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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!

The Medicines and Healthcare products Regulatory Agency (MHRA) UK News and updates from April 2012 to Present


mhra logo

Updated: 1st November 2015

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 click on this link www.tvt-messed-up-mesh.org.uk/worldwide-registers-reporting-adverse-incidents-for-medical-devices.html to view all the details on how to obtain your medical records and how to submit your adverse incident report, thank you.

The main purpose of adverse reporting is to show the MHRA how many people are harmed and to collate data on all the TVTs/Meshes medical devices also to show the MHRA there is a real serious growing health problem in the UK. It is the MHRA who should be asking the manufacturers WHY is this happening and to give answers on their faulty medical devices, specifications, RCTs etc etc directly to them only and not to allow the manufacturers to approach ill people who are in a vulnerable state of health plus for putting the surgeons in a very awkward sitution after receiving permission to disclose private and confidential medical information between patient and surgeon, this is breaking patient confidentiality and also putting vulnerable people under pressure.

How is a medical device regulated and passed for the CE Mark (an acronym for the French “Conformite Europeene”)? It should go through the approval process however, unfortunately sometimes medical devices are just cleared to go onto the European market! The regulatory system is currently under investigations.
eu-regulatory-system poster

12th November 2012
Press release: MHRA seeks views on the regulation of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) today urged healthcare professionals and the public to give their views on new draft European laws for the regulation of medical devices such as breast and hip implants and hospital equipment, such as dialysis machines. Medical device regulation continues to be a hot topic of debate following PIP breast implants and the recent safety concerns involving metal-on-metal hips. The MHRA has been pressing the European Commission to strengthen the current European system of regulation for four years and we have now launched a ten-week consultation so that healthcare professionals and the public can give their views on whether new draft legislation from the European Commission goes far enough in the following areas.

24th October 2012
Press statement:
MHRA statement on European regulatory system for medical devices

Date: 24 October 2012
Time: 15:00
Subject:Following stories in the Daily Telegraph about their joint investigation with the British Medical Journal into the European regulatory system for medical devices, the MHRA have released the following statement:

An MHRA spokesperson said:
“We recognise that improvements to the regulation of medical devices need to be made. That’s why we fed into the European Commission’s review, specifically recommending improving the oversight of Notified Bodies, the improved surveillance of post-market events and the better collaboration between national regulatory bodies.

“The European Commission published their proposals on 26 September that includes many of the areas of improvement that the UK has been pushing for. We will shortly be consulting on the approach that the UK should take for negotiating the proposed legislation.”

This is what the MHRA are referring to within their statement:
European Commission
Public Health
Medical Devices
Revision of the medical device directives - Proposals of the European Commission
On 26 September 2012, the European Commission adopted a package on innovation in health consisting of....click on the link below to view all the PDF's...
ec.europa.eu/health/medical-devices/documents/revision/index_en.htm >>>

17th October 2012
News from the MHRA
Email sent to TVT Mum from the MHRA dated 9th October 2012

Dear Lorraine:
This is just to let you know that there was a very successful meeting the other day between one of the new Commissioners, representatives of the Professional Bodies and Royal College of Obstetricians and Gynaecologists, the Department of Health and MHRA concerning the above. This took into account the concerns of patients about these devices which were openly discussed.

There was agreement that there needed to be actions by all parties so that we could keep a careful eye on these issues, ensuring best practice for patients.

There is going to be a press briefing within the next week to 10 days and I will let you know exactly when this is going to be. In the meantime it was acknowledged that the reports from you and your friends and colleagues on adverse events had been extremely helpful in bringing this issue to our attention and that MHRA wanted to promote the future onward reporting of all adverse events so that we can keep an eye on the problems and further discuss with the Professional Bodies as indicated.

I hope that you will recognise that you and your organisation have done a tremendous job in bringing about raising of the profile of this important issue and bringing about changes in practice.

With very best wishes.
Dr Susanne Ludgate
BSc (Hons) MB ChB DMRT FRCR FRACR
Clinical Director, Devices
Medicines and Healthcare products Regulatory Agency

28th September 2012
A recent Development at the MHRA
There will be a forthcoming meeting at the MHRA in the very near future with the Department of Health, the Royal Colleges and Professional Bodies and the Commissioners who commission hospital treatments for patients.

I put in a request for an invite to attend the meeting and then I received a response to say the meeting will be very much internal in the first instance, however, the MHRA would like us included by way of submitting a list of concerns we have on Vaginal Tapes and Meshes to be forwarded to the Commissioner.

The MHRA also mentioned they think it's very important that friends and colleagues understand that they have not stood still on this one but are trying to do the absolute best for patients.

One of the recent emails received from Dr Susanne Ludgate at the MHRA:
Subject: Vaginal Tapes and Meshes
Delivery Date: Monday, September 24, 2012
Abstract from the email..
It seems as though I am sure from your end that moving forward is not happening quickly enough. I thought I should write and tell you however that what we have started is now becoming a very much bigger project and one with which I am sure you would approve. We are bringing the Professional Bodies and the Department of Health and Commissioning Board are all anxious now to work together on this issue which they see as a major initiative and we will be having a meeting in the near future with all parties to discuss how to take this forward. I really feel that this is an excellent outcome although it has taken a long time because it means that it has been recognised by all parties that this is a topic that they need to address. Congratulations on your persistence.

With best wishes.
Dr Susanne Ludgate
BSc (Hons) MB ChB DMRT FRCR FRACR
Clinical Director, Devices
Medicines and Healthcare products Regulatory Agency

If you would like to submit your concerns regarding Vaginal Tapes and Meshes to be put forward to the Commissioner please can you send your email with the subject header: MHRA Meeting Vaginal Tapes and Meshes and send to lorraine@tvt-messed-up-mesh.org.uk. Many thanks for your support to our cause.

Date: 18th April 2012
Email from the MHRA
We are not considering issuing a Medical Device Alert on vaginal tapes and mesh as we do not have enough evidence to indicate the problem is with the mesh devices being unsafe, as opposed to a failure of the surgical procedural involved in implanting them. Although as you are aware we continue to review this situation and to investigate all incidents and clinical evidence with the tape and mesh manufacturers. THIS IS A MUST READ please click on the link below:
Latest email to the MHRA dated April 2012 >>>

Date: April 2012
Vaginal mesh for pelvic organ prolapse

Vaginal mesh implants used to treat pelvic organ prolapse (POP) include a range of different types of mesh implanted in the pelvic floor area in a number of different ways to support the vaginal wall and/or internal organs. The mesh can be synthetic, ‘biological’ or a combination of the two and it may be absorbable or non-absorbable.

In light of an increasing number of adverse events and patient concerns being reported, the MHRA has launched an investigation to better understand the use of these devices and the complications associated with their use.

The MHRA held a workshop in March 2012 under the chairmanship of Professor Paul Abrams, which included representatives of the Royal College of Obstetricians and Gynaecologists, the British Association of Urological Surgeons, the British Society of Urogynaecology, NICE, the University of Aberdeen Health Services Research Unit, and representatives of some manufacturers of these devices, to consider how to make this a safer procedure.

The meeting covered:
types of vaginal mesh
clinical experience, training and outcomes of prolapse surgery
complications arising from the use of vaginal mesh
NICE/IPAC guidance
adverse event reporting
responsibilities of involved parties (clinicians, regulators and manufacturers).

Further information on the outcomes of this workshop will be made available shortly.

In February 2012, the MHRA commissioned an independent review of all current and up-to-date evidence on the use and potential problems associated with both vaginal tapes and mesh for stress urinary incontinence and pelvic organ prolapse. This is expected shortly. We will publish the findings of this research as quickly as possible so that surgeons and doctors can give the best information possible to patients about the benefits and risks of this type of surgery.

Source: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Vaginalmeshforpelvicorganprolapse/index.htm

Draft
Committe on the Safety of Devices
3 November 2011
Summary and Minutes
con140885.pdf >>>

Questions patients may want answered before undergoing insertion of vaginal tapes for incontinence should discuss with their surgeon prior to surgery:

Advice for new patients considering Vaginal Tape/Mesh implant from the Medicines and Healthcare Products Regulartory Agency (MHRA)

  • Full description of what the treatment involves

  • Why this type of treatment is appropriate

  • What are the different devices available?

  • Pros and cons of different devices

  • What are the alternative treatments?

  • Possible side effects or adverse events associated with the treatment

  • What happens if this particular surgery does not work?

  • Has the surgeon performed this operation before and if so in how many patients?

  • Has the surgeon performed an audit of his or her results of the procedure proposed? If so, what were the success and complication risks?

Worldwide Registers reporting adverse incidents for medical devices
Please press here to view how to obtain your medical records and to submit your adverse incident report >>>

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 >>>

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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