All Bard urogynaecological mesh – voluntary product withdrawal, implanted devices do not need to be removed (MDA/2019/014)
Manufactured by C.R. Bard (Becton, Dickinson and Company (BD)) – surgical mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) is being withdrawn from hospitals and distribution centres.
Action
If you work in procurement or are a healthcare professional:
- Identify and quarantine affected, unused devices listed in the
- Ensure, in cooperation with implanting surgeons, that suitable alternative devices are available
- Follow the actions listed in the
- Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not
If you are a patient and have this device implanted:
- You don’t need to have the device removed or have any extra follow-up checks
- Read the
- If you have any concerns about your implanted device, contact your GP or healthcare professional
- Report any problems you have with the mesh to the Yellow Card Scheme in England or the appropriate authority in Scotland, Northern Ireland and Wales
Action by
All healthcare professionals who use these devices and staff responsible for the stock and purchasing of these devices.
Deadlines for actions
Actions underway: 14 March 2019
Actions complete: 21 March 2019
Device details
All urogynaecological mesh products for SUI and POP manufactured by C.R. Bard. See the for a full table of devices affected
Problem/background
Bard has chosen to stop production and distribution of these devices. They are removing all urogynaecological mesh products from hospitals and distribution centres.
Bard has taken the decision to stop production of these devices as part of its business strategy. We understand from Bard’s explanation that they are stopping production rather than continuing to invest in clinical data to support additional EU requirements. Therefore, implanted devices don’t need to be removed and no additional follow-up is required for patients implanted with these devices.
We have continued to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications with mesh devices.
We encourage anyone – patient, carer or healthcare professional – who is aware of a complication after a medical device is implanted, to report to us via the Yellow Card scheme, regardless of how long ago the implant was inserted.
Manufacturer contacts
Email BDUKFieldAction@bd.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 NICAS liaison officers for onward distribution to all relevant staff including:
- Day surgery units
- Gynaecologists
- Gynaecology departments
- Gynaecology nurses
- Medical directors
- Nursing executive directors
- Obstetricians
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Operating department practitioners
- Purchasing managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urological surgeons
- Urological surgery, directors of
- Urology departments
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners (for information only)
- General practice managers
- General practice nurses
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Clinics
- 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 Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/014 or 2019/002/025/291/005.
Technical aspects
Tel: 020 3080 6000
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC)
CMO Group
Department of Health, Social Services and Public Safety
Tel: 0208 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident.
Wales
Population Healthcare Division, Welsh Government
Tel: 02920 823 624 / 02920 825 510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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