The US Food and Drug Administration (FDA) has reaffirmed that certain per- and polyfluoroalkyl substances (PFAS) used in medical devices—specifically fluoropolymers—remain safe for patient use, based on decades of application and recent safety reviews. Their recent statement described the uses and reviews of the materials and follows a previous statement from the American Optometric Association (AOA) regarding “forever chemicals,” particularly "the purported presence of organic fluorine in certain contact lenses," which is a marker for PFAS.

PFAS is a broad class of more than 15,000 chemicals with varied industrial uses. While some small-molecule PFAS have been linked to environmental and health concerns, the PFAS used in medical devices are large-molecule fluoropolymers, such as polytetrafluoroethylene (PTFE), and have been in medical applications since the 1950s.

Fluoropolymers are essential for a range of devices, including cardiovascular stents, pacemakers, vascular grafts, and guidewires. Their properties include lubrication for stents and minimally invasive surgical delivery systems, electrical insulation for pacemaker leads, and biostability to enable long-term implantation without degradation that could cause harmful device fragments to break off inside the body. Due to their large molecular size, fluoropolymers are considered highly unlikely to cross cell membranes or cause patient toxicity.

To evaluate ongoing safety, the FDA partnered with ECRI, a US Department of Health and Human Services–designated Patient Safety Organization. ECRI’s 2021 independent review incorporated data from more than 1,800 health care provider organizations nationwide, more than 1,750 peer-reviewed scientific articles, and real-world surveillance from ECRI’s network of clinics and hospitals and found no conclusive evidence of patient health issues linked to PTFE in medical devices.

In its statement, the AOA asserted that soft contact lenses are required to meet rigorous health and safety standards and are reviewed and approved as medical devices by the FDA. 

The FDA continues to monitor fluoropolymer safety through scientific literature, adverse event reports, and collaboration with independent safety bodies. At present, the agency states there is no reason to restrict the use of these materials in medical devices.