The media, followed by national medical authorities, have raised concerns about problems related to the use of large-head, metal-on-metal, stemmed total hip arthroplasties. At the onset one implant manufacturer with one implant (The ASR hip) was singled out. The reason was the recall action initiated by this manufacturer and the announced multibillion dollar provision in preparation of pending lawsuits. It is now recognized that all stemmed implants with large-head metal-on-metal bearings are in fact concerned. Following, other major manufacturers such as Zimmer and Smith & Nephew have also stopped the commercialization of these types of implants. Due to this state of events the Executive Board of EFORT issued a statement and encourages surgeons to provide follow-up to all patients with a large-head metal-on-metal stemmed total hip arthroplasty.
The European Commission and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have launched a public consultation on the preliminary opinion on “the safety of Metal-on-Metal joint replacements with a particular focus on hip implants”. The aim of this opinion is to assess whether the use of MoM implants in arthroplasty, could give reasons for concern from the health point of view and, if possible, to provide indications on the design and patient groups and also to identify needs for further research.
All interested parties are invited to submit written comments on the preliminary opinion by 25 April 2014 in view of gathering specific comments, suggestions, explanations or contributions on the scientific basis of the opinion, as well as any other scientific information regarding the questions addressed, to enable Scientific Committees to focus on issues which need to be further investigated.
To read and comment on this preliminary opinion please follow the link http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_20_en.htm
More information:
- Consensus statement “Current Evidence on the Management of Metal-on-Metal Bearings” (PDF document, 7 pages, 253kb)
- Preliminary Opinion (PDF document, 66 pages, 1.5Mb)
- Rules of procedures (PDF document, 55 pages, 480kb)
