For Patients with Polyester-based Polyurethane (PE-PUR) Exposures, Potential Health Risks Include Cancers and Organ Failures
(Posted by Tom Lamb at Drug Injury Watch)
UPDATE: On June 30, 2021 the FDA issued this document to alert and inform patients, "Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication", which listed the Philips Respironics ventilators, BiPAP, and CPAP machines manufactured between 2009 and April 26, 2021 that are covered by the June 2021 Philips products recall.
In June 2021, the healthcare technology company Royal Philips issued a products recall for certain Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices due to possible toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in these Philips products. From our perspective, a few cancers and some organ failures are the most serious possible medical conditions for patients with toxic exposures of PE-PUR from these Philips products.
We start with this June 14, 2021 document, "Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices", with this stated purpose at the outset:
[P]rovides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
From these excerpts from that June 2021 Philips recall notification, we get some important details:
- Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam 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 has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.
In a separate document, "Medical Device recall notification (U.S. only) / field safety notice (International Markets)", from Philips Respironics, there is some product identification information about the various Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices affected by this June 2021 Philips products recall -- as well as what Philips products are not affected by this recall, and why.
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For another viewpoint on this Philips medical device safety issue, we refer you to this June 23, 2021 document issued by the United Kingdom's Medicines and Healthcare products Regulatory Agency, "National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds".
Based on current information, here are the most serious possible related medical conditions for a patient with past harmful particulate exposures and/or chemical exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in the recalled Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices:
Cancers, such as:
-- Lung Cancer
-- Liver Cancer
-- Kidney Cancer
Organ Failures, such as:
-- Liver Failure
-- Kidney Failure
We are investigating product liability lawsuits against Philips for patients with toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in the Philips products recalled in June 2021. These lawsuits could be personal injury cases or wrongful death cases, depending on the facts.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.
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