The company responsible for a worldwide recall of sleep apnea machines announced on Monday that it will discontinue sales of the devices in the United States. This decision comes as part of a proposed agreement with regulators, which could result in a financial loss of nearly $400 million for the manufacturer.

Philips has issued a recall for over 5 million pressurized breathing devices as a precautionary measure. The reason for the recall is due to the potential breakdown of internal foam over time, which could result in users inhaling small particles and fumes while using the device during sleep.

The problem was initially disclosed by the company in mid-2021. However, the process of fixing or replacing the machines has been ongoing for several years, causing frustration among patients in the United States and other nations.

Philips, a major Dutch manufacturer, announced that it has reached a consent decree with the Food and Drug Administration and the Department of Justice. The agreement is still pending finalization and will require approval from a U.S. judge. The company’s executives revealed the tentative deal during a quarterly earnings report.

According to the terms of the agreement, Philips will still provide maintenance for machines that have already been sold in the U.S., but they are not allowed to sell any new machines until they fulfill the corrective actions specified by the FDA. Executives of the company stated that they have allocated $393 million for making necessary operational changes and upgrades to meet the requirements.

The CEO of Philips, Roy Jakobs, assured analysts and investors that the company would prioritize safety and quality and increase accountability in all aspects of their operations.

According to the FDA’s website, consuming the sound-dampening foam may result in various health risks such as headaches, asthma, allergic reactions, and potentially more severe issues. In November, the FDA also issued a warning that the machines have a rare possibility of overheating and causing fires.

The agency stated that it is unable to provide a comment on Philips’ announcement until a final agreement is officially “signed and filed with the court.”

In 2022, the FDA made the uncommon decision to require Philips to increase its communication with customers regarding the recall, including providing “more explicit details about the potential health hazards of their products.” The agency estimated that only 50% of individuals in the U.S. who owned the affected machines were aware of the recall at the time.

Clients who are attempting to receive reimbursements or acquire new or reconditioned gadgets from the corporation have experienced months of extended waiting periods.

The majority of the devices that have been recalled are known as continuous positive airway pressure (CPAP) machines. These machines use a mask to deliver air and maintain open airways during sleep. Additionally, the company has issued recalls for specific models of ventilators and other respiratory devices.

Sleep apnea that is not treated can result in individuals experiencing hundreds of episodes of not breathing during the night, which can lead to hazardous fatigue and a higher likelihood of heart attacks. This condition is more prevalent in men compared to women, with estimated rates ranging from 10% to 30% of adults affected.

Philips reiterated on Monday that studies conducted by the company indicate that inhaling foam from their machines is not likely to cause significant harm to patients. As a result, the company has discontinued several of the recalled models.

The most recent update does not settle 675 complaints of bodily harm that have been filed against the company for their devices. These lawsuits have been combined and will be heard in a federal court in Pennsylvania.

The company’s update states that Philips is dealing with comparable legal disputes in Canada, Australia, Israel, and Chile.

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