Philips will stop selling sleep apnea devices over fears they could cause CANCER

Medical device maker Philips will halt all sales of its sleep apnea devices after a recall of more than five million devices in a potential deal with regulators.

A pending settlement with federal regulators could cost the Dutch manufacturer a lot of money more than 393 million dollars to cover repairs and upgrades.

In 2021, the company’s CPAP machines, used to treat sleep apnea, were found to blow gas and foam into users’ airways while they slept, putting them at increased risk of cancer.

The discovery led the company to recall more than 5 million machines, but efforts to repair and replace the affected machines have dragged on for years.

Now the company says it has agreed to a deal with the Food and Drug Administration and the Justice Department, pending U.S. court approval. It stipulates that the company will continue to service existing machines, but suspend new sales until specific conditions are met.

An estimated 30 million Americans suffer from sleep apnea, a condition characterized by pauses in breathing or gasping for air during sleep. But only about 6 million people have received a diagnosis, while about 5 million Americans have at least tried a CPAP machine.

Sleep apnea is often associated with snoring and sudden gasps for air, but continuous positive airway pressure, or CPAP, machines are an effective means of combating the condition that causes patients to briefly stop breathing several times a night.

The machine delivers a steady stream of mild air pressure through a tube connected to a snorkel-like mask to prevent airway collapse.

In addition to the costly recall, Philips faces more than 600 lawsuits over the devices, all of which have been consolidated in a federal court in Pennsylvania.

Philips CEO Roy Jakobs said: ‘Patient safety and quality remain Philips’ top priority within the company.

“Resolving the impact of the Respironics recall on our patients and customers is a key area of ​​focus and I acknowledge and apologize for the distress and concern caused. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”

It’s a major setback for the sleep device company, which is expected to grow from a valuation of $0.95 $5 billion in 2021 to $7.2 billion in 2030.

For its part, the FDA said, “Until there is a final agreement signed and filed with the court, we cannot comment further.”

In a 2021 recall, Philips withdrew millions of its Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilators for the same reason: foam used to muffle the machine’s noise , can deteriorate and enter the respiratory tract, posing a risk of cancer.

The foam particles can potentially cause irritation and inflammation in the respiratory system, which is especially threatening for individuals with pre-existing lung conditions or poor cardiopulmonary function.

Exposure to degraded foam can also cause inflammatory reactions, headaches, asthma and adverse effects on other organs such as the kidneys and liver. including ‘toxic carcinogenic effects’.

The foam in the recalled CPAP machines was made of polyester-based polyurethane, which was found to break down into smaller particles and toxic gases that would be inhaled by the user.

In addition to potentially causing asthma, respiratory infections and organ damage, this foam has also been linked to lung, bladder, kidney, breast, stomach, liver, thyroid and blood cancers, such as leukemia and non-Hodgkin’s lymphoma .

Philips Respironics has documented numerous complaints related to the discovery of black debris or particles in the part of the machine that supplies air to the sleeping person.

There have also been reports of various symptoms such as headaches, upper respiratory tract irritation, coughing, chest pressure and sinus infections.

Philips is currently facing more than 700 packs about claims that its products were causing users to develop cancer and other health problems. One of those lawsuits comes from Kansas native Robert Dix, who filed suit against Philips in April 2022.

Mr Dix was prescribed and purchased a Philips CPAP machine in March 2016, but later suffered injuries including damage to his respiratory system, cellular damage, DNA damage, and lung cancer.’

Philips said it has conducted tests on its CPAP machines since the 2021 recall and that use of the devices is “not expected to result in appreciable harm to patient health.”

Last fall, Philips reached a $479 million partial settlement in a class-action lawsuit over design flaws that caused cancer-causing foam particles to enter users’ airways.

Sleep apnea becomes more common with age, and more men suffer from it than women.

It occurs in about 3 percent of normal-weight people, but affects more than 20 percent of obese people.

Patients snore, choke and gasp during the night, 20 to 30 times an hour, and as a result wake up unconsciously and repeatedly, meaning the body is not getting enough rest.

To test for sleep apnea, sleep experts will connect a person to equipment that monitors breathing patterns and blood oxygen levels while they sleep, known as a sleep study.

When breathing stops for 10 seconds or more at a time, oxygen levels in the blood drop, increasing the risk of high blood pressure, stroke and heart attacks later in life.