Guidance

Reporting adverse incidents: breast implants

For manufacturers reporting adverse incidents with breast implants under the European vigilance system.

This publication was withdrawn on

Withdrawn due to the end of the Brexit transition period. Please see https://ec.europa.eu/docsroom/documents/37284

Documents

Adverse incidents with breast implants

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Details

Guidance on how and when to report adverse incidents with breast implants. You need to read this alongside the European Commission’s guidelines on the vigilance system for medical devices.

Published 1 October 2009