For sleep apnea patients with recalled CPAP machines, restless nights

Shields, like millions of Americans, has sleep apnea, which causes short pauses in breathing, raising the risk of heart disease, stroke, high blood pressure and an irregular heartbeat. Devices called continuous positive airway pressure, or CPAP, machines are the recommended treatment. The small bedside units pump a steady stream of air through a hose and face mask to ensure uninterrupted breathing during sleep.

Today, those machines are at the heart of one of the biggest medical device debacles in decades. In June 2021, the Dutch health-care conglomerate Royal Philips announced that millions of CPAP machines and mechanical ventilators had a hidden flaw: The foam used to reduce the noise of the motor could disintegrate, releasing debris and chemicals into the air hoses.

If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. The Food and Drug Administration classified the recall as the most serious type, saying “use of these devices may cause serious injuries or deaths.”

But as the voluntary recall enters its second year, the pace is excruciatingly slow. Philips says it has repaired or replaced about 1.7 million of 2.8 million affected devices in the United States and about half of 5.5 million machines around the world. The recall, originally scheduled to be completed this fall, will stretch into next year.

That leaves millions of patients in the lurch, many of whom are railing against Philips on social media and flooding the inboxes of FDA officials with complaints. Attorneys are trolling for clients on television and Twitter, with lawsuits against the company proliferating.

“This is dangerous, you stop breathing, that’s why you are using it,” said Christine Hinckley, who lives in Prospect, Conn. “Someone needs to do something. Months go by and you hear nothing. Nothing.”

The FDA, usually tight-lipped about companies, has taken an aggressive stance with Philips, accusing the company of being too slow in notifying consumers about machines that the agency suggests were defective from the outset.

In May, the FDA announced it had received 21,000 reports, including 124 deaths, concerning the breakdown of the polyester-based polyurethane foam in sleep apnea machines and ventilators during the past year — a sharp increase from 30 the previous decade. The agency said the reports, by Philips and others, do not prove that foam deterioration caused injuries. The FDA also said there was evidence some company officials knew about problems as early as 2015 — six years before the FDA was notified.

Now, the agency is threatening to take the unprecedented step of requiring Philips to submit a detailed plan to repair or replace the devices or refund the cost so consumers can buy their own or be reimbursed if they have already done so.

Philips, in a statement to The Washington Post, denied dragging its feet in notifying the FDA and consumers. Spokesman Steve Klink acknowledged that Philips Respironics, the subsidiary that made the machines, handled occasional foam problems on a “case-by-case” basis in years past but said that when Philips’s executive committee became aware of the issue in early 2021, “we took adequate actions leading to the voluntary recall notification.”

Today, patients who have not received replacement machines face difficult decisions. Some continue to use the recalled devices, most of which are DreamStation 1 CPAPs, saying it is the only way to avoid pounding headaches or nodding off during the day. Others have stopped treatment altogether, raising the risk of health problems. Still others have bought new machines, which can cost $1,000 or more, or tried changing sleeping positions or losing weight to deal with their sleep apnea.

“Patients are stuck between a rock and a hard place,” said Vinay Rathi, an otolaryngologist and health policy researcher at Massachusetts Eye and Ear.

Josh Alba, a 32-year-old utility worker and stand-up comedian, was desperate when his doctor told him to stop using the Philips CPAP machine.

“Hello, I can’t breathe when I sleep, can you help me?” he said he told operators at the Philips call center. When the Brooklyn resident received a replacement machine, key parts were missing. He was finally bailed out by a “kind man in Queens” who gave him an old device made by a different company, he said.

To medical device experts, the problems with the Philips recall partly reflect weaknesses in the FDA’s oversight of…