CPAP Cancer Risk – Senator Puts Pressure on Philips America.

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September 8, 2021 – San Diego, CA.  The pressure is mounting for CPAP maker Philips North America in its massive CPAP recall efforts.  There is currently a cancer risk from using CPAP machines related to its sound abatement foam deteriorating and off-gassing. 

The recalled CPAP and BiPAP devices use “PE-PUR”, a polyester-based polyurethane foam that can be dangerous if inhaled. Philips also revealed that as the foam degrades and breaks down over time, their popular CPAP machines may begin to emit toxic organic compounds that are known to cause organ damage and lung cancer. 

The recalled devices are Philips CPAP and BiPAP machines purchased between 2009 and 2021 and include: 

  • Philips DreamStation CPAP
  • Philips DreamStation Auto CPAP
  • Philips DreamStation BiPAP
  • Philips DreamStation Go CPAP
  • Philips DreamStation Go APAP
  • Philips Dorma 400 CPAP
  • Philips Dorma 500 CPAP
  • Philips REMStar SE Auto CPAP

Health side effects to look out for when using Philips CPAP and BiPAP devices include: 

  • Asthma
  • Lung irritation
  • Throat inflammation
  • Gastrointestinal conditions
  • Liver conditions
  • Kidney issues
  • Persistent or chronic cough, congestion or headaches
  • Persistent or chronic nausea or vomiting

On August 24, Senator Richard Blumenthal, D-Conn., wants answers and has given the company until September 7 to reply.  Philips issued a Class I recall of its CPAP and ventilators in mid June.  

In his 3-page letter he seeks to find solutions that are affecting hundreds of thousands of CPAP users. He says he’s personally heard from some of his constituents who have voiced concerns about the lack of communications and planning for users.

In his letter he states; “The current situation is untenable, unacceptable and must be immediately rectified.” He continues with; “I look forward to reviewing your answers to these questions. In the meantime, I urge Philips to continue its outreach to impacted patients, immediately expedite its replacement and repair program, submit a mitigation plan with sufficient evidence to FDA for authorization and work to ensure that such a mass recall does not occur again in the future.” 

His 3-page letter has these questions for Philips America.

  • How many devices have been impacted by this recall, and how many patients are believed to have been impacted by this recall? 
  • What percentage of impacted patients have used the Philips established registration process to register a recalled device? Please also provide the total number of impacted patients who have registered. 
  • How has Philips reached out to affected patients to alert them to this problem and how is Philips continuing to ensure all affected patients learn of this problem? 
  • What percentage of impacted patients who have registered their device have received a response from Philips regarding their recalled device? Please also provide the total number of impacted patients who have received any response. 
  • What percentage of impacted patients have had their recalled device repaired or replaced by Philips’ “comprehensive repair and replacement program”? Please also provide the total number of impacted patients who have had the issue completely resolved through replacement or repair. 
  • When does Philips expect to submit a mitigation plan to FDA for authorization to permanently resolve this problem? If it has done so, has it provided FDA with sufficient evidence to show that the mitigation plan eliminates the product defect and the product is now safe and effective for use? 

What Actions Has Philips Taken in the CPAP Recall?

It was on September 1 that Philips America announced that it was working with the FDA and now has approval to change out the problematic foam for new foam used for sound abatement.

According to some health care medical device retailers, Philips is shipping out about 1,500 replacement machines per day.  However some of these retailers still have no idea if they are getting new CPAP machines or machines that have had the foam replaced.    

Philips America has issued communications to patients, users and caregivers on its repair and replacement program and offers a claims processing support center on its website that allows people to enter the device serial number to see if the CPAP machine is part of the current recall.

Were you affected by CPAP Cancer?

For more information about the possible Philips CPAP lung cancer and recall and what you should do, please contact us directly at 1-800-631-5656.

Our team of injury advocates at Schmidt National Law Firm is highly concerned about the cancer risks associated with these recalled sleep apnea CPAP machines and is offering free consultations to anyone who uses these devices. 

Our law firm is actively investigating these medical devices and potential injury cases resulting from the usage of these devices in an effort to help protect the health of CPAP users and hold manufacturers accountable. 

Contact us today for a confidential consultation using the 100% secure form, or you can call us directly at 1-800-631-5656.

DO NOT STOP USING YOUR CPAP MACHINE UNTIL YOU SPEAK TO YOUR DOCTOR.

Sources:

https://www.hmenews.com/article/philips-recall-senator-pushes-for-answers

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

CPAP Cancer | Senator Puts Pressure on Philips CPAP Recall Page Updated on September 8, 2021.