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Following a massive recall of Philips CPAP, BiPAP and mechanical ventilator machines issued earlier this summer, millions of sleep apnea sufferers have been left with many unanswered questions about the potential long-term side effects and health problems they may face after inhaling toxic particles and chemicals released by defective sound abatement foam in the machines.
On June 14, Philips Respironics, also known as Koninklijke Philips, recalled approximately 3.5 million breathing machines that contained a polyester-based polyurethan (PE-PUR) foam, which was intended to reduce vibrations and noise. However, the company now indicates that the machines pose a serious health risk for users, as the foam may degrade and release black particles or toxic gases directly into the air pathways of the machine and lungs of users, who often use the devices regularly for treatment of sleep apnea and other respiratory conditions.
More than two months after the recall, little information or guidance has been provided by the manufacturer about the specific health risks and side effects Philips CPAP machines may cause. However, independent reports indicate that long-term users have developed various types of cancer, respiratory failure, pulmonary fibrosis, auto-immune disorders, heart conditions, kidney disease, liver disease, and other chronic problems.
According to allegations raised in a number of Philips CPAP machine lawsuits, chemicals contained in the degraded foam may include: toluene diamine, which has been deemed a “potential carcinogen” by the National Institute for Occupational Safety and health; toluene diisocyanate, which has been labeled as “highly toxic” by the European Union; and diethylene glycol, which health officials have indicated “cannot be considered safe.”
As the foam breaks down, harmful gas emissions may also be released by the Philips CPAP PE-PUR foam, including Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl).
Although users have been urged to immediately stop using their Philips CPAP/BiPap machines for sleep apnea therapy, no confirmation has been provided about the types of symptoms or injuries they should monitor for, how much exposure is considered too dangerous or what treatments they may require in the future.
Last month, the FDA issued a list of Frequently Asked Questions in order to provide some information not being provided by Philips for concerned CPAP users. However, even that provided no information on what types of illnesses might be linked to the recalled devices, and only advised them they could continue using the devices if the health care provider determines the benefits outweigh the risks.
It remains unclear how doctors could make that determination if nobody has informed the medical community, or the public, what those actual risks might be.
This has left millions of individuals without CPAP therapy for their sleep apnea, since no replacements are currently being provided, and mounting concerns about the potential long term side effects they may face after years of inhaling the toxic foam.
The Dutch manufacturer, Koninklijke Philips, N.V. generated over $23 billion in revenue last year, and is expected to face massive liability over the next few years from CPAP machine settlements, as a growing number of individual and class action claims continue to be filed in courts nationwide, including both class action claims that seek reimbursements for the costs of purchasing CPAP machine replacements and medical monitoring, as well as personal injury claims brought by users who have already been diagnosed with cancer, lung damage or other ailments allegedly caused by exposure to the toxic particles.