Since June 2021, Philips Respironics CPAP machines have been subject to a Class I recall. The recall came after the FDA received reports that the noise-proofing foam in the machines could break down and enter the tubing. Thereafter, the CPAP machine might force the foam particles into users’ lungs, causing potentially serious complications.
Now the FDA reports that it has received reports of at least 124 deaths linked to the recalled machines. However, the FDA has not completed its investigation of these reports, and it has not added “death” as a possible complication linked to the recalled devices.
However, the recall has many people in the Aberdeen area looking for a CPAP alternative for sleep apnea treatment, either because of the risks or because they can’t get a CPAP machine due to the recall.
Why Philips Recalled Its CPAP Machines
One of the complaints about CPAP machines historically has been that they are loud, making it hard for the wearer or their sleep partner to get good sleep. To make the machines quieter, manufacturers often use foam to muffle the noise of the pump. This foam is the source of the recall.
The foam used by Philips Respironics can break down, causing two potential problems. First, the foam creates fine particles that the pump can suck in, push into the tubing, and drive into the lungs and/or stomachs of CPAP users. The foam can also degrade and give off toxic gasses. The CPAP pump can also suck up these gasses.
High heat and humidity, such as we can get in Aberdeen, NC, all summer, seem to accelerate the foam degradation. In addition, some unapproved cleaning techniques might speed the breakdown of the foam.
Potential Risks of Exposure
Philips and the FDA decided a recall was the best solution for this problem because there were potentially serious risks related to exposure.
In the recall, Philips lists several potential risks related to fine particulates. People who inhale these particles might experience:
- Swelling, redness, and irritation of the skin, eye, and respiratory tract
- Headache
- Asthma
- Toxic and carcinogenic effects
- Damage to kidneys and liver
Philips considered these effects to be a “worst-case” scenario. However, they’re all based on either complaints about the foam or the result of exposure to the particles in the lab.
In addition, Philips said that the gasses from the foam might lead to:
- Dizziness
- Headaches
- Irritation of the respiratory tract, nose, eyes, and skin
- Vomiting and/or nausea
- Toxic and carcinogenic effects
Again, Philips says these are possible but worst-case scenarios. Some gasses emerge immediately and taper off quickly. Other gasses increase over time.
Signs of Exposure to Watch for
How do people in Aberdeen, NC know if they’ve been exposed to toxic foam or gasses? You can check the recall to see if your CPAP machine is affected. In addition, you should look for:
- Black particles or debris in the:
- Tubing
- Humidifier
- Mask
- Device outlet
- Headaches
- Cough
- Upper airway irritation
- Sinus infection
- Chest pressure
There may also be other symptoms that haven’t been reported yet.
Are These Deaths Linked to Recalled CPAP Machines?
Since the initial CPAP recall in June 2021, more people have started reporting complications linked to the recall. In late May, the FDA decided it was best to inform the public that among the complication reports are at least 124 deaths.
However, it’s important to know that the FDA doesn’t necessarily believe that these deaths were caused by the recalled CPAP machines. The system people used to report the deaths, called the medical device reporting (MDR) system, is not precise. There are low standards for evidence, and there’s no proof that the deaths are linked to the CPAP machines.
For example, sleep apnea increases a person’s risk of death. A person using the CPAP machine might have died of complications linked to sleep apnea, either because their diagnosis came too late or they weren’t using their CPAP machine enough to improve their health. (About half of people prescribed CPAP don’t use it as much as they should to see benefits.)
Is It Time to Reconsider CPAP?
We know that many people in the Aberdeen, NC, area find this recall troubling. CPAP can be a lifesaving therapy, but this recall shows that there are potential dangers. These dangers are above and beyond the standard nuisance and difficulties associated with CPAP treatment: difficulty cleaning, trouble putting it on, discomfort from use, etc. This makes people look for a CPAP alternative.
People in Aberdeen are also looking for a CPAP alternative because the Philips recall has exacerbated a nationwide CPAP shortage. People who sent in their CPAP machines are waiting months to get a replacement, and some people looking to start CPAP treatment have to wait just as long. Since untreated sleep apnea has health risks and diminishes your quality of life, people hope to find a treatment they can get more quickly.
A CPAP Alternative in Aberdeen, NC
If you are among those looking for an alternative to CPAP treatment for your sleep apnea in Aberdeen, Kuhn Dental Associates can help. Aberdeen sleep dentist Dr. Mandy Grimshaw can fit you with an oral appliance that is comfortable, convenient, and effective.
To learn whether you’re a candidate for oral appliance therapy, please call (910) 692-4450 or use our online form to request an appointment at Kuhn Dental Associates on Sandhills Boulevard less than 10 minutes from the Southern Pines Golf Club.
