- FDA reported there have been 561 deaths since 2021 linked to Philips machines
- There were 111 reports of deaths linked to machines in just three months last year
- READ MORE: Philips halts sales of sleep apnea machines over cancer fears
A 62-year-old Louisiana man battled kidney cancer he believes was caused by his sleep apnea breathing machine manufactured by health tech giant Philips.
Sheriff Brett Stassi had been using his Philips DreamStation CPAP mask every night for four years to treat his sleep apnea and would often found tiny black particles on his pillow left behind by the machine.
It wasn’t until a recall of the devices in June 2021 that he learned those particles were far from harmless.
He said: ‘You’re worried about dying in your sleep, and you come to find out that the machine might be doing more damage than the apnea.’
One month before the recall, Mr Stassi was rushed into emergency surgery after a routine doctor visit found he had kidney cancer. He had to undergo surgery to remove his right kidney, according to ProPublica.
While the sheriff is now in remission, nearly 600 people who used the now-recalled CPAP machines have died in the last three years of illnesses linked to foam and potentially toxic gases that blow into users’ airways while they wear the device.
Philips has pulled millions of faulty sleep apnea ventilators from the market amid an ever-growing mountain of cases in which long-time users have been diagnosed with cancers, pneumonia, asthma, and other severe health problems.
Sheriff Brett Stassi, 62, used the Philips DreamStation for four years before being rushed into emergency surgery when his doctor discovered he had kidney cancer. It was only after the recall that he learned the black specks from his CPAP could harm his kidneys and liver
Sheriff Stassi is one of hundreds of people suing Philips whose ventilators contained foam that emitted carcinogenic gases including formaldehyde, benzene, methylene chloride
Now, the Food and Drug Administration has reported that since initiating a recall of approximately 15 million devices in 2021, 561 CPAP users have died as a result of illnesses linked to faulty machines while thousands are battling other severe health conditions.
The deaths were recorded in 116,000 medical device reports, the FDA’s database for reporting adverse effects. There were 111 deaths recorded from July to September of 2023 alone, out of a total of more than 7,000 medical device reports filed in that narrow period.
Millions of people suffer from sleep apnea, a condition characterized by pauses in breathing or shallow breaths during sleep which, over time, vastly increases one’s risk of heart attack and stroke.
An estimated eight million Americans rely on a CPAP machine to sleep through the night, and given Philips’ status as a leader in the CPAP devices market, a large share of those eight million devices are likely included in the recall.
The problem stems from the type of foam used in the headgear of the machine that is affixed around the head and connected to a snorkel-like device. It’s meant to dampen sound and vibrations as the machine operates.
But the foam, made with polyester-based polyurethane, has been shown to degrade and break off into tiny particles and release harmful chemical gases such as formaldehyde, benzene, methylene chloride, volatile organic compounds, and solvents – all of which have been linked to different types of cancers and respiratory problems.
The device is used to treat sleep apnea by delivering continuous pressurized air through a person’s airway via a face mask connected to tubing.
The airflow’s pressure is precisely high enough to keep the airway from collapsing when the muscles at the back of the throat relax, resulting in continuous sleep without abrupt waking and choking.
St Louis native and father of four Terry Flynn lost his battle with esophageal cancer in 2021 just two weeks after receiving the diagnosis, according to reporting from ProPublica.
The 63-year-old had used a recalled Philips device for nine years, and while his family will never know if the faulty device was the exact cause of his illness, they faulted the company for failing to warn about health risks sooner.
Meanwhile, 58-year-old retired music teacher and father of three Mark Edwards has experienced years of recurring respiratory infections and benign tumors which he believes were caused by the Philips DreamStation ventilator.
He told PBS News: ‘I noticed when I was first using my new machine what we saw like black specks, white specks, it just went from like pure, distilled water to look and like water you would see in like a polluted creek.
‘The walls on my lungs are shot now. So they’ll never work again. I can’t get a lung transplant because nobody will be wanting to transplant your lung into an infected area where it’s just going to go bad.’
Also in New York, a man named Lawrence Braverman sued Philips over claims that its machine, which he had been using since 2011, had caused repeated bouts of mouth cancer starting in 2015.
Parts of his mouth and tongue had to be biopsied and surgically removed, and he was forced to use a feeding tube.
Terry Flynn of St Louis, Missouri died of esophageal cancer in 2021 just two weeks after being diagnosed. His family will never know for certain that the Philips machine lead to his deadly cancer, but they fault the company with failing to warn customers sooner
Mark Edwards, pictured left, is a retired music teacher and father of three who used the Philips DreamStation ventilator from 2017 to 2021. He has suffered several bouts of severe respiratory infections and two benign throat tumors
The foam near the mouthpieces of the machines has been linked to more than just throat and oral cancers.
In Johnson County, Kansas, 70-year-old Robert Dix was diagnosed with lung cancer in late 2019. He had been using the Philips Respironics DreamStation Auto CPAP device since 2016.
According to his lawsuit against the company, he faces permanent disability and ‘now requires constant and continuous medical monitoring and treatment due to the defective nature of the subject device and/or defendants’ wrongful conduct.’
These lawsuits, like roughly 700 others, are ongoing.
The FDA announced a deal this week that it struck with Philips, what’s formally known as a consent decree, which stipulated that the company would halt all sales of its sleep apnea masks in the US.
In addition to recalling CPAP, or Continuous Positive Airway Pressure, machines, the company is recalling several similar BiPAP, or Bilevel Positive Airway Pressure, machines.
At the same time, it will have to take massive steps to correct problems with the devices, an undertaking that Philips executives estimate will cost roughly $393 million.
The company’s efforts to fix the defective devices starting in 2021 have been a long process and have frustrated users who need the devices to sleep. As the recalls expanded beyond the original for five million devices, the repair-or-replace efforts have bled into 2024.
Recent reporting from ProPublica revealed that Philips knew its products’ foam was faulty and potentially dangerous well before it became public knowledge.
Philips withheld more than 3,700 complaints about the machines, including 370 reports of deaths, from the FDA for 11 years before the recall.
Philips had seen examples of the foam breaking down in its ventilators in Japan and had conducted tests in the US that showed the black specks released gaseous chemicals. Still, the company did not warn the public.
The company did not initiate a formal inquiry into the issue until 2019, which was nine years after the initial wave of complaints and three years after the company’s first known tests revealed the degradation of the foam.
Last September, Philips agreed to pay $479 million to settle a CPAP class-action suit to anyone who purchased, leased, or rented one of the recalled devices.
Philips is facing roughly 750 other lawsuits, meaning punitive damages levied against the company will likely number into the tens of millions of dollars.