while inhaling chemicals from the disintegrating foam could lead to similar symptoms, as well as dizziness, a hypersensitivity reaction or nausea and vomiting. Both instances could also potentially result in “toxic or cancer-causing effects.
The agency said the MDRs it has received so far detail many of those reactions, including reports of chest pain, infection, difficulty breathing, pneumonia and cancer, among others.
Philips, meanwhile, has pushed back on those claims. Though it initially issued similar warnings about the possible risks tied to the PE-PUR foam’s breakdown, the company now claims that exposure to any debris or chemicals from the foam “is unlikely to result in an appreciable harm to health in patients.”
That conclusion is based on the results of safety testing that Philips conducted alongside five independent testing labs, with the results reviewed by third-party qualified experts and an external medical panel.
For its part, the FDA has in turn pushed right back on Philips’ claims and kept its original safety warnings in place. Last fall, the regulator reported that it had asked the company to conduct more safety tests—to which Philips agreed—stating, “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices.”
The FDA’s request for additional testing came after experts interviewed in a ProPublica investigation took issue with the genotoxicity results—denoting a substance’s ability to damage a cell’s genetic information—in Philips’ tests. Though Philips said the results fell within acceptable guidelines, the experts argued that any evidence of genotoxicity is cause for concern.