For sleep apnea sufferers like Terri Domingo, using a breathing device isn’t just about getting a good night’s sleep.
“I feel like this machine keeps me alive,” said Domingo, a health care worker in Virginia, who was diagnosed six years ago with the sleep disorder that disrupts her breathing. Ever since, she’s used a Philips DreamStation CPAP to help her breathe at night.
But now, she’s among up to four million people searching for answers and an alternative after Philips voluntarily recalled millions of its breathing devices in June due to serious safety concerns.
The recall affected more than a dozen CPAP, BIPAP and mechanical ventilator machines after testing showed that sound abatement foam inside the devices can degrade into small particles that can be inhaled or swallowed. The company also found the foam could release harmful chemicals into the device’s airway.
Though Philips states it has received a ‘limited number of reports of possible patient impact,” The Food and Drug Administration warns the problems can “result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.” The FDA has labeled the action its most serious type of recall, Class I.
Several Philips customers, like Domingo, told News4 they’re upset for a variety of reasons, including that they weren’t immediately notified of the recall and because Philips does not yet have a replacement for their damaged machines. The company is still waiting on regulatory approval to deploy repair and replacement kits now in production.
Philips told News4 it launched a “comprehensive communication program” to notify patients worldwide, including through call centers and dedicated mailings, and is working with medical device retailers to directly reach out to clients.
But Domingo said she only heard about the recall through a coworker a month after it was announced, and faces a terrible choice.
“My health care provider doesn't know what to say. She hasn't told me: ‘Yes, use it. No, don't use it,’” Domingo said, adding, “This is life-altering.”
Class Action Lawsuits Filed
The issue is now the subject of at least two class action lawsuits on behalf of affected customers.
“To recall a product that people rely on to live … without a replacement device provided, is completely reckless,” said Dena Young, one of the attorneys representing nearly 2,000 Philips customers in lawsuits against the company.
The fillings allege Philips knew about serious risks “long before the recall” and that patients “complained about black particles in their machines for many years.”
Young said that, while the class action suits aim to help recover customers’ economic losses, her firm is also representing clients with personal injury claims related to using the devices.
“We’re seeing significant lung injuries develop after use of this machine,” she said, such as chronic obstructive pulmonary disease, pulmonary fibrosis and lung cancer.
A Philips spokesman said the company does not comment on pending litigation but told News4, “Only in recent years did we see an increase in device complaints” before testing in 2021 revealed the possible risks.
He added the issues with the “PE-PUR foam were unforeseen, but now that we have discovered them, we will correct this thoroughly.”
The company said it plans to replace or repair all of the affected devices at no cost to the consumers. And the spokesman said Philips is already producing roughly 55,000 repair kits and replacement devices a week with hopes to increase production to 80,000 units a week by the fourth quarter of 2021.
The company expects to complete the repair and replacement programs within a year of receiving regulatory approval, he said.
In a statement to News4, an FDA official said the company’s “mitigation plan” is a “high priority for the FDA” and that it will “authorize such a plan as soon as the company provides the agency with sufficient evidence to support the safe and effective mitigation of the product defect.”
The official added the FDA has the option of enforcement action when a company’s “voluntary action is not rapid or complete.”
Dr. Raman Malhotra, the president of the American Academy of Sleep Medicine, said his university’s sleep center treats more than 10,000 patients with sleep apnea who were affected by the Philips recall.
“We’ve never experienced anything like this in my medical career, with this many machines,” Malhotra said.
He advised patients to consult their doctors about whether to continue to use their recalled CPAP, adding that decision will differ by patient and available alternatives.
Malhotra said his patients face myriad obstacles in obtaining a device, ranging from difficulties getting insurance to cover it to supply constraints.
“We are hearing that sometimes the machines may not be available,” he said. “We’ve never had that issue before.”
As for Domingo, she said that, while she’s still angry she wasn’t quickly notified about the risks with her machine, she’s decided to keep using it until she has another option. In the meantime, she’s monitoring the machine for foam degradation.
“I don't want to die in my sleep. I have children, a husband, a life,” she said. “I need this piece of equipment.”
The American Academy of Sleep Medicine says if you’ve been impacted by the sleep machine recall, here's what you should do:
- If your doctor recommends you continue using your CPAP, look for signs of black residue in the humidifier tank;
- Only clean the device following recommendations by the company;
- Ask your doctor about a dental device that can be custom made to keep your airway open;
- Try sleeping on your side or upright with extra pillows.
Philips users affected by the recall can register their device to get up-to-date information on a repair or replacement here.