Certain Philips Respironics CPAP, BiPAP and Ventilator Machines Recalled
What is This About?
Philips, a leading global manufacturer of electronic and medical devices has issued a voluntary recall on several of its popular products, including certain CPAP and BiPAP machines and ventilators.
This recall was issued due to concerns regarding the breakdown of the PE-PUR (polyester-based polyurethane) foam used to reduce the machine’s noise level. Current evidence suggests that the foam may break down, with particulates potentially entering the airway where they could be ingested or inhaled by the user.
Given the known toxicity of PE-PUR foam, particularly as a known carcinogen, patients using these machines are strongly encouraged to speak with their healthcare provider about an immediate alternative.
Potential risks associated with use may include an increased risk of developing breast cancer, leukemia, lung cancer, liver cancer, kidney cancer, pancreatic and other deadly cancers.
What Products are Included in Philips CPAP Recall?
The voluntary recall, issued June 14th, 2021 included the following products.
CPAP and BiPAP Devices
- E30
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
Ventilators
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
- A-Series BiPAP Hybrid A30 (not marketed in the US)
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BiPAP A30
The Potential Risks Associated with the Philips Sleep Apnea Machine Recall
PUR foam is a known cancer-causing agent, much like gasoline. In fact, PUR foam is often referred to as ‘solid gasoline’. Despite its known potential as a serious health hazard, this foam was broadly used in several Philips CPAP, BiPAP and Ventilators.
The foam used in these devices is prone to decomposition over time. As it does so, the foam can emit toxic gases that pose a serious health threat to the user. Immediate inhalation may result in respiratory problems, headaches, nausea, vomiting, cognitive difficulty and more. Longer-term use may result in the development of deadly cancers.
Many of these injuries can result in serious, debilitating and even life-threatening outcomes or long-term impairment.
PUR Foam and Cancer
Let’s take a brief look at the science…
According to the British Journal of Industrial Medicine, two substances used widely in the polyurethane foam manufacturing industry (Toluene diisocyanate and methylene diphenyl diisocyanate) are mutagenic (potentially cancer-causing) and TDI is itself carcinogenic to animals.
According to the National Toxicology Program at the Department of Health and Human Services, its 14th report on carcinogens states that Urethane is reasonably anticipated to be a human carcinogen.
According to the Occupational Safety and Health Administration (OSHA), polyurethane polymers, which are components of polyurethane foams, and Isocyanates, used to produce such foams, are known to cause cancer in animals and have the potential to be human carcinogens as well.
The American Chemistry Council, in its Material Safety Data Sheets (MSDS) goes on to warn that polyurethane products are a risk for several health hazards including but not limited to allergic reactions of the skin and lungs, and irritation or damage to the skin, lungs, nose, throat and eyes.
Exposure to PE-PUR foam, such as that used in some Phillips devices may also cause:
Cancers, including but not limited to:
- Lung Cancer
- Kidney Cancer
- Liver Cancer
- Leukemia
- Breast cancer
- Lymphatic cancer
- Nasal cancer
- Non-Hodgkin Lymphoma (NHL)
- Brain cancer
- Multiple Myeloma
- Prostate cancer
- Bladder cancer
- Testicular cancer
- Stomach cancer
- Hematopoietic cancer
- Papillary carcinoma and other thyroid cancers
Organ Failures, Including:
- Liver Failure
- Kidney Failure
How Many Victims May Have Been Impacted?
There are currently between 1-2 million Phillips CPAP machines in use in the United States, with the worldwide recall impacting between 3-4 million across European nations.
Complaints Made to Philips
According to the Food and Drug Administration (FDA), Philips has received several complaints regarding the appearance of dark particulates and/or debris found within the air pathway of certain Philips devices. Further, Philips Respironics has received consumer reports of chest pressure, coughing, upper airway irritation, headaches and sinus infections that may or may not be related to the use of PUR foam, but warrants further investigation.
The Response from Philips
In April of 2021, Philips made a public update about its effort to address the potential health issues surrounding certain components of products in its respiratory care and sleep portfolio.
Out of what Philips is calling ‘an abundance of caution’, the company is advising consumers and healthcare professionals about the potential health risks associated with the sound abatement foam it uses in certain devices. The company went on to state that investigations and analysis surrounding the potential health risks of this foam is are ongoing.
In June of 2021, as a result of these investigations, Philips announced that it was issuing a voluntary recall in the USA, and a field safety notice for affected devices sold outside of the USA.
The purpose of these notifications is meant to educate users and consumers of the potential health risks associated with the devices, and that use of them may result in exposure to hazardous or toxic chemicals, resulting in serious health conditions, injury or death.
Philips further went on to disclose that it had received a limited number of reports that potentially indicated patient impact due to foam degradation, none related to chemical emissions, and that it would continue to monitor the situation closely for potential safety issues, adhering to the regulations of the markets in which it operates.
Lack of Ongoing Medical Monitoring: a warning sign?
Cancer can take years, sometimes decades, to manifest from exposure to chemicals. Given what we know about PUR foam as a known carcinogen and toxic material, one might expect that there would be ongoing medical monitoring of those using impacted CPAP machines and ventilators. However, so far that is not the case. Which begs the question why?
Although simply conjecture at this point in time and not in any way an accusation, there have been circumstances in the past where a company would fail to medically monitor these situations so as to potentially reduce evidence that may come to light which would be unfavorable to the company’s bottom line.
Actions Taken by the FDA
On July 29th of 2021, the FDA sought to address commonly asked questions consumers had about the recall, and in this same month, the FDA further made the call to classify the device problem as a ‘Class I’ recall, the most serious type of recall it can issue.
This recall indicates that the FDA has deep concerns regarding the potential health threat these devices could pose to the public, and wants to ensure that Philips Respironics thoroughly evaluates the issues associated with the devices in order to implement appropriate corrective action.
Expanding its investigation, the FDA is currently analyzing medical device reports connected to affected devices dating as far back as 2009.
IMPORTANT NOTE: At this time, the FDA has reported that it does not have any evidence that devices other than those listed in the recall were affected.
Get the Help You Need, and the Compensation You Deserve
Our firm is currently investigating product liability lawsuits related to the use of some Philips products. You may qualify for filing a claim.
If you or someone you know has used one of the recalled Phillips devices for more than six months, and later experienced organ failure or developed cancer, reach out for a free case evaluation.
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