The U.S. Food and Drug Administration disputes Philips' safety assurances on recalled sleep apnea devices, citing inadequate testing and potential health risks.
Debbie Cenziper, ProPublica, and Michael D. Sallah and Michael Korsh, Pittsburgh Post-Gazette.
In short:
- Philips claimed their recalled sleep apnea devices were safe, but the FDA disagreed, citing insufficient testing.
- The FDA's concerns highlight the potential severe health risks, including cancer, from the devices.
- This dispute reveals a lack of transparency affecting patients and healthcare providers.
Key quote:
“The bottom line is that lives were at risk,”
— Dr. Bob Lowe, former emergency room physician and public health advocate.
Why this matters:
This controversy underscores the critical importance of rigorous safety testing and transparent communication in healthcare. It highlights the potential dangers patients face when using medical devices with insufficiently tested safety claims, especially those with long-term health implications.
The role of environmental health research is to examine areas of the environment that impact our health so that we can make personal and policy changes to keep ourselves safe and improve human health and wellbeing.
