Philips Halts Gross sales of Sleep Apnea Machines After Pumping Harmful Foam Into Folks’s Lungs

Philips introduced on Tuesday that it gained’t promote sleep apnea machines within the US after a worldwide recall over issues that its units may trigger most cancers dangers and different well being issues for hapless sleepers.

The Dutch well being expertise big pulled 5 million of its respiration machines off the market beginning in 2021 as a result of foam used to dampen sound contained in the units may break down, forcing tiny black particles and different doubtlessly harmful chemical substances into customers’ lungs.

The corporate initially promised to restore its sleep apnea machines, however the course of dragged on for years because the recall expanded to extra of its units. The issue left sufferers caught selecting between harmful machines or untreated sleep issues. On an earnings name Tuesday, Philips introduced it reached a tentative take care of the US Meals and Drug Administration to halt gross sales of its Respironics units altogether within the US. The corporate mentioned it is going to proceed servicing present machines and estimated the method could price upwards of $400 million.

“Resolving the implications of the Respironics recall for our sufferers and clients is a key focus space and we acknowledge and apologize for the misery and concern brought about,” Philips spokesperson Steve Klink mentioned in an e-mail. “We’re absolutely dedicated to complying with the consent decree, which is a crucial step and supplies a transparent path ahead.”

Sleep apnea is a situation wherein breath stops and begins whereas an individual is sleeping, normally as a consequence of bodily points with the airway. The commonest therapies are BiPAP and CPAP machines, which use air strain to maintain the breath flowing with masks that strap onto your face.

“Based mostly on the outcomes up to now, Philips Respironics and the third-party consultants concluded that use of the sleep remedy units will not be anticipated to end in considerable hurt to well being in sufferers,” Klink mentioned. “Additional testing associated to the sleep remedy and ventilator units stays ongoing.” He added that “the remediated sleep and respiratory care units that include the brand new silicone foam could proceed for use in response to their directions to be used.”

In line with Philips, the consent decree lays out a collection of pointers and necessities the corporate must meet earlier than it might probably carry sleep apnea machines again available on the market within the US. In different components of the world, nonetheless, Philips plans to proceed its sleep apnea enterprise “topic to sure necessities,” Klink mentioned.

The consent decree nonetheless must be accredited by a decide earlier than it goes into impact. The FDA declined to remark till the decree has been signed and submitted to the court docket.

Replace 01/31/2024, 9:41 a.m. ET: This story has been up to date with extra feedback from Philips.

Replace 01/30/2024, 12:13 p.m. ET: This story has been up to date with a response from the US Meals and Drug Administration.