The U.S. Food and Drug Administration (FDA) partnered with ECRI (originally founded as Emergency Care Research Institute), an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation.
As part of the FDA’s ongoing commitment to promote the safety of medical devices, the FDA and ECRI are publishing these safety summaries for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time.
The first four safety summaries are now available. The FDA will release safety summaries as they become available.
- Polypropylene (often used in surgical mesh)
- Siloxanes (often used in breast implants)
Five Key Questions
In compiling this safety information, the team focused on the following five key questions about local and systemic response to materials commonly used in medical devices.
- What is the typical or expected local host response to the material?
- Does the material elicit a persistent or exaggerated response that may lead to systemic signs or symptoms – beyond known direct toxicity problems?
- Are there any patient-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response?
- Are there any material-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response?
- What critical information gaps exist and what research is needed to better understand this issue?
- CDRH/ECRI Project Presentation Video: 2021 Regulatory Education for Industry (REdI) Conference
- Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions
- Biocompatibility Assessment Resource Center
- Safety of Metals and Other Materials Used in Medical Devices