Health tech company Philips is halting sales of its sleep apnea devices in the United States following safety concerns and hundreds of related deaths.
The Food and Drug Administration initially announced in 2021 that multiple BiPAP and CPAP machines as well as ventilators produced by Philips Respironics had been recalled due to concerns about the breakdown of polyester-based polyurethane foam in the devices.
“If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury,” reads the FDA’s website. “The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer.”
The FDA has recorded 116,000 medical device reports and 561 deaths that have been associated with select devices since April 2021. Of the reported deaths, 187 were recorded between January 1, 2023 and September 30.
Philips Respironics has agreed with the FDA on the terms of a consent decree. The company will no longer sell CPAP, BiPAP, or respiratory devices in the United States, according to a press release. The company will, however, continue to service devices already in the possession of healthcare providers and provide new devices, services, replacement parts, and accessories outside the United States.
Janet Gray, a resident of White Settlement who suffers from sleep apnea, told CBS News Texas that she was one of many who had one of the recalled devices and had received a refurbished device 18 months after the recall. She said however that when she received it she no longer had faith in the company and became fearful for her life.
“You are afraid to go to sleep because if you go to sleep without it, you might die but if you go to sleep with it, it might kill you down the road,” said Gray in a 2023 interview, according to CBS. “So I just sleep with it (C-PAP device) and pray.”
Philips Respironics has since issued a statement claiming that the devices and reportedly associated deaths are unrelated. An email to The Dallas Express also explained that about 93% of the MDRs filed since April 2021 up to December of last year were “alleged malfunctions” that did not involve injury or death.“
Based on the investigations to date, 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,” said a spokesperson for the company, in the statement provided to The Dallas Express. “Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death.”
Philips Respironics has since remediated 99% of the affected sleep therapy devices across the globe. Recent studies have also confirmed that affected PAP devices did not increase cancer risks and that the PE-PUR foam is not expected to cause “appreciable harm” to patients, however tests are ongoing.
“Patient safety and quality remain Philips’ highest priority across the company. Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” said Roy Jakobs, CEO of Royal Philips in the press release. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
In September 2023, Philips Respironics agreed to pay at least $479 million to compensate users of these devices in a class action settlement. Consumers who are eligible to receive payment may file their claim on the settlement administrator’s website.
