Silicone gel filled breast implants - updated information on filler
(Poly Implant Prothese (PIP) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (MDA/2012/011)
CAS deadlines
Action underway: 18 April 2012, action complete: 17 May 2012
Device
Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP).
All implanted devices.
Problem
In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material. The MHRA’s advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078, published in October 2010.
Updated information from AFSSAPS suggests that there is no guarantee that PIP silicone gel breast implants manufactured prior to 2001 contained the approved filler. Therefore, all women implanted with PIP silicone gel breast implants should be supported and managed in line with the Department of Health’s recommendations of January 2012.
Information recently received from the UK supplier of PIP breast implants suggests that up to 7,000 women may have received PIP silicone gel breast implants prior to January 2001. This is in addition to the approximately 40,000 women previously believed to have received affected implants after 1 January 2001.
Action
Implanting surgeons
- Identify additional women who were implanted with PIP silicone gel breast implants prior to 1 January 2001.
- Offer all women with these implants the support and management as set out on the Department of Health’s website .
GPs
- Follow the advice provided by the Department of Health on its website .
Note: the recommendations in this MDA update the advice given in MDA/2010/025 and MDA/2010/078.
Action by
- Medical directors.
- Plastic surgeons and all surgeons involved in breast reconstruction.
- Directors of surgical units involved in breast reconstruction.
- Nurse executive directors.
- Specialist nurses involved in breast cancer care.
Distribution
This MDA has been distributed to:
- NHS trusts in England (chief executives)
- HSC trusts in Northern Ireland (chief executives)
- NHS boards in Scotland (chief executives)
- NHS boards and trusts in Wales (chief executives)
- Primary care trusts in England (chief executives)
Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:
Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Medical directors
- Plastic surgeons and all surgeons involved in breast reconstruction
- Directors of surgical units involved in breast construction
- Nurse executive directors
- Specialist nurses involved in breast cancer care
Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- Practice managers
- Practice nurses
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Clinics
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Feedback
If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/011 or 2010/003/030/081/019
Technical aspects
Ian Smith or Clare Huntington
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7306/7163
E-mail: ian.smith@mhra.gsi.gov.uk or clare.huntington@mhra.gsi.gov.uk
Clinical aspects
Dr Susanne Ludgate
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 6800
E-mail: susanne.ludgate@mhra.gsi.gov.uk
How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website
Northern Ireland
Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
Wales
Enquiries in Wales should be addressed to:
Dr Chris Jones
Medical Director
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
Download documents