More than 1 million patients wait on replacements for recalled Philips CPAP machines

Published: Apr. 28, 2022 at 6:13 AM EDT
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CLEVELAND, Ohio (WOIO) - Millions of Americans go to sleep at night with the aid of a CPAP machine, but many of them are losing sleep these days now that they’ve been alerted to a serious recall issued for the models used by more than 2.5 million people.

But those patients are waiting months for a fix, forcing them to choose between their immediate health and potential health risks, including cancer.

Philips Respironics acknowledges the potential health risks related to millions of their sleep apnea and respiratory care products.

The problem is in the sound abatement foam, which is the part that reduces noise and vibration.

According to the FDA, it’s breaking down and potentially getting inhaled. Those particles come with a host of health risks.

“I didn’t sleep very well. Also, I was snoring a lot,” said Stephen Hujarski, who was diagnosed with sleep apnea three years ago.

A prescription was cut for a CPAP machine, and Hujarski was issued a Philips Dream Station model, recommended by Cleveland Clinic.

But over the summer, he got a letter from the Cleveland Clinic alerting him that the device he was using was part of a large recall “due to issues related to certain foam used in these devices.”

The FDA recalled more than a decade’s worth of Philips manufactured CPAP machines. It’s a class one recall; the most serious type.

“The FDA and even Philips has come forward to acknowledge this sound dampening foam is breaking down. Not only that, but getting directly in to your airways while you sleep,” said Jay Kelley, managing partner with the law firm Elk & Elk.

According to the FDA’s recall the foam used in these devices, may break down and potentially enter the device’s air pathway, releasing black debris or certain chemicals which may be inhaled or swallowed by the person using the device.

Among the risks, according to the FDA, are toxic or carcinogenic effects to organs like the kidneys and liver.

“The Dream Station is a very common device out there that’s being recalled. The questions are pretty fast and furious,” said Kelley.

He says they’re finding cancer cases among people who’ve used the recalled devices for more than six months, although it’s too early to link these cases to cause.

“We found people who have used it over time, and who have cancer of the lungs, liver, kidney. That’s where we are primarily focusing right now. Can we relate there, or is there another cause? That’s stuff we’re doing research on now,” he said.

“I’m whiffing in potentially something that can be harmful to my lungs,” said Syl Goldberg.

He was also diagnosed with sleep apnea and has been using a System One device for five years. It too was recalled over the same concerns about the breakdown of the foam component.

A statement from the Cleveland Clinic says, “We have reached out to our patients who use these devices and are advising them on whether or not to continue therapy while awaiting replacement/repair of their device.”

Goldberg, who is not a Cleveland Clinic patient, says he followed instructions to register his recalled device

Hujarski was hoping for a safe, interim solution after he registered his device.

“You’ve got a CPAP for a reason. And if you don’t use it, that reason could intensify. You might end up back in the emergency or something like that. You’re really caught between a rock and a hard place there. If you stop using it, you could run into other health issues. If you continue to use it, you may contract cancer,” said Hujarski.

In the end, both patients chose to continue to use their recalled machines, reasoning their need for immediate relief outweighed the risk of toxic exposure and they waited for a replacement.

Hujarski waited four months.

Goldberg has been waiting eight months.

“I think Philips was not prepared to respond quick enough,” said Hujarski.

In a statement, Philips said “To date, Philips Respironics has shipped a total of more than 650,000 replacement devices to customers in the us, and aims to complete the repair and replacement program in the fourth quarter of 2022.”

The FDA says many patients and caregivers have reached out to share their concern over Philips’ response and they said they’ve taken several actions to hold Philips accountable.

“Our most recent action ordered the company to provide notification within 45 days to patients about the recall and the risks of the recalled devices because they did not satisfy their obligation. This is one example of our commitment to use the regulatory tools available to us that hold companies accountable when they do not adequately correct device safety issues,” said an FDA official.

In addition to enforcement actions, the FDA continues to monitor the effectiveness and timeliness of Philips’ actions to repair and replace their recalled devices and assure Philips has met all requirements related to the Class I recall.

Now that he has a new machine, but also known exposure, Hujarski’s says he’ll play closer attention to his health moving forward.

“Your body will tell you when something doesn’t feel right. I listen a little more to what my body tells me,” he said.

Philips says after two rounds of customer and patient outreach, they believe they’ve reached the majority of customers using these recalled machines.

Click here to see if you or someone you know is using one of the affected machines.

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