FDA Warns 350 Deaths Linked To Philips CPAP Machines

FDA Warns 350 Deaths Linked To Philips CPAP Machines

Introduction

According to a recent assessment by federal authorities, the disintegration of sound abatement foam in recalled Philips CPAP sleep apnea devices has been connected to roughly 350 fatalities and nearly 100,000 claims of health issues among former users.

Following widespread reports of small black particles being found in the tubing and face masks, which were released by a polyester-based polyurethane (PE-PUR) foam intended to reduce noise and vibrations while the sleep apnea machines were used at night, a Philips CPAP recall was issued in 2021, affecting millions of machines sold since 2009.

As a result of the potential CPAP foam health risks, federal health officials immediately advised all consumers to stop using the recalled machines, unless necessary for life-sustaining therapy, and reports of former users developing various cancers, lymphoma, lung damage, and other injuries linked to the toxic chemicals and gases released as the sound abatement foam degraded began to surface.

Thousands of Philips CPAP claims have been filed across the federal court system, and it is widely believed that the litigation will quickly become one of the greatest mass torts in the United States.

The US Food and Drug Administration published an update on the current number of medical device reports received by the agency that are associated with PE-PUR foam deterioration in recalled Philips CPAP equipment on February 9.

Since April 2021, the FDA has received more than 98,000 medical device reports related to exposure to recalled sleep apnea equipment, as well as recalled ventilators and BiPAP machines. This figure contains 346 instances of fatalities connected to foam particles.

According to the FDA update, the MDRs received comprised both mandated reports from Philips and voluntary reports from health professionals, customers, and patients. Cancer, pneumonia, asthma, other respiratory issues, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest discomfort have all been observed in these MDRs.

The information comes after Philips revealed in December that it had conducted its own evaluation of the recalled DreamStation CPAP devices, concluding that the health risks posed by PE-PUR foam are negligible. However, Philips recognised at the time that the FDA's interpretation of the evidence may differ.