European Commission Issues Final Opinion on Metal-on-Metal Hip Implants

Regulatory NewsRegulatory News | 10 October 2014 |  By 

This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.

The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) issued on 9 October 2014 its final opinion regarding the safety of Metal-on-Metal (MoM) joint replacements, and hip implants in particular.

SCENIHR's report concludes that all types of MoM implants release metals that may lead to local and/or systemic adverse health effects, and implants with large diameters (large-head) show the highest incidence of such reactions.  Moreover, large-head MoM implants used in total hip replacement should be avoided due to their high failure risk, SCENIHR said.

The use of all MoM hip implants should be carefully considered on a case-by-case basis, SCENIHR said, noting their higher health risks compared with alternative implants.

SCENIHR also recommends systematic follow-up for all MoM implant 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 replacement on a routine basis and for hip resurfacing patients at least in the first postoperative years.  In that regard, SCENIHR endorses the overall MoM strategy outlined in the European Consensus Statement.




© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy