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In an evaluation from last march, the FDA will be holding a panel to discuss the biocompatibility standards of metal implants, and its current practices. The Immunology Device Panel meeting of the Medical Devices Advisory Committee will be held from Nov. 13-14. The goal is to discover and mitigate possible issues that may occur before an implant is received.
According to iData’s industry analysis, Titanium and titanium alloy are the predominant material types for dental implants. They nearly accounted for the whole market share of total implant volume. Titanium and titanium alloys have long been the only available and successfully used material option for dental implant treatments. However, if metal implants and dental implants are determined to have adverse effects that correlate to a hypersensitivity response, then this may cause a negative affect to growth in the market. Ceramic or zirconia dental implants boast some benefits over implants made from titanium or titanium alloys. Ceramic implants offer an alternative solution for patients who demonstrate allergic reactions to metal materials and prefer an implant with improved aesthetics that closely mimics the color of natural teeth. Despite these benefits, ceramic implants represent a niche market, due to a relatively high cost and lack of long-term supportive studies.
According to the FDA, the organization “continues to believe that the benefits of metal or metal alloys in medical device implants outweigh the risks for most patients.” They followed up by explaining they “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.”
The FDA will “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.”
For Further Information
To get in an in-depth market analysis which includes in-depth interviews and procedural volumes, please read iData Research’s’ 4503 page Global Dental Implants Market Analysis, Size, Trends Report.