The EU Commission mandated in 2012 its Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) to produce an opinion paper on “Safety of Metal-on-Metal Joint Replacements”, following health concerns raised in a number of scientific publications in recent years . The opinion, adopted on 24-25 September, is based on the work of the SCENIHR Working group and takes into account results of the public consultation on the preliminary opinion that was open from 13 March to 25 April 2014. The aim of the opinion was to determine the short, medium and long-term local and systemic health effects caused by metal particles, metal ions, and metallic-organic compounds resulting from the implanted medical device.
Another objective of the opinion was to provide indications on limit values for the metals in any form, and advice on the predictive value of metal ions in body fluids, clinical strategies and other aspects needed to ensure the safety of implanted patients.
Finally, the opinion aimed to identify criteria for the safety and safe use of MoM implants used in arthroplasty (joint surgery), paying special attention to design and patient groups. This should inform related medical decisions and identify needs for further research.
The adopted opinion concludes that all types of MoM hip arthroplasties release metals in any forms which, once in the body fluids and tissues, may lead to local and/or systemic adverse health effects. MoM implants with large diameters (large-head) show the highest incidence of local reactions; moreover, the subgroup of large-head MoM in total hip arthroplasty should be avoided on the basis of their high failure risk. Due to the higher health risk when compared with alternative implants, the application of MoM hip arthroplasty should carefully be considered on a case-by case basis.
SCENIHR endorses the strategy as outlined in the European Consensus Statement endorsed by EFORT, the European Hip Society (EHS), the German Arbeitsgemeinschaft Endoprothetik (AE) and the “Deutsche Arthrosehilfe” (DAH). The Consensus recommends systematic follow-up for all patients and all implants, including clinical and radiographic investigation at intervals depending on local protocols. In particular, metal ion determination is recommended for large-head MoM total hip arthroplasty on a routine basis and for hip resurfacing arthroplasty patients at least in the first postoperative years.
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- European Commission Consultation on Metal-on-Metal
- European Commission Fact Sheet on Metal-on-Metal hip replacements (PDF document, 1 page, 284kb) | En français | En español | In Deutsch
- Full EU Commission Final Opinion on Safety of Metal-on-Metal Joint Replacements (PDF document, 64 pages, 1.4Mb)
- Results received from the public consultation on the preliminary opinion and response provided by SCENIHR (PDF document, 28 pages, 270kb)
- Consensus statement “Current Evidence on the Management of Metal-on-Metal Bearings” (PDF document, 7 pages, 253kb)
- European Commission and the Scientific Committee on Emerging Newly Identified Health Risks