Worldwide Registers reporting adverse incidents for medical devices
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.
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:
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:
- The name of the medical device
- The name of the manufacturer
- The modal and serial number
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.
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
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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
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Out thoughts on the MHRA
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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
Reporting an Adverse Incident :
Department of Health, Social Services and Public Safety
Health Facilities Scotland
A division of NHS National Services Scotland
How to Report Adverse Incidents
Medical Devices - Reporting Adverse Incidents
Note: You can ask the MHRA for the final manufacturer conclusion report on your medical device report!
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
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
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:
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
Department of Health
The Government of Hong Kong Special Administrative Region
Report Medical Device Adverse Incidents
Surgical Mesh - Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse - Notice to Hospitals
Medical device incident reporting & investigation scheme (IRIS)
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 >>>