[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[btreger]

drugwatch

Philips CPAP Cancer Risk

Most of the Philips CPAP cancer risk comes from chemicals in PE-PUR foam, including isocyanates. Isocyanates are potential human carcinogens that are known to cause cancer in animals, according to the Occupational Safety and Health Administration. These compounds also cause asthma and lung problems, and some studies have found an increased risk of lung cancer. They also affect the eyes, nose, throat, and skin. Other cancers associated with polyurethane include non-Hodgkin lymphoma and rectal cancer.

In addition, Philips CPAP lawsuits have named several other cancers as potentially caused by PE-PUR foam.

https://www.drugwatch.com/philips-cpap/cancer-risk/

[dlj3000]

Hello everyone, 

August 11:  Previous DME notified me by email about the Philips recall.   

August 16:  Told my sleep doctor that I will stop using the DS and wait for Philips to send the replacment....plus the motor was making a high-pitch noise. 

October 4: Previous DME left voice mail stating the new DS2 was being shipped to my place.

October 14:  Package was at my door this morning.  No tracking number or email....nothing.

[WakeUpTime]

<< above >>

We appreciate the detailed update.  Thanks.  I was curious about a few things.  If you have time, could you please let us know...

1. How old was your DS1?  I was wondering if it was a more-recent purchase and therefore still under warranty.
   
2. During your Recall Registration, did you indicate if you were a SoClean user?
   
3. Given your timeline, do you think your previous DME or sleep doctor did anything to speed up your device replacement?  
   
4. Were you an early Recall Registrant?
   

[WakeUpTime]

Philips CPAP Cancer Risk
https://www.drugwatch.com/philips-cpap/cancer-risk/

That seems to be one of the best summaries of possible health concerns related to use of the faulty Philips xPAP devices with carcinogenic decomposing foam.  All current and previous Philips Recalled Device owners should read it, and store it, as a reference for current and future health issues.

Philips CPAP Cancer Risk
Cancers linked to PE-PUR foam in studies and CPAP lawsuits include:

• Bladder Cancer
  
• Brain Cancer
  
• Breast Cancer
  
• Hematopoietic Cancer
  
• Kidney Cancer
  
• Leukemia
  
• Liver Cancer
  
• Lung Cancer
  
• Lung Damage
  
• Lymphatic Cancer
  
• Multiple Myeloma
  
• Nasal Cancer
  
• Non-Hodgkin Lymphoma
  
• Papillary Carcinoma
  
• Prostate Cancer
  
• Rectal Cancer
  
• Stomach Cancer
  
• Testicular Cancer
  
• Thyroid Cancer
  

I highlighted the above cancers of people that I know (friends, family, acquaintances) who are/were xPAP users (I don't know if they were Philips recalled device owners) who died in the past 3-5 years.  (Note: Red indicates they're still living with the condition.)  Of course, that's not implying that their illness was directly caused by Recalled Philips xPAP devices, since I'm not aware of all of their detailed histories, though people with the above conditions that are still living should take note of the link to the faulty foam.  

Ideally, independent researchers should investigate the correlation further to see if it indeed is likely causation rather beyond just correlation.

[dlj3000]

We appreciate the detailed update.  Thanks.  I was curious about a few things.  If you have time, could you please let us know...

1. How old was your DS1?  I was wondering if it was a more-recent purchase and therefore still under warranty.
   
2. During your Recall Registration, did you indicate if you were a SoClean user?
   
3. Given your timeline, do you think your previous DME or sleep doctor did anything to speed up your device replacement?  
   
4. Were you an early Recall Registrant?
   

1)  I was diagnosed on 6/7/2018 so I was still under the 5 year warranty.
2)  I bought the So-Clean 4 months later, and, yes, I did put that in the recall form.
3)  Maybe .....I stopped using the former DME because my job changed insurance coverage but they were ALOT more helpful than Dr hey-its-up-to-you .  Even the current DME tried to help.  But on every phone call, former and current DMEs would say "There's not much we can do......It's up to Philips handle who and when"
4)  No I wasn't.  I was completely in the dark about the recall until the previous DME sent the email.

[ST Dog]

Ideally, independent researchers should investigate the correlation further to see if it indeed is likely causation rather beyond just correlation.

That's the issue. Lists of stuff may cause/increase risk of cancers (especially in California).


In most cases it's only vague correlation.

Seldom do you seen anything about dosage.
100ug has a different effect than 100g.

100g total over 10 years is different than 100g at once.

What is the release rate on the Philips machines even?

[WakeUpTime]

In most cases it's only vague correlation.

There are many situations in life where it's almost impossible to prove with 100% certainty that such causation exists.  It may be completely sufficient and justified for a judge or jury to show that the known previously proven carcinogenic chemical compounds used in the Philips Recalled Device foam, and released during off gassing, contributed or directly caused cancers to occur in some individuals.  

What's the amount of ingestion that, without question, causes direct harm?  Too many factors.  If someone already had compromised health conditions, and then the above carcinogens were added to their organs, could that be the difference in the creation of a life-threatening illness?  No one knowingly agreed to ingest any amount of the above toxins when making their purchase of their Philips Recalled device.

Judges, and juries, can convict without finding the weapon; sometimes without even finding the body.

[ST Dog]

Judges, and juries, can convict without finding the weapon; sometimes without even finding the body.

That they do. And often it's overturned on appeal.


My point is just there no info on the dosage and that matters. We are exposed to all sorts of proven carcinogens daily but in such low doses that it has no effect.

Nowhere in any of this has anyone given numbers on how much is given off over any time period. Nor any mention of what dose is considered dangerous.

Calling it "cancer foam" is a huge leap.

I expect the foam in my pillow, mattress, and furniture off gas similar and in much higher quantities.

The FDA and companies that deal with the FDA err on the side of caution most of the time. They will recall/pull items over very low risks.

I think the mechanical degradation is the bigger issue, but one solved with a particulate filter.

But I'm erring on caution too (replacement machine), and waiting to see more info. But I'm not calling it cancer foam or swearing off Philips products. And not joining /filing lawsuits.

[btreger]

I just received this response from an e-mail I had sent:

Therapeutic Goods Administration

Department of Health

Thank you for your inquiry. Please accept my apologies for the delay in response.

It is my understanding that the foam being used to repair/replace affected devices is a silicone foam that is currently also used in the DreamStation 2 platform. I understand that your members are being provided the DS2 devices as replacements currently.

The TGA is currently undertaking a post-market review of ventilators, CPAPs and BiPAPs supplied in Australia and has requested sponsors of the ventilator, CPAP, and BiPAP devices in the ARTG to provide information about their product, including:

    the type of soundproofing material used;
    the manufacturer risk assessment and risk mitigation strategies; and
    whether the devices pose any unnecessary risk to the health of the user during normal use. 

To date, the recall action is limited to the Philips devices utilizing RE-PUR foam in the airway circuit however the TGA will publish further information if we become aware of health risks relating to other brands and/or models. 

For further information please refer to https://www.tga.gov.au/behind-news/post-...ap-devices. As updates are made available they will be published here also. 

Kind regards, 

Sarah
Recalls Section
Manufacturing Quality Branch

[Neelix]

I find it somewhat amusing that the majority of the email text was apparently stitched together from text copied and pasted directly from the website referred to at the end of the message. In case anyone viewing the page missed it, the updates the email refers to appear to be hidden within a drop-down box triggered by clicking the text "Ventilator Expert Working Group". (not that there's much there yet)

I'm curious what prompted you to contact the TGA though. Did you purchase your DreamStation in Australia?

-Neelix