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)
- 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.
- Implanting surgeons
Deadlines for actions
Actions underway: 2 October 2015, actions complete: 9 October 2015
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
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.
Merrow Business Park
Telephone: 01483 456 007
Genesis Medical Ltd
7 Trojan Business Park
London NW10 9ST
Tel: 020 8451 4100
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
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecology departments
- Gynaecology nurses
- Maxillofacial departments
- Medical device safety officers
- Medical directors
- 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
- Urological surgeons
- Urological surgery, directors of
- Urology departments
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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/034 or 2015/009/022/071/001.
Telephone: 020 3080 7306
Dr S Jagdish
Telephone: 020 3080 7187
Reporting adverse incidents in England
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
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Reporting adverse incidents in Northern Ireland
Report directly to NIAIC using the forms on the website.
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 25 September 2015
Issued: 25 September 2015