Concerning Chemicals Found in Replacement Philips CPAP Silicone Abatement Foam

Philips Respironics is once more under fire for the handling of its respiratory device recall, this time specifically due to the silicone foam used as a replacement to previous polyester-based polyurethane foam in recalled devices.

As the company trudges through its remediation process, ProPublica and the Pittsburgh Post-Gazette published how it appears Philips received AE reports about deteriorating abatement foam back in 2010. The company, however, didn’t inform FDA of any such documents, and thousands of additional reports it received, for more than a decade. Additionally, the ProPublica and Post-Gazette exposé reported that FDA missed potential opportunities to mitigate harm to patients using Philips recalls breathing machines. For example, the article suggested that FDA knew Philips Respironics had a history of withholding adverse event reports from the agency but allowed the company to submit late reports without appropriate enforcement for such violations.

Continued reporting also alleges that CEO Roy Jakob’s knew of the ongoing issues and allowed for sale of defective product.

The latest report from the news outlets found tests by independent laboratories showing the silicone foam used to replace the original that was deteriorating also emitted formaldehyde and other dangerous chemicals.

While the silicone foam first raised concerns for FDA two years ago, the agency decided that while additional tests into the safety of the foam were ongoing, patients were fine to continuing using devices where the foam was present, namely the DreamStation 2 CPAP machine, which was sent to a percentage of users as a replacement for recalled devices. FDA, however, has not provided any updated information pertaining to the outcome of those safety tests.

In response to questions about the silicone foam, Philips reported that the material was tested against safety limits recognized by FDA and the World Health Organization (WHO), and did not emit chemicals at unsafe levels, according to the ProPublica and Post-Gazette article. The company also noted that formaldehyde only became a risk at high exposure.

“The repaired and new replacement devices with the silicone sound abatement foam are safe,” and findings that said otherwise are ‘inaccurate,’” the company said in a statement.

Independent experts who reviewed the tests for the exposé, however, said that the findings were “troubling” and shows levels of formaldehyde that exceeded safety thresholds established by multiple organizations, including the Environmental Protection Agency (EPA). “Thresholds vary, they said, and those cited by Philips allow for far higher formaldehyde levels than others,” the report said.

The report continued, “ProPublica and the Post-Gazette obtained communications sent by a scientist at Philips who was alarmed about test results showing formaldehyde over the ‘threshold for safe exposure.’ ‘FDA has the data. Are they just waiting for the final report from Philips? How is this sustainable?’”

Apart from issues with the potential safety of the silicone foam, additional warnings have been released about the CPAP device some patients received as a replacement for the initial recall, the DreamStation 2. The notice warned of potential device overheating which could lead to burns, smoke, and fire.

This new twist to the winding regulatory tale of Philips Respironics comes only weeks after two prominent United States Senators published an open letter to the Government Accountability Office calling for a probe into how FDA tracks warnings about dangerous and recalled devices as well as how it takes action against companies that put its customers at risk. The open letter, according to its authors — Senators Dick Durbin, D-Ill, and Richard Blumenthal, D-Conn — was spurred by Philips recall of its CPAP and BiPAP machines, and more specifically, the revelatory reporting by ProPublica and the Post-Gazette.

Read ProPublica and the Pittsburgh Post-Gazette’s continued investigative coverage on the ProPublica’s website.