Philips CPAP Recall Breaking News Update

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Could Your CPAP Machine Be Putting You at Risk of Cancer?

Millions of Philips sleep apnea machines and ventilators are being recalled for an alarming reason: a potential risk of cancer or other health issues, according to Reuters.

Here’s what you need to know about the recall and what to do next.

Philips CPAP Recall 2021

On June 14, 2021, multinational health technology company Philips announced that it would be recalling CPAP and ventilator devices. This recall notification comes more than a month after Philips noted a “quality issue” involving CPAP machines and ventilators while publicizing the company’s first-quarter 2021 sales results.

The U.S. Food and Drug Administration noted that the purpose of the recall was to “mitigate potential health risks related to the sound abatement foam component” of the devices.

What Is the Risk Associated With Recalled Philips CPAP and Ventilator Machines?

The components in question are made of polyester-based polyurethane (PE-PUR) foam and are used to make the machines quieter. The problem is that, as testing has demonstrated, this foam can pose risks to patients by:

  • Degrading into particles that the user may ingest
  • Off-gassing chemicals that the user could inhale

These particles and gases can be harmful or even toxic. Ingesting these particles or inhaling these gases could put you at risk of developing cancer, according to CBS News. Environmental exposure to high levels of heat and humidity can worsen the problem of foam degradation, as can the use of unapproved cleaning methods like ozone.

Which Medical Devices Are Included in the CPAP Recall?

The Philips medical devices included in the recall, as of January 16, 2021, are:

  • All Philips CPAP devices manufactured before April 26, 2021, under all serial numbers
  • All Philips BiLevel PAP devices manufactured before April 26, 2021, under all serial numbers
  • E30 model continuous ventilator, minimum ventilatory support for facility use
  • DreamStation non-life supporting continuous ventilator models ASV, ST, and AVAPS
  • SystemOne ASV4 model continuous ventilators, non-life supporting
  • C Series continuous ventilator, non-life supporting models ASV, S/T, and AVAPS
  • OmniLab Advanced Plus in-lab titration device
  • SystemOne Q series models of non-continuous ventilators
  • DreamStation CPAP, Auto CPAP, and BiPAP ventilator models
  • DreamStation Go CPAP and APAP models of non-continuous ventilators
  • Dorma 400 and 500 CPAP models of non-continuous ventilators
  • REMStar SE Auto CPAP models of non-continuous ventilators
  • The Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent continuous ventilators
  • The A-Series BiPAP V30 Auto and Hybrid A30 continuous ventilators for minimum ventilatory support for facility use
  • Outside the United States, the A-Series BiPAP A30 and A40 non-life supporting continuous ventilators

Between 3 million and 4 million ventilators and CPAP machines are included in the recall, according to Reuters.

What Should You Do If Your Machine Has Been Recalled?

Hearing about this recall can leave Philips device users uncertain of what to do. Here’s what Philips recommends at this time:

If the Recalled Philips Device You Are Using Is a Life-Sustaining Mechanical Ventilator…

Patients who are using life-sustaining mechanical ventilators should not stop using the device without first talking to a doctor. The consequences of any disruption in your therapy can be severe.

Speak to your doctor as soon as possible about your options and the risks and benefits of continuing to use the device.

  • In some cases, a doctor may be able to identify alternate ventilator options that will provide the therapy you need without exposing you to health risks caused by foam degradation.
  • If you have to keep using the recalled device because alternatives are not available, Philips advises patients to install a component called an inline bacterial filter.

If the Recalled Philips Device You Are Using is a BiLevel PAP or CPAP Machine…

Philips recommends that patients using recalled BiLevel PAP and CPAP machines stop using the devices right away.

It’s still important to get in touch with your physician or your Durable Medical Equipment provider promptly so that you can explore other options for treatment or quickly receive a replacement device that does not pose a risk of foam degradation.

Inhaling and ingesting potentially toxic gases and particles poses serious health risks, but so does allowing sleep apnea to go untreated. Speak to your doctor about any risks and concerns that are specific to you.

What If You Suspect Philips CPAP Foam Degradation Caused Your Cancer?

A recall like this can cause patients to feel a great deal of anxiety. What if you have used these recalled devices, possibly every night over the course of years?

It’s hard to say right now just how common it may be for this potential health risk identified through testing to turn into a definitive cancer diagnosis in real patients. This is a cause for concern, certainly, but please don’t panic.

What you can and should do is discuss the Philips CPAP foam degradation recall with your doctor. Speaking to a physician is particularly important in any of the following instances:

  • You have noticed erosion or degradation of the foam components of your machine
  • You have unexplained health conditions that you think might have to do with the recalled machine
  • Getting screened for the kinds of cancer most likely to arise from exposure to these particles and gases would ease your mind after learning about the recall

If you have been diagnosed with cancer already and you wonder if your CPAP machine is to blame—particularly if you don’t have known risk factors for the type of cancer you developed—you should speak to your doctor about the concerns. Additionally, you should consider reaching out to a lawyer. 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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