As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.
The agency released a statement Friday from Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health that addresses recent advances in materials science and how these advances have impacted the safety of medical devices.
"Materials used in today's medical devices vary as widely as the devices themselves—whether the material is metal, plastic, silicone, an animal-derived product or some combination of these," Gottlieb and Shuren noted. "Because, in the case of implantable or insertable devices, these materials come into contact with tissue or other parts of the body for sometimes extended periods of time, we do a careful evaluation during our premarket review to determine if there is a potential adverse biological response resulting from contact of the device’s component materials with the body and whether the associated risks are unacceptable."
The vast majority of patients implanted with medical devices have no adverse reactions, according to the statement. "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," they said.
These patients may develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life, Gottlieb and Shuren said.
In 2016, FDA finalized updated guidance for the device industry that addressed biocompatibility evaluations in order to ensure device manufacturers have adequately addressed the potential of their device to cause adverse biological responses in patients. But more work needs to be done, the agency noted.
The statement called for the public, scientists, and industry stakeholders to help FDA determine the current state of the science, critical gaps in the existing science, and what approaches should be considered to further the agency's understanding of medical device materials in order to improve the safety of devices for patients.
Specifically, the agency is looking at materials and implantable devices that have a troublesome track record of creating safety concerns for some patients. This includes silicone breast implants; metal; nitinol-based devices including the highly controversial Essure birth control device; and metal-on-metal hip devices.
FDA said it will also take a closer look at the safety of devices made from animal-derived materials such as additives used for device coatings or heart valves made from pig tissue.
"We know that animal-derived materials may provide benefits over metal or synthetic materials because they can more closely match the biophysical properties of tissues within the human body," Gottlieb and Shuren said in the statement. "But these materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured."