Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda - temporary suspension of the CE certificate
Suspension due to particles found on some devices (MDA/2015/034)
Action
- Do not implant/use affected devices
- Quarantine devices
- Await further advice from the distributor(s) and/or MHRA
- If patients enquire they can be reassured that this situation is being investigated as a matter of priority with our European counterparts to decide on further action. However, if they would like to be kept up-to-date they can register for email updates and they will be kept informed.
Action by
- Implanting surgeons
Deadlines for actions
Actions underway: 2 October 2015, actions complete: 9 October 2015
Device details
The following devices distributed in the UK by Eurosurgical are affected:
-
silicone implants for plastic surgery: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery
-
silicone invasive devices: sizers for silicone implants
-
silicone implants for general surgery: blocks and sheets
The following devices distributed in the UK by Genesis Medical are affected:
- implants for urology: testicular implants, penile implants, vaginal stents and periuretheral constrictors
Problem/background
The German medical device regulatory authority informed MHRA on Friday 18 September 2015 that a German notified body had temporarily suspended the marketing and distribution of all medical devices manufactured by Silimed lndustria de lmplantes Ltda.
A recent inspection of the manufacturing facility by the notified body identified particles on the surface of some devices.
MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
Distributor contacts
Eurosurgical Ltd
Merrow Business Park
Guildford
Surrey
GU4 7WA
Telephone: 01483 456 007
Email: sales@eurosurgical.co.uk
Genesis Medical Ltd
7 Trojan Business Park
Cobbold Road
London NW10 9ST
Tel: 020 8451 4100
Email: avia@genmedhealth.com
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Day surgery units
- Dermatologists
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecologists
- Gynaecology departments
- Gynaecology nurses
- Maxillofacial departments
- Medical device safety officers
- Medical directors
- Obstetricians
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Orthopaedic surgeons
- Paediatric surgeons
- Paediatric surgery, directors of
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urological surgeons
- Urological surgery, directors of
- Urology departments
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- 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.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/034 or 2015/009/022/071/001.
Technical aspects
Ian Smith,
MHRA
Telephone: 020 3080 7306
Email: ian.smith@mhra.gsi.gov.uk
Clinical aspects
Dr S Jagdish
MHRA
Telephone: 020 3080 7187
Email: soundararajan.jagdish@mhra.gsi.gov.uk
Reporting adverse incidents in England
Northern Ireland
Northern Ireland Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
CMO Group
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Email: NIAIC@dhsspsni.gov.uk
Northern Ireland Adverse Incident Centre (NIAIC)
Reporting adverse incidents in Northern Ireland
Report directly to NIAIC using the forms on the 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
Telephone: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
NHS boards and local authorities in Scotland should report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients should report to Health Facilities Scotland.
Private facilities providing care to private clients should report to the Care Inspectorate and MHRA.
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Welsh Government
Telephone: 02920 823 624 / 02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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