Agency will investigate the materials used and their impact on patient health.
Increasing reports of negative responses to long-term implants by a certain subset of patients is leading the U.S. Food and Drug Administration (FDA) to investigate the use of various materials in their construction.
Both local and generalized symptoms have been reported in some patients several years after the implants were installed, including fatigue, rash and muscle and joint pain, symptoms often observed in immune reactions. In a statement, FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said “It’s clear more work needs to be done. 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.”
The agency is looking at possibilities such as developing new tests to identify at-risk patients, modernizing the FDA’s review of medical device materials, issuing safety notices and working with companies to recall and correct issues after devices are on the market.
Textured silicone breast implants will receive particular attention because the number of cases of people developing anaplastic large cell lymphoma, a rare type of non-Hodgkin's lymphoma that develops in the scar tissue surrounding a breast implant, has increased recently. Some metal devices, including metal-on-metal hip replacements (none currently have approval), will also be given extra scrutiny. Patients that received these implants often have higher levels of metal ions in their blood, including cobalt and chromium. Discontinued coiled-wire birth control devices comprising multiple metals, including the nickel–titanium alloy nitinol, will also be evaluated in detail.
The FDA will soon be publishing draft guidance on the use of nitinol in other devices, and an advisory panel will investigate hypersensitivity to nitinol and other metals in devices. The agency also plans to publish a white paper discussing the current state of scientific knowledge regarding biocompatibility.