WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) issued an update to a recall affecting millions of Philips sleep apnea machines, saying they may have been linked to at least 561 reported deaths. The FDA has received more than 116,000 reports about the respiratory devices since April 2021, finding that they have been found to break down and cause serious health hazards including choking, inhalation of foreign particles and increased risk of cancer. The devices were made with polyester-based polyurethane (PE-PUR) foam, which has been found to break down over time and enter the airways of people using them.
According to the FDA notice, the foam degrades with use, causing “black pieces of foam, or certain chemicals that are not visible” to be “breathed in or swallowed by the person using the device.” Philips attempted to fix this issue after an initial recall of over 5 million devices in 2021. Since then, Philips has agreed with regulators to stop selling these and similar devices in the U.S., and a proposed class action settlement is underway.
Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports. Importantly, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death.”
The affected devices include a range of ventilators, CPAP, and BiPAP machines used for sleep apnea and similar disorders. The issues stem from the breakdown of a foam component, which poses a serious injury risk to users. Philips has agreed to pay at least $445 million in compensation to users of the affected devices under a proposed class-action settlement for people who purchased a recalled Philips Respironics CPAP, BiPAP, or Ventilator sold in the U.S. between 2008 and 2021.
The recall affects a wide range of products, including specific models of BiPAP and CPAP machines, ventilators, and even certain Trilogy Evo ventilators with specific serial numbers. The company has also recalled certain reworked Philips Respironics Trilogy 100/200 Ventilators after the FDA asked for additional safety testing on the silicone foam material used to replace the problematic PE-PUR foam.
People who qualify for the settlement can submit a claim to receive compensation via the settlement website. This does not prevent them from filing further action, meaning impacted people can still bring further action at a later date. Those who qualify are entitled to a device payment award, a device return award, and/or a device replacement award if their sleep apnea machines posed a risk and needed to be replaced with a different model.
It’s crucial to monitor and address sleep apnea, a common condition where breathing stops and restarts during sleep, as it can lead to a range of health issues if left untreated. The gold standard of treatment for sleep apnea is using a continuous positive air machine, or CPAP, which helps maintain the respiratory cycle without interruption. Untreated sleep apnea can lead to high blood pressure, cardiovascular issues, diabetes, and mental health disorders, such as depression.
In conclusion, addressing sleep apnea, understanding the risks associated with certain CPAP and BiPAP machines, and taking the necessary steps to seek compensation for affected individuals is crucial for overall public health and safety.