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On June 14, Philips Respironics issued a formal recall notification for specific Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and mechanical ventilator devices. The recall was due to “identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component of these devices.”

This guide delves deeper into Philips Respironics to help you understand the reason behind the recall and the potential health risks linked to the defective devices.

WHAT IS SLEEP APNEA?

Sleep apnea is a chronic breathing disorder affecting millions of Americans. It causes patients to stop breathing for at least 10 seconds per apnea event, sometimes hundreds of times a night. The condition results from a partial or complete collapse/obstruction of the upper airway, or a weak signal by the brainstem to initiate breathing.

During apnea events, blood oxygen levels drop and the heart rate increases disrupting the patient’s sleep. That, in turn, affects their sleep quality, daytime focus, and overall health.

TYPES OF SLEEP APNEA

Sleep apnea is classified as one of three main types.

WHAT ARE CPAP AND BIPAP MACHINES
AND VENTILATORS?

Treatment for sleep apnea is typically done using device-aided therapy, including CPAP, Bi-PAP, and mechanical ventilators.

CPAP MACHINE

A CPAP machine is specially designed for people with obstructive sleep apnea. The device increases air pressure in the airway, preventing it from relaxing and causing an obstruction when you breathe.

HOW DOES A CPAP WORK?

A CPAP machine provides continuous pressurized air via a mask that covers your nose and/or mouth. The device pushes air at pressures high enough to keep your airway open. A physician will determine the appropriate air pressure based on your specific needs. Factors that may determine your pressure include weight, anatomy, and the results of your sleep study.

BIPAP MACHINES

BiPAP machines have similar supplies and attachments as CPAP machines. However, these machines are designed to treat complex sleep apnea, central sleep apnea, or chronic obstructive pulmonary disorder (COPD).

HOW DOES IT WORK?

BiPAP machines pump pressurized air into your airways at two distinct pressure levels. That way, you can breathe in at high pressure and breathe out at a lower pressure.

The device helps:

  • People struggling to acclimate to CPAP machines
  • Improve air swallowing
  • With claustrophobia
  • Improve comfort when pressures are 15 cmH2O or higher

VENTILATOR

A ventilator helps to mechanically assist or control the patient’s breathing by delivering predetermined amounts of oxygen in the breathing gas.

In apnea treatment, continuous ventilators are set to fluctuate between a predetermined minimum and maximum pressure to deliver the perfect pressure for each breath. The devices track and adjust their pressure to match the patient’s breathing pattern

RISK OF CANCER FROM PHILIPS
BREATHING MACHINES

Philips used polyester-based polyurethane sound abatement foam to dampen the sounds and vibrations in the recalled devices.

The said polyester-based polyurethane (PE-PUR) foam may:

  • Degrade into particles that may then be swallowed or inhaled by the user. Breakdown of the foam is exacerbated by high humidity, warm environments, or the use of ozone and other unapproved cleaning methods.
  • Release volatile chemicals into the air which are then inhaled by the user.

According to Philips’ lab results, degraded polyurethane foam produced potentially harmful chemicals such as:

If you use Philips devices whose foam has degraded, you’re likely to inhale these potentially harmful chemicals. These chemicals may then enter your body, reach the bloodstream, and travel to any body tissue and organ.

Unfortunately, most of the harmful chemicals from the degraded foam are carcinogenic and can cause cancer in living tissues.

CDC warns that Toluene Diisocyanate is present in the foam and is a potential toxin and carcinogen. The United States Environmental Protection Agency (USEPA) cautions that exposure to isocyanates (present in the foam) has many potentially harmful effects. Isocyanates also contain compounds classified as known animal carcinogens and potential human carcinogens. Moreover, the International Agency for Research on Cancer states that the methylene diphenyl diisocyanate, present in polyurethane foam, is a probable carcinogen associated with bladder cancer.

Thus, once these harmful chemicals travel to your organ and body tissues, they can cause mutations and DNA damage that may eventually lead to cancer.

TYPES OF CANCER THAT POLYURETHANE FOAM CAN CAUSE

As noted above, polyurethane foam present in the recalled Philips devices contains compounds that are known or potential carcinogens.

Here’s an outline of some scientific evidence linking the exposure to polyurethane foam to different types of cancer.

OTHER HEALTH/BREATHING SYMPTOMS

Chest pressure

Cough

Headache

Sinus Infection

Upper airway irritation

These issues may be linked to degraded polyurethane foam.

Besides cancer, there are other potential risks linked to exposure to PE-PUR chemicals, such as:

Asthma

Headache

Dizziness

Skin, nose, eye, and respiratory tract hypersensitivity

Eye irritation

Nausea/vomiting

WHO IS PHILIPS RESPIRONICS?

Philips Respironics is a leading manufacturer and distributor of CPAP, BiPAP, and other machines to help treat people suffering from sleep apnea. The company is committed to delivering solutions that result in healthier practices, patients, and businesses.

To date, Philips has produced millions of CPAP, BiPAP, and ventilation devices using PE-PUR sound abatement foam. According to Frans van Houten, Philips’ CEO: 3-4 million devices have been targeted in the recall. 80% of these machines treat sleep apnea, and nearly two-thirds of the machines have been recalled in the U.S.

PHILIPS CPAP PRODUCT RECALL

On June 14, 2021, Philips Respironics voluntarily recalled BiPAP machines, CPAP machines, and ventilation devices distributed between 2009 and April 2021.

This recall was due to the possibility of PE-PUR foam used in the devices:

  • Degrading into particles that may be swallowed or inhaled by users
  • Off-gassing potentially harmful chemicals

Philips reported the foam degradation to be caused by:

  • High environmental heat
  • High environmental humidity
  • Using ozone and other unapproved cleaning products
  • Off-gassing can result from device usage.

According to Philips, the highlighted issues can be fatal. They can also cause permanent impairment or require immediate medical attention to prevent the same.

If exposed to degraded foam:

You may experience an inflammatory response, irritation (skin, eye, and/or respiratory tract), asthma, headaches, and adverse effects on body organs.

Philips noted that to date, they have received sizable complaints concerning the presence of black particles/debris within the device’s air path—extending to the device mask, tubing, humidifier, and outlet. They have also received complaints about some of the highlighted health risks above.

If exposed to chemical emissions:

You may experience nausea, headaches, skin irritation, hypersensitivity, carcinogenic exposure, and toxic effects.

According to Philips, they have yet to receive reports of serious harm or health impact due to the issue.

From the recall notification, the company is continuing with the analysis of potential health risks and keeps updating the public with new information. In the meantime, Philips is providing patients and clinicians with information and resources on the potential risks of using affected devices. They are also issuing instructions on the next steps.

The company is also committed to replacing the current PE-PUR foam with new material that’s safe from harmful degradation and off-gassing.

FDA RESPONSE

On July 29, 2021, the FDA posted answers to FAQs about the Philips recall. The organization then labeled the device recall as a Class I recall, the most serious scenario.

The FDA is ensuring Philips Respironics evaluates:

  • The defects in the recalled devices
  • The scope of the device recall
  • Appropriate mitigation measures
  • Corrective actions

The organization is also analyzing MDRs (medical device reports) for the affected devices distributed between 2009 and 2021 to identify any documentation related to the issue. While the FDA does not have evidence that any other devices from Philips and other manufacturers are affected, it’s monitoring the supply and demand of these devices to assess potential shortages.

The organization is also committed to continually share any new information with the public.

RECALLED DEVICES

Products listed in the Philips recall notification include:
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent
  • A-Series BiPAP Hybrid A30 (Not available in the U.S.)
  • A-Series BiPAP V30 Auto
  • A-Series BiPAP A40 (Not available in the U.S.)
  • A-Series BiPAP A30 (Not available in the U.S.)

WHO IS PHILIPS RESPIRONICS?

Philips Respironics advises users as follows:

THE FDA RECOMMENDS THE FOLLOWING:

Talk to your doctor to weigh the risks of continued use and decide on a suitable way to move forward. This may include:

  • Discontinuing device usage
  • Using a similar but safer (unaffected) device
  • Continuing device usage if the doctor determines that the benefits of continued therapy outweigh potential risks
  • Using alternative sleep apnea treatments, such as oral appliances or positional therapy
  • Initiating long-term sleep apnea therapies, such as stopping smoking, avoiding alcohol, and losing weight. Surgical operations may be recommended in cases of severe sleep apnea.

In the case of at-home care:

  • Do not alter or change the prescribed therapy before discussing it with your healthcare provider.
  • Discuss with your doctor about using an inline bacteria filter to reduce exposure to degraded polyurethane foam particles. At this time, the FDA does not have concrete evidence of the effectiveness and safety of a bacteria filter for reducing exposure to form particles. They are continuing to investigate.
  • Overall, bear the following in mind:
    • Bacteria filters may not reduce exposure to volatile organic compounds and other chemicals in the PE-PUR foam.
    • Bacteria filters may affect the device’s performance as they may increase airflow resistance through the machine.

Therefore, closely monitor any foam particles/debris on the filter. You should also monitor any airflow resistance through the device after placing the filter.

If you suspect you are having a problem with a BiPAP, CPAP, or mechanical ventilator, report the issue via the FDA’s MedWatch Voluntary Reporting Form.

In the case of health care providers and facilities:

  • Evaluate whether the benefits of continued use of the defective device outweigh the identified potential risk and advise the patient accordingly.
  • Service affected devices and determine whether there’s evidence of foam degradation like black debris or particles.

If foam degradation is evident, discontinue the use of the device, if possible, then report the issue via the FDA’s MedWatch Voluntary Reporting Form.

HOW TO REGISTER YOUR DEVICE FOR RECALL AND WHAT TO EXPECT NEXT?

To register your sleep apnea therapy device and determine if it is part of the recall:

Locate your device serial number. This number is usually located on the label at the bottom of the device. It’s a series of numbers and letters after SN or S/N. If you cannot locate your device serial number, here’s a handy guide.

Next, head to Philips Respironics recalls website page.

Fill out the registration form. Provide your contact information (name, phone number, and address) to make it easier for Philips Respironics to contact you concerning the recall. Use your current information even if it differs from the personal information you provided during purchase.

Watch for confirmation. Once you’ve completed the registration, you’ll be notified whether or not your device is included in the recall. If it’s not, you’ll see a message stating the device is not included in the recall. If your device is included, you’ll receive a registration confirmation number and important recall updates from the company.

Save the received registration confirmation number and note down the next steps in the process as directed by Philips Respironics.

If you cannot access the internet or visit the Philips recall website for any reason, call 877-907-7508 instead.

REPLACEMENT AND REPAIR PROGRAM

Philips Respironics is offering needed information concerning the recall to relevant regulatory agencies. Philips will replace the current foam with new, safer material and the company has already started the work by obtaining regulatory clearance.

Philips will strive to address all defective devices in the scope of the recall and correction expeditiously.

In the meantime, the company is striving to ensure the supply of sleep apnea devices meets the demand by increasing the production of their DreamStation 2 CPAP machines. This category is not affected by the recall.

DO I QUALIFY FOR A CLAIM? GET A FREE CASE EVALUATION.

Many factors come into play when determining whether you may be eligible for compensation in the Philips device recall lawsuit.

Such factors include:

  • Whether you’ve been using one of the defective devices
  • Your diagnosis and past and current treatments
  • The reason for using the faulty machine over other available options
  • Continued use of the recalled devices for lack of suitable alternatives

If you think you have a potential claim, discuss it with our licensed attorneys during a free consultation to determine eligibility. Note, the deadlines for filing claims still apply, so it’s best to contact us right away.

PHILIPS CPAP PRODUCT RECALL

Defective product cases are often different and unique based on the available facts. Overall, faulty equipment/machine claims usually include compensation for:

Past or future treatment costs relating to patient’s diagnosis and potential health risks caused by the recalled products

Physical and mental pain and suffering linked to said health issues

Lost earning capacity due to health issues emanating from the use of the devices

DO I NEED A LAWYER?

Yes. Philips is a large organization with extensive resources. They can hire multiple lawyers to defend them from defective device claims. That makes having a skilled and knowledgeable attorney a necessity.

A defective products lawyer is also better poised to evaluate the facts surrounding your case and determine whether you’re eligible. If you’re eligible, they can help you gather all the necessary evidence, such as proof of BiPAP or CPAP use, medical documentation, and other evidence linking your health condition to the defective devices. Furthermore, lawyers have mastered their negotiation skills throughout the years, making them better positioned to get you a better deal/compensation.

CALL NST LAW TO DISCUSS ANY POTENTIAL
PHILIPS RESPIRONICS CPAP CLAIM

If you or anyone you know is suffering serious health conditions like cancer, and you suspect the culprit to be the recalled Philips devices, you (or the affected person) may be eligible for compensation. Let a team of NST Law defective product attorneys review your claim to help determine the legal options that may be available to you.