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. 

While Philips has sent out approximately 250,000 replacement devices, patients have complained that their new devices give off strong odors, which induce headaches and nausea. Once again, this has left many users feeling extremely anxious, frustrated, and disheartened. As the FDA awaits more conclusive test results, patients are advised to continue to use their replacement devices because stopping sleep apnea treatment has its own health risks. 

Consult With A Highly Knowledgeable Western New York Product Liability Attorney

If you, or a loved one, have developed cancer or any other illnesses after using a Philips sleep apnea device or a replacement machine, do not hesitate to get in touch with Jed Dietrich, Esq., famed as Best of the Best Top 10 Personal Injury Attorney, and his battle-tested team of dangerous medical device lawyers. The Dietrich Law Firm P.C.’s lawyers are disciplined, dedicated, and determined to ensure that you obtain the justice and monetary compensation that you deserve. Our elite team offers no-obligation lawsuit evaluations and would be honored to speak to you about your case. We are available 24 hours per day and 7 days per week by dialing 716-839-3939 or completing our online consultation form.