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CPAP Machines and Mechanical Ventilators Recalled Over Issues with Foam

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CASE UPDATE: 

On January 29, 2023, Philips Respironics announced it would halt sales of all its breathing machines in the United States after reaching a settlement with the FDA over continuing problems with the devices. The company’s ventilators and CPAP machines were recalled after reports that they blew bits of foam and potentially toxic gases into consumers’ airways. The company and the FDA cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.

Under the settlement, Philips will have to meet a list of standards in a “multiyear” plan before it can resume business in the United States. The company said it would continue to repair existing devices and provide service for people using them. Further details will be disclosed when the agreement is finalized in court.

This news comes after the September 2023 court order for Phillips to pay a $429 million reimbursement to users of the devices and vendors who might have financed replacements for consumers as part of a class-action lawsuit. Philips initially began the recall of millions of devices in June 2021. More than 100,000 injuries and 385 reports of deaths were possibly related to the foam breakdown. 

BACKGROUND:

A Philips continuous positive airway pressure machine, or CPAP, treats obstructive sleep apnea, which is a condition where intermittent airflow is blocked during sleep and causes a person to stop breathing. Philips DreamStation CPAPs come with a fitted facemask, tubing and a machine that generates air pressure. Philips, the largest maker of CPAP devices in the world, issued a recall for some of its DreamStation CPAP devices in June 2021.

CPAP devices take air from the room, pressurize it and push it through a tube to a mask a person wears on their face, helping them to breathe better as they sleep. The pressure settings can be adjusted by a medical professional, depending on what each user needs, so the machine is personally customizable.

How Does a CPAP Machine Treat Sleep Apnea? 

In order to treat sleep apnea, a CPAP machine constantly pushes air into a person’s nose through a mask or apparatus strapped to the face. The airflow keeps the uvula, soft palate and tongue from obstructing the airway, reducing snoring, and allowing a person to breathe better while they sleep.

The goal of CPAP treatment is to improve sleep quality, reduce or eliminate snoring and have less daytime sleepiness, according to the National Heart, Lung and Blood Institute. Patients have to use the machine every time they sleep, including during naps, in order for it to be effective.

Side Effects 

The usual and expected side effects are relatively mild, such as trouble sleeping the first few nights, dry mouth and runny nose, and they do not significantly impact a user’s quality of life. Additionally, many of these mild side effects go away after a user gets used to the machine. Users who experience stomach bloating or discomfort should stop using the machine and contact a medical professional immediately.

Between April 2021 and August 2022, the FDA has reported receiving more than 69,000 voluntary medical device reports about various side effects connected to the PE-PUR foam in Philips respiratory devices. The PE-PUR foam is used for sound abatement within the devices, and may release particles and gases when it breaks down inside the machine. The foam particles that are released are then inhaled or swallowed by the CPAP users. Adverse events reported include cancers (lung, bladder, stomach, and kidney), infections, respiratory problems, chest pain, headache, difficulty breathing, asthma and pneumonia.

According to a 2022 study evaluating 2,571 patient injuries associated with CPAP between 2014 and 2021, 4.62% of patients reported cancer development after use, the second most commonly documented issue, but since these reports are voluntary, FDA cannot conclusively connect them to the device. Even so, the FDA considers them a valuable source of information that can help determine the device’s risk to benefit ratio.

Philips Recalls CPAP Machines 

On June 30, 2021, the U.S. Food and Drug Administration issued a Safety Communication about Philips’ voluntary recall of some of its BiPAP, CPAP and ventilator devices. Philips is the largest producer of CPAPs in the world and as many as four million machines could be affected.

Shortly after the recall was announced, lawyers began investigating Philips CPAP lawsuits on behalf of patients who used subsequently recalled devices and were diagnosed with cancer or other health issues such as respiratory problems following their use.

In September 2021, Philips began replacing PE-PUR foam in some machines with what they claimed was a safer silicone foam. In November 2021, however, the FDA released a Philips CPAP recall update informing the public that the new silicone foam may also pose a potential health risk. The agency also released an inspection report that revealed that Philips knew as far back as 2015 that PE-PUR foam could degrade but failed to inform the public.

In June 2022, Philips released some results of its PE-PUR testing. The company said emissions of toxic chemicals were below established limits and were not anticipated to cause long-term health consequences. Philips also pointed to methods for cleaning a CPAP machine that involve devices, which are not FDA-approved, that emit ozone gas to sanitize machines.

If you have experienced some of the above symptoms or injuries since using a Phillips CPAP machine, please contact a lawyer who can help to see if you qualify and can file a lawsuit.


Find out if you qualify to join this lawsuit

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PHONE: 878 425 3782


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