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.
UPDATE February 2023: The FDA added 3 new safety summary reports to the list of safety summaries below:
- Colbalt Chromium (CoCr)
- Stainless Steel
The vast majority of patients implanted with medical devices have no adverse reactions. The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.
The FDA is also beginning to see manufacturers incorporate new types of materials in devices. CDRH’s Office of Science and Engineering Laboratories (OSEL) has been conducting a wide array of research studies to learn more about the new advances in device materials.
The FDA believes that an increased understanding of the behavior of materials over time will ultimately result in an overall improvement in the safety and effectiveness of medical devices.
The following safety summaries are now available. The FDA will continue to release reports as they become available.
- Acrylic acid derivatives, which includes di-, tri- and glycerol methacrylates, often used in dental resins
- Cobalt Chromium (CoCr)
- Hyaluronic Acid (HA)
- PEG (polyethylene glycol), used broadly and as a coating for stents and catheters
- PET (polyethylene terephthalate), used broadly
- Poly (2-Hydroxyethyl Methacrylate) (pHEMA)
- Polycaprolactone (PCL)
- Polyether ether ketone (PEEK)
- Polyhydroxy acids, including PLA, PGA, and other blends and copolymers, the most common class of bioresorbable polymers
- Polymethyl methacrylate
- Polypropylene, often used in surgical mesh
- Polytetrafluoroethylene (PTFE)
- Siloxanes, often used in breast implants
- Silver, used as an antimicrobial agent
- Stainless Steel
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