Long Term Side Effects of CPAP Machine Foam

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.

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Philips DreamStation lawsuits and settlements are now being pursued for individuals who have experienced long-term side effects of CPAP foam exposure, including:

  • Cancer, Leukemia, Lymphoma or other Tumors
  • Pulmonary Fibrosis
  • Interstitial Lung Disease (ILD)
  • Sarcoidosis
  • Pneumoconiosis
  • Auto-Immune Disorders
  • Chronic Bronchitis
  • Chronic Asthma
  • Recurrent Pneumonia
  • Hypersensitivity
  • Respiratory Failure
  • Acute Kidney Injury
  • Acute Liver Injury
  • Heart Attack
  • Heart Failure
  • Stroke
  • 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.

Do You Suffer Philips CPAP Side Effects?

What are symptoms and side effects of using Philips CPAP machines?

According to information released at the time of the Philips CPAP recall, serious symptoms experienced as the sound abatement foam breaks down may include:

  • Headaches
  • Irritation of the skin, eyes and respiratory tract
  • Inflammation
  • Respiratory Injury
  • Carcinogenic Side Effects

While it may take years to confirm the long-term side effects of using recalled CPAP machines and breathing the toxic foam particles, user reports and allegations have identified a number of specific types of cancer, lung issues and CPAP machine risks that users may face.

Does Philips CPAP machine cause cancer long-term?

Studies on the risk of cancer from Philips DreamStation and other recalled CPAP machines are still being conducted, and it may be years before studies confirm the specific types of cancers the CPAP machines may cause. However, lab analysis of recalled Philips CPAP machines have found a number of harmful chemicals and volatile compounds, which are known to cause cancer side effects.

Long-term users of the sleep apnea machines have reported a number of different types of cancer caused by Philips CPAP machines, and the lawyers at Saiontz & Kirk, P.A. are evaluating potential lawsuits involving diagnosis of any cancer, including:

  • Laryngeal cancer

    This form of throat cancer from a CPAP machine may develop in the larynx, also known as the voice box, causing changes in the voice and persistent sore throat. Laryngeal cancer is diagnosed via a throat and neck examination, CT and MRI scans, a laryngoscopy, PET scans or through a biopsy. Treatment is usually conducted through radiation therapy, chemotherapy immunotherapy and the surgical removal of tumors.

    Symptoms can include:

    • Sore Throat
    • Persistent Cough
    • Voice Changes
    • Pain and Difficulty Swallowing
    • A Lump in the Neck or Throat
    • Ear Pain
    • Trouble Talking

    The prognosis for laryngeal cancer varies greatly, and it is one case where there is a significantly high chance of it being cured. If put in remission for more than five years, there is a very small chance it will return, even in advanced cases.

  • Oropharyngeal Cancer

    Philips CPAP machines may cause oropharyngeal cancer when cells form in the oropharynx, which is the middle part of the throat located behind the mouth. This includes the tonsils, soft palate, the walls of the throat and the back one-third of the tongue. Oropharyngeal cancer is typically diagnosed through a physical exam and health history examination, a neurological exam, MRI, PET-CT Scan, or a biopsy. Treatment is usually conducted through surgery, radiation therapy, chemotherapy or targeted therapy.

    Symptoms can include:

    • Chronic Sore Throat
    • Problems Swallowing
    • Inability to Fully Open the Mouth Or Move the Tongue
    • Weight Loss
    • Ear Pain
    • Lumps in the Throat, Neck or Back of the Mouth
    • White Patches on the Tongue or Lining of the Mouth
    • Coughing with Blood

    Patients with early-stage oropharynx cancer have a 62% five-year survival rate. That can drop as low as 29% depending on how far the cancer has spread before it is diagnosed.

  • Nasopharyngeal Cancer

    Nasopharyngeal cancer caused by a Philips CPAP machine may develop in the upper throat, behind the nose, in the nasopharynx, which is above the roof of the mouth.

    Symptoms can include:

    • A Lump in the Neck
    • Double Vision
    • Chronic Ear Infections
    • Numbness or Pain in the Face
    • Headaches
    • Nosebleeds
    • Chronic Stuffy Nose
    • Sore Throat
    • Hearing Loss
    • Tinnitus, or Ringing In the Ears

    Diagnosis occurs through physical examination, usually involving looking for a lump in the neck, which is the most common symptom. It can also be diagnosed through chest x-rays, CT scans MRI, neck ultrasound, or a biopsy. Treatments include radiation therapy, chemotherapy and, in rare cases, surgery. Survival rates for nasopharyngeal cancer is 85% if caught early, but in cases where the cancer has spread, that rate can drop substantially.

  • Hypopharyngeal cancer

    Hypopharyngeal cancer is a rare form of throat cancer that may be caused by Philips DreamStation foam, developing in the bottom part of the throat, including the larynx, esophagus and trachea.

    Symptoms can include:

    • Persistent Sore Throat
    • Lump in the Neck
    • Ear Pain
    • Difficult or Painful Swallowing
    • Voice Changes

    It is usually diagnosed through a physical examination of the throat, but other means of diagnosing Hypopharyngeal cancer can include a neurological exam, CT scan, PET scan, MRI, endoscopy, biopsy, bone scan, esophagus x-ray, esophagoscopy or bronchoscopy. Treatment is usually conducted through surgery, radiation therapy or chemotherapy.

  • Sinonasal Cancer (Nasal Cancer or Sinus Cancer)

    A rare side effect of CPAP machine is nasal cancer or sinus cancer, which may also be referred to as sinonasal cancer, developing in the nasal cavity or paranasal sinuses. Sinonasal cancers from Philips CPAP machines may include squamous cell carcinoma, adenocarcinoma, melanoma, giant cell tumor, adenoid cystic carcinoma and others.

    Symptoms can include:

    • Bloody Nose
    • Runny Nose
    • Bulging Eyes
    • Double Vision
    • Nasal Obstruction
    • Nasal Infections

    Diagnosis of sinonasal cancer following CPAP use may be conducted through an examination of the nasal cavity, detection of a mass in the naval cavity and a tissue biopsy. There is no established treatment protocol, but may include surgery, radiation therapy and chemotherapy.

    Prognosis can vary significantly depending on the type of cancer, some of which are slow to progress, while others may spread rapidly.

  • Thyroid Cancer

    Thyroid cancer as a side effect of CPAP machines may occur if tumors develop in the thyroid gland, which creates the hormones that regulate the metabolism, when thyroid cells begin growing out of control.

    Symptoms can include:

    • A Lump in the Neck
    • Swelling of the Neck
    • Neck Pain
    • Voice Changes and Hoarseness
    • Trouble Breathing and Swallowing
    • Persistent Cough

    Diagnosis can occur through physical examination backed up by certain tests, including ultrasound, radioiodine scan, chest x-ray, CT scan, MRI, PET scan, or biopsy. Treatment can include surgery, radioactive iodine therapy, thyroid hormone therapy, external beam radiation therapy, chemotherapy or targeted drug therapy. Fortunately, thyroid cancer has a near 100% five-year survival rate.

  • Liver Cancer

    Exposure to the Philips CPAP foam may cause liver cancer to develop, which can take various forms depending on the types of cells affected, such as hepatocellular carcinoma, intrahepatic cholangiocarcinoma and hepatoblastoma. However, it is far more common for cancer to spread to the liver than to begin in the liver itself.

    Symptoms of liver cancer from a CPAP machine may include:

    • Unexplained Weight Loss
    • Loss of Appetite
    • Upper Abdominal Pain
    • Fatigue and Weakness
    • Nausea and Vomiting
    • Abdominal Swelling
    • Jaundice
    • White, Chalky Stool

    Diagnosis of liver cancer can occur via blood tests, ultrasound, CT scans or MRI scans, or a biopsy of liver tissue. Treatment can depend on the stage and type of cancer, and can include tumor removal surgery and liver transplant surgery, as well as some localized treatment such as heating or freezing cells, killing the tumors with alcohol injections, chemotherapy and radiation therapy.

  • Kidney Cancer

    There are a number of types of cancers that attack the kidneys, with renal cell carcinoma being the most common. Fortunately, it is often discovered at an early stage, which increases survivability.

    Symptoms kidney cancer following use of a Philips CPAP machine may start with:

    • Bloody Urine
    • Persistent Back Pain
    • Loss of Appetite
    • Unexplained Weight Loss
    • Fatigue
    • Fever

    Diagnosis of kidney cancer can involve blood and urine tests, imaging tests such as ultrasound, x-ray, CT scans or MRIs, or a kidney tissue biopsy. Treatment usually involves surgery to remove the cancer. It is often the only treatment needed if the cancer is found in the early stages. This can mean removal of just a part of the kidney or removal of a whole kidney if the cancer has spread too far to save it. If it recurs or has spread, treatment can also include targeted therapy, immunotherapy, or radiation therapy.

  • Lung Cancer

    The potential Philips CPAP machine lung cancer risk is one of the most concerning, especially among individuals who do not have a history of smoking, as particles from the sound abatement foam may directly enter the lungs.

    Lung cancer is the second most common type of cancer in both men and women, with the American Cancer Society estimating that there are about 235,760 new cases of lung cancer diagnosed in the U.S. each year, and about 131,880 deaths. However, non-smokers typically only account for a small portion of all cases.

    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
    • Worsening Chest Pain
    • Hoarseness
    • Loss of Appetite
    • Unexplained Weight Loss
    • Shortness of Breath
    • Feeling Tired and Weak
    • Chronic Bronchitis or Recurrent Pneumonia
    • Wheezing

    Lung cancer is usually suspected through medical history and physical exams, as well as imaging tests such as x-rays, MRIs, CT scans, PET scans, and ultransounds when cancer is detected. However, the actual diagnosis only occurs when the lung cells are examined in a laboratory. It is often divided into small cell lung cancer and non-small cell lung cancer.

    Treatment can involve surgery, immunotherapy, radiation therapy, chemotherapy, targeted drug therapy, immunotherapy and radiofrequency ablation. The type of treatment is often dependent on the type of lung cancer, how far it has spread, and the patient’s response to other treatments.

  • Prostate Cancer

    Occurring only in males, prostate cancer one of the most common types of cancer, but typically is not seen among men younger than 50 years old. Therefore, for younger individuals, it may be more likely that a prostate cancer was caused by a Philips CPAP machine for sleep apnea.

    Symptoms of prostate cancer include:

    • Problems Urinating
    • Bloody Urine
    • Bloody Semen
    • Bone Pain
    • Unexplained Weight Loss
    • Erectile Dysfunction

    While most prostate tumors grow slowly and stay confined to the prostate, some types are aggressive and spread quickly, requiring rapid diagnosis and treatment.

    Usually diagnosed through prostate screening, the screening of healthy men with no apparent symptoms has become controversial in recent years. However, when someone decides to have a prostate screening test, it usually involves a digital rectal exam or a prostate-specific antigen test. Once detected, further tests will be needed to determine if it is aggressive or if it even needs to be treated at all. When treatment is necessary, it could involve prostate removal surgery, radiation therapy, hormone therapy, chemotherapy, immunotherapy, or targeted drug therapy.

  • Breast Cancer

    Breast cancer is the most common form of cancer affecting women in the United States, forming in the breast cells. However, it can also develop in men as well, though such cases are generally rare. There are a number of different forms of breast cancer, including angiosarcoma, ductal carcinoma in situ, inflammatory breast cancer, invasive lobular carcinoma, lobular carcinoma in situ, and Paget’s disease of the breast.

    While it may not immediately be apparent that there could be a connection between breast cancer and CPAP machine exposure, the toxic chemicals and gasses released by the sound abatement foam could be a factor. This is especially the case for men diagnosed, or women under the age of 40, who rarely develop breast cancer.

    Symptoms can include:

    • A Breast Lump Differing from the Surrounding Tissue
    • Changes in Breast Size, Shape and Appearance
    • Changes to Breast Skin, Such as Dimpling
    • Nipple Inversion
    • Peeling, Scaling, Flaking of Skin Around the Areola
    • Redness or Pitting of Breast Skin

    Diagnosis often involves a breast exam, mammogram, breast ultrasound and, ultimately, a breast tissue biopsy. Treatment can involve removing the cancer cells or tumor, known as a lumpectomy, removing the entire breast (mastectomy), removal of certain lymph nodes or removing both breasts. Treatment can also involve radiation therapy, chemotherapy, hormone therapy, targeted drug therapy, or immunotherapy.

  • Acute Myeloid Leukemia (AML)

    Acute Myeloid Leukemia (AML) is a type of cancer of the blood and bone marrow, which progresses rapidly as myeloid cells interfere with the production of normal white blood cells, red blood cells and platelets.

    According to an FDA inspection report, recalled Philips CPAP machines have been linked to the release of formaldehyde, which is a known cause of AML.

    Symptoms of AML following CPAP foam exposure may start with:

    • Fatigue
    • Fevers
    • Loss of Appetite
    • Weight Loss
    • Night Sweats

    Myeloid leukemia can be diagnosed through blood samples, bone marrow samples, and the testing of spinal fluid through a lumbar puncture. The primary treatment for myeloid leukemia is chemotherapy. However, treatment can also include a targeted therapy drug and stem cell transplants.

  • Multiple Myeloma

    Multiple myeloma is a cancer of plasma cells, which attacks white blood cells that make antibodies. It builds in the bone marrow and causes a number of health complications.

    Symptoms of multiple myeloma caused by a Philips CPAP machine may start with:

    • Bone Pain
    • Chest Pain
    • Spine Pain
    • Nausea
    • Constipation
    • Weight Loss
    • Confusion
    • Loss of Appetite
    • Infections
    • Fatigue
    • Weakness in the Legs
    • Excessive thirstiness

    Diagnosis of multiple myeloma can include blood tests, urine tests, bone marrow exams, x-rays, MRI, CT scans or PET scans. Multiple myeloma can be slow to advance, in which case treatment may not be immediately necessary. However, if it begins to progress, treatments can include radiation therapy, chemotherapy, targeted therapy, immunotherapy, corticosteroids, or a bone marrow transplant.

  • Non-Hodgkin’s Lymphoma (NHL)

    This is another form of blood cancer that may be linked to CPAP foam particles or gasses, which occurs when white blood cells become cancerous and then attack the lymphatic system. There are more than 30 subtypes of NHL, which range significantly in the speed at which they spread and the chances of survival.

    Symptoms can include:

    • Lymph Node Enlargement
    • Swollen Abdomen
    • Chest Pain
    • Difficulty Breathing or Shortness of Breath
    • Fever, Fatigue, Anemia or Tired Feelings
    • Sudden Weight Loss

    NHL is diagnosed via physical examinations, biopsies, chest x-rays, CT scans, MRI, ultrasound, PET scans, and bone scans. Treatment can vary based on the type of non-Hodgkin’s lymphoma, but typically include chemotherapy, immunotherapy, targeted drug therapy, radiation therapy, stem cell transplant and surgery.

What lung issues may result from Philips CPAP machines?

Years of breathing the toxic chemicals, gases and foam debris released by Philips DreamStations and other recalled CPAP machines have been linked to variety of respiratory side effects. These symptoms are often similar to potential serious lung injury, which may be caused by Philips CPAP machines.

Potential Philips CPAP lung damage lawsuits are being investigated and reviewed for individuals diagnosed with a number of respiratory conditions that have been reported among users of DreamStation machines and other sleep apnea machines with PE-PUR sound abatement foam, including:

  • Pulmonary fibrosis

    Breathing the toxic foam particles released by a Philips CPAP machine may cause lung scarring, or pulmonary fibrosis, which causes tissue in the lungs to stiffen, thus making breathing more difficult over time.

    Symptoms pulmonary fibrosis from the CPAP machine foam may include:

    • Coughing
    • Fatigue
    • Shortness of Breath
    • Weight Loss
    • Muscle and Joint Pain
    • Clubbing (widening) of the tips of the fingers and toes

    Pulmonary fibrosis can be detected through a number of different means, such as chest x-rays, CT scans and echocardiograms, as well as lung function tests and biopsies. Unfortunately, the lung damage from pulmonary fibrosis caused by a CPAP machine cannot be reversed and the progression cannot be stopped with current medical technology.

    The best doctors can do is provide treatments that improve quality of life, such as certain medications, oxygen therapy, pulmonary rehabilitation such as physical exercise and breathing techniques and, in severe cases, lung transplants. The average life expectancy after being diagnosed with pulmonary fibrosis is only three to five years, though early detection can help slow its progression.

  • Interstitial Lung Disease (ILD)

    Similar to pulmonary fibrosis, ILD is the name for a group of lung diseases that may result from breathing CPAP foam particles and chemicals released during use of a Philips DreamStation or other sleep apnea machine. Scarring or fibrosis of the lungs associated with interstitial lung disease makes it difficult to breathe, which is frequently irreversible and worsens over time.

    Symptoms can include:

    • Shortness of breath
    • Dry Cough
    • Chest Pain
    • Fatigue
    • Weight Loss

    Diagnosis is usually conducted through a CT scan, chest x-ray and lung function test. Diagnosing the type of ILD can require a lung biopsy or bronchoscopy. Treatment includes corticosteroids, oxygen therapy, pulmonary rehabilitation and, in some cases, a lung transplant, but the damage is irreversible.

    Sarcoidosis, idiopathic pulmonary fibrosis, interstitial pneumonia, hypersensitivity pneumonitis and acute interstitial pneumonitis are just some types of ILD, meaning prognosis can vary greatly.

  • Sarcoidosis

    Exposure to a Philips CPAP machine may be linked to sarcoidosis, a rare disorder that results in granulomas, small areas of red, swollen tissue, to develop inside the lungs or on the skin.

    Symptoms of the CPAP machine sarcoidosis side effects may include include:

    • Persistent Cough
    • Red, Tender Skin Bumps
    • Shortness of Breath
    • Abnormal Heart Rhythm
    • Bone and Joint Pain
    • Kidney Stones
    • Headaches

    A variety of tests can detect sarcoidosis, depending on where in the body it strikes, such as chest x-rays for the lungs, biopsies or CT scans. Fortunately, most who develop sarcoidosis do not need substantial treatments, and the problems may resolve within a few years. However, in severe cases, the lung damage from sarcoidosis can result in loss of lung function and other health problems.

  • Pneumoconiosis

    Pneumonoconiosis is a form of lung disease that can lead to forms of pulmonary fibrosis. It is caused by inhaling certain dusts, which damages the lungs and causes them to become inflamed. There are different types of pneumonoconiosis, which are based on the type of substance which was inhaled. One of the most well known being “black lung” caused by coal dust from mining operations.

    It is possible that pneumonoconiosis could be caused by a CPAP machine after breathing debris from the sound abatement foam as it breaks down. Symptoms may include:

    • Coughing
    • Breathlessness
    • Fatigue

    Diagnosis of pneuomoconiosis is usually achieved through a review of the patient’s medical history and chest X-rays. There is no cure for the condition, and treatment to improve quality of life usually involves pulmonary rehabilitation, oxygen therapy, and removal of irritants, such as stopping smoking. The condition develops slowly over time, and the most dangerous aspects are the complications, which can cause COPD, pulmonary hypertension or even lung cancer; all of which have different prognoses.

  • Chronic/Severe Asthma

    Asthma occurs when inflammation in the airways causes them to swell, become narrow, and sometimes fill with mucus, making breathing more difficult. It is often the result of an immune response and typically begins in childhood, but in many cases the cause is unknown.

    If chronic asthma develops after CPAP machine use later in life, it may be the result of exposure to the chemicals and gasses released by the toxic Philips PE-PUR sound abatement foam. Unfortunately, this potential side effect may result in a chronic condition that persists throughout life.

    Symptoms of asthma beginning after CPAP exposure may include:

    • Shortness of Breath
    • Wheezing
    • Tightness in the Chest
    • Coughing

    Diagnosing asthma can be done through a variety of tests, including pulmonary function tests, spirometry with bronchodilator tests, bronchoprovocation tests, allergy tests, peak expiratory flow tests, bronchoprovocation tests and fractional exhaled nitric oxide tests. The condition is typically treated with daily controller medications, inhalers and a plan to manage symptoms and prevent asthma attacks.

  • Chronic Bronchitis

    Bronchitis occurs when the airways, known as bronchi, become inflamed, causing overproduction of mucus. It is defined as chronic when the inflammation is long-term, which leaves the person exposed to more frequent lung infections.

    For non-smokers diagnosed with chronic bronchitis after CPAP exposure, it may be caused by long-term exposure to off-gassing or debris released by the sound abatement foam. Those with chronic bronchitis almost always also have chronic obstructive pulmonary disease (COPD).

    Symptoms can include:

    • Persistent Cough
    • Coughing Up Mucus
    • Wheezing
    • Chest Discomfort

    Diagnosis of chronic bronchitis often involves the use of pulmonary function tests, such as spirometry and peak flow monitoring, as well as arterial blood gas checks, chest x-rays, pulse oximetry and CT scans. Treatment usually involves quitting smoking, treatment through oral or inhaled medications, supplemental gas, and, in more severe cases, lung reduction surgery to remove damaged parts of the lungs, or total lung transplant.

  • Recurrent Pneumonia

    Pneumonia is an infection that inflames the air sacs in one or both lungs. However, repeated instances of pneumonia after starting use of a Philips CPAP machine may suggest a common cause. Recurrent pneumonia involves multiple cases of pneumonia occurring within close proximity. These lower respiratory tract infections are often caused by slow-growing organisms, such as fungi or mycobacteria, which does not completely leave the body between bouts of illness.

    Symptoms can include:

    • Coughing
    • Wheezing
    • Dyspnea
    • Chest Pain

    Pneumonia is fairly easy to diagnose and often done via a chest exam without the need of an x-ray or other medical scan. Treatment can include supplemental oxygen, antibiotics and other more specific treatments based on the suspected cause of the recurring bouts of illness. The prognosis often depends heavily on the underlying cause.

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:

1

Foam breaks down into small black particles that may enter the CPAP machine tubing and be swallowed when the mask is used.

2

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)

When did Philips know about black foam particles in 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.

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.

Are SoClean sanitizing machines responsible for the CPAP foam problems?

In February 2020, the FDA issued a warning about problems with CPAP cleaning products that use ozone or ultraviolet light, such as SoClean. These products have been widely marketed to clean, disinfect or sanitize CPAP machines, including the masks, tubing and headgear.

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:

  • Coughing
  • Difficulty breathing
  • Nasal irritation
  • Headaches (often referred to as “CPAP headaches”)
  • Asthma attacks
  • Other breathing problems

It now appears that many of these problems may have been the result of foam in the Philips CPAP machines degrading and releasing small particles or chemicals into the air pathways.

Although Philips Respironics had made several statements suggesting that SoClean may be to blame for the CPAP foam problems, the ultimate responsibility for the recall still rests squarely on Philips Respironics for selling a defectively designed and unreasonably dangerous sleep apnea machine.

Why didn’t Philips warn about the CPAP machine risks?

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.

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Philips CPAP Cancer Lawyers

Serious 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 CPAP 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.

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