Philips Respironics has issued a recall that covers more than 300,000,000 respiratory machines because of defects that can lead to serious health issues.
The problem associated with the breathing devices concerns the decay of sound proofing polyurethane foam which is known as PE-PUR. The decaying foam matter then either gets inhaled or ingested. Volatile organic chemicals (VOC) are then breathed in and may lead to an array of serious health problems including lung, kidney, or liver cancer. There is also the potential that these toxic chemical may affect the heart and cause heart attacks or strokes.
In a memo to care providers Philips spoke of the risks, “Lab testing performed for and by Philips has also identified the presence of VOCs which may be emitted from the sound abatement foam component of affected device(s). VOCs are emitted as gases from the foam included in the CPAP, BiLevel PAP and MV devices and may have short- and long-term adverse health effects.”
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According to the FDA recall notice, “The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract; inflammatory response; headache; asthma; and toxic or carcinogenic effects to organs, such as the kidneys and liver.”
The FDA Statement continued to say, “The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.”
While it is not clear how long officials at Philips Respironics have known about this very serious toxicity problem with their medical device, we do know that on April 26, 2021, Philips made it publicly know that they had received numerous complaints of “black debris within the device’s air pathway” and reports of headache, upper airway irritation, cough, chest pressure, and sinus infection in users of the devices.
Polyurethane foam degrades due to factors like heat, oxygen, sunlight, bacteria, and fungus. As it disintegrates it hardens before crumbling apart. As the particles break off, they are propelled by the air being pumped through the machine into patients, where they are a serious hazard. While this process occurs, the foam discolors, from off-white to yellow, then to a reddish-brown, and finally to the black particles users unknowingly inhale or ingest.
It is important to note that some users may not have found any visible particulate matter. However, this does not mean their devices are safe to use. Lab testing has found that where bad foam is present so too are concerning chemicals like Toluene Diisocyanate, which the European Union considers “highly toxic” and too dangerous even in hair dye.
In addition to the particulate matter, the foam may be emitting noxious gases in the form of VOCs. Like the particles, VOCs may be inhaled or ingested through the airways, but unlike the solid particles, these emissions may also be absorbed through the skin and tissues into the bloodstream.
Those reports led to the understanding that the “sound abatement” foam Philips used to minimize noise in several CPAP and BiLevel PAP (BiPAP) respirators posed serious health risks to users.
On June 14, 2021, the company issued its recall of millions of these dangerous devices. In addition to these CPAP and BiPAP devices, Philips included in the recall products including:
The number of products recalled coupled with ubiquity of the products already in use leads me to believe that there will be thousands of civil lawsuits and the potential for an MDL (multi district litigation) is highly likely.
If you or a loved one have been using one of these defective products and have experienced any of the symptoms mentioned above, please contact the defective medical device lawyers at Rheingold Law. We will be happy to assist you with a free initial consultation.
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