Date: 30th November 2011
Where you see this image 
it has been updated today
PLEASE SCROLL DOWN THE WEBPAGE TO VIEW ALL INFORMATION
DATED: 30th November 2011
Warning Notice: Concerning Activities from the MHRA and the Manufacturers
Unbelievable and shocking behaviour. To those who have submitted their adverse report into the Medicines and Healthcare Regulatory Agency (MHRA) Do not give permission or allow the manufacturers to contact your surgeon to allow them access to your medical records! To read more please click here www.tvt-messed-up-mesh.org.uk/notice-mhra-concerns.html >>>
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 >>>
2nd September 2011: 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. Read more on the following links
www.mhra.gov.uk/home/groups/clin/documents/websiteresources/con128943.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 >>>
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...
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 >>>
Download Petition to collect Signatures:
www.tvt-messed-up-mesh.org.uk/petition.pdf >>>
We need your help to continue with our work
please click the donate button
You can follow us on Twitter http://twitter.com/TVTMum >>>
Join us on Facebook: http://www.facebook.com/tvtmum >>>
Advice and Help
