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FDA Statement on continued efforts to evaluate materials in medical devices to address potential safety questions

Innovation in medical devices, spurred in many cases by advances in materials sciences, continues to improve the lives of patients. The growing number of available materials used in today’s medical devices ‒ such as metal, plastic, silicone, animal-derived products or some combination of these ‒ reflects continued evolution in this field that the U.S. Food and Drug Administration has routinely worked to evaluate as part of our ongoing commitment to foster safety and innovation to ensure that patients have access to safe and effective medical devices.

As part of our role in protecting patients, our staff regularly evaluates and monitors scientific evidence, as well as adverse event reports, to learn more about risks from devices—including those that may be related to the materials used in devices. In the case of medical device implants where materials may come into contact with tissue or other parts of the body for extended periods of time, we evaluate during our premarket review the potential adverse biological response that could result from contact of the device’s component materials with the body.

Today we’re announcing the next steps the agency is taking as part of its ongoing work to better evaluate the safety of specific materials used in medical devices. This includes holding our first public advisory committee meeting to convene experts and the public on this issue and providing new information on scientific evidence pertaining to specific materials—metals and metal alloys—used in medical devices.

As we shared last March, we are evaluating the growing body of evidence that suggests a small number of patients who receive medical device implants may have biological responses to certain types of materials in those devices, such as inflammatory reactions and tissue changes that cause pain and fatigue. Importantly, the majority of patients using medical devices, including medical device implants, do not have adverse reactions and rely on their devices to help manage their health or treat their symptoms. We are continuing our efforts to determine how to better identify patients who might be at increased risk of experiencing a hypersensitivity response before they receive a metal-containing implant, so that they, along with their health care providers can better consider those risks along with the device’s benefits.

To further understand how a patient responds to materials used in medical device implants and improve the safety of devices in patients, the FDA is working to engage the public—in particular, scientists, patients, and health care providers—as well as industry stakeholders to determine the current state of the science, critical gaps in the existing science and what approaches should be considered.

As part of this broader work, today, we are announcing an Immunology Devices Panel meeting of the Medical Devices Advisory Committee to be held Nov. 13-14, 2019, to discuss metal-containing implants and dental amalgams. Specifically, the panel will be looking at the potential for certain patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions and whether current approaches and standards for biocompatibility are adequate. The panel may provide input on additional scientific information that the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams. Additionally, the panel will also evaluate potential gaps in current scientific knowledge to help determine what additional studies may further our understanding as we look to strengthen the steps we’re taking to mitigate risks.

One of the purposes of November’s public meeting is to discuss advances in the scientific community’s understanding of immunology and how related emerging and evolving scientific data may help address certain risks to specific patients. For example, this information may be useful in helping identify patients who are part of a small subset at increased risk of experiencing a hypersensitivity response to a device and ways in which this risk could be mitigated, whether by testing patients before they receive an implant, modifying device design, or other mechanisms. We believe this will help to ensure that patients and healthcare providers can make more informed decisions and fully discuss the benefits and risk of a device before it is used.

Today, we have also posted two scientific reviews authored by FDA staffs background material ahead of the November meeting. The first review summarizes the current scientific knowledge regarding different aspects of metal implants, including how the structure and function of these devices are impacted by the body’s tissues, muscles and blood supply and how the metal components wear over time and interact with the body’s immune cells.

The second review provides an updated assessment of the latest literature and data assessing potential risks reported to be associated with dental amalgam. We are interested in stakeholders’ perspectives on our recent review, as well as any new information that they may have to share, to help inform our understanding of the current benefit-risk profile of dental amalgam. We look forward to discussing and hearing feedback on these materials during the November public meeting.

The FDA continues to believe that the benefits of metal or metal alloys in medical device implants outweigh the risks for most patients. However, we recognize that it is critical to closely monitor and evaluate new data as science is always evolving. We continue to explore ways to modernize the FDA’s review of medical device materials in an effort to support safety and innovation in medical devices that can significantly improve patient health and quality of life while working to minimize the potential for patient risk. As we move forward, we’ll continue to gather input from patients, device manufacturers, researchers and physicians to learn more about their experiences, ideas, and feedback related to materials in medical devices. We’re committed to advancing new initiatives that are rooted in sound science with a focus on ensuring patient safety remains at the forefront.

Posted on the FDA website on 30 September 2019

2019-10-08T21:47:33+00:0008.10.2019|Pharmacovigilance, Regulatory Affairs|