Medical Device Alert: All types, makes and models of breast implants (MDA/2011/017)

Technical aspects
Bayode Adisa or Ian Smith
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7223 / 7306
Fax: 020 8754 3965

Email: bayode.adisa@mhra.gsi.gov.uk or ian.smith@mhra.gsi.gov.uk 

Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 6800
Fax: 020 8754 3965

Email: 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 Central Alerting System website (external link).

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

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

There is uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast.

The MHRA has not received any adverse incident reports identifying ALCL in association with breast implants in the UK. Discussions with the relevant UK professional bodies have not identified any cases.

The FDA recently published a Safety Communication entitled ‘FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants’ (external link).

In a thorough review of scientific literature published from January 1997 to May 2010, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. The FDA’s adverse event reporting systems also contains 17 reports of ALCL in women with breast implants. This is a very small fraction of the 5-10 million women who have received breast implants worldwide.

Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin’s lymphoma (NHL), a cancer involving the cells of the immune system. It is a very rare tumour in the breast, accounting for less than 1% of all breast malignancies.

To date there have been no corresponding reports of this disease association to the MHRA. The MHRA encourages all surgeons to report all adverse incidents, including cases of ALCL, to the adverse incident centre (aic@mhra.gsi.gov.uk).

The MHRA will review any evidence that comes to light and take appropriate action as needed.

There is no indication for any routine action in the form of explantation or regular radiological examination including MRI. Women should be advised to self examine and consult their medical practitioner if they notice any changes in the breast or have any concerns.

• No change to current best practice is needed.
• If you are contacted by concerned women about this issue, reassure them that ALCL is a very rare form of cancer.
• During initial consultation and subsequent follow-up examinations encourage women to self examine for changes in their breast and seek medical advice if concerned.
• Report any confirmed cases of ALCL in women with breast implants to the MHRA.

This MDA has been sent 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 relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Directors of surgical units involved in breast reconstruction or augmentation
• Medical directors
• Nurse executive directors
• Plastic surgeons and all surgeons involved in breast reconstruction or augmentation
• Specialist nurses involved in breast cancer care

Primary care trusts
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:

• Breast augmentation centres
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk