Millions of Philips CPAP, BiPAP, and Ventilator Machines Recalled Over Cancer Risk

Philips Respironics has recalled millions of CPAP and BiPAP machines and certain mechanical ventilators due to the risk that the sound abatement foam used inside the devices may degrade over time and release toxic debris or gases into the devices’ air pathway. These machines are typically used to help people with obstructive sleep apnea breathe more easily during sleep. However, we now know that the polyester-based polyurethane (PE-PUR) sound abatement foam designed to reduce sound and vibration in the medical devices may expose users to harmful foam particles or chemicals off-gassed from the foam. As a result, former users may be at risk for cancer and other serious adverse health effects. To learn more about the Philips CPAP recall and what it means for you, contact Consumer Safety Watch today.

Philips Medical Devices Removed from Market

Philips Respironics has received several reports of adverse events involving its Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator machines, which led the company to remove the medical devices from the market. In a recall announcement issued on June 14, 2021, Philips identified a potential health risk associated with the polyester-based polyurethane (PE-PUR) sound abatement foam used in these medical devices, which the company warns can put users at risk for cancer and other adverse health effects. The FDA followed up Philips’ recall announcement with its own safety communication issued on June 30, 2021, which announced the recall and warned that the issues with the allegedly defective sound abatement foam “can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.”

Cancer, Other Side Effects Linked to Recalled Breathing Machines

Philips has manufactured millions of CPAP, BiPAP and mechanical ventilator devices using the allegedly defective sound abatement foam, which may “degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals,” Philips warns in the recall notification. The company also notes that “The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.” Among the potential side effects related to particulate exposure are headache, inflammation, irritation, respiratory issues, and possible toxic and carcinogenic effects. Chemical exposure due to off-gassing may result in headache, nausea and vomiting, irritation, and hypersensitivity, as well as possible toxic and carcinogenic effects.

CPAP, BiPAP and Ventilator Machines Included in Recall

The Philips recall is for certain CPAP, BiPAP and ventilator devices manufactured between 2009 and April 26, 2021. CPAP and BiPAP machines are commonly used as a treatment for people with obstructive sleep apnea, which is a condition in which a person’s breathing stops involuntarily for brief periods of time while they are sleeping. A CPAP machine helps a person breathe normally during sleep by delivering a constant stream of pressurized air that keeps the airway open. A BiPAP machine is similar in that it uses air pressure to open and support the airway, but while the CPAP delivers a single pressure, the BiPAP alternates between two pressure settings: an inhale pressure and an exhale pressure. Compared to CPAP and BiPAP machines, mechanical ventilators are designed to mechanically control or assist a person’s breathing by delivering oxygen-rich air into the lungs and helping them breathe out carbon dioxide.

Recommendations for Patients Affected by Recall

According to Philips, the majority of the devices affected by the recall are in the first-generation DreamStation product family. For patients with the recalled Philips CPAP and BiPAP machines, the company recommends discontinuing use of the device and working with their physician to determine the best path for continued treatment. Unfortunately, for those using mechanical ventilators affected by the Philips recall, there may be few, if any, alternative options for therapy. If you or someone you know has experienced cancer or another serious side effect allegedly caused by exposure to toxic debris or chemicals from the sound abatement foam used in the recalled Philips CPAP, BiPAP or ventilator devices, contact us today to find out if you are eligible to file a product liability lawsuit against Philips Respironics.