Breaking News
More () »

FDA reviewing thousands of reports of foam breaking down in recalled ventilators, CPAP, BiPAP machines

From May 2022 through July 2022, the FDA received more than 48,000 reports, including 44 reports of death, associated with foam breaking down in recalled devices.

JACKSONVILLE, Fla — Troy Bouk is seeing firsthand what he believes are health impacts of recalled CPAP devices.

“We are seeing tumors on the tongue and back of the throat,” Bouk said. “A lot of bladder cancer, liver cancer, kidney cancer.”

Bouk is an attorney working on mass tort and class action lawsuits against Philips Respironics. His law firm represents patients whose breathing machines have been recalled.

“So far, there are about 60,000, plaintiffs across the U.S. involved in this litigation, and the number is rising,” Bouk said.

Philips Respironics announced in June 2021 it was recalling millions of CPAP, BiPAP and ventilator devices. The company cited foam used in the devices to make them quieter that could break down and emit toxic gasses or be ingested or inhaled resulting in potentially life-threatening injuries.

According to an FDA safety alert, the devices contain a foam that can cause serious illness, even cancer.

“I'm absolutely shocked at seeing some of the documents, to see the fact that the foam that they were using in the device, polyester-based polyurethane foam was never intended to be used in a medical device,” Bouk said. “And the reason is fairly obvious. You know that type of foam breaks down over time.”

Click here for a full list of full recalled devices.

RELATED: Sleeping Safely: Millions of CPAP machines recalled, now what?

The FDA now says since April 2021, it has received more than 69,000 medical device reports, including 168 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in the recalled devices.

“I'm also seeing a lot of asthma cases, you know, like, adult-onset asthma which is sort of unique in a sense," Bouk said.

In addition to the personal injury claims, Bouk says there is also pending litigation for economic injuries for those who can no longer use their device as well as pending a class action lawsuit to pay for future medical monitoring.

“Our clients have used these devices, sometimes for, you know, 10, 11,12 years,” Bouk said. “So, they're worried if they haven't already suffered an injury, that they'll suffer an injury in the future. So, the medical monitoring side, that will cover the cost of annual or biannual testing for certain types of cancers.”

It could take years for these cases to work their way through the court system.

“We’re really talking probably close to three more years before there's an actual outcome in this case,” Bouk said. “And that's just sort of a guesstimate.”

Mario Fante, Senior Press Officer with Philips Global Press Office sent the following statement to First Coast News:

Let me please reiterate that we regret the concern and inconvenience that the June 2021 recall notification for specific CPAP, BiPAP and mechanical ventilator devices may have caused for patients and care providers, and we apologize for that. This is one of the largest field actions in the medical technology industry, and we take the remediation very seriously. A dedicated team of more than 1,000 colleagues are working very hard to get a resolution to patients as fast as possible. We have taken a systematic approach to addressing the unknowns and expand production capacity. In an average year, we produce and distribute around one million sleep devices. In the meantime, despite ongoing global supply chain challenges we have scaled up by a factor of 3, but inevitably it still takes time to remediate 5.5 million devices globally.

Philips Respironics has produced more than 3 million replacement devices and repair kits, of which we have shipped around 1.4 million units to the US. Philips Respironics expects to complete around 90% of the production and shipments to customers in 2022. While we are working as fast as we can, we acknowledge that this has been worrying for patients. More information on the recall notification, as well as instructions for customers, users, and physicians can be found at www.philips.com/src-update. Patients with affected devices currently in use are requested to register their products on this website to facilitate the repair and replacement program.

For completeness, at the time the recall notification was issued in June 2021, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. Since then, together with five certified, independent testing laboratories in the US and Europe, as well as other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds (VOCs).

On June 28, 2022, Philips Respironics provided an update on the testing results to date. Philips will continue to provide regular updates as new test results and assessments become available, as not all tests have been completed to date. 

I would also like to point out our recently published summary of a systematic literature review of Positive Airway Pressure device use and cancer risk: Based on 13 epidemiological studies identified from a systematic literature review, no association has been established between use of PAP devices, including Philips Respironics PAP devices, and risk of cancer in patients with OSA (obstructive sleep apnea). Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.

Click here for a full list of full recalled devices.

RELATED: Toxic Trouble: Millions of CPAP, BiPAP and ventilators recalled

RELATED: Yes, Philips has recalled some of its ventilators, CPAP and BiPAP machines

Before You Leave, Check This Out