A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and US officials are weighing legal action to speed a replacement effort that is set to drag into next year. Sound-dampening foam in the pressurized breathing machines can break down over time, leading users to potentially inhale tiny black particles or hazardous chemicals while they sleep, manufacturer Philips warned in June 2021. Philips initially estimated it could repair or replace the units within a year. But with the recall expanding to more than 5 million devices worldwide, the Dutch company now says the effort will stretch into 2023, per the AP.
That’s left many patients to choose between using a potentially harmful device or trying risky remedies, including removing the foam themselves, buying second-hand machines online, or simply going without the therapy. Most patients are better off using a recalled device because the risks of untreated sleep apnea still outweigh the potential harms of the disintegrating foam, physicians say. Doctors have been hard pressed to help patients find new machines, which were already in short supply due to supply chain problems. The recalled devices include Dreamstation and SystemOne CPAP models and several other Philips machines, including Trilogy ventilators.
More than 340 personal injury lawsuits against Philips have been consolidated in a Pennsylvania federal court, and thousands more are expected. Last March, the FDA took the rare step of ordering Philips to expand its communication effort, including “clearer information about the health risks of its products.” Regulators estimated then that only half of US consumers affected had registered with the company. The agency hadn’t issued such an order in decades. The FDA has received more than 70,000 reports of problems attributed to the devices, including pneumonia, infection, headache, and cancer. Such reports aren't independently confirmed and can't prove a causal connection. They can be filed by manufacturers, patients, physicians, or attorneys.
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Since the recall, Philips has been using a new type of foam made from silicone to refurbish machines. But FDA alerted consumers last November that the new material had failed one safety test, and regulators asked the company to perform more testing to clarify any health risks with both the new foam and the recalled material. Philips says independent testing has not identified any safety issues. (More sleep apnea stories.)
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