A massive recall of millions of sleep apnea machines has sparked outrage and frustration among patients, and US officials are balancing unprecedented legal action to speed up replacement efforts that are set to continue next year.
Manufacturer Philips warned in June 2021 that the sound-dampening foam in pressurized breathing machines can degrade over time, causing you to inhale tiny black particles or dangerous chemicals while you sleep.
Philips initially estimated that it could repair or replace the units within a year. But with the summons expanded to more than 5 million devices worldwideThe Dutch company now says the effort will extend into 2023.
This left many patients to choose between using a potentially harmful device or trying risky treatments, including removing the foam themselves, buying used machines online or simply going without treatment.
The devices are called continuous positive airway pressure, or CPAP, machines. They force the air through a mask to keep the passages open during sleep.
Untreated sleep apnea can cause people to stop breathing hundreds of times each night, leading to dangerous drowsiness and an increased risk of heart attacks. The problem is more common in men than in women, with estimates ranging from 10% to 30% of affected adults.
Doctors say most patients are better off with a recalled device because the risks of untreated sleep apnea still outweigh the potential harms of the decomposing foam. But doctors were 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 make new machines all of a sudden,” said Dr. John Saito, a respiratory specialist near Los Angeles.
Foam risks include headaches, asthma, allergic reactions, and carcinogenic effects on internal organs, according to Food and Drug Administration. The recalled devices include the Dreamstation, SystemOne CPAP models, and several other Philips devices, including Trilogy ventilators.
Last March, the Food and Drug Administration (FDA) took the rare step of Philips order to expand communication efforts, including “clearer information about the health risks of their products.” Regulators estimated at the time that only half of affected American consumers had registered with the company.
The agency has not issued such an order in decades.
In a statement, Phillips said ongoing testing on recalled machines is “encouraging” and shows low levels of particulates and chemical by-products emitted from its flagship machine brand. Phillips said her initial communication about the risks posed by the foam was a “worst-case scenario for potential health risks.” The company noted that the deterioration appears to be exacerbated by unauthorized cleaning methods.
The FDA has received more than 70,000 reports of problems attributed to the devices, including pneumonia, infection, headache, and cancer. Such reports have not been independently confirmed and a causal relationship cannot be established. It can be lifted by manufacturers, patients, doctors or lawyers.
Jeffrey Reed, of Marysville, Ohio, had been using his Philips for about a year when he started seeing black spots in the tube and mask. His equipment supplier said the debris resulted from improper cleaning, so he kept using it.
Over the next seven years, Reed says, he experienced persistent sinus infections, including two bouts of pneumonia, which were not resolved with antibiotics. After hearing about the recall, he suspected that foam particles might play a role.
“As soon as I got off theirs, it was all cleared up immediately,” said Reed, 62, who got a competitor’s device several months later. Like other users, Red can’t prove conclusively that his problems were caused by a Philips device.
More than 340 personal injury lawsuits against Philips have been consolidated in federal court in Pennsylvania and thousands more are expected to be announced in the coming months. Reid is not part of the litigation.
Like the vast majority of CPAP users in the United States, Reed obtained his device through a medical equipment supplier contracted by his insurance company. The company went out of business prior to the recall and was never heard from them for a replacement.
Even under normal circumstances, these companies usually don’t track patients long-term.
“After two years, I forgot 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 device.”
Cordero learned that his Philips device had been recalled through his work at ECRI, a non-profit organization that reviews the safety of medical devices.
In May, the FDA put out a notice to Philips that it was considering releasing a file second grade It would force the company to improve and speed up the repair and replacement program.
Medical device companies usually take recalls voluntarily, and former Food and Drug Administration officials say the agency has not actually used its authority to enforce additional steps.
“The FDA shares the frustrations expressed by patients awaiting a resolution to this recall,” the agency said in a statement. Philips has not yet provided “all the information we have requested to assess the risks posed by chemicals released from the foam”.
Phillips revealed earlier this year that it had received a subpoena from the Department of Justice regarding the subpoena. The agency has not commented publicly on the matter, in accordance with federal rules.
But the FDA examination Phillips’ Pennsylvania offices revealed a series of red flags last fall, including emails suggesting the company had been warned of the problem six years before it was pulled. In an October 2015 email, a customer appeared to warn Philips that polyester polyurethane foam could degrade, according to the Food and Drug Administration.
Between 2016 and early 2021, the FDA found 14 cases in which Philips had been informed of the problem or was analyzing the problem internally. FDA inspectors frequently noted that “no other design change, corrective action, or field correction was performed.”
In an email in May 2018, foam supplier William T. Burnett wrote to Philips in an email: “We do not recommend the use of polyester foam in such an environment. … It will eventually degrade into a sticky powder,” according to an affidavit provided as part From a lawsuit over foam.
Since the recall, Philips has been using a new type of silicone-based foam to refurbish the machines.
But the US Food and Drug Administration alerted consumers last November that the new substance had failed a single safety test. Regulators have asked the company to run more tests to show any health risks with both the new foam and the recalled materials. Phillips says Independent testing has not identified any safety issues.
The company says it has replaced or repaired about 69% of recalled devices globally and aims to ship 90% of devices ordered by the end of the year. On average, the company produces about one million sleep devices per year.
“We’ve more than tripled our expansion, but inevitably it still takes time to fix 5.5 million devices globally,” the company said. About half of them are in the United States
Jeffrey Reed is among those still waiting.
Reed is signed up for a replacement device in June 2021 – within a week of redemption. This month, he received an email from Philips stating that his device had been discontinued and was not available for immediate replacement. Instead, the company offered him $50 to return the machine or the option to provide additional information to get a newer machine.
“For them to have to wait until October to tell me my device is too old, when they know exactly which one I’ve had since the day I signed up—that’s frustrating,” Reid said. “It’s disappointing that the provider of life-saving equipment treats people in this way.”
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