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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!

Archive work done with the MHRA Archive

Archive work done with the Medicines and Healthcare Regulatory Agency (MHRA) Year 2010 to March 2012

Please scroll down the webpages to view all information

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. Please click here to read more www.tvt-messed-up-mesh.org.uk/notice-mhra-concerns.html >>>

Date: 20th March 2012
Our Meeting with the MHRA
Abstract from an email received from Dr Susanne Ludgage BSc (Hons) MB ChB DMRT FRCR FRACR MBA
Clinical Director
Medicines and Healthcare products Regulatory Agency

Dear Lorraine

I would like to thank you and Hayley very much indeed for seeing me yesterday in Bristol. This was an extremely helpful meeting and allowed me to understand much better the extent of the problems that we face in relationship to these devices.

It seems to me that there are a number of serious issues here in relationship to both the devices and practices and I will be discussing these and feeding these into our workshop and particularly with the clinicians involved in the workshop, who as you know include Marcus Drake, Chris Chapple and Sohier El-Neil.

We are obviously going to have to take a number of actions and I will keep you up to date with exactly what is happening. Thank you both very much for taking the time and trouble to talk to me and provide this information. There is absolutely no doubt in my mind that we have an issue which was much wider than we as the Regulator had understood.

Date: 25th March 2012
TVT Mum Support Group
Since 2009 I have received thousands of enquiries and helped hundreds of women suffering severe health problems from the TVTs/Mesh implants. Our health situation is critical and at this present time there are very few surgeons in the UK to help us. To read more please click on the PDF as below:
TVT-Mum-Support-Group.pdf >>>

Date: 28th March 2012
Open Letter
Lorraine and Hayley had a meeting with Dr Susanne Ludgate BSc (Hons) MB ChB DMRT FRCR FRACR MBA Clinical Director at the MHRA. The purpose of the meeting was to bring more awareness on our critical health situation and to point us in the right direction to receive more expert help within the medical world. To read more please click on the link below:
open-letter-28-march-2012.pdf >>>

Date: 30th March 2012
Sharing my telephone call to the MHRA
This is brief notes on my telephone call to the MHRA regarding our meeting we had on the 20th March 2012

The Mhra said it was a very good meeting, and they will have a workshop on Vaginal Meshes with the Manufacturers and clinicians in london

There is a number of actions going to be taken
Pamphlet for patients. I said we want to have our own thoughts on the Pamphlet and the MHRA thought this is a good idea to do this together


National Institute of Clinical Excellence (NICE) meeting will look at everything again and will put alternative treatments in their guidelines and arrange multi-disciplinary teams

Concerning the Public Health Notice it will not be like the one issued by the FDA but the MHRA will put something on their website - we will request a Medical Device Alert. The MHRA quoted - From the MHRA point of view, we have no comments to make except to say that because of the difference in regulations between Europe and America, we currently have no means of issuing a public health notice.

All Actions will be put onto the MHRA website as and when achieved it will take a bit of time to process but will happen this year.

National TVT Mesh Register is going ahead for this year!

I mentioned about A&E issues where nurses do not recognise the problem, she will put this down on the educational list of things and thought this was good to know

First priority is the pamphlet

The clinicians seem to insist it is good sling but I said I don't agree considering people are loosing their bladder and bowel and they can't say where the mesh goes when it breaks off and migrates etc I said for severe cases yes where there are no other alternative but not for people with mild SUI etc and disagreed on the age and the MHRA agreed age is an important factor

Date: 30th March 2012
Correspondence from the MHRA
Abstract: I thought you would like to know that we had a very successful workshop on Wednesday which brought together manufacturers, relevant clinicians and ourselves.Notes of this meeting will appear shortly on our website together with the proposals from this workshop which will cover the responsibilities of the parties concerned, pushing for a registry and production of guidance for patients with the sort of questions that they should ask when seeing their surgeon

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

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. MUST VIEW more please click on the link below:
Latest Email for April 2012 >>>

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.

updated17th 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

To return back to the MHRA News please click on the link below:
www.tvt-messed-up-mesh.org.uk/news-from-the-mhra.html >>>

Date: September 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 >>>

2nd September 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.
european-association-of-urology.html >>>

12th September 2011
Our concerns and thoughts on The Medicines and Healthcare products Regulatory Agency (MHRA) from everyone in the UK. Please click here to view www.tvt-messed-up-mesh.org.uk/our-thoughts-on-the-mhra.html >>>

mhra urgent notice

There is a serious under-reporting both from the Medical World and from Patients why? because no one knew they had to put in an adverse report it is only through our website we have had to tell people since 2008 to submit their adverse report to show the MHRA we have tried to tell them these TVT medical devices and other mesh products are faulty!

On the 15th August 2011 published in the Daily Mail the MHRA have stated - Meanwhile, here, the Medicines and Healthcare Products Regulatory Agency has launched an investigation. ‘We are planning to publish our findings soon,’ a spokesman said. ‘If people are experiencing problems with a device, we would encourage them to report this to our adverse incident centre.’ Our TVT Mum support Group have been telling them for years there are not enough experienced surgeons in the UK to treat us and we are all in daily pain and suffering. Everyone has sent hundreds of emails and we have made numerous phone calls to the MHRA only to be told the MHRA want to publish in a peer article and not issue a Public Health Notice on their website.

This is the first time I have ever seen the MHRA in the public domain for everyone to put in an adverse report, unless people knew about the MHRA how would they have known to put in an adverse report before now? I have heard they cannot get involved with self-help groups yet they agreed for us to show their posters as below so people are aware to submit their adverse reports, it was through our website pointing everyone to the MHRA website they got their significant numbers yet now they don't want to get involved with self help groups. Incidently the MHRA have told us they have put up their posters in all hospitals and clinics I for one have never seen one and I have spoke to others and they have never seen the posters too. Have you ever seen one? Please scroll down to view their posters.

The MHRA
About us
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. www.mhra.gov.uk/Aboutus/index.htm >>>

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

FDA in the USA Second Public Health Notice
Date Issued: July 13th 2011
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
POP = Pelvic Organ Prolapse
SUI = Stress Urinary Incontinence www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm >>>

There are many people trying to tell the MHRA to release a Public Health Warning Notice. Please scroll down to view some of correspondence.

Dated: 30th June 2011

This is what the MHRA told me:
The workshop to discuss Vaginal Tapes was held in mid March 2011. Following this meeting we plan to place some guidance on our Website in the near future. It is also my understanding that the Chairman from the meeting is going to publish an article on this matter.

This is the MHRA decision:
I have only just been able to establish the route of publication that is being taken. It has been decided by the chairman of the meeting to publish the document in a peer review journal, this process is very variable but as a guideline, it will be around 3 months until publication. 20th August 2011 It is now August 5 months on and still nothing, this has been going on like this for years. Due to their incompetence many hundreds possibly thousands more people have now been harmed by these faulty medical devices. They have to issue the Public Health Notice immediately so people can have an informed choice (too late for us but will save others from harm) they should be protecting the public and keeping us safe. The consultants are not telling their patients the risks with these TVT medical devices and other mesh products, they tell us the normal surgery risks yes but not on the risks associated with mesh related complications from these medical devices.

Lorraine reply to the MHRA:
Please re-consider your decision as a publication in a peer reviewed journal is very different from a warning notice from the MHRA. I feel it will have very little impact and will probably not be widely read. We need a warning, similar to the FDA and Canadian organization, this is far more appropriate.

At this present time I have got to wait 20 days for the MHRA to re-consider their decision.

20th August 2011
Their decision is as follows
Dear Mrs Evans
Thank you for your e-mail of 30th June 2011 where you requested the papers from the workshop discussing vaginal tapes which was held in mid-march.
We have identified the agenda and the minutes from the meeting as relevant to your request. A copy of the agenda from the meeting is enclosed.
However, the minutes from the meeting are exempt under section 22 of the Freedom of Information Act. This is because the information is intended for publication at a future date. The Department’s decision is therefore to withhold this document.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of receipt of the response to your original letter and should be addressed to:
MHRA
Information Centre, Area 4T
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ
Please remember to quote the reference number above in any future communications.
If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

This is an important read please look at this second public health notice released from the FDA.

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Date Issued: July 13, 2011
Abstract
Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

To read more please click on this direct link to view
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm >>>

Why are the MHRA delaying the Public Health Notice for the UK? All of us have been trying to tell them since 2008.

28th June 2011 an email sent to the MHRA by a TVT Mum member

Thank you for your e-mail Publication in a peer review journal will not be widely read.

It is not the same as putting a warning on your website as both the FDA the Canadian authorities have done. It is gross negligence on your behalf not to issue warnings to the general public about the adverse incidents regarding these incontinence slings. I don't know how your chairman sleeps at night

My life has been totally devasted by this medical implant and my future looks very bleak. Do you care?? I think the answer to that is obviously not!! How many more ladies are going to be harmed before you react to this situation and stop or at least warn the public about these faulty medical devices? They were after all launched on to the market without any robust clinical trials

I am making a freedom of information request. I would like to be sent all the papers pertaining to the meetings you had with the maufacturers back in mid march 2011.

Please expedite my request.

Yours sincerely in great anticipation

6th June 2011

BREAKING NEWS IMPORTANT
MHRA - Medical Device Alert: Various products. Manufactured by Boston Scientific (MDA/2011/062)

Resolution™ II Clip
Pinnacle™ Pelvic Floor Repair Kit
Flexiva 365™ High Power Single-Use Laser Fiber
Flexiva 550™ High Power Single-Use Laser Fiber
Flexiva 1000™ High Power Single-Use Laser Fiber
AccuMax™ 365 Single-Use Holmium Laser Fiber
Advantage™Transvaginal Mid-Urethral Sling System
Advantage Fit™System
Manufactured by Boston Scientific
Click the link below and click on the Download documents to view the PDF:-
www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON120222 >>>

3 June 2011 - A TVT Mum member tried to tell the MHRA she could not access her medical records at this time due to very bad health and this is their response:-

TVT Mum Member
I am unable to access my medical records at the moment as I am too ill to do so but I am enclosing a picture of the tape that my surgeon exised from inside my urethra which goes to prove that trans vaginal tape is not inert in the human body. Your comments would be appreciated.

The MHRA
Thank you for your e-mail and my apologies for the delay in replying. I am afraid that I am not in a position to comment on the image of the tape that has been removed. If you would like it analysed the manufacturer of the device is in a position to do this, or an Independent party could be commissioned to carry out an analysis of this tape. However, your surgeon is best placed to advise you on this matter.

TVT Mum Member
Thankyou for your advice regarding the picture of my exsised TVT tape, which incidentally was totally innapropriate. It would not be a wise decision to sent my tape for analysis to either my surgeon, or the manufacturers, for obvious reasons.

Its about time you followed the FDAs advice and warned the public about the adverse incidents regarding the implantation of these meshes.

When are you going to wake up to the fact that hundreds of women in the UK are being harmed, and there lives ruined by these devices and still you do nothing.

I personally have had my life ruined, am in constant pain, have had to have multiple surgeries, and have been reduced to wearing nappies like a baby. That is no life at all is it ?

Please forward my email to your manager. I would like some assurances that steps are being put in place to warn the unsuspecting public about these evil meshes. They were after all unleashed on us poor women without any long term RCTs.
No response from the MHRA as yet
Permission granted to publish onto the website.

21 May 2011 - MHRA and Other News

Please find below the recent correspondence with TVT Mum, the MHRA and our Medical Advisor as below:

Email to the MHRA from TVT Mum
Dated: May 2011

You mention in your last email back in October 2010 you are having a meeting early this year apparantly it was held early April 2011. Please can you let me know if you have anything to report.

We are all waiting to hear from the MHRA to take action especially for news on the notice from the FDA released back in 2008 which has also been released in Canada, why not in the UK or for Europe?

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

I am receiving emails every single day from people needing help, advice and support and it is becoming very difficult to cope, at this present time I have had nearly 200 approach me for help and asking numerous questions a couple in particular - why there is not enough expert surgeons to deal with mesh complications? and why are they still putting the mesh tapes in people? when they know the facts surrounding meshes maim people and badly affect their quality of life.

I have asked everyone to put in their adverse report to the MHRA.

Please treat as urgent. Thank you.

Reply from the MHRA to TVT Mum
Dated: May 2011

Many thanks for your e-mail and my apologies for the delayed response. The workshop to discuss Vaginal Tapes was held in mid March. Following this meeting we plan to place some guidance on our Website in the near future. It is also my understanding that the Chairman from the meeting is going to publish an article on this matter.

The MHRA regulates medical devices, as mentioned before, if you have questions to do with clinical practice, please direct them to a relevant medical body such as the Royal College of Surgeons.

Reply from our Medical Advisor to TVT Mum in response to the MHRA email
Dated: May 2011

MEDIAL DEVICES - FDA STRICTER THAN EUROPE AND UK

It may be that the MHRA has not issued a warning similar to the USA FDA because the FDA regulation of Medical Devices is much stricter than the laxer Europe and UK regulation.

This is why the article that has just been released by the European group of cardiologists has called for much stricter device regulation in Europe along the lines of the FDA and similar to drug regulation. Absract from this document and full PDF as below:

Abstract
The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established .20 years ago as a ‘New Approach’ to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011. End of abstract
PDF: please click here to view the document eurheartj.ehr171.full.pdf >>>

The FDA produced a list of information that must be given to the patient to obtain valid consent. This is supposed to happen in the UK along the lines of the NICE Guidelines on consent for new procedures where the long term effects are unknown. Unfortunately surgeons rarely do this and many of their websites are overtly enthusiastic about these products. Some quoted figures are probably untrue as surgeons may often give testimonials from satisfied patients but never seem to include comments from patients who have suffered failed procedures or major complications.

In English law, all patients should be told about these risks whatever the success rates and skills of the individual surgeon. Even if the risk is low, the unpleasant and serious nature of the complications is a relevant material matter in assisting the patient on whether to give valid consent to proceed or to decline.

I hope the intended MHRA advice will be robust.

24 May 2011
Reply to the MHRA from TVT Mum

Dear Clare,

Thank you for getting back to me. Please can you let me know when you have arranged the guidance on your website and also when the chairman has done his article.

I have already contacted many relevant medical bodies thank you.

All including everyone who is interested in our work is looking forward to seeing your notice on the website.

Kind Regards
Lorraine

22 May 2011
In response to the MHRA email received as above dated May 2011
Comment received from another TVT Member from the UK

I am furious at the MHRA lets be fair in the near future is just not good enough because we are talking about life changing surgery still happening and ruining unsuspecting womens life everyday so nice of them to be so bloody cavalier.

Its also her understanding that the chairman is going to publish an article on this matter, well she is paid to damn well know and not be so vague. The bit that says 'on this matter' its almost like they can't give it a name 'this matter' don't make me laugh!!!

The last bit might as well say bog off and don't bother me again. I don't understand how the MHRA can very conveniently remove themselves by saying direct them to the royal college of sugeons, shouldn't the MHRA be liaising with the Royal college of surgeons could they not give each other useful information?

The very best and most classic bit is ' the MHRA REGULATES MEDICAL DEVICES' , well sorry but NO you don't because if you bloody well did we would not be in the predicament in the first place, shame on them!!!!

I want to say BEEP! to the lot of them, so angry.

Look what they have put on their MHRA about us webpage: The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.

Sigh and nods head with disgust!

I will keep you posted on any further developments from the MHRA, and like our Medical Expert has said - Let's hope the intended MHRA advice will be robust.

18 June 2010 - News from the Mhra
From the MHRA Publication of new enforcement strategy 2010
Abstract: The document sets out the MHRA strategy for the enforcement of medicines and medical devices legislation. It reflects Government Better Regulation initiatives, as well as the recommendations contained in the Hampton Review (external link), and the Regulators' Compliance Code (external link), which set out the principles and characteristics to be applied in the enforcement of regulations. View here the Enforcement Strategy 2010 details and download the full pdf document to read all information.

MHRA - Medicines and Healthcare products Regulatory Agency has previously distributed leaflets and posters to GP surgeries and other healthcare facilities to be displayed, which encourage patients to report adverse incidents involving medical devices.
The poster can be found at the link: http://www.mhra.gov.uk/Publications/Postersandleaflets/CON2030971
And the leaflet can be found at the link: http://www.mhra.gov.uk/Publications/Postersandleaflets/CON2030970
Following are the posters showing on the MHRA website as below...

mhra poster one

mhra poster one

mhra poster one

mhra poster one

BREAKTHROUGH NEWS 8 MAY 2010

Latest News from the MHRA investigation....Reply received..

TVT Mum has received a reply today from the MHRA. To all Members and anyone affected with complications including mesh erosion associated with polypropylene synthetic mesh used in Medical Devices please adhere to the MHRA advice with TVT Mum response as outlined below..

MHRA response and advice - I would like to clarify that the MHRA only regulates medical devices and has no control over the actions of healthcare professionals. Your allegations appear to be primarily directed towards the surgeons implanting these devices. I would like to suggest that you should pursue your complaint directly with the Medical Director of the individual hospitals concerned.

The number of reports received by the MHRA where complications could be attributed to the device itself have been very low. MHRA will investigate adverse reports that are reported to us and I would encourage women who have had device related adverse incidents to report these via our website at
www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm

The MHRA intends to seek further advice from experts on this issue as part of our investigation.

Whilst investigating this issue, I have come across a document published by NICE (National Institute for Clinical Excellence) which provides patients with guidance on various treatment options. It also highlights some important questions that could be asked of the clinician, in order to obtain a clear picture of the procedure recommended by that particular clinician. This document can be found at
www.nice.org.uk/nicemedia/live/10996/30284/30284.pdf


TVT Mum will respond with..

Paragraph 1 - This is good advice from the MHRA to all our members and anyone who is experiencing complications. The issue is not solely on the surgery itself it is also the issue on the use of Polypropylene Synthetic Mesh used in the actual Medical Device that is causing the most suffering. Once this mesh is in us it is known it is in for life. When the mesh erodes which can happen from day 1 up to seven years later it will involve multiple surgeries to get it out of the body. It is an extremely difficult and complicated surgery and as mentioned there are inexperienced surgeons trying to take it out. This is causing great concern and is a growing health problem.

Our message to the NHS please understand we are aware of - There are inexperienced surgeons putting the medical devices into people and also inexperienced surgeons taking the eroding mesh out. There are very few surgeons in the UK who can perform mesh extraction surgery, women are desperately seeking experienced surgeons. If you know of or you are an experienced surgeon please contact TVT Mum immediately as we are hearing from ladies in our group some surgeons have not performed this type of surgery before and making matters worse for the patient. We are sure you will agree this is of great concern. The MHRA has the authority to recall these medical devices for further investigations and we feel they have a duty besides the surgeons to protect the patient.

Paragraph 2 - Again very good advice from the MHRA on the issue concerning reporting adverse reports. Although the MHRA are saying the adverse reports are low we consider 655 people is high although you may not have received all their adverse reports. We are concerned it is not known to the patients around the UK to put in an adverse report to the MHRA, so how can they put in their adverse report when it is not known to do so? As far as we can see it is only through TVT Mum website the women know they have to report to the MHRA. We have people approaching us every week on complications associated with the Polypropylene Synthetic Mesh used in the medical devices plus complications with the actual surgery. Any other suggestions to make it known?

Paragraph 3 - Fantastic news the MHRA are doing an investigation, many thanks.

Paragraph 4 - Very good advice from the MHRA to suggest people to read the PDF link regarding the National Institute of Clinical Excellence (NICE) guidelines to all new patients who are offered the TVT medical device or other medical devices using the Polypropylene Synthetic Mesh will be helpful to new patients to make a decision.

For those who have already had this medical device it is too late as we were not told on the full complications, this is why we are actively seeking help to get experienced surgeons to deal with complications related to mesh erosion and other complications associated with the mesh used in the medical devices and from what we are hearing and being told so far the NHS is failing us. Please visit this link on our website to view complications we are all facing Recognised Complications Associated with the Surgery and from the Mesh

TVT Mum requested a helpline from the NHS but we were declined. As far as we can see and know of TVT Mum is the only helpline available for all sufferers. We need the NHS to help us please.

Our synopsis in brief surrounding the scenario regarding this matter we have concluded the Manufacturer's who are marketing these medical devices using Polypropylene Synthetic Mesh in them and selling them in the UK and Worldwide is at fault for not relaying the full complications associated with the Polypropylene Synthetic Mesh used in the Medical Devices. Our research indicates they are bringing out new specifications to confuse and are trying to say they have improved the medical devices when in fact... All the medical devices still have the MESH in them which is the source of the problem and is causing a growing serious health concern.

It is putting a huge strain on the NHS to deal with the people suffering and also we are sorry to say this but we can see they have blinded all the Governing Bodies to the word Cost instead of Patient Safety. Another issue we feel is important is the misrepresentation of the product. The Manufacturer's are saying the word TAPE on their products when in fact the correct description is Polypropylene Synthetic Mesh Tape, yes it does look like a piece of tape and most people assumed the word tape means a piece of kind and gentle woven tape and not a piece of Mesh with serrated edges which embeds into our tissues and continues to travel if the body rejects it. It is common sense MESH does not belong in the human body and we were not told by our consultants it is MESH with serrated edges and will adhere to our tissues like velcro. I can assure you most of us suffering would never of agreed to having this mesh inside our bodies if were told the truth.


Petition
There are many people who have signed our online petition and some have shared their stories. Some have also downloaded a copy to collect signatures. It is fantastic to see the men are starting to sign the petition too, we need you all to support our cause and help all women who are wives, mothers, sisters and daughters suffering.

Online Petition:
TVT Mum Petition to sign online >>>

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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