Testicular implants and inflatable vaginal stents – temporary suspension of the CE certificate
Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda - MDA/2015/036
- Do not implant affected devices
- Quarantine devices
- Await further advice from the manufacturer 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.
Deadlines for actions
Actions underway: 22 October 2015, actions complete: 29 October 2015
All batches of the following devices manufactured by Coloplast A/S are affected:
Testicular implants, product codes: PR3001, PR3002, PR3003, PR3004, PR3005
Vaginal stents – inflatable, product codes: VS3020, VS3022, VS3024, VS3026
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. See MHRA’s alert MDA/2015/034 published on Friday 25 September 2015.
It has subsequently been established that testicular implants and vaginal stents manufactured by Coloplast A/S are made under sub-contract by Silimed lndustria de lmplantes Ltda and so are also affected by the temporary suspension.
MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
The manufacturer issued a field safety notice (FSN) dated 9 October 2015.
Telephone: +45 4911 3339
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:
- Cosmetic surgeons
- Day surgery units
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecology departments
- Gynaecology nurses
- Medical device safety officers
- Medical directors
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Paediatric surgeons
- Paediatric surgery, directors of
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- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Urological surgeons
- Urological surgery, directors of
- Urology departments
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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: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/036 or 2015/010/009/299/003
Ian Smith or Bayode Adisa
Telephone: 020 3080 7306 / 7723
Dr S Jagdish
Telephone: 020 3080 7187
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
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Department of Health, Social Services and Public Safety
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Enquiries and adverse incident reports in Scotland should be addressed to:
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Health Facilities Scotland
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Fax: 0131 314 0722
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Enquiries in Wales should be addressed to:
Healthcare Quality Division
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