Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation - diagnosis of breast cancer difficult in some cases

(Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult. (MDA/2012/022)

CAS deadlines

Action underway: 30 April 2012, action complete: 14 May 2012

Device

Dermal filler for breast augmentation.

Macrolane™ Volume Restoration Factor (VRF).

Manufactured by Q-Med AB (a Galderma division).

Macrolane VRF20 and VRF30 is an injectable filler for volume restoration and body contouring in a range of indications including breast augmentation.

Problem

Use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation can make diagnosis of breast cancer more difficult, particularly with the use of mammography.

The MHRA has been made aware of a Dear Doctor Letter (160Kb) issued in April 2012 to clinicians by Q-Med about the use of Macrolane recommending that it is not used for injection into breasts because it can make diagnosis of breast cancer more difficult, particularly during mammography.

The manufacturer has stated:
‘Macrolane is detectable in mammography, ultrasound examination and MRI examination of the breasts.

Mammograms
A clinical study indicates that the presence of Macrolane may significantly reduce the diagnostic quality of mammograms, since Macrolane will appear as a gray/white shadow in the mammogram. In this case ultrasound can be used as a complementary examination.

Ultrasound
Ultrasound can be used to diagnose lumps in the breast after a Macrolane treatment. Ultrasound may also be a complement to mammography at breast screening and diagnosing. Some radiologists explain that Macrolane has a typical appearance in an ultrasound, similar to that of water, but with a snowstorm appearance.’

Breast diagnostics and Marolane

There is no association with cancer and no safety concerns have been identified for this product. The product remains on the market for use elsewhere in the body.  The manufacturer plans to issue updated instructions for use in due course with updated indications for Macrolane use.

Action

Do not use Macrolane for breast augmentation.

Have procedures in place for radiographers to check with patients presenting for breast examination for any history of breast injection.  Staff should request the card (appendix 1) that the patient was given at the time of injection, identifying Macrolane as the product used, and pass it on to the examining radiologist.

Women may present with concerns that the injected Macrolane has affected mammogram results. GPs may wish to consider referral for repeat imaging.  

Action by

  • Breast surgeons
  • Cosmetic surgeons
  • GPs
  • Mammographers
  • Plastic surgeons
  • Radiographers
  • Radiologists

Distribution

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • Local authorities in Scotland (equipment coordinators)
  • 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 includingtion to all relevant staff including:

  • Breast nurse specialists
  • Breast screening units
  • Breast surgeons
  • Clinical governance leads
  • General surgeons
  • General surgery
  • General surgical units, directors of
  • Mammography units
  • Medical directors
  • Medical oncologists
  • Medical oncology, directors of
  • Nursing executive directors
  • MRI units, directors of
  • Outpatient clinics
  • Plastic surgeons
  • Radiographer superintendents
  • Radiographers
  • Radiologists
  • Radiology departments
  • Radiology directors
  • Risk managers

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Directors of public health
  • General practitioners

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

This alert should be read by:

  • Clinics
  • Cosmetic surgeons
  • Hospitals in the independent sector
  • Independent treatment centres
  • 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.

Manufacturer contact

David Wall
Director of Sales & Marketing, Q-Med, OTC & Ireland
Galderma UK & Ireland
Meridien House
69-71 Clarendon Road
Watford
WD17 1DS

Tel: 01923 208 950
Fax: 01923 208 998

Email: David.wall@galderma.com

Feedback

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

Appendix

Information for your radiologist (236Kb)

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/022 or 2012/004/023/291/010.

Technical aspects

Miss Feza Haque or Mr Ian Smith
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7066 / 7306
Fax: 020 8754 3965

Email: feza.haque@mhra.gsi.gov.uk or ian.smith@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@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

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

Dr Chris Jones
Medical Director
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

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

Download documents

Medical Device Alert: Dermal filler for breast augmentation Macrolane™ Volume Restoration Factor (VRF) manufactured by Q-Med AB (a Galderma division) (MDA/2012/022) (982Kb)

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.