logo tvt messed up mesh tvt mumtvt mum petition

The Voices Today on Messed up Mesh (TVT Mum)
Help and support to both men and woman who have had the medical device TVT Retropubic, TVT-Secur, TVTO and TOT, synthetic polypropylene mesh for hernias, prolapse, stress incontinence and bladder and bowel disorders. You're not alone!

Home | About us | Patient Support Group | Medical Device Reporting | Clinicians | Latest News | Contact us

Worldwide Registers reporting adverse incidents for medical devices

Updated: 15 April 2019

world registers Have you been harmed by the TVT Retropubic, TVT-Secur, TVT-Obturator and TOT medical devices for stress urinary incontinence (SUI) or from any other products using synthetic polypropylene mesh used for pelvic organ prolapse (POP), hernias (common types) and Rectopexy (Bowel)? If you have please report to the appropriate governing regulatory authorities. I have tried to put a list of contacts from various organizations around the Globe. It is very important every-one submits their adverse report to show the medical world how serious this growing health problem is regarding synthetic meshes.

Important Message for everyone in the United Kingdom
Please can everyone injured by a synthetic mesh implant report it to the Medicines and Healthcare Products Regulatory Agency (MHRA) this will help us enormously to show the MHRA and the NHS England there's serious concerns with synthetic meshes. You don't need your medical device details to submit an adverse incident report although it's helpful to have this information. Please view all the details as below on how to obtain your medical records and how to submit your adverse incident report, thank you.

united kingdom flag scotland flag wales flag ireland flag europe flag
United Kingdom (Great Britain, Ireland, Europe, U.K., G.B,)

Medicines and Healthcare Products Regulatory Agency (MHRA)
The MHRA is for:
• Clinicians, healthcare and social care workers
• Patients and other members of the public
• Medical device manufacturers

Here is the direct link to submit Reporting adverse incidents involving medical devices:
https://yellowcard.mhra.gov.uk/ >>>

mhra logo

Reporting your faulty medical device to the Medicines Healthcare Regulatory Agency (MHRA)

First you need to get your medical devices details. You can ask your surgeon's secretary for these details or you can find your medical device details in your medical records, you can apply for your medical records directly from the NHS:-
How do I access my medical records? Please click on the NHS external link www.nhs.uk/chq/Pages/1309.aspx?CategoryID=68&SubCategoryID=160 >>>

The details you require on your medical device are as follows:

If your surgeons secretary asks why you want these details please say you want to put in your adverse incident report into the MHRA as there are already significant numbers on their database plus they have launched an investigation.

mhra reporting adverse events

Online MHRA reporting adverse incidents involving medical devices:- www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm >>>

Latest news from the MHRA Year April 2012 to Present
Please press here to view more >>>

Archive work done with the MHRA from Year 2010 to March 2012
Please click to view the archives >>>

Public Health Alert issued from the MHRA
Please press here to view information >>>

Out thoughts on the MHRA
Please press here to view information >>>

Article by a Solicitor concerning adverse incident reports with a link will appear here soon, thank you for your patience.

Adverse Incidents in Northern Ireland, Scotland and Wales

nothern ireland banner
Northern Ireland
Reporting an Adverse Incident :
Department of Health, Social Services and Public Safety
https://www.health-ni.gov.uk/topics/safety-and-quality-standards/northern-ireland-adverse-incident-centre-niaic >>>

scotland banner
Health Facilities Scotland
A division of NHS National Services Scotland
How to Report Adverse Incidents
http://www.hfs.scot.nhs.uk/services/incident-reporting-and-investigation-centre-iric/adverse-incidents-/ >>>

wales banner
Healthcare Excellence
Medical Devices - Reporting Adverse Incidents
www.wales.nhs.uk/sites3/page.cfm?orgid=465&pid=56203 >>>

Note: You can ask the MHRA for the final manufacturer conclusion report on your medical device report!

united states flag
United States of America (also referred to as the United States, the U.S., the USA, or America)

FDA U.S.Food and Drug Administration

MedWatch Online Voluntary Reporting Form (3500)
Report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:
FDA-regulated drugs,
biologics (including human cells, tissues, and cellular and tissue-based products)
medical devices (including in vitro diagnostics)
special nutritional products and cosmetics

Online: MedWatch Online Voluntary Reporting Form (3500)4

Website: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm >>>

Truth in Medicine
We are patients educating and supporting other patients! Industry, the FDA, the CDRH and the health system in general are NOT addressing the problem. But WE ARE!
www.truthinmedicine.us.com/worldwideregistry.php >>>
www.tvt-messed-up-mesh.org.uk/truth-in-medicine.html >>>

Hong Kong flag
Department of Health
The Government of Hong Kong Special Administrative Region
Report Medical Device Adverse Incidents
www.mdco.gov.hk/english/report/report.html >>>

canada flag
Surgical Mesh - Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse - Notice to Hospitals
www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/surgical-mesh_nth-aah-eng.php >>>

PDF: Medical-Device-Regulatory-Requirements-for-Canada.pdf

australia flag
Medical device incident reporting & investigation scheme (IRIS)

new zealand flag
New Zealand
Medsafe Reporting a defect
Medical Device Adverse Event Reporting

Helpful Resource: Adverse Events

I will add more countries over time to this webpage. If you can help with more information or any advice to improve this area of concern please click here to contact us >>>

All enquiries are treated as strictly private and confidential.

You will see and hear from people who decided not to go ahead with surgery after reading our website. They have been saved from harm!

For more information on our petition please visit here www.tvt-messed-up-mesh.org.uk/petitions.html >>>

Navigation links within the TVT Mum website

Hidden Disability Chronic TVT/Mesh Implant Inflammation |
Articles, Urology/Urogynaecology Conferences and Research from around the World |
Articles and Letters by TVT Mum

British Medical Journal | Dispatches Channel 4 Documentary 'The truth about going under the knife'

Advice and Help Guide on TVT, TVT-Secur,TVT-O and TOT Tape/Mesh Medical Devices | Alernative Treatments for Stress Urinary Incontinence (SUI) and Prolapse (POP) | Men's Health | Mesh Related Complications | Mesh Unexplained Symptoms | Mesh Surgery Experiences | Mesh Removal Stories | Synthetic Mesh Other Nasty Products | TVT, TVT-Secur, TVT-O and TOT, Medical Devices | TransObturator Tape (TvT-O and TOT) Medical Devices | TVT Medical Terminology

Medicine and Healthcare Products Regulatory Agency (MHRA) | Worldwide Medical Device Incident Reporting
TVT Mum Volunteers | The History of TVT MUM| Latest News |
Frequently Asked Questions | Press and Media | Testimonials |
Privacy and Data Protection | Terms and Conditions | Website Map | Links

Location: Stoke Gifford, Bristol, United Kingdom


copyright notice

Website Design by Lorraine Evans at TVT Messed up Mesh

Back to top of Page