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.
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 >>>
The National Patient Safety Agency
We help healthcare managers and practitioners to understand, manage and prevent performance concerns.
www.npsa.nhs.uk/ >>>
www.nrls.npsa.nhs.uk/ >>>
TVT Messed up Mesh (TVT Mum) - National Mesh Register
The National Register is for all the people suffering from mesh related complications and will be produced by our medical advisor who has experience of National Registers of operations through work with the Royal College of Obstetricians (RCOG) and National Institute for Health and Clinical Excellence (N.I.C.E).
Full details arriving soon
Please read the following to give a more understanding on adverse reporting.
16th May 2011 - Thousands of people face painful and expensive surgery to remove failing medical devices such as metal hip replacements and cardiovascular implants, according to investigations by the BMJ and Channel 4 Dispatches.
www.channel4.com/info/press/news/investigations-question-safety-regulation-of-medical-devices >>>
In December 2010, two new European guidelines on medical device clinical studies were published. One covers serious adverse event (SAE) reporting while the other provides guidance on when clinical investigations should be conducted, together with general principles to be observed when conducting such investigations. This article discusses the SAE reporting guideline, which is likely to have the greatest impact on European medical device clinical studies.
By: Dr. Maria E. Donawa
PDF: Serious-Adverse-Event-Reporting-During-European-Device-Clinical-Investigations.pdf >>>
When it comes to medical devices, it seems that Europeans get a worse deal than US patients, and even that their safety could be being compromised. Deborah Cohen and Matthew Billingsley compare the regulatory systems, read more on this PDF: europeans-are-left-to-their-own-devices.pdf >>>
Adverse Event Reporting in the EU and the USA:
Similarities and Differences
By Elisabethann Wright and Steven Datlof
PDF: Adverse-Event-Reporting-in-the-EU-and-the-USA.pdf >>>
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 >>>
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
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
Medical device incident reporting & investigation scheme (IRIS)
www.tga.gov.au/safety/problem-device-iris.htm
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.
Advice and Help
