Philips CPAP Side Effects Facts
Common Side Effects
Face marks or rashes, swallowing pressurized air, dry eyes, initial problems sleeping, nose inflammation or nosebleeds, respiratory infections and mask leaks
Serious Side Effects
Airway inflammation, hypersensitivity reactions, various cancers, organ damage, asthma and respiratory tract irritation

Latest Side Effects Information for Philips CPAP Machines

As of June 14, 2024, the FDA’s MAUDE Database showed that the most frequently reported side effects included headache, dyspnea and asthma.o Over 500 adverse event reports concerning Philips Dreamstation CPAP devices were filed in 2024 alone.

At least 9 people have died and 30 users received a cancer diagnosis after using the devices, according to the FDA.

In June 2023, the U.S. Food and Drug Administration updated a safety communication about certain Philips ventilators, CPAP and BiPAP machines that the company had recalled a year earlier. The FDA referenced the medical device reports they received as proof that the defects that led to the recall could be linked to severe side effects.

MaryAnn DePietro, CRT
“If you choose to use a CPAP, it may take some trial and error to find the right mask and settings to sleep comfortably and remain compliant with treatment.”
MaryAnn DePietro CERTIFIED RESPIRATORY THERAPIST

Ava Cavaco was a user of one of the recalled machines. She told Drugwatch that the device changed her life when she first started using it in 2017. However, she developed respiratory problems ahead of the recall.

“By this point I was still not able to walk up a whole flight of stairs, and I am on an Advair Diskus even now,” Cavaco said. “My doctor has said that all this stuff that I’m experiencing is because of this CPAP machine.”

What Causes Philips CPAP Machine Side Effects?

Philips used polyester-based polyurethane (PE-PUR) foam to make CPAP and other machines quieter and to reduce vibration. However, the foam can break down, causing the users to potentially inhale or swallow chemicals or small pieces of the foam. This can be dangerous and may cause a wide range of side effects.

“It’s kind of all over the board because it’s such a toxic exposure from the breakdown of that insulation that it, you know, from our standpoint, it can cause all sorts of injuries, not just what you would imagine would be what you’re breathing in,” CPAP attorney Trent Michael told Drugwatch.

In June 2021, Philips recalled millions of machines because of the foam problem. The company also notified doctors that tests showed the foam could potentially cause a range of health problems, from mild symptoms to long-term or life-threatening injuries.

What are CPAP machines, and why were many recalled? - Featuring Trent B. Miracle, Esquire
Trent B. Miracle, Esquire | 0:45 What are CPAP machines, and why were many recalled?
Lawyer Trent Miracle explains the side effects linked to recalled Philips CPAP machines and why Philips is being sued.

“Patients using affected Philips CPAP machines may experience short-term side effects like coughing, chest pressure, sinus congestion or even more severe respiratory symptoms,” Mike Breslin, owner of ProMed Durable Medical Equipment in Stuart, Florida, told Drugwatch.

Philips released a warning for the people who used the machines with this foam and were experiencing any of these symptoms, encouraging them to seek medical attention immediately.

Common Side Effects of Philips CPAP Devices

Common Philips CPAP side effects may include dry eye, respiratory infections, skin irritation and nasal inflammation. Many patients cite discomfort from improper air pressure and the mask itself. Recalled Philips CPAP machines may cause more serious side effects, including cancer.

Users of continuous positive airway pressure machines may experience common side effects periodically, even after the initial adjustment period.

Common CPAP Side Effects
Aerophagia
Abdominal discomfort, acid reflux or flatulence due to swallowing pressurized air.
Claustrophobia
Mask wear may trigger fear of being in small or enclosed spaces.
Discomfort
Mask wear may be uncomfortable.
Dry Eye
Typically caused by air passing through nose ducts, air leakage or bacteria trapped by the mask.
Ear Pressure/Pain
Middle ear pressure caused by breathing through CPAP machines.
Facial Hair Growth Issues
Reduced facial hair growth in children because of prolonged usage.
Insomnia
Sleep issues caused by CPAP machine noise or adjustment period.
Nasal Inflammation or Dryness
Nasal discomfort from continuous pressurized airflow.
Respiratory Infections
Often caused by bacteria in the mask or air pathway.
Skin Irritation
Rashes, sores or marks due to a mask’s composition or fit. Skin irritation can become serious and, in susceptible people, skin infection can develop.
Sleep Apnea
If pressure is inadequate due to air leaks, it will not reduce obstruction properly and apnea can still occur.
Tooth Shifting or Chipping
Dental issues resulting from tight chin straps or tongue position.

Consider discussing all side effects with your physician. Pressure adjustments or using a different mask may alleviate your symptoms. You may also ask your doctor about alternatives to CPAP to treat your sleep apnea.

Serious Side Effects of Philips CPAP Machines

Potential long-term side effects from recalled Philips CPAP machines include respiratory problems, asthma and cancer risks.

Several people have filed Philips CPAP lawsuits over their recalled devices, claiming that the company produced a defective product and failed to warn users of the potential risks.

Long-Term Health Issues Associated With Philips CPAP Machines
  • Abdominal cancers
  • Asthma
  • Hematopoietic cancer
  • Liver cancer
  • Lung cancer
  • Mammary gland cancer
  • Melanoma
  • Organ damage
  • Pancreatic cancer
  • Prostate cancer
  • Rectal cancer
  • Respiratory issues

Ingested or inhaled PE-PUR foam particles or chemical gases may lead to carcinogenic, toxic or respiratory side effects. Philips has identified several chemical particles and gasses that users may ingest from inhaling degrading foam.

Ingestible chemical particles and gasses found by Philips include:
Dimethyl Diazine
Associated with intestinal diseases and colorectal neoplasms, according to the National Institutes of Health (NIH).
Phenol 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)
Exposure may cause irritation to the eyes, nose, skin, throat and nervous system. Symptoms include weight loss, weakness, exhaustion, muscle aches, pain, liver and kidney damage, skin burns, tremors, convulsions and twitching, according to the Centers for Disease Control and Prevention (CDC).
Diethylene Glycol
Can cause abdominal pain, diarrhea, dizziness, drowsiness, confusion, nausea, vomiting and unconsciousness. Associated with acidosis, kidney diseases, acute kidney necrosis and liver injury, according to the NIH.
Toluenediamine
Can irritate eyes, skin, nose and throat; can cause dermatitis; ataxia, tachycardia, nausea, vomiting, convulsions, respiratory depression, methemoglobinemia, cyanosis, headache, weakness, exhaustion, dizziness, bluish skin, liver injury and some types of cancers, according to the CDC.

“The potential long-term health risks associated with inhaling or swallowing particles from degraded foam in recalled Philips CPAP machines are concerning,” Breslin said.

“Consulting with health care providers is essential for appropriate guidance and support.”

Other Short-Term Side Effects of Philips CPAP Machines

Due to the effects of recalled Philips CPAP machines, patients may experience short-term symptoms such as difficulty breathing, cough and runny nose. Not all patients will have long-term health issues after inhaling particles from degraded foam.

Short-Term Side Effects of Philips CPAP Machines
  • Allergic and skin reactions
  • Airway inflammation (especially dangerous for people with lung disease or reduced breathing capacity)
  • Chest pressure
  • Cough
  • Dizziness
  • Headache
  • Hypersensitivity reactions
  • Irritation of the respiratory tract, eyes, nose and skin
  • Nausea or vomiting
  • Sinus infections

The severity of side effects may depend on how long you’ve used a recalled machine and your overall health. Consider informing your doctor of any symptoms, no matter how minor or occasional.

If you use a recalled CPAP machine for sleep apnea, you may consult with your doctor about the benefits and risks of using a recalled or repaired device. Sometimes, not using the CPAP machine may be riskier than continuing to use it. You and your doctor can decide if the benefits of continuing use outweigh any risks.

Case Study: CPAP Machine Blamed for Cancer

Background
Robert and Bonnie Setser, from California, claim in court documents that using a Philips CPAP machine containing dangerous foam led to Robert’s cancer.

Philips’ Announcement and Recall
In April 2021, Philips announced that the foam used in their CPAP, Bi-Level PAP and ventilator devices could break down over time, releasing harmful particles and gases. In June 2021, Philips recalled these devices because they contain harmful chemicals such as Toluene Diamine (TDA) and Diethylene Glycol (DEG).

Health Risks and Impact
Robert Setser, who used a Philips DreamStation CPAP every night, was diagnosed with oropharyngeal cancer in September 2021. The Sesters claim Philips was aware of the risks but failed to inform users until the recall.

Legal Action
The Sesters filed a CPAP lawsuit in August 2022 seeking compensation for medical costs, pain and suffering and ongoing health monitoring. Bonnie Setser is also claiming damages for the impact on their marriage.

Tips for Preventing CPAP Machine Side Effects

Tips for preventing CPAP side effects include keeping your machine clean and using it only as directed. If you experience side effects, it’s recommended that you speak with your doctor before you adjust or stop using your machine.

Steps To Prevent Philips CPAP Side Effects
  • Adjust your mask for a tight, comfortable fit. Try a different mask if needed.
  • Clean the tube and mask daily and replace as required using manufacturer-recommended methods.
  • Get used to the machine while awake to avoid claustrophobia. Start with holding the mask to your face, then work up to using it while sleeping. Different-sized masks may help.
  • Gradually increase pressure if the machine has an adjustable feature. Consult with a doctor to adjust pressure settings if it doesn’t.
  • Pressure sores can develop due to the mask. Using a nasal pad may help.
  • Use a chinstrap to prevent dry mouth.
  • Use humification to reduce dryness; always use sterile water to reduce the risk of infection.

The FDA advises against removing foam from recalled Philips CPAP machines, as this may lead to side effects or damage. Hot and humid environments, UV light and ozone cleaners can also degrade PE-PUR foam.

Editor Lindsay Donaldson contributed to this article.

Please seek the advice of a medical professional before making health care decisions.