Philips announced on Tuesday that it won’t sell sleep apnea machines in the US after a global recall over concerns that its devices could cause cancer risks and other health problems for hapless sleepers.
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The Dutch health technology giant pulled 5 million of its breathing machines off the market starting in 2021 because foam used to dampen sound inside the devices could break down, forcing tiny black particles and other potentially dangerous chemicals into users’ lungs.
The company initially promised to repair its sleep apnea machines, but the process dragged on for years as the recall expanded to more of its devices. The problem left patients stuck choosing between dangerous machines or untreated sleep problems. On an earnings call Tuesday, Philips announced it reached a tentative deal with the US Food and Drug Administration to halt sales of its Respironics devices altogether in the US. The company said it will continue servicing existing machines and estimated the process may cost upwards of $400 million.
“Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and we acknowledge and apologize for the distress and concern caused,” Philips spokesperson Steve Klink said in an email. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
Sleep apnea is a condition in which breath stops and starts while a person is sleeping, usually due to physical issues with the airway. The most common treatments are BiPAP and CPAP machines, which use air pressure to keep the breath flowing with masks that strap onto your face.
“Based on the results to date, Philips Respironics and the third-party experts concluded that use of the sleep therapy devices is not expected to result in appreciable harm to health in patients,” Klink said. “Further testing related to the sleep therapy and ventilator devices remains ongoing.” He added that “the remediated sleep and respiratory care devices that contain the new silicone foam may continue to be used according to their instructions for use.”
According to Philips, the consent decree lays out a series of guidelines and requirements the company will have to meet before it can bring sleep apnea machines back on the market in the US. In other parts of the world, however, Philips plans to continue its sleep apnea business “subject to certain requirements,” Klink said.
The consent decree still has to be approved by a judge before it goes into effect. The FDA declined to comment until the decree has been signed and submitted to the court.
Update 01/31/2024, 9:41 a.m. ET: This story has been updated with additional comments from Philips.
Update 01/30/2024, 12:13 p.m. ET: This story has been updated with a response from the US Food and Drug Administration.
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