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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!

Worldwide Registers reporting adverse incidents for medical devices

Updated: 1 November 2015

world registers Have you been harmed by the TVT (Gold standard), TVT-Secur, TVT-O and TOT medical devices for stress urinary incontinence (SUI) or from any other products using synthetic polypropylene mesh used for pelvic organ prolapse (POP) and hernias? If you have please report to the appropriate governing 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 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.




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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:
www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm >>>

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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

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Northern Ireland
Reporting an Adverse Incident :
Department of Health, Social Services and Public Safety
www.dhsspsni.gov.uk/index/hea/niaic/niaic_reporting_incidents.htm >>>

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

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Wales
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!

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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
Information on Surgical Mesh for Hernia Repairs
Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm >>>

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Issued: October 20, 2008
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm >>>

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
Mail: use postage-paid FDA form 3500 available at: MedWatch Forms5
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

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!
WORLDWIDE REGISTRY OF COMPLICATIONS OF SYNTHETIC MESH
www.truthinmedicine.us.com/worldwideregistry.php >>>
www.tvt-messed-up-mesh.org.uk/truth-in-medicine.html >>>

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

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Canada
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

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Australia
Medical device incident reporting & investigation scheme (IRIS)
www.tga.gov.au/safety/problem-device-iris.htm

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New Zealand
Medsafe Reporting a defect
Medical Device Adverse Event Reporting
www.medsafe.govt.nz/profs/defect/device.asp

Helpful Resource: Adverse Events
en.wikipedia.org/wiki/Adverse_effect

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 >>>




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