62-year-old Louisiana sheriff claims the sleep apnea mask he used for four years gave him KIDNEY CANCER – as FDA reveals nearly 600 deaths linked to Philips CPAP machines

A 62-year-old Louisiana man was battling kidney cancer that he said 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 often found small black particles on his pillow left by the machine.

It was only during a recall of the devices in June 2021 that he discovered that those particles were far from harmless.

He said, “You’re afraid you’re going to die in your sleep, and you find out the machine might be doing more damage than the apnea.”

A month before the recall, Mr Stassi underwent emergency surgery after a routine doctor’s visit revealed he had kidney cancer. He had to undergo surgery to remove his right kidney ProPublica.

While the sheriff is now in remission, in the past three years, nearly 600 people who used the now-recalled CPAP machines have died from illnesses related to foam and potentially toxic gases that blow into users’ airways while wearing the device.

Philips has withdrawn millions of defective sleep apnea ventilators from the market amid a growing mountain of cases in which long-term users have been diagnosed with cancer, pneumonia, asthma and other serious health problems.

Sheriff Stassi is among hundreds of people suing Philips whose fans contain foam that emits cancer-causing gases including formaldehyde, benzene and methylene chloride

Now the Food and Drug Administration has reported that since the start of a recall of approximately 15 million devices in 2021, 561 CPAP users have died due to illnesses linked to faulty machinery, while thousands suffer other serious health problems.

The deaths were recorded in 116,000 Medical Device Reports, the FDA’s adverse event reporting database. From July to September 2023 alone, 111 deaths were recorded, out of a total of more than 7,000 medical device reports filed in that short period.

Millions of people suffer from sleep apnea, a condition characterized by pauses in breathing or shallow breathing during sleep, which over time dramatically increases the 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 device market, a large portion of those eight million devices are likely to be affected by the recall .

The problem stems from the type of foam used in the machine’s headgear, which is secured around the head and connected to a snorkel-like device. It is intended to dampen noise and vibration while the machine is operating.

But the foam, made from polyester-based polyurethane, has been shown to break down and disintegrate into small particles, releasing harmful chemical gases such as formaldehyde, benzene, methylene chloride, volatile organic compounds and solvents – all of which have been linked to several types of cancer and breathing problems.

The device is used to treat sleep apnea by continuously sending pressurized air through a person’s airways through a face mask connected to a tube.

The pressure of the airflow is just high enough to prevent the airways from collapsing when the muscles at the back of the throat relax, resulting in continuous sleep without abruptly waking and choking.

Terry Flynn, a St. Louis native and father of four, lost his battle with esophageal cancer in 2021, just two weeks after he was diagnosed, according to reporting from ProPublica.

The 63-year-old had used a recalled Philips appliance for nine years, and while his family will never know whether the faulty appliance was the exact cause of his illness, they blamed the company for not warning about health risks earlier.

Meanwhile, 58-year-old retired music teacher and father-of-three Mark Edwards has suffered for years from recurring respiratory infections and benign tumors, which he believes were caused by the Philips DreamStation ventilator.

He told PBS News: ‘When I first used my new machine I noticed what we saw as black dots, white dots, it went from pure, distilled water to the water you would see as a polluted creek.

‘The walls of my lungs are now shot through. So they will never work again. “I can’t get a lung transplant because no one wants to transplant your lung to an infected area where it’s only going to get bad.”

Also in New York, a man named Lawrence Braverman sued Philips over claims that his machine, which he had been using since 2011, repeated attacks of oral cancer from 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 sure that the Philips machine led to his fatal cancer, but they blame the company for not warning its customers sooner.

Mark Edwards, pictured left, is a retired music teacher and father of three who used the Philips DreamStation fan from 2017 to 2021. He has had several bouts of serious respiratory infections and two benign throat tumors

The foam at the machines’ nozzles has been linked to more than just throat and mouth cancer.

In Johnson County, Kansas, 70-year-old Robert Dix was diagnosed lung cancer at the end of 2019. He had been using the Philips Respironics DreamStation Auto CPAP machine since 2016.

According to his lawsuit against the company, he faces permanent disability and “now requires constant and ongoing medical monitoring and treatment due to the defective nature of the device in question and/or the wrongful conduct of the Defendants.”

These lawsuits, as do about 700 othersare ongoing.

The FDA this week announced a deal with Philips, formally known as a consent decree, under which the company would halt all sales of its sleep apnea masks in the US.

In addition to the CPAP (Continuous Positive Airway Pressure) machine recall, the company is also recalling several similar BiPAP (Bilevel Positive Airway Pressure) machines.

At the same time, it will have to take huge steps to fix the problems with the devices, an undertaking that Philips executives estimate will cost about $393 million.

The company’s efforts to fix the faulty devices starting in 2021 have been a long process and have frustrated users who need the devices to sleep. With recalls expanding beyond what was originally intended to cover five million devices, repair or replacement efforts have not been completed until 2024.

Recent report of ProPublica revealed that Philips knew the foam in its products was defective and potentially dangerous long 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 in Japan of the foam in its fans breaking down and had conducted tests in the US showing that the black dots were releasing gaseous chemicals. Yet the company did not warn the public.

The company only launched a formal investigation into the issue in 2019, nine years after the first wave of complaints and three years after the company’s first known tests revealed the foam’s degradation.

Last September, Philips agreed to pay $479 million to settle a CPAP class action lawsuit against anyone who purchased, leased or rented one of the recalled devices.

Philips faces approximately 750 other lawsuits, meaning damages awarded against the company are likely to be in the tens of millions of dollars.