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EU Scientific Working Group on Metal-on-metal Hip Implants Risk Assessment
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According to European Commission officials, a preliminary evaluation indicates that the number of European patients implanted with metal-on-metal (MoM) hip replacements exceeds 100,000. Metal-on-metal hip replacements offer the potential to decrease wear, but pose additional challenges such as the release of metal ions, including cobalt and chromium. Both metals are known to be toxic under specific circumstances. The European Commission further notes that although the health implications remain unclear, concerns related to hypersensitivity reaction and subsequent osteolysis, T-cell infiltration and pseudotumor have been raised in a number of recent scientific publications. Long-term effects are still not fully assessed especially in terms of carcinogenicity, genotoxicity and reproductive toxicity.
Within this context, the European Commission Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has decided to provide a scientific opinion on the safety of MoM joint replacements with a particular focus on hip implants. A call for experts was launched in the summer 2012 to involve relevant experts in the development of the scientific opinion.
A successful submission was made by two EFORT members, Prof Klaus Peter Günther, and Prof Luigi Zagra, who were appointed to join the working group on MoM hip implants. The main tasks of the group consist of:
- determining the short-, medium- and long-term local and systemic health effects caused by metal particles, metal ions, metallo-organic compounds resulting from the implanted medical device and if possible to provide indications on limit values for the metals in any forms;
- advising on the predictive value of metal ions in body fluids, clinical strategies and other aspects needed to ensure the safety of implanted patients. Criteria that should inform the medical decision with respect to the implanted patient should be identified where possible;
- identifying criteria regarding the safety and safe use of MoM implants used in arthroplasty, paying special attention to design and patient groups; and
- identifying needs for further research (where relevant).
The work of the expert group started in December and the Scientific Committee is expected to release its opinion by 31 March.
The appointment of two EFORT members within the Scientific Expert Group of the European Commission is a positive step in raising the profile of the organization and its members towards EU policy makers.
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- More details available at http://www.efort.org/communications/statements_09.aspx