Research on silicone breast implants by RIVM completed

The reassessment of the technical files of silicone breast implant manufacturers, which RIVM carried out on behalf of the Health and Youth Care Inspectorate, has been completed. This shows that the technical files of all manufacturers have improved. However, a number of improvements, mainly administrative, are still needed. This does not require any direct intervention by the Inspectorate.

The Inspectorate calls on every manufacturer to further improve the deficiencies found and to contact the relevant notified body accordingly. The Inspectorate shall independently infgoogorm the notified bodies and urge them to take action that leads to further improvement of the technical files. In addition, the Inspectorate shall keep the European member states where the manufacturers and notified bodies are established up-to-date on the research results so they can keep track of the improvement actions.