In 2019 cobalt was added on the list of harmonised classification and labelling of hazardous substances of the European Delegated act 2020/17 as presumably carcinogenic. The entry into force of this piece of legislation was 1st October 2O21.
EFORT decided to launch a 3 phases approach:
- A meta-analysis on adverse events to patients.
- Linkage between implant registries and cancer registries.
- A Delphi-type approach with different European stakeholders using the IPSSI concept.
A dedicated working group on Cobalt was created aiming at analysing scientific literature and proposing expert-based recommendation. Within this working groups, 5 work packages were created on:
- Resurfacing versus large metal head patients.
- Active surveillance and aftercare of MoM.
- Toxicity levels and safety.
- Risk assessment.
- Knee implants.
The process is abased in 5 steps
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