On June 14, 2021, the U.S. Food and Drug Administration (FDA) and Philips Respironics issued a recall alert for millions of Philips Respironics CPAP machines. This recall follows years of consumer complaints, internal testing, and a possible link to serious and life-threatening side effects.
The health issues in question relate to the machines’ polyester-based polyurethane (PE-PUR) sound abatement foam. The foam was found to degrade and enter the affected devices’ air pathways. Those using the CPAP device would inhale the foam’s resulting black debris and chemicals.
Though Philips handled consumer complaints on a case-by-case basis in the years prior, they didn’t take major action until 2021, when the FDA’s investigation confirmed potential health repercussions in patients. If you have used one of the listed CPAP machines manufactured between 2009 and April 26, 2021, and have experienced any of the following Philips CPAP side effects, you might be entitled to compensation.
CPAP Devices Recalled
Philips listed the following continuous ventilator machines in the 2021 recall:
- Trilogy 100
- Trilogy 200
- Garbin Plus
- DreamStation ASV
- System One ASV4
Certain BiPAP machines were recalled, including the A-Series BiPAP Hybrid A30, which is not marketed in the United States. Visit Philips’ page for a complete list of devices manufactured before April 26, 2021.
Philips CPAP Side Effects from Recalled Machines
Though most CPAP side effects are mild and experienced in some regard by all CPAP users, the gases, toxins, and debris released by PE-PUR in recalled devices caused severe respiratory side effects. Using non-FDA-approved ozone as a cleaning method can create toxic chemicals. Philips found these chemicals to cause various cancers.
Some of these chemicals the Philips CPAPs can give off are incredibly hazardous. The Environmental Protection Agency (EPA) has labeled toluene diisocyanate as ” extremely toxic, even in short-term exposure” and the Centers for Disease Control and Prevention (CDC) recognizes that ethylene glycol can cause kidney failure and damage. The CDC also identified toluene diamine as a possible carcinogen. Though instances of cancer are rare, other unusual side effects are more common.
Particulate Exposure Symptoms
People who have inhaled debris from PE-PUR may experience the following unusual symptoms.
- Pressure in the chest
- Recurring and difficult sinus infections
- Respiratory tract irritation as well as irritation of the eyes, nose, and skin
- Inflammation of the airway (those with reduced lung capacity or lung disease are particularly at risk)
- Organ damage (most issues have been found in the kidneys and liver)
Some long-term users of the device have developed other severe conditions such as cancer and the effects of exposure to toxins.
Off Gassing Exposure Symptoms
If there is no sign that someone may have inhaled debris, they still could have been exposed to toxic gases. The EPA states that symptoms of off gassing exposure include:
- Throat irritation
- Shortness of breath
- Chest pain
- Reduced ability to fight respiratory infections
None of these side effects are normal and prolonged exposure may cause life-threatening reactions.
The Rsk of Infection Could Entitle You to Damages in Your Defective CPAP Case
A CPAP machine can put you at risk of an upper respiratory or sinus infection without a recall. Airways can also develop mold, yeast, or fungus. This is especially the case when users do not clean their machines regularly or properly.
To reduce your risk of infection, clean your machine weekly using distilled hot water and dish soap. If you are sick, take care to clean it more often. You’ll also want to replace filters and reduce condensation inside the device’s tubes, so water doesn’t sit.
Does a Philips CPAP Machine Cause Cancer?
If CPAPs, by their nature, caused cancer, doctors would not prescribe them. Therefore, for a CPAP machine to be linked to possible cancer development, a user must be exposed to a carcinogen while using it.
According to the Occupational Safety and Health Administration (OSHA), isocyanates (a chemical PE-PUR can create) is carcinogenic. Isocyanates pose a very real risk to humans. The most common form of cancer linked to PE-PUR is lung cancer.
Other cancers that have been linked to PE-PUR exposure in the lawsuit include:
- Non-Hodgkin’s lymphoma
- Papillary carcinoma (thyroid cancer usually caused by exposure to radiation)
- Multiple myeloma (cancer formed in the plasma cells of the body)
- Hematopoietic (blood cancers like leukemia)
Has Anyone Died from a Philips CPAP?
As of yet, no recall-related deaths have been directly caused by using a recalled Philips CPAP machine.
Have I Been Exposed to PE-PUR?
You’ll be able to tell if you’ve been exposed to the degradation of PE-PUR by looking for black particles and debris in your machine’s tubes, mask, humidifier, or outlet.
However, it may be more challenging to tell if you’ve been exposed to off gassing. You should note what you clean your device with and then ask yourself if you’ve been experiencing any of the side effects we listed above.
What Should I Do If I Experience Serious Side Effects?
Speak with your physician if:
- You believe you or a loved one was exposed to degrading PE-PUR or off gassing
- You or a loved one are experiencing a severe and unusual side effect
- You or a loved one are dealing with the long-term effects of using the recalled Philips CPAP machine
A CPAP device is essential for those who suffer from sleep apnea, and stopping CPAP therapy entirely could be dangerous. You should not stop using the machine without speaking to your doctor. If your doctor wants you to keep using the device, consider purchasing an inline bacterial filter.
Register Your Device with Philips So They Can Take Corrective Action
Philips then asks all affected users to register their devices online, whether they’ve experienced side effects or not. Visit the company’s recall website. There, they will keep you updated with information about the recall status and how you can find permanent corrective action.
Once you’ve spoken to your doctor, you can retain your lawyer. Our team offers free case evaluations. Our personal injury team can tell you what you need to do to move forward with your case.
Less Severe Side Effects of CPAP Machines that Could Qualify You for Damages
CPAP machines come with their own set of side effects that users may experience regularly, or as they get used to the device.Mayo Clinic says that a first-time CPAP user can take a few weeks to get used to the machine. These side effects shouldn’t be cause for alarm, as they pose no serious threat to one’s health.
Perhaps the biggest complaints regarding CPAP therapy are air pressure and mask discomfort. Both of these can be resolved by adjusting the machine settings and the fit of the mask. However, you should not make these adjustments on your own. Always speak with your doctor first.
Marks and Rashes
CPAP users who have an ill-fitting mask may see marks, ulcers, or other sores on their skin from where the mask makes contact with the face. Users most commonly see sores on the bridge of the nose. People who have a latex allergy or otherwise sensitive skin may develop a rash.
Dry Mouth and Nose Due to Air Leakage
Another problem caused by an ill-fitting mask is air leakage. An obvious side effect when it happens, air leakage usually occurs if the mask is too big. You can check for air leakage by feeling around the outside of the mask when turned on. If air is escaping, you need to have your mask refitted by your doctor.
When air leaks from the mask, your nose and mouth, and even your eyes, are more prone to dryness. Dryness can cause nosebleeds, damage to gums and teeth, and a parched mouth.
Because some people may have difficulty breathing against the CPAP’s air pressure, they could experience insomnia. This side effect typically improves over time as the user gets used to the device.
Aerophagia, or air swallowing, is when the CPAP pressure forces air into the esophagus. The user is essentially force-fed air. This can result in a full, bloated stomach, passing gas, burping, and general discomfort.
Central Sleep Apnea
It may feel counterintuitive for a machine used to treat sleep apnea to cause a different type of sleep apnea. Those who have central sleep apnea breathe on and off regularly throughout the night. But when the pressure is too high, people may start to experience breath-holding characteristics of central sleep apnea.
Children who use a CPAP machine may experience midface growth problems because of where the mask rests on the bridge of the nose.
This Recall Is No Joke, Chalik & Chalik Injury Lawyers Wants to Help
Those who suffer from sleep apnea or rely on CPAP devices for life-supporting ventilation cannot afford the life-threatening inconvenience of a recall. The Philips Respironics recall lawsuit has shown that many have been suffering in silence.
Give Chalik & Chalik Injury Lawyers a call today at (855) 529-0269. Jason and Debi Chalik are ready to support you, including visiting you in a Florida hospital.