FDA says more needs to be done to assess materials in devices

The Food and Drug Administration (FDA) has said that more work needs to be done when it comes to further enhancing patient safety regarding materials used in medical devices and implants.

The FDA highlighted that while the majority of patients do not suffer from adverse effects due to medical device implants, there is a “growing body of evidence” that suggests some patients have biological responses to certain types of materials in implants.

The news comes following recent medical device scandals in which patients have suffered from debilitating effects. In particular, devices including breast implants and mesh designed to treat stress urinary incontinence have been linked to certain cancers and autoimmune diseases respectively.

As well as outlining the steps that are taken to ensure medical devices on the market are as safe as possible, the FDA acknowledged that more needs to be done.

In a statement highlighting the next steps, FDA commissioner Scott Gottlieb and director of the Center for Devices and Radiological Health Jeff Shuren said: “Modernising the regulatory framework pertaining to the FDA’s review of medical device materials requires a multi-step approach. We’ll gather input from patients, device manufacturers, researchers and physicians to learn more about their concerns and ideas for how the FDA should proceed. Any new initiatives we implement must be rooted in putting patient safety first and based on sound science.

“More closely evaluating the potential for certain materials to cause immune or inflammatory reactions in a small number of patients may improve our understanding of materials, help uncover ways to identify patients predisposed to these reactions and improve the overall safety and performance of medical devices.”

Some of the examples highlighted in the FDA’s evaluation with government and academia suggests patients have suffered from fatigue, rash, joint and muscle pain or weakness – suggesting they could share common underlying or immune inflammatory pathways and mimic more well-established inflammatory conditions.

The statement continued: “In the small subsets of patients who have reported these symptoms, the symptoms may not develop for several years following implantation. As a result, they may not be detected even in larger and longer clinical studies. To date, these symptoms have not been reported with most materials used in medical devices, including most metals. Moreover, when reported, they have tended to be limited to small subsets of patients.

“As an example, some patients, mostly with a history of pre-existing allergies, may develop allergic skin lesions with certain device use. This risk is usually identified by patch testing for potential device material-related allergens. However, not all device-related reactions are allergic in nature. Therefore, the utility of skin patch testing is limited.

“Enhancing our collective understanding of materials science could lead to identifying materials that may cause an exaggerated response in sensitive individuals and advance the development of safer materials. Development of new tests to identify at-risk patients would help ensure they do not receive implantable devices that contain the material to which they are sensitive, therefore further enhancing patient safety and advance a precision medicine approach to the selection of device interventions.”