Orlando, Florida — Carrie Markham spent three years struggling to breathe, suffering from lung problems that began in March of 2020, puzzling her doctors.
“They just kept saying, ‘We just don’t know,'” Markham said. “‘Some type of inflammatory condition. But we don’t know what it is.'”
The 48-year-old registered nurse and mother of three said she’d been using a Philips DreamStation continuous positive airway pressure (CPAP) machine to treat her sleep apnea since 2018.
Then, in June of 2021, she discovered on Facebook that machines like hers had been voluntarily recalled due to sound abatement foam used inside the machines that could degrade.
According to Philips, the recall of millions of CPAP breathing machines was due to “potential risks” that included “toxic and carcinogenic effects,” along with the possibility of developing “asthma” and an “inflammatory response.”
“I was, like, flabbergasted,” Markham told CBS News. “I was like, this explains everything I feel like I’ve been going through.”
She also couldn’t believe she had not received a recall notification from the company.
“I hadn’t seen it anywhere but on Facebook,” Markham said. “And why am I finding this on Facebook?”
Markham is one of many users now suing Philips, saying the company had been told about foam degradation inside some of its CPAP machines and ventilators as far back as 2015, according to the Food and Drug Administration, but did not initiate a recall until 2021.
Nearly two years on, some patients on social media complain they still have not gotten a replacement machine from Philips.
“I think this recall shows us how bad things can go when we don’t get it right,” said Dr. Vinay Rathi, an otolaryngologist at Massachusetts Eye and Ear hospital in Boston who studies medical device regulation.
“You basically bought a device, you find out that, actually, it could harm you,” Rathi said. “And then you struggle to find a replacement device…If I were a patient, I would be livid.”
Philips told CBS News in a statement that, as of January, it has “produced more than 90% of replacement devices that are needed.”
The company said it has so far shipped replacements to about 2.5 million customers, roughly half of those who needed them.
It also said that its latest testing showed “foam degradation is low” and within “applicable safety limits.” It said that “exposure to particulate matter emissions from degraded foam…is unlikely to result in an appreciable harm to health in patients.”
Philips told CBS News it cannot comment on pending litigation, including Markham’s lawsuit.
Markham now uses a different company’s CPAP machine. However, she said that because of her health issues, she is now unable to work at the nursing job she loves.
“I don’t know if I’ll be around for my grandchildren,” an emotional Markham said.
Source : https://www.cbsnews.com/news/sleep-apnea-cpap-machine-recall-philips-dreamstation-replacement/