- Datum objave
- 25. rujna 2014.
- Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)
WG on metal-on-metal hip implants
SCENIHR members: Igor Emri, Peter Hoet
External experts: Charles Patrick Case, Wolfgang Dekant, Wim De Jong, Klaus-Peter Günther, Arne Hensten, Habil. Michael Morlock, Susanna Stea, Catherine Van der straiten, Cees Verheyen, Luigi Zagra
Acknowledgement: Special acknowledgement goes to Prof Dr Michael MORLOCK and Prof Klaus-Peter GÜNTHER for the use of the photographs in this opinion.
Contact:SANCO-C2-SCENIHRec [dot] europa [dot] eu (SANCO-C2-SCENIHR[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 25 September 2014
Content of the opinion:
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. This should inform related medical decisions and identify needs for further research.
The SCENIHR concludes that all types of MoM hip arthroplasties release metals. These, once in a person’s 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. In addition, this type of implant should be avoided in total hip arthroplasty 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.
The SCENIHR endorses the strategy as outlined in the European Consensus Statement which 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.
Total hip arthroplasty, hip resurfacing, metal-on-metal, metal ions, metal debris, health effects, adverse reaction, pseudotumours, ALVAL, ARMD
Opinion to be cited as:
SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), the safety of Metal-on-Metal joint replacements with a particular focus on hip implants, 25 September 2014.