I-Team: Philips Respironics CPAP Recall Leaves Many Patients With Difficult Choice

BOSTON (CBS) -- An I-Team investigation into a recall of Philips Respironics Continuous Positive Airway Pressure (CPAP) machines has many sleep apnea patients telling WBZ-TV they are now left with a difficult choice: leave their condition untreated or risk using a device that could potentially cause cancer.

An investigation into the recall has uncovered an FDA report suggesting the machine's manufacturer may have been aware of possible health concerns years before the recall.

It looks bulky and uncomfortable, but for Dan Satinsky, his CPAP machine helps him get a good night's sleep. Satinsky said before he got the machine, he was falling asleep in the middle of the afternoon and was struggling to concentrate. Dan uses the Phillips Dream Station CPAP for his sleep apnea, a disorder that can lead to heart disease and high blood pressure.

He calls the machine "a lifesaver."

For patients like Satinsky who suffer with sleep apnea, breathing dangerously stops and starts throughout the night. The CPAP helps by releasing a steady stream of air into the nose and mouth to keep the airway open. But in June, Phillips voluntarily recalled its Dream Station CPAP machine, saying sound-dampening foam may degrade into particles and off gas certain chemicals.

The Federal Drug Administration says breathing in the gas can cause serious injury, which can be life-threatening or cause permanent impairment.

Satinsky said he is concerned about what might be getting into his lungs, but said he has to use the machine.

"It's just not an option not to use it, so there we sit. Very frustrating," he said.

Phillips told the I-Team it voluntarily recalled five million devices, but so far has only been able to send out repair kits to a million and a half patients. Satinsky wasn't one of them.

Dr. David Neumeyer of Lahey Medical Center said patients should stop using the machine if they see dark grey or black specs. But they should also be concerned about what they can't see that could also be seeping into the machine.

"The CPAP recall has been a significant issue for many patients," Dr. Neumeyer says.

The I-Team found FDA records show Phillips had been aware of the problem since 2016, but didn't notify patients until five years later.

In FDA inspection reports, the agency said, "There were at least fourteen instances....where your firm was aware of issues and concerns related to potential foam degradation...and found...no...corrective action...was conducted..."

Phillips responded to the findings in a statement.

An FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act ... We remain fully committed to supporting the community of patients.

All of that is of little comfort to Satinsky, who has been using a recalled device for nine months.

"The choice you have is to either not be treated or take a chance that whatever you are breathing in that particular old machine may or may not be going into my lungs," he said.

Phillips Respironics said it hopes to repair or replace the defective machines by the end of 2022. Some Massachusetts customers are taking their concerns to court and have filed a class action lawsuit claiming the company failed to warn them of the dangers. Other customers have filed additional lawsuits alleging they have health problems from the defective machine.

Phillips released a full statement in regards to the recall of the CPAP machines:

"We fully understand and regret the impact that this recall / field safety notification is having on patients. We have launched a comprehensive patient and customer communication program, which includes dedicated mailings, call centers and websites in more than 100 countries. We continue to provide updates on our dedicated web site for the recall / field safety notification: www.philips.com/SRC-update

In many cases, Philips Respironics does not own or manage the CPAP patient's contact information – many patients purchase their devices through third parties. Philips Respironics is working with those third parties (Durable Medical Equipment providers - DMEs) to also reach patients directly as quickly as possible. We are working around the clock to continue to reach out to our customers and patients.

This recall / field safety notification affects around 5 million devices worldwide. To address affected devices, Philips has mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with new foam not affected by this issue. The repair and replacement program will be at no cost to consumers.

At this time, Philips is already producing repair kits and replacement devices in large quantities. To date, Philips has produced 1.5 million repair kits and replacement devices, with about 750,000 in the hands of customers. These devices and kits are being sent to patients as they are available. As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients.

Regarding estimated timing, we are working to address this issue as expeditiously as possible. We expect to complete the repair and replacement programs in in the fourth quarter of 2022.