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.
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.
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:
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.
The Philips medical devices included in the recall, as of January 16, 2021, are:
Between 3 million and 4 million ventilators and CPAP machines are included in the recall, according to Reuters.
Hearing about this recall can leave Philips device users uncertain of what to do. Here’s what Philips recommends at this time:
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.
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.
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:
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. While it’s too soon to say if this situation will set off a tide of litigation, our personal injury attorneys can offer advice on how to preserve your legal rights should a potential claim arise and how to best monitor news on this ongoing situation.