Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe

Date: 2nd September 2011

Let's not forget we have been telling the MHRA since mid 2008 there is a serious health problem in the UK

To: Everyone in the UK
Since the MHRA held their workshop on 13th March 2011 we have been waiting months for them to release a Public Health Notice. We have been requesting this information for months and I found it myself through doing my own research. Why on earth didn't the MHRA tell us this PHN has been published on the European Urology Website? This is not showing on the MHRA website - wonder why? Just goes to show how they don't want the public to be aware of the current situation concerning TVT's, TOT, TVT-O and other mesh products.

Date: July 2011
Recent Public Health Alert issued from the MHRA
Advice from the MHRA:
Synthetic vaginal tapes for stress incontinence
The MHRA has seen a recent increase in numbers of adverse event reports in comparison to numbers received in previous years, increasingly from patients. As a result, the MHRA has launched an investigation to better understand the use of these devices and the complications associated with their use. Please click on the following links to read more:
MHRA-PUBLIC-NOTICE.pdf >>>

August 2011:
HERE IT IS! - THE PUBLIC HEALTH NOTICE WE HAVE BEEN WAITING FOR FROM THE MHRA BUT IT IS SHOWING ON THE EUROPEAN ASSOCIATION OF UROLOGY WEBSITE Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe Paul Abrams , Christopher R. Chapple, Marcus Drake, Suzy El-Neil, Susanne Ludgate, Anthony R.B. Smith. Please scroll down this webpage to view the information.

Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe
Paul Abrams , Christopher R. Chapple, Marcus Drake, Suzy El-Neil, Susanne Ludgate, Anthony R.B. Smith.
Full PDF: august-2011-synthetic-vaginal-tapes-for-stress-incontinence>>>

Direct link to European Association of Urology: www.europeanurology.com/article/S0302-2838(11)00868-2/fulltext >>>

Accepted 4 August 2011,
Published online 13 August 2011
Full PDF: European Association of Urology
Letter to the Editor
Synthetic Vaginal Tapes for Stress Incontinence: Proposals for Improved Regulation of New Devices in Europe Paul Abrams , Christopher R. Chapple, Marcus Drake, Suzy El-Neil, Susanne Ludgate, Anthony R.B. Smith.
Abstract
In the field of stress urinary incontinence (SUI), a number of new devices including synthetic vaginal tapes have become widely used in the last decade. This paper results from a workshop held at the Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2011 and arose through concerns from the MHRA with respect to the number of adverse events reported following insertion of synthetic tapes for female SUI. The MHRA, the UK government organisation responsible for the regulation of medical devices, contacted urologists and gynaecologists active in this field and also invited some of the relevant manufacturers to attend a day-long meeting. Read More >>> www.europeanurology.com/article/S0302-2838(11)00868-2/pdf/Synthetic+Vaginal+Tapes+for+Stress+Incontinence%3A+Proposals+for+Improved+Regulation+of+New+Devices+in+Europe >>>

Let's not forget we have been telling the MHRA since mid 2008 there is a serious health problem in the UK please view TVT Mum support group work here www.tvt-messed-up-mesh.org.uk/news-from-the-mhra.html >>>