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“A continuous positive airway pressure (CPAP) machine is the most commonly prescribed device for treating sleep apnea disorders.” (1) Basically, these devices send a steady flow of oxygen into your mouth and nose while you are sleeping. The devices keep your airways open and help you breathe.
A CPAP machine uses a compressor, or motor. This motor generates a steady stream of pressurized air. The air moves through an air filter into a flexible tube. This tube allows purified air to move into a mask you wear. The mask is sealed around your nose and/or mouth. (2)
Ideally, you experience uninterrupted sleep. Because the air from this device is pressurized, it pushes against any blockages. Your airways remain open and your lungs receive oxygen. (3)
In addition to CPAP devices, other breathing machines include APAP and BiPAP devices. All are intended to help you breathe normally while you are sleeping. Here is a breakdown of these devices: (4)
This breathing device is programmed to generate pressurized air at one constant air pressure level. If you want to change the air pressure setting, you need to reset the device.
This automatic positive airflow pressure machine monitors how you breathe throughout the night. It adjusts the air pressure automatically if you change position while you are sleeping. This device also compensates for medications you are taking that may have changed how you breathe.
A bi-level positive airflow pressure device comes with two pressure settings. One uses pressure for inhaling. A second uses a lower pressure for exhaling. BiPAP devices can come with a backup respiratory rate to help patients with central sleep apnea. The backup makes sure you breathe. This device works better if you cannot tolerate CPAP machines, or have higher levels of carbon dioxide in your blood.
According to the U.S. Food & Drug Administration (FDA), “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.” (5)
On November 12, 2021, the FDA provided an update on the recall. The FDA had inspected a Philips facility “to determine what may have caused or contributed to the foam issues and to assess adherence to the agency’s quality system regulations.” (6)
During the inspection, the FDA learned that Philips’ replacement foam, which is silicone-based, may contain volatile organic compounds (VOCs). The FDA requested an independent laboratory test the foam for any potential safety risks.
Additionally, the FDA inspection revealed that Philips was aware no later than 2015 that the polyester-based polyurethane foam (PE-PUR) foam that is the subject of the recall had a degradation issue that was dangerous to users. Internal company testing also revealed the toxicity and potential carcinogenicity of the PE-PUR foam degradation products, yet Philips chose to keep using the PE-PUR foam over safer alternatives. (7)
Philips Respironics, the manufacturer, used PE-PUR foam to lessen the sound and vibration of its breathing devices. However, if this foam comes into contact with your airways or digestive tract, dangerous side effects or medical complications may occur: (8)
Inhaling or swallowing PE-PUR foam particles can lead to serious injury. Possible injuries can be life-threatening. Injuries may also be permanent. Medical treatment may be necessary to prevent irreversible damage. (9)
Philips has received complaints from patients. Some patients have noted black debris, or particles, in their breathing device’s air pathway. Patients have reported headaches, irritation in their upper airway, chest pressure, a cough, and sinus infections. These side effects may be linked to inhalation of foam particles. (10)
If you have inhaled or swallowed PE-PUR foam particles, you may experience a variety of side effects and complications, including: (11)
Long-term, permanent, and life-threatening health complications – including cancer – of PE-PUR foam are possible. If you are diagnosed with any of these conditions, your illness may be linked to your use of Philips CPAP and BiPAP:
Another serious concern is the possibility of developing different types of cancer. These cancers include:
On June 30, 2021, the FDA alerted the public that Philips recalled certain devices due to concerns regarding its polyester-based polyurethane sound abatement foam. (12) The FDA has recognized this as a Class I recall, “the most serious type of recall. Use of these devices may cause serious injuries or death.” (13)
“The off-gassed chemicals and foam particles may lead to serious or life-threatening injuries, difficulty breathing (respiratory distress), swelling (inflammation), a lack of oxygen (hypoxia), too much carbon dioxide (hypercarbia), or toxic reactions.” (14)
There have been 83 complaints reported as of July 22, 2021. All serial numbers of these types of devices and models have been recalled: (15) (16)
If you or a loved one suffered serious medical complications or a health injury after using a recalled Philips medical device, you may be entitled to compensation. Compensation may cover medical expenses, as well as your pain and suffering, loss of earnings, and potential future income loss. Punitive damages may also be awarded.
Possible compensation you could receive includes:
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