Guidance

Device-specific vigilance guidance: breast implants

Published 15 January 2025

漏 Crown copyright 2025

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This publication is available at /government/publications/breast-implants-reporting-adverse-incidents/device-specific-vigilance-guidance-breast-implants

滨苍迟谤辞诲耻肠迟颈辞苍听听

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.听听

The aim of this guidance is to complement the requirements of . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.听听

What to report聽

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.聽

1. Report as individual incidents (in line with reporting timescales)聽

Clinical / symptomatic (IMDRF ANNEX E codes)聽聽

The IMDRF annex codes associated with each text description are included as guides in the following:聽

  • breast cancer E180101 / E1403聽

  • suspected and confirmed cases of BIA-ALCL E180102聽

  • lymphoma E180104聽

  • double capsule E2341聽

  • siliconoma E2317聽

  • recurrent seroma/fluid collections E0307聽

  • unexpected breast swelling (seroma / fluid collections with no clinical history for trauma or infections) E0307聽

  • unexpected breast inflammatory reaction (breast inflammatory reaction and/or lymphadenopathy with no clinical history for trauma or infections) E0308聽

  • unexpected breast infection (breast Infections with no clinical history for previous systemic infections) E1906聽

  • systemic adverse reaction, hypersensitivity, allergic reaction E0402聽

  • autoimmune disease or syndrome induced by adjuvants (ASIA) E0401聽

Device (IMDRF Annex E codes)聽

The IMDRF annex codes associated with each text description are included as guides in the following:聽

  • silicone migration A010402聽

  • valve failure (during or after implantation) A041001 / A05 / A1501 / A1406聽聽

2. Incidents that may be included in periodic summary reports (PSR) on agreement聽

If you cannot use PSR, then report these events individually.聽

Clinical / symptomatic (IMDRF ANNEX E codes)聽聽

The IMDRF annex codes associated with each text description are included as guides in the following:聽

  • capsular contracture causing breast deformity and/or pain and/or hard breast E2303 / E1402 / E2332 / E2308 - report every 3 months or as agreed聽

Device (IMDRF Annex E codes)聽

The IMDRF annex codes associated with each text description are included as guides in the following:聽

  • implant ruptures (independently by the implantation time) A0412 / A040101/ A0413 / A0414 / A140102 - report every 3 months or as agreed聽

  • post FSCA/FSN incidents provided they have been previously agreed with the MHRA -聽聽 reporting frequency as agreed聽

3. Report at the time of a significant increase in the frequency or severity of incidents聽

Clinical/symptomatic (IMDRF Annex E codes)聽

The IMDRF annex codes associated with each text description are included as guides in the following:聽

  • extrusion of the implant.聽

  • wrinkling of the breast E1723聽

  • loss of nipple sensitivity E1409聽

  • breast swelling/ infection/ inflammatory reaction and/or lymphadenopathy with positive clinical history for previous systemic infections or trauma E2338聽

  • calcium deposits E230901聽

Device (IMDRF Annex E codes)聽

The IMDRF annex codes associated with each text description are included as guides in the following:聽

  • rotation /folding/ displacement of the implant A010402 / A0512聽

  • extrusion of the implant A0411 / A050401

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