In a new statement, FDA distinguishes fluoropolymers from other PFAS chemistries, saying that they are critical to medical device technologies and that they “have been safely used for decades.”
“Medical devices are critical components of health care delivery, and a large number rely on the unique properties of PFAS. Some of these devices are necessary to save and sustain lives, including cardiovascular stents, pacemakers, vascular grafts, and guidewires. Currently, no other materials exist that can perform the critical roles of fluoropolymers in these devices. The materials have unique properties that are essential for devices to function.” – U.S. FDA