WASHINGTON – A mass recall of millions of sleep apnea machines has stoked anger and frustration among patients, and US officials are weighing unprecedented legal action to speed up a replacement effort that will drag on into the next year.
The sound-deadening foam in pressurized respirators can break down over time, leading users to inhale tiny black particles or dangerous chemicals while sleeping, manufacturer Philips warned in June 2021.
Philips initially estimated that 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 run until 2023.
That has left many patients to choose between using a potentially harmful device or trying risky remedies, such as removing the foam themselves, buying secondhand machines online, or simply forgoing therapy.
The devices are called continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep the ducts open during sleep.
Untreated sleep apnea can cause people to stop breathing hundreds of times a night, leading to dangerous sleepiness and an increased risk of heart attack. The problem is more common in men than women, with estimates ranging from 10% to 30% of affected adults.
Most patients are better off using a recalled device because the risks of untreated sleep apnea still outweigh the potential harm from disintegrating foam, doctors say. But doctors have been hard-pressed to help patients find new machines, which typically 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 make new machines out of thin air,” said Dr. John Saito, a respiratory specialist near Los Angeles.
Risks of foam include headache, asthma, allergic reactions and carcinogenic effects on internal organs, according to the Food and Drug Administration.
Last March, the FDA took the rare step of directing Philips to expand its communication effort, including “clearer information about the health risks of its products.” Regulators then estimated that only half of affected US consumers had signed up with the company.
The agency had not issued such an order in decades.
In a statement, Philips said ongoing tests on the recalled devices are “encouraging” and show low levels of particulates and chemical by-products emitted by its leading brand of machines. Philips said its initial communication about the dangers posed by foam was “a worst case scenario for possible health risks”. The deterioration appears to be worsened by unauthorized cleaning methods, the company said.
The FDA has received more than 70,000 reports of problems attributed to the devices, including pneumonia, infection, headaches and cancer. Such reports are not independently confirmed and cannot prove a causal connection. They can be filed by manufacturers, patients, physicians, or attorneys.
Jeffrey Reed, from Marysville, Ohio, had been using his Philips machine for about a year when he started seeing black spots on the tube and mask. His equipment supplier said the debris was caused by improper cleaning, so he continued to use 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 learning of the recall, he suspected foam particles might be playing a role.
“Once I got off their machine, that all cleared up,” said Reed, 62, who got the device from a competitor after several months. Like other users, Reed cannot definitively prove that his problems were caused by the Philips device.
More than 340 personal injury lawsuits against Philips have been consolidated in federal court in Pennsylvania with thousands more expected in the coming months. Reed is not a party to the litigation.
Like the vast majority of CPAP users in the US, Reed obtained his device through a medical equipment provider contracted by his insurer. The company closed before the recall and he never heard from them about a replacement.
Even under normal circumstances, those companies typically don’t follow patients long-term.
“After a couple of years, you’re just forgotten in the system,” said Ismael Cordero, a biomedical engineer 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 organization that reviews the safety of medical devices.
In May, the FDA notified Philips that it was considering a second order that would require the company to improve and speed up its repair and replacement program.
Medical device companies often carry out recalls voluntarily, and former FDA officials say the agency has never actually used its authority to force additional steps.
“The FDA shares the frustrations expressed by patients waiting for a resolution to this recall,” the agency said in a statement. Philips has not yet provided “all the information we requested to assess the risks of the chemicals released from the foam.”
Philips revealed earlier this year that it received a subpoena from the Department of Justice for the recall. The agency has not publicly commented on the matter, per federal rules.
But an FDA inspection of Philips’ Pennsylvania offices uncovered a number of red flags last fall, including emails that suggested the company had been made aware of the problem six years before the recall. In an email from October 2015, a customer appeared to warn Philips that polyester polyurethane foam could degrade, according to the FDA.
Between 2016 and early 2021, the FDA found 14 cases where Philips was aware of the problem or was looking into it internally. “No further design changes, corrective actions, or field corrections were made,” FDA inspectors repeatedly note.
In an email from May 2018, foam supplier William T. Burnett wrote to Philips in an email: “We would not recommend the use of polyester foam in such an environment. … It will eventually break down into a sticky powder,” according to an affidavit filed as part of a lawsuit over the foam.
Since the recall, Philips has been using a new type of foam made from silicone to refinish machines.
But the FDA alerted consumers last November that the new material had failed a safety test. And regulators have asked the company to conduct further testing to clarify any health risks with both the new foam and the withdrawn material. Philips says that independent tests have not identified any safety issues.
The company says it has replaced or repaired around 69% of recalled devices globally and aims to ship 90% of those ordered by the end of the year. On average, the company produces about 1 million sleep aids a year.
“We have increased by more than a factor of three, but inevitably it still takes time to remedy 5.5 million devices worldwide,” the company said. About half are in the US.
Jeffrey Reed is among those still waiting.
Reed signed up for a replacement device in June 2021, a week after retirement. This month, he received an email from Philips stating that his device has been discontinued and is not available for immediate replacement. Instead, the company offered him $50 to return the machine or the option of providing additional information to get a newer one.
“For them to wait until October to tell me my machine is too old, when they know exactly what device I have since the day I signed up, that’s frustrating,” Reed said. “It is disappointing that a supplier of lifesaving equipment treats people like this.”
Follow Matthew Perrone on Twitter: @AP_FDAwriter
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