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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