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Public Health (13-03-2014)

Public consultation on the Preliminary opinion on the safety of Metal-on-Metal joint replacements with a particular focus on hip implants

Today, the European Commission and its non-food Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), have launched a public consultation on the preliminary opinion on “The safety of Metal-on-Metal (MoM) joint replacements with a particular focus on hip implants”

The consultation will run until 25 April 2014. Interested parties are invited to provide comments on the scientific evidence of this preliminary opinion online: http://ec.europa.eu/health/scientific_committees/open_consultation/index_en.htm

The aim of the opinion is to determine the short, medium and long-term local and systemic health effects caused by metal particles, metal ions, and metallo-organic compounds resulting from the implanted medical device. If possible, it should provide indications on limit values for the metals in any form, and advise 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 should 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.

Some conclusions in the SCENIHR preliminary opinion being put forward for public consultation today are: all types of MoM hip implants release metals which, once they enter body fluids and tissues, may lead to local and/or systemic adverse health effects; MoM implants with large diameters (large-head) have the highest incidence of local reactions; large-head MoM in total hip arthroplasty have a high failure rate and should be avoided; metal ion determination is routinely recommended for patients that have undergone total hip replacement or hip resurfacing using large-head MoM, at least in the first postoperative years.

A general conclusion is that due to the higher health risk when compared with alternative implants, use of MoM hip implants should be carefully considered on a case-by case basis.

For more information on the work of the Commission's independent scientific committees: http://ec.europa.eu/health/scientific_committees/policy/index_en.htm