Long Term Side Effects of CPAP Machines Recalled Due to Foam Issues
The Philips DreamStation and other CPAP machines are intended to be used every night for sleep apnea and other breathing issues. However, prolonged exposure to chemicals and particles released as the CPAP sound abatement foam deteriorates may expose users to serious health risks.
Each of the recalled Philips Respironics CPAP machines contain a polyester-based polyurethane (PE-PUR) CPAP foam, which was intended to reduce sound and vibrations. The manufacturer now acknowledges that the foam degrades and releases black particles directly into the lungs through the CPAP tubing and the face mask.
Philips DreamStation lawsuits and settlements are now being pursued for individuals who have experienced long-term side effects of CPAP foam exposure, including:
- Respiratory Failure
- Pulmonary Fibrosis
- Interstitial Lung Disease (ILD)
- Auto-Immune Disorders
- Chronic Bronchitis
- Chronic Asthma
- Acute Kidney Injury
- Acute Liver Injury
- Heart Attack
- Heart Failure
- Malignant Tumors
- Wrongful Death
To find out whether you or a loved one may be entitled to financial compensation, contact the lawyers at Saiontz & Kirk, P.A. and request a free consultation and case evaluation.
Philips CPAP Recall Side Effects and Symptoms
According to information released at the time of the Philips CPAP recall, symptoms experienced as the sound abatement foam breaks down may include:
- Irritation of the skin, eyes and respiratory tract
- Respiratory Injury
- Carcinogenic Side Effects
In February 2020, the FDA issued a warning about problems with CPAP cleaning products that use ozone or ultraviolet light. These products have been marketed to clean, disinfect or sanitize CPAP machines, including the masks, tubing and headgear. However, it now appears that products like SoClean and other CPAP cleaners may exacerbate the foam deterioration and increase the rate at which particles enter the machine’s air pathways.
At the time this warning was issued before the Philips recall, the FDA indicated that it had received various reports involving side effects from the CPAP cleaning products, including:
- Difficulty breathing
- Nasal irritation Headaches (often referred to as “CPAP headaches”)
- Asthma attacks
- Other breathing problems
It now appears that many of these symptoms may have been the result of foam in the Philips CPAP machines degrading and releasing small particles or chemicals into the air pathways.
Does Philips CPAP machine cause cancer long-term?
Studies on the risk of cancer from Philip DreamStation and other CPAP machines are still being conducted. However, lab analysis of recalled Philips CPAP machines has found a number of harmful chemicals and volatile compounds, which are known to cause cancer side effects.
Users reports have identified a number of different types of cancer caused by Philips CPAP machines, including:
- Lung Cancer
- Thyroid Cancer
- Oropharyngeal Cancer
- Laryngeal Cancer
- Nasopharyngeal Cancer
- Hypopharyngeal Cancer
- Kidney Cancer
- Liver Cancer
- Colon Cancer
- Prostate Cancer
- Pancreatic Cancer
- Blood Cancers like Leukemia, Lymphoma or Myeloma
Can a CPAP Machine Cause Lung Cancer Symptoms
The potential Philips CPAP machine lung cancer risk is one of the most concerning, since particles from the sound abatement foam may directly enter the lungs.
Symptoms of lung cancer are similar to many of the reported side effects of Philips CPAP foam exposure already reported by users, including:
- Persistent Cough
- Coughing up blood or rust-colored phlegm
- Chest pain
- Loss of appetite or unexplained weight loss
- Shortness of breath and feeling tired
- Infections like bronchitis and pneumonia
Following the CPAP foam recall, researchers are examining the link between sleep apnea machines and lung cancer, especially among non-smokers who typically only account for a small portion of all lung cancers diagnosed each year.
If you or a loved one have been diagnosed with ANY cancer or injury that may be caused by serious side effects of the Philips CPAP foam, request a free consultation and claim evaluation. There are no fees or expenses unless a recovery is obtained.
What is wrong with Philips CPAP sound abatement foam?
PE-PUR “sound abatement” foam in Philips Respironics DreamStation, CPAP and BiPAP respirators may degrade under certain circumstances, resulting in two long-term problems as the sleep apnea machines are used:
Foam breaks down into small black particles that may enter the CPAP machine tubing and be swallowed when the mask is used.
Foam degrades and releases certain toxic chemicals (known as “off-gas”) that are then inhaled throughout the night when the sleep apnea machine is used.
While the full extent of issues from the foam chemicals released by Philips CPAP machines are still being evaluated, early reports and lab testing found a number of harmful chemicals in the degraded foam, including:
- Toluene Diamine, which has been deemed unsafe for use even as a hair dye and categorized by the National Institute for Occupational Safety and Health as a “potential carcinogen”
- Toluene Diisocyanate, which has been labeled as “highly toxic” by the European Union
- Diethylene Glycol, which health officials have suggested “cannot be considered safe”
As the foam breaks down, harmful gas emissions from PE-PUR foam may also result in unsafe levels of chemical compounds like:
- Dimethyl Diazine
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)
Reports of Black Foam Particles in Philips CPAP Machines
For years before the recall, Philips Respironics has received complaints from consumers about black debris or black particles inside the CPAP machines, masks, tubing or filters. This should have caused the manufacturer to issue an earlier recall and warnings for consumers.
According to the findings of an FDA inspection conducted months after the recall, internal emails between Philips and a raw foam supplier in October 2015 documented knowledge that polyester polyurethane foam was degrading, which was later confirmed by the foam supplier on 8/5/2016. A later email message on 4/10/2018 documented that complaints had been received involving foam degradation, where disintegrated foam had been pulled into the machine and patient air pathways.
An FDA keyword search of all consumer complaints submitted to Philips Respironics since 1/1/2008 found over 222,000 complaints involving keywords that suggest issues with deteriorating foam, including over 20,000 of which that occurred before 2017, when most of the recalled Philips DreamStation devices were sold.
In addition to private reports submitted directly to the manufacturer, owners of the machines have posted public statements on the internet about problems with the DreamStation producing black particles shortly after use or cleaning, describing the CPAP foam issues with comments like:
- “Black Sticky dust in CPAP machine”
- “Black mold-like substance” in DreamStation water reservoir”
- “Black particles in my CPAP tubing”
- “CPAP filter turning black”
These black particles are actually pieces of the PE-PUR foam from inside the CPAP machines.
When Did Philips Know About CPAP Black Foam Issues?
It appears that Philips Respironics knew or should have known about the DreamStation CPAP foam issues for years. However, rather than immediately warning consumers and the medical community, the company went about designing and developing a new version of the DreamStation that does not experience the same foam degradation problems, known as “DreamStation 2”.
More than a month before consumers were first notified that their CPAP machines were recalled and that they should immediately stop using DreamStation products, Philips issued a statement for investors in a Quarterly Report (PDF) issued on April 26, 2021.
Buried within this report is a section titled “Regulatory Update”, where Philips acknowledges that it has determined from user reports and testing that PE-PUR foam in millions of CPAP machines may pose a health risk as the foam degrades.
Rather than outlining the recall strategy or taking actions to inform owners of these products, the company reassured investors that it had conveniently launched a next-generation DreamStation 2 CPAP machine weeks early, which it claims does not experience the same foam problems.
These statements are clear evidence that the company was more focused on protecting profits over consumer safety.
What causes CPAP foam to deteriorate?
Breakdown of the sound abatement foam in recalled Philips CPAP machines can occur over time as the product is used in the normal and expected manner. The CPAP foam deterioration may also be exacerbated by a number of factors, including:
- High Heat Exposure: locations with hot weather or direct exposure to high temperatures may cause CPAP foam to break down at an accelerated rate
- High Humidity Environments: States in the southeast U.S., such as Florida, Texas and Louisiana, as well as northwest U.S., such as California, Oregon and Washington, are among the most humid and may cause the sound abatement foam deterioration
- CPAP Cleaning Products: Philips has suggested that use of certain ozone and UV light cleaners may be to blame for the quick break down of CPAP foam
While each of these factors may accelerate the rate at which Philips CPAP foam degrades, lawsuits allege that the ultimate cause of the deterioration is a defective and unreasonably dangerous design used in the product.
In 2021, Philips introduced a new CPAP sleep apnea machine, the DreamStation 2, which it claims does not experience the same foam issues. This clearly establishes that a safer alternative design was available to avoid the CPAP foam deterioration.
Can Philips CPAP foam be removed?
Rather than replacing recalled CPAP machines with a new DreamStation 2 device that does not experience the same foam problems, Philips has indicated that it will attempt to remove PE-PUR sound abatement foam as part of a recall repair program.
Owners of these machines should not attempt to make any repairs or changes to their CPAP machine, as this may introduce additional debris or compromise the safety of the device.
In September 2021, a Philips CPAP foam removal and replacement program was announced by the manufacturer, which is expected to take at least a year to complete. However, questions remain about the effectiveness of these repairs and whether it will be safe to use a sleep apnea machine after Philips CPAP foam is removed and replaced.
Philips CPAP Cancer Lawyers
Side effects of recalled Philips CPAP machines may cause immediate injuries and respiratory symptoms, as well as long-term health risks like cancer, which may develop years later.
The CPAP recall lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations for individuals throughout the United States, to help understand what legal options are available and whether a settlement may be available for cancer, lung damage or other respiratory side effects caused by sound abatement foam particles.
All cases are pursued by our Philips DreamStation cancer lawyers on a contingency fee basis, which means that there are never any out of pocket costs to hire our law firm, and we only receive an attorney fee or expenses if a recovery is obtained for side effects caused by the CPAP foam.