The company responsible for a global recall of sleep apnea machines will be barred from resuming production in the U.S. until it meets a number of safety requirements, under a settlement announced yesterday. Via the Associated Press:
Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said.
The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.
Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep. Left untreated, sleep apnea can lead to dangerous drowsiness and increased risk of heart attack.
Coincidentally, I am getting my replacement C-pap today. For the past five months, my Phillips c-pap has been spewing what I presume are toxic, cancer-causing fumes into my sinuses and lungs. I can’t tell you what it took for me to put that goddamned mask on every night, knowing the possible long-term damage. And every morning, I woke up with a weird, chemical-tasting film on the inside of my mouth and pain in my chest.
Oh, and my sleep doctor told me a few weeks ago I now have asthma. Wonder how that happened?
Via ProPublica, whose investigative work uncovered the story with the Pittsburgh Post-Gazette:
A ProPublica and Pittsburgh Post-Gazette investigation last year found the medical device giant had withheld thousands of complaints about the foam for more than a decade before warning its customers — including medically vulnerable patients such as infants and the elderly — about the dangers.
The news organizations also revealed that a new, silicone-based foam that the company used in the replacement machines was also found to emit dangerous chemicals, including formaldehyde, a known carcinogen.
Patient safety advocates say it will take years to assess the impact of the devices on patient health. At the time of the recall, both Philips and the FDA described potential health risks including respiratory tract illnesses, headaches, nausea, and toxic and carcinogenic effects.
The FDA has said it received 561 reports of deaths reportedly associated with the degrading foam since 2021. The Post-Gazette and ProPublica previously identified reports that described nearly 2,000 cases of cancer, 600 liver and kidney illnesses, and 17,000 respiratory ailments.
Though the company says the foam in the recalled devices does not lead to long-term harm, the material has repeatedly tested positive for genotoxicity, the ability of a chemical to cause cells to mutate, a process that can lead to cancer.
As a result of this massive recall, C-pap machines are on backorder. I began looking for a replacement in January, and just got it.
Here’s information about the class action settlement.
