European Commission investigates the safety of Metal-on-Metal hip implants
The European Commission asked the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) for a scientific opinion to assess the safety of Metal-on-Metal (MoM) joint replacements with a particular focus on hip implants. The final opinion has been adopted on September 24th 2014.
The opinion aims to assess whether there are any health concerns linked to the use of MoM implants in arthroplasty. It also seeks, where possible, to provide indications on design of the devices, on patient groups and to identify needs for further research.
Scope of the evaluation
- Determine the health effects caused by metal particles, metal ions, and metallo-organic compounds resulting from the implanted medical device;
- Provide indications on limit values for the metals;
- To advise on the predictive value of metal ions in body fluids and clinical strategies to ensure the safety of implanted patients;
- To identify criteria for safe use of MoM implants;
- Postmarketing data;
- The effectiveness of surveillance systems.
Conclusions of the evaluation:
The SCENIHR concludes that all types of Metal-on-Metal hip arthroplasties release metals. MoM implants release metals that may lead to local or systemic adverse health effects where large diameters (large-head) show the highest incidence in this respect.
Due to high risk exposure comparing with alternative implants, the use of MoM hip implants should be carefully considered on a case by case basis.
SCENIHR highly recommends systematic follow-up for all MoM implant patients and all implants, including clinical and radiographic investigation at intervals depending on local protocols.
A special accent is put on metal ion determination for large-head MoM hip implants on a routine basis and for hip resurfacing arthroplasty patients at least in the first postoperative years.
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