The following examples indicate how to report device performance problems associated with breast implants that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident. 1. Report as individual incidents (in line with reporting timescales) Clinical / symptomatic (IMDRF ANNEX E codes) The IMDRF annex codes associated with each text description are included as guides in the following: breast cancer E180101 / E1403 suspected and confirmed cases of BIA-ALCL E180102 lymphoma E180104 double capsule E2341 siliconoma E2317 recurrent seroma/fluid collections E0307 unexpected breast swelling (seroma / fluid collections with no clinical history for trauma or infections) E0307 unexpected breast inflammatory reaction (breast inflammatory reaction and/or lymphadenopathy with no clinical history for trauma or infections) E0308 unexpected breast infection (breast Infections with no clinical history for previous systemic infections) E1906 systemic adverse reaction, hypersensitivity, allergic reaction E0402 autoimmune disease or syndrome induced by adjuvants (ASIA) E0401 Device (IMDRF Annex E codes) The IMDRF annex codes associated with each text description are included as guides in the following: silicone migration A010402 valve failure (during or after implantation) A041001 / A05 / A1501 / A1406 2. Incidents that may be included in periodic summary reports (PSR) on agreement If you cannot use PSR, then report these events individually. Clinical / symptomatic (IMDRF ANNEX E codes) The IMDRF annex codes associated with each text description are included as guides in the following: capsular contracture causing breast deformity and/or pain and/or hard breast E2303 / E1402 / E2332 / E2308 - report every 3 months or as agreed Device (IMDRF Annex E codes) The IMDRF annex codes associated with each text description are included as guides in the following: implant ruptures (independently by the implantation time) A0412 / A040101/ A0413 / A0414 / A140102 - report every 3 months or as agreed post FSCA/FSN incidents provided they have been previously agreed with the MHRA - reporting frequency as agreed 3. Report at the time of a significant increase in the frequency or severity of incidents Clinical/symptomatic (IMDRF Annex E codes) The IMDRF annex codes associated with each text description are included as guides in the following: extrusion of the implant. wrinkling of the breast E1723 loss of nipple sensitivity E1409 breast swelling/ infection/ inflammatory reaction and/or lymphadenopathy with positive clinical history for previous systemic infections or trauma E2338 calcium deposits E230901 Device (IMDRF Annex E codes) The IMDRF annex codes associated with each text description are included as guides in the following: rotation /folding/ displacement of the implant A010402 / A0512 extrusion of the implant A0411 / A050401

Medicines & Healthcare products
Regulatory Agency

Guidance

Device-specific vigilance guidance: breast implants

Published 15 January 2025

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This publication is available at https://www.gov.uk/government/publications/breast-implants-reporting-adverse-incidents/device-specific-vigilance-guidance-breast-implants

Introduction

This document provides guidance for manufacturers of breast implants. It outlines specific scenarios to consider when determining if an incident is reportable. You should read this document in conjunction with guidance on post-market surveillance.

The aim of this guidance is to complement the requirements of SI 2024 No. 1368. You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.

What to report

The following examples indicate how to report device performance problems associated with breast implants that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident.