WASHINGTON — A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and U.S. officials are weighing unprecedented 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 originally estimated that it would be able to repair or replace units in less than 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.
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.
These devices are known as continuous negative airway pressure ,, or CPAP. To keep the airways open while you sleep, they force air through a mask.
Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected. Doctors say that the risk of sleep apnea not being treated is still greater than the possible harms from the disintegrating foam. But doctors have been hard pressed to help patients find new machines, which generally cost between $500 and $1,000, and were already in short supply due to supply chain problems.
“What happened is the company just said, ‘Talk to your doctor.’ But doctors can’t manufacture new machines out of the blue,” said Dr. John Saito, a respiratory specialist near Los Angeles. According to the Food and Drug Administration, the foam can cause headaches and allergic reactions, as well as cancer-causing effects on the internal organs.
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 U.S. consumers affected had registered with the company.
This order was the first such issued by the FDA in many decades.
In a statement, Philips said ongoing testing on the recalled devices is “encouraging” and shows low levels of particles and chemical byproducts emitted by its leading brand of machine. Philips said its initial communication about the dangers posed by the foam was “a worst-case scenario for the possible health risks.” The deterioration appears to worsen with unauthorized cleaning methods, the company noted.
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.
Jeffrey Reed of Marysville in Ohio noticed black specks on his mask and tubing after using the Philips machine for approximately a year. The equipment supplier told him that the debris had been caused by poor cleaning so he kept using it.
Over the next seven years, Reed says he experienced persistent sinus infections, including two bouts of pneumonia, that didn’t resolve with antibiotics. After hearing about the recall, he suspected the foam particles might be playing a role.
“Once I got off their machine, all of that cleared right up,” said Reed, 62, who obtained a competitor’s device after several months. Like other users, Reed can’t definitively prove his problems were caused by Philips’ device.
More than 340 personal injury lawsuits against Philips have been consolidated in a Pennsylvania federal court and thousands more are expected in coming months. Reed isn’t part of the litigation.
Like the vast majority of U.S. CPAP users, Reed got his device through a medical equipment supplier contracted by his insurer. The company went out of business before the recall and he never heard from them about a replacement.
Even in normal circumstances, those companies typically don’t track patients long term.
“After a few years you’re just forgotten by the system,” stated Ismael Cortero, a biomedical engineering student and CPAP user. “I stopped hearing from my supplier about three years after I got my machine.”
Cordero learned that his Philips machine had been recalled through his work at ECRI, a nonprofit that reviews medical device safety.
In May, Philips was notified by the FDA that it would be considering another order to force them to speed up their repair-and-replace process.
Medical devices companies usually conduct recalls voluntary. Former FDA officials claim that the FDA has not used its authority in any way to forbid additional actions.
“The FDA understands the frustrations of patients who wait for a resolution to this recall,” it said. Philips still hasn’t provided “all information we requested to evaluate the risks from the chemicals released from the foam.”
Philips disclosed earlier this year that it received a Department of Justice subpoena over the recall. Federal rules require that the agency not comment publicly on this matter.
But, an FDA inspection at Philips’ Pennsylvania office found a number of red flags. These included emails that suggested the company had been warned six years prior to the recall. In an October 2015 email, one customer appeared to warn Philips that the polyester polyurethane foam could degrade, according to FDA.
Between 2016 and early 2021, FDA found 14 instances where Philips was made aware of the issue or was analyzing the problem internally. FDA inspectors repeated the observation that “No additional design changes, corrective actions or field correction were conducted.”
In a May 2018 email, foam supplier William T. Burnett wrote to Philips in an email: “We would not recommend use of polyester foam in such an environment. According to an affidavit in a case over the foam, “It will eventually decompose into a sticky powder.”
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 claims that independent testing hasn’t found any safety problems.
The company says it has replaced or repaired about 69% of recalled devices globally and aims to ship 90% of those requested by year’s end. On average, the company produces about 1 million sleep devices annually.
“We have scaled up by more than a factor of three, but inevitably it still takes time to remediate 5. 5 million devices globally,” the company said. About half are in the U.S.
Jeffrey Reed is among those still waiting.
Reed registered for a replacement device in June 2021 — within a week of the recall. This month, he received an email from Philips indicating that his device has been discontinued and isn’t available for immediate replacement. Instead, the company offered him $50 to return the machine or an option of providing additional information to get a newer one.
“For them to wait until October to tell me that my machine is too old, when they’ve known exactly what device I have since the day I registered — that’s frustrating,” Reed said. “It’s disappointing that a provider of life-saving equipment treats people like this.”
Follow Matthew Perrone on Twitter: @AP_FDAwriter
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