Your recent reporting on silicone sound abatement foam in Philips Respironics CPAP devices is disappointing and irresponsible. It will cause unnecessary and unfounded anxiety among patients who use these and similar devices for life-enhancing treatment of sleep apnea.

Silicone foam is commonly used across the CPAP industry. It has been extensively tested for Philips Respironics by multiple independent, certified laboratories in accordance with the applicable regulatory standards, and no safety issues have been identified.

In your article you raise formaldehyde, a compound omnipresent in daily life that could be a risk only when the exposure levels are above applicable regulatory thresholds. The levels of formaldehyde detected in all tested Philips Respironics devices that contain silicone foam were well below the World Health Organization’s limit, which is more than twice as strict as the threshold set by the Food and Drug Administration.

You omit these important facts, instead stating the foam “posed risks to patients” without any credible or verifiable backup and no such finding by any regulatory authority. The FDA has had the test results from the independent, certified laboratories for more than a year and has not changed its guidance that patients should continue to use their devices.

Our priority at Philips is patient safety and quality. It’s critical that patients and care providers have access to accurate information and know the foam is safe.

Leslie McGibbon

Head of Communications and Brand

Philips

Note to readers

The Post-Gazette and ProPublica stand behind our reporting about Philips Respironics. The FDA, which flagged failed emissions testing on the foam in 2021, said last month that additional safety tests are still needed.

First Published: January 7, 2024, 10:30 a.m.