Here’s What You Should Know about Philips CPAP, BiPAP, and ASV Recalls.
Millions of commonly used Continuous Positive Airway Pressure (CPAP), Adaptive-Servo Ventilation (ASV), and Bi-Level Positive Airway Pressure (Bi-PAP) devices, used to treat sleep apnea, have been recalled after it was discovered that disintegrating polyurethane foam inside the breathing apparatus puts users at risk for lung cancer, leukemia, breast cancer, liver cancer, pancreatic cancer, kidney cancer, and many more potentially deadly cancers.
Polyurethane foam has long been known to present potential hazards. In fact, according to the National Association of Fire Marshals’ 2015 publication, “A to Z of D-Toxing,” fire marshals refer to this foam as “solid gasoline.” It is toxic and dangerous, and especially concerning in these machines because they channel carcinogen-tainted air directly into the body.
What CPAP/BiPAP/ASV Devices Have Been Recalled?
Philips, the company that manufacturers the Bi-PAP and CPAP devices, issued a recall June 14, 2021 on several of its ventilation products:
- SystemOne Q Series
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP and APAP
- Dorma 400/500 CPAP
- REMStar SE Auto CPAP
- DreamStation ASV
- DreamStation SV/AVAPS
- SystemOne ASV4
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- E30 Continuous Ventilator
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
- A-Series BiPAP V30 (not marketed in the U.S.)
All recalled devices were manufactured prior to April 26, 2021, and all serial numbers of these devices are included.
What are the Dangers of Recalled Philips CPAP/BiPAP/ASV Devices?
Recalled Philips sleep and respiration devices contain a patented sound abatement foam called PE-PUR. The foam, made from polyester-based polyurethane, decomposes over time. As it does so, it emits toxic gases that can cause illness, including asthma, headache, nausea and vomiting, hypersensitivity, respiratory problems, cognitive difficulties, and a number of different cancers.
What Types of Cancers are Associated with Breathing Polyurethane Foam?
Several cancers are caused by inhaling gases emitted from polyurethane foam, including:
- Leukemia
- breast cancer
- lymphatic cancer
- liver cancer
- nasal cancer
- lung cancer
- non-Hodgkin’s lymphoma
- brain cancer
- multiple myeloma
- prostate cancer
- bladder cancer
- testicular cancer
- stomach cancer
- hematopoietic cancer
- papillary carcinoma and other thyroid cancers
What if I have been Diagnosed with Cancer after Using a Philips Sleep Device?
If you have used a recalled Philips sleep or respiration device and have now been diagnosed with cancer, contact the medical device attorneys at OnderLaw. We have stood with clients against makers of dangerous medical devices since 2002.
Contact us today for a free, no-obligation consultation.
What Chemicals Could I be Breathing from my CPAP Machine?
The following chemicals are emitted (or “off-gassed”) when polyurethane foam decomposes:
- Benzene –may damage a cell’s DNA, has been linked to leukemia (AML), breast, lymphatic, and hematopoietic cancers.
- Formaldehyde – inhalation linked to nasal cancers
- Methylene Chlorine (also called dichloromethane) – may cause malignant lung and liver tumors. Also now associated with NHL, brain cancer, and multiple myeloma.
- PFOS (perfluorooctanesulfonate) – These fall under the category of PFAS, and have been associated with elevated risk for prostate, breast, bladder, liver, pancreatic, kidney, and testicular cancers.
- Solvents – may cause stomach cancer, lung cancer, bladder cancer, hematopoietic cancer
- VOCs (volatile organic compounds) – may cause nasopharyngeal (nasal) cancer
- Flame Retardant – may cause learning disabilities, lower IQ levels and uterine, thyroid (papillary carcinoma and others) and liver cancer, as well as damage to cellular DNA.
How Many CPAP Sleep Devices Have Been Recalled?
An estimated 2 million to 3 million Philips CPAP, Bi-PAP, and AVS breathing devices used to treat sleep apnea and other respiratory problems have been recalled. Two-thirds of those devices were sold in the United States.
What Makes the Problem Worse?
Decomposition of polyurethane foam inside of recalled Philips breathing machines is dangerous in and of itself, and there is no way to avoid the risk if you are using one of these machines except to discuss alternatives with your physician immediately and to stop using these specific CPAP and other ventilation devices.
According to the recall and statement issued by Philips, unapproved cleaning methods, such as use of ozone cleaning machines, which are often marketed for this purpose, as well as high heat and high humidity can make the problem worse.
Where Can I Learn More About the Dangers of Polyurethane Foam in my Sleep Machine?
Below are just a few of the studies and articles published regarding specific gases emitted by polyurethane decomposition in recalled Philips CPAP/BiPAP and ASV devices:
- https://www.cancer.org/cancer/cancer-causes/benzene.html
- https://www.ncbi.nlm.nih.gov/pmc/articles
/PMC3893912/ - https://www.ncbi.nlm.nih.gov/pmc/articles
/PMC4314245/ - https://monographs.iarc.who.int/wp-content/uploads/2018/
06/mono110-01.pdf - https://www2a.cdc.gov/nioshtic-2/BuildQyr.asp?s1=%27organic
+solvent%2A%27&f1=%2A&Startyear=&B1
=Search&terms=3&Adv=1&Limit=
500&Sort=DP+DESC&D1=10&End
Year=&PageNo=1&RecNo
=2&View=f& - https://iaqscience.lbl.gov/voc-cancer
- https://dukespace.lib.duke.edu/dspace/
bitstream/handle/10161/15444/CIE
%20Thyroid%20Cancer
%20Accepted%20MS.pdf?sequence=1&
;isAllowed=
What Should I Do if My Sleep Breathing Device Has Been Recalled?
According to Philips, patients using recalled BiLevel PAP and CPAP devices should discontinue use immediately and talk to their doctors regarding safer alternatives.
Those using life-sustaining devices should talk with their physicians to discuss the risks and determine what steps should be taken.
In all cases, physicians and patients should discuss their individual cases to make care decisions based upon their circumstances. Philips is in the process of developing a replacement program with foam it says will be safer to use. We remain diligent in following this process.
What if I have been Diagnosed with Cancer and I’ve Used a Recalled Sleep or Ventilation Device?
If you have been diagnosed with leukemia, breast cancer, lymphatic cancer, liver cancer, nasal cancer, lung cancer, non-Hodgkin’s lymphoma, brain cancer, multiple myeloma, prostate cancer, bladder cancer, testicular cancer, stomach cancer, hematopoietic cancer, or papillary carcinoma or other thyroid cancer, and have used a recalled Philips CPAP or other breathing device, Contact us today. We will fight for you.