FDA to Scrutinize Implantable Medical Device Materials

Posted March 26, 2019

Following reports of “painful” reactions from patients with an implanted medical device, the Food and Drug Administration (FDA) has announced a “broad effort” to examine the effects of different medical device materials, identify gaps in knowledge, and advance the science of developing implantable materials.

While “the vast majority of patients” do not experience an adverse reaction after having a medical device implanted, a growing body of evidence suggests that “a small number of patients may have biological responses to certain types of materials,” such as inflammation and tissue changes, outgoing FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a joint statement. These reactions can cause pain and may interfere with a patient’s quality of life, they wrote.

The FDA released final guidance in 2016 that set the agency’s expectations for evaluating biocompatibility for premarket submissions and additional final guidance earlier this month that focused on reducing the risk of disease transmission from animal-derived materials. While Gottlieb and Shuren described current testing as “a reliable predictor of a material’s safety,” the agency is now looking to advance the science of how implantable medical device materials are evaluated and patient risk is understood.

“Our understanding of medical technologies evolves over time. As we learn more about long-term effects of materials and as materials science advances and new innovations become a reality, it’s imperative our regulation of devices evolves along with these advances to ensure patients are protected,” Gottlieb and Shuren wrote, adding that evidence points to “a small subset” of patients who may be predisposed to develop an immune or inflammatory reaction when exposed to some materials, sometimes years after implantation.

The FDA plans to focus its efforts on:

  • Breast implants
  • Metals used in medical devices (e.g., hip replacements, permanent birth control implants, nitinol-containing devices)
  • Animal materials used in devices (e.g., some device coatings, heart valves)
  • Innovative materials (e.g, graphene, nanoparticles)

The agency’s next steps will be to publish draft guidance recommending premarket testing of nitinol-containing devices, release a white paper that evaluates the potential risk of immune reactions to medical devices containing metals, and gather feedback from medical device manufacturers, researchers, clinicians, and patients.