Mesh

Every symptom, every story, every report helps to build the bigger picture.

Suspected safety concerns or complications involving vaginal mesh implants, also known as urogynaecological (UG) mesh and tapes, can be reported to the Yellow Card scheme.

Every report is an early warning to MHRA of emerging safety issues and could help protect others.

What is the Yellow Card scheme?

The Yellow Card scheme collects information on suspected safety concerns or incidents involving medicines and medical devices. It relies on reporting by members of the public and healthcare professionals.

The Yellow Card scheme helps the MHRA listen, gather evidence and act to improve public health.

How does your report contribute?

Yellow Card reports are used alongside clinical data and information from authorities around the world to build a more complete picture and flag suspected faulty medicines and medical devices.

Each Yellow Card report helps us act earlier and can help us help others.

Find out more {link to new mesh page on gov.uk} about UG mesh implants and patient safety.

How and what to report

It is important to give as much information as you can in your Yellow Card report. Details such as the serial number and brand of your mesh implant; the date of your procedure and the name of the hospital as well as any symptoms and complications you experienced help our investigations.

The list below will help you get ready to make a report or you can watch our instruction video. Even if you don’t have all this information you can still fill in a Yellow Card report, every piece of information counts.

• Brand of mesh implant

• Serial number of mesh implant

• Date of procedure

• Name of hospital

• Symptoms and complications experienced

• DEVICES TO ADD ANYTHING ELSE KEY TO THIS LIST

Who can report

Anyone can make a report – including patients, carers {Hyperlink to ‘public and patients’ section further down this doc} and healthcare professionals. Hyperlink to ‘healthcare professionals’ section further down this doc}

When to report

You can report at any time, even if your complication has happened in the past. Every piece of information counts.

What happens next

You will receive a confirmation of your report via email. You’ll be contacted again by MHRA if any more information is needed for your report.

Make a report

Report {Link to Devices report} a UG mesh implant complication to the Yellow Card scheme.

Healthcare professionals

If your patient is or may be experiencing a complication from a vaginal mesh device, you should make a report to MHRA via the Yellow Card scheme:

-you should report it through your local incident reporting system and/or your national incident reporting authority as appropriate: England and Wales (Yellow Card Scheme), Scotland (IRIC - how to report an incident) or Northern Ireland (NIAIC - reporting an adverse incident). Reporting by healthcare professionals’ forms part of professional standards.

-private healthcare providers in Scotland should report via the Yellow Card scheme

your patient should be informed once a report is made by you, but they can also report (see above and give your patient the report reference number issued to you)

Public and patients

If you have or are worried you might have a complication with vaginal mesh, first speak to your GP, current surgeon or original implanting surgeon.

Patients and public can then report vaginal mesh implant complications through our Yellow Card scheme – the system for reporting suspected side effects of medicines or possible problems with a medical device. It does not matter how long ago the UG mesh was implanted. We call them medical device ‘adverse incident reports’.

If you don’t have all the details needed to report (such as model/make of UG mesh) it will still be added to our database containing all reports. Your report will be updated if you contact us later with new information.

Watch our video on how to report a problem with a medical device – A Yellow Card guide for patients.

Find out more about vaginal mesh implants

Find out more {link to new mesh page on gov.uk} about UG mesh implants, safety considerations and MHRA regulatory advice for these types of medical devices in the UK.

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MHRA has developed other videos through national campaigns aimed to encourage the reporting of suspected side effects which you can see on the Yellow Card MHRA <a href="https://www.youtube.com/user/MHRAgovuk" target="_blnk">YouTube</a> channel:
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