The company behind a global recall of sleep apnea devices announced Monday that it would stop selling the devices in the United States, part of a tentative agreement with regulators that could costing the manufacturer nearly $400 million.
Device maker Philips has recalled more than 5 million pressurized breathing devices due to concerns that their internal foam might degrade over time, leading users to inhale tiny particles while they sleep.
The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the United States and other countries.
The Dutch company said it agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The agreement has not yet been finalized and will need to be approved by a US judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.
$393 million reserved
Under the terms of the agreement, Philips would continue to service the recalled machines in the United States, but would not be able to sell new ones until it complied with several corrective measures set by the FDA. Company executives said they have set aside $393 million to meet compliance expenses.
The company promised it would put “safety and quality at the center of everything we do with a greater level of accountability,” Philips CEO Roy Jakobs told analysts and investors.
The FDA website warns patients that risks from ingesting sound deadening foam could include headaches, asthma, allergic reactions, and more serious problems. In November, the agency issued a new warning that the machines could overheat, in rare cases causing fires.
The agency said it could not comment on Philips’ announcement until a final agreement was “signed and filed with the court.”
In 2022, the FDA took the rare step of ordering Philips to increase its customer outreach about the recall, including “clearer information about the health risks of its products.” At the time, the agency estimated that only about half of people in the United States with affected machines knew they had been recalled.
Customers trying to get refunds or new or refurbished devices from the company have reported months of delays.
The devices are called continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep the passages open during sleep.
Untreated sleep apnea can stop people from 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 adults affected.
The latest announcement does not resolve the 675 personal injury lawsuits filed against the company over the devices. These lawsuits were consolidated in federal court in Pennsylvania.
Philips faces similar lawsuits in Canada, Australia, Israel and Chile, according to the company’s update.
Note: The content and images used in this article is rewritten and sourced from www.cbsnews.com