Sleep Apnea Replacement Devices Could Be Dangerous Too
Approximately 18 million adults throughout the country suffer from obstructive sleep apnea. Which, when left untreated, can lead to acute health complications, such as diabetes, high blood pressure, cardiomyopathy, heart failure, and stroke. Many sleep apnea sufferers rely on airway pressure machines to prevent upper airway tissues from collapsing and increase their oxygen levels. However, in June 2021, Philips Respironics, a chief manufacturer of sleep apnea treatment devices, issued a voluntary recall of as many as 4 million devices due to hazardous components. The company’s recalled breathing machines contain a polyester-based polyurethane (PE-PUR) foam known for degrading into tiny black particles and placing users in unnecessary danger of inhaling toxic gases or ingesting carcinogens. Consequently, users scrambled to secure alternative sleep apnea machines, which abruptly went into short supply. Since then, numerous lawsuits have been filed alleging that Phillips was aware of the above hazards for years but postponed recalling the devices until they could manufacture safer ones.
The FDA Warns That Silicone-Based Foam May Be Hazardous
As part of the recall, Philips promised to replace or repair the affected devices. In September, the company began producing and distributing replacement devices to users. Based on lab results provided by Philips, which demonstrated acceptable outcomes, the Food and Drug Administration (FDA) approved a silicone-based foam for the repair and replacement program. Nevertheless, after an inspection of Philips’ Murrysville facility, the FDA warned that the use of silicone-based foam in substitute sleep apnea devices might also be unsafe. The FDA expressed concern after a similar silicone-based foam in a replacement device failed safety tests because it released potentially toxic vapors. The FDA has requested Philips to commission an independent research lab to conduct further analysis on the new foam to determine the potential dangers.