History in the Making Petition by Meshies United UK Group

Apr 30th, 2012 | By | Category: Op-Ed
 Petition Delivered to 10 Downing Street

Teresa Hughes delivers petition 10 Downing St.

I would like to introduce myself. My name is Teresa Hughes The Owner and Founder of The Meshies United Group in the United Kingdom.

I originate from Liverpool, Merseyside, England the home of The Beatles and Liverpool Football Club.

I had an operation for stress incontinence and the mesh medical device transobturator tape was inserted. This operation took place in April 2006 and ever since this operation I have suffered with severe groin pain, and leg pain.

We are a voluntary support group based in The United Kingdom who comfort and support one another through what have become difficult times for all.

We have made history by being the first support group in The United Kingdom to hand over a petition to Number 10 Downing Street The Prime Minister’s residence.

We have asked the government to reveal to us the number of transvaginal mesh operations that have taken place in The United Kingdom and the number of transvaginal mesh removals. We also asked the government what are they going to do about the amount of serious complications that have arisen through the use of this mesh medical device.

This petition was handed in on the 26 January 2012.

I have also held talks with The Honourable Shaun Woodward my Member of Parliament at Westminster in London.

My member of parliament Mr. Shaun Woodward tabled 5 questions to The Health Secretary of State at Parliament England and the answers to these questions were related back to me in a hard copy and where also put into The Hansard Book in Parliament England. This is history in the making.

These figures that I received back from my Member of Parliament show that nearly 3,000 mesh removal operations have taken place within The National Health Service Hospitals, but these figures are just for England alone. They also exclude any operations that have taken place in the private health sector.

These figures exclude Ireland, Wales and Scotland who are part of The United Kingdom. These figures for transvaginal mesh operations to implant and remove will be far higher if the figures for Ireland Wales and Scotland were collated together.

The Medicine Health Regulator UK have to date from 2006-2011 a total of 107 adverse incidents logged with them regarding transvaginal mesh removal complications. The hospital statistics say that no data has been collated before the year 2005.

I have been a staunch campaigner campaigning since the year 2008 and was the first person to have a petition on the Downing Street e-petition site to ask the government to investigate the medical mesh device transvaginal tape operation because of the serious complications that have arisen and are causing great concern to women in The United Kingdom and Worldwide.

I have tried over the part 4 years to have talks with the Medicine Health Regulator in The United Kingdom about what has happened to us all regarding these Transvaginal Mesh operations and the complications that we are suffering after having this mesh medical device implanted into us.

I have also had a telephone conversation recently with a member of The Medicine Health Regulator UK 17 April 2012 about the statistics of mesh removals that I received via my member of parliament.

I am disgusted with The Medicine Health Regulator in The United Kingdom and The National Health hospitals because The Medicine Health Regulator have denied knowing anything about these statistics and yet these statistics come from English NHS hospital statistics so if that is the case it would appear that one half do not know what the other half are doing.

I am ashamed to live in a country that cannot keep track of serious complications of a medical device that has been implanted and causing so much havoc and ruining thousands of women’s lives and to be told that The Medicine Health Regulator do not know of the statistics.

According to the medicine Health Regulator in The United Kingdom, they do not have these figures and have only become aware of them through me giving them these statistics through my reply from parliament.

I find that this is a very serious issue when they rely on a member of the public to disclose to them how many transvaginal operations have been implanted and also the transvaginal mesh removals.

These figures are from the Source: Hospital Statistics for England and would be known to each hospital because every operation that takes place within the National Health Service has a special code.

What we do know is that surgeons in The United Kingdom at this moment in time are allowed to only voluntary report adverse incidents to the MHRA. It has become obvious by the figures obtained from parliament that they are taking advantage of not reporting complications.

There needs to be a law enforced within The United Kingdom to make sure that all surgeons who remove transvaginal mesh due to complications report them as an adverse incident by contacting The Medicine Health Regulator in The United Kingdom.

Statement from MHRA Workshop held March 2011 online December 2011

http://www.europeanurology.com/article/S0302-2838(11)00868-2/fulltext#section-2-product-development

The MHRA has received an increasing number of reports of adverse events resulting from the use of tapes for SUI from manufacturers, users, and the public, with 42 reports in 2010. The total number of tapes implanted in 2010 is unknown, and therefore the denominator is not clear. However, there is also an underlying concern at MHRA of a marked under reporting of the complications from these devices.

The above statement by The Medicine Health Regulator UK states they have received and increasing number of adverse events with 42 reports in 2010 this is for The United Kingdom.

According to the statistics I have received for England alone the rise for an adverse incident report from 2008 to 2009 is the total sum of 1 more that the previous year

The statistics show adverse incident reports to The MHRA is a total of 18 adverse incident reports for 2008 and a total of 19 adverse incident reports  for 2009.

This must mean that the other 41 reports in 2010 must be for Ireland, Scotland and Wales who are part of The United Kingdom.

Within this article The MHRA say that they do not know the statistics for 2010 this is in a European Urology workshop in March 2011 which was printed in a peer article August 2011 which cost £15 to download.

My member of parliament Shaun Woodward contacted Sir Kent Woods about the cost and it was removed from the website and The MHRA apologised saying that it was an error on their behalf.

I really cannot comprehend that a government body in March 2011 does not know the figures for the previous years for adverse incidents. This does not make any sense at all.

These mesh removals from Hospital Statistics in England should all be recorded as adverse incidents. We should have an health publication put out in The United Kingdom the figures and facts are there for all to see from parliament which would see a rise of 4.5% adverse incidents in mesh removals

Upon two occasions I have traveled to MHRA headquarters at 151 Buckingham Palace Road London England and asked to see Sir Kent Woods Chief Executive or anyone else that may be available to talk me.

I have stood with a placard and have done a silence protest outside their headquarters on both occasions.

The Medicine Health Regulator in the United Kingdom did no obviously like my approach to parading with a placard and on both occasions they sent the security and the police to try to get rid of me.

The police and security men were very nice to me and we talked about what I was doing and why I was doing the protest.

I did also quote to them the Human Rights Act the right to a peaceful demonstration and basically there was nothing they could do about my protest this was because I was not doing anything wrong.

I was exercising my democratic rights in what is supposedly a free country.

What underhanded bullying tactics The Medicine Health Regulator have tried but I am afraid they did not succeed.

I now have an e-petition on line to have and independent review of The Medicine Health Regulator in The United Kingdom because they are failing to look after the health of the public.

It is their duty of care as a government body to look after the people who have had serious complications with transvaginal mesh or any other products.

These people who are being paid vast amounts of money for supposedly looking after the interests of the public and they are hiding away over a block of shops in a shopping precinct and are telling people who wish to talk to them that it is private land.

Whoever heard of a Government Department being on private land and not being able to access them? I was told that the only public part of access available was when they invited you into their offices.

I have now become a patient advocate and travel to speak to hundreds of women who are suffering complications of transvaginal mesh.

I have given talks to the many women in Liverpool who were operated on by a Gynaecologist called George Rowland who worked at The Women Hospital, Liverpool England.

This Consultant George Rowlands did hundreds of transvaginal mesh implants and also removals. Mr George Rowlands was left to his own devise when operating on these women and has left so many women in dreadful pain and suffering.

My Fantastic Members who are all sufferers in The United Kingdom will carry on with the task in hand by highlighting to women the serious complications which can come about when having surgery using transvaginal mesh in the bladder area and campaign for better legislation, a national register and a database

Our voices will be heard and we will not keep suffering in silence.

Teresa Hughes  Meshies United Group UK

——————————————————————————————————-

The Hansard Book Parliament

Figures below for England the number of operations and removals.

The Honourable Mr Shaun Woodward Member of Parliament

Questions: to The Secretary of State for Health: answered February 2012 on behalf of the Meshies United Group United Kingdom

To ask the Secretary of State for Health how many NHS operations to insert a Transobutrator Tape procedure or Tensions free vaginal tape procedure polypropylene mesh bladder sling to treat stress urinary incontinence in women have there have been in each of the last eight years and how many (a) adverse events reports there have been associated with such slings (b) operations to remove such slings in the same period:

This information excludes Ireland Scotland and Wales Statistics

The information is shown in the following tables for England:

Procedure    2006-07         2007-08         2008-09         2009-10         2010-11

Insert TOT      2,580              5,045              5,750              5,569              5,426

Removal        68                    79                    96                    128                 95

Insert TVT      6,137              8,817              8,503              8,397              8,087

Removal        287                 417                 506                 475                 508

 

Source Hospital Episodes Statistics:

Activity in English NHS Hospitals and English NHS commissioned activity in The Independent Sector

They are unable to provide Data for the years previous to 2006-07

The Medicine Health Regulator UK has received 107 incident reports since the year 2005 involving Vaginal Mesh Tapes used for Stress urinary Incontinence as follows:

Adverse Incident Reports   2005   2006   2007   2008   2009   2010   2011

 8         25        3          18        19        15        19

In addition the MHRA has also had 6 reports in 2010 and 19 in 2011 where the device is unknown but they believe they are likely to be related to Vaginal Tape SUI

24,370            Tot Inserted             Removal 466

39,941            TVT Inserted           Removals 2,193

Total  64,311 Inserted and 107 Adverse Incident Reports.

Leaving under reporting by Surgeons, which is on a voluntary basis a total of 2,659 removals in England alone.

——————————————————————————————————-

This leaflet below was given out to the delegates attending the 19th Annual Scientific Meeting UKCS 2012 Incontinence Conference at Liverpool St. Georges Hall. The figures for England were also attached when I went to Liverpool on the 18 April 2012 to protest outside.

I was approached by 3 of the organisers of this event in Liverpool and was treated with the utmost respect and we had talks about why I was there and why I had given the leaflet out to delegates and the way forward.

It was a very prosperous day in reaching out to delegates about our plight as sufferers of this mesh medical device.
——————————————————————————————————-

Ban Transvaginal Mesh Operations in Women

Suffering in Silence and Maimed for Life

Transvaginal Mesh is not inert in the human body especially in the bladder area. Thousands of women in The United Kingdom and Worldwide are suffering serious complications.

Changes need to be made to the regulation of these products especially in Europe where they are passed as safe with a kite mark to put them onto the worldwide market.

We are suffering in silence and we have nowhere to go and we need help from competent surgeons. According to the statistics enclosed from Hospital Episodes this is just for England alone and excludes Ireland Scotland and Wales.

Between 2006 and 2011 a Total of 64,311 tapes have been inserted into women for stress urinary incontinence.

Surgeons who are doing the mesh removal operations which so far is a total of 2,659 in England alone these mesh removals have not been recorded with The Medicine Health Regulator in The United Kingdom as adverse incidents because surgeons are allowed to volunteer an adverse incident to The MHRA UK.

The total of adverse incidents should read nearly 3,000 mesh removals. The voluntary reporting by surgeons who do mesh removal needs to be changed by law.

Many women have lost their jobs their homes and some have lost their husband or partner. Their sex lives have changed forever in fact many women do not have a sex life because of the erosion and damage caused by the mesh.

Men have also been affected because the mesh has cut their private parts. Some women have died and others wish they were dead because of the amount of pain they are in.

General Practitioners do not know how to deal with this situation and many women who contact their GP for help are being referred to a mental health team because their lives have fallen apart.

Would you like to be maimed for life by this barbaric operation?

Teresa Hughes

Owner and Founder www.meshiesunitedgroup.co.uk

 

 

 

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58 Comments to “History in the Making Petition by Meshies United UK Group”

  1. Jane Akre says:

    What has the response been? Teresa answers:

    “Downing Street sent the petition details onto Health Dept to reply back. They replied back with refer to The Medicine Health Regulator UK once again. I then revealed the figures for implants and explants to the mhra uk which where recieved back via my member of parliament to me.
    The Medicine Health Regulator UK denied even knowing about these statistics which are now history in parliament.

    How can you deny history?

    They have said they will not issue a health publication.

    I am meeting with Professor Christopher Chapple in Sheffield, United Kingdom 25 May 2012. Chris Chapple is one of the chairs in European urology, because I feel that if The Medicine Health Regulator in this country will not listen then we have to target them another way down different avenues.

    It may be that we will have to do something drastic in a way of getting publicity soon.
    I am working on this!”

    Hope this helps ~ Teresa

  2. Ann Boni says:

    Well done Teresa for hi-lighting our plight once again. Hope we get the publicity we so richly deserve. How much longer do the MHRA think they can get away with this not long with you on the case I suspect.

    Ann Boni

    • Anne

      I know that you work so tirelessly to keep this serious issue of transvaginal mesh medical complications in the limelight. I know that you have suffered consideraby with very serious complications of the device you had implanted.

      You are a tower strength to us all.

      Thank you

      Teresa xx

  3. Liz Reece says:

    Teresa has worked so incredibly hard and with great guts to get this information into the public domain. I so admire her tireless campaigning.
    As a resident in England who has written several times to the MHRA regarding the mesh problems I had, requesting them to take steps to at least ensure that there is a compulsory register, I have no doubt that they are not taking seriously the situation that is faced by 100s of women, probably 000s, dealing with mesh complications. Some may not even be aware that they have mesh problems because the symptoms arise several years after mesh is inserted. These are therefore likely to be under reported.

    I agree with all that Teresa says about the appalling lack of data that MHRA seems to be aware of, despite it being made available through her MP. It’s hard to understand why they allow these barbaric mesh practices to continue: at least the FDA gave out a public health warning last year.

  4. Ann and Liz

    Thank you for your input and comments.

    We have a government who is doing nothing to help, a health department who is doing nothing to help and also a Medicine Health Regulator foremost who are burying there heads in the sand and who are ignoring the statistics which are now history. Who do we try to reach now? God!

    Someone somewhere needs to stand up and take responsibility for what has happened to us women and for what is still happening.

    It would seems from all the meetings they have had which does not seem to be very many they cannot come to a conclusion according to email enclosed from Europe. It’s about time they did!

    They talk about strengthening the reporting requirements. Somebody should be telling the hundreds of women in The Liverpool Womens Hospital how to report an adverse incident because they haven’t had a clue about adverse incidents until I spoke to them in one of my talks recently.

    This would have been another 500 adverse incidents to add to the MHRA UK.

    Dear Ms Hughes,

    Thank you for your email dated 02 April that Commissioner Dalli transferred to me. I fully share your concerns over the high number of surgical complications following the use of surgical meshes.

    According to the medical devices legislation, serious incidents occurring following the placing of devices on the market must be reported by the manufacturers to the concerned Member State.

    The Commission is aware of serious incidents on patients who have undergone surgery where meshes were used for treatment of pelvic organ prolapse. These cases are being actively investigated by several national competent authorities, including the MHRA. None of these agencies have yet come to a final conclusion.

    Whereby the EU legislation requires the monitoring of the safety and performance of medical devices through data obtained from a postmarket surveillance plan, the use of registers to monitor the safety and performance of devices is not a legal obligation and remains a national competence.

    This legislation is under review. The intention is to further strengthen the reporting requirements, including by healthcare professionals and patients and to encourage the use of national registers when appropriate.

    Regarding this specific case, according to our information national authorities and concerned physicians (gynaecologists and uro-gynaecologists) are actively investigating these serious adverse incidents. None has yet reached a final conclusion on the safety of use of surgical meshes in female patients.

    I hope this is helpful,

    Best regards,
    Sabine Lecrenier
    Head of Unit

    Link to Women operated on by Consultant George Rowland Liverpool Womens Hospital Liverpool England
    http://www.dailymail.co.uk/news/article-1259229/Dozens-women-claim-10m-surgeon-George-Rowland-botched-bladder-operations.html

    • karen newman says:

      I am still trying to find out which device I had fitted so I can report it to the MHRA, once I have the details I will report it.
      It’s a shame the medical profession still treats woman in this barbaric manner, what worries me so much about it all, is how many woman are out their unaware they may have a problem on the horizon.
      Is this the NHS’s ticking timebomb.

  5. Here is the link to The MHRA UK for reporting avderse incidents in other words complications of transvaginal mesh.

    To report complications of transvaginal mesh with Medicine Health Regulator UK you will need to know the Device name, batch number and serial number.

    This can be obtained by asking the Consultant who did your operation or writing to the ch9ief executive at the hospital involved with your surgery and asking them to supply this information back to you inorder to record the adverse incident with The MHRA UK.

    My own local hospital I found out did not keep these details of the device which is totally out of order, but you can still register with the MHRA UK because the surgeon should know of which pharmacutical company that he chooses to supply and use.

    Link to recording your adverse incident with MHRA

    http://www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm

    • Hilary says:

      Teresa – as you know if it wasn’t for the fact my partner saw your article in the Liverpool Echo, I too may be another sufferer like you. I have posted information that I found on your wonderful site onto the talkhealth website warning other unsuspecting women as I was, and have had some replies but many viewings.

      I have an appointment at my GP’s surgery on Friday (the people who referred me and then eventually I was offered the TVT procedure by the hospital) and I will show them the information I have taken from your site including the statistics which I’m sure they will not be aware of. Hopefully this is another way of informing the ‘intermediate’ people about the dangers of something I thought would just be ‘an easier option than having to remember to do my pelvic floors’. I have also found 2 non invasive ideas which I will ask them about.

      I agree with the other ladies who have left comments – you and many other ladies are working so very hard to make the powers that be aware of this barbaric procedure. If you weren’t doing this, people would, like me, just go ahead with the procedure and then maybe end up in agony for the rest of their lives.

      Thank you for making me aware.

      • Dear Hilary

        I thank the day that you found The Meshies United Group UK also.

        Having done your research and asking questions about this operation and also talking to our members I hope that this was an eye opener in you making your decision whether to have this mesh device inserted or not.

        This is what we are about in making people aware of the serious complications that can happen by having mesh inserted within the bladder area.

        Teresa Hughes

        • Dear Teresa
          Thanks for all your hard work and endeavour. I am to see a surgeon re a mesh repair as I had an anterior prolapse which was repaired normally but has failed. Been referred to another surgeon by the one who did the origianl repair as this new one is an expert in mesh repair, supposedly . Wasn’t sure about it so after doing a bit of research and reading all the horror stories on American sites and then finding yours; it has frightened me so much I shall refuse a mesh repair and tell him the reasons why too. I have slight discomfort at the moment but that is nothing compared to all the horror stories. The surgeon was so matter of fact about it – no mention of what possible/probable consequences could occur, and do they actually give a damm? I am appauled by the Medical Health Regulatory body – what purpose do they serve for us! (Another quango of self serving individuals). I will be keeping an eye on your site as this issue makes my blood boil. You have probably saved me from a terrible fete.

          Patricia

          • Dear Patricia

            I am so glad that you found our site and that it has helped you deal with your situation.
            Thank you for your input and please feel free to join our site if you need help and support.

            Teresa

  6. Anne Darwin says:

    One way of supporting my sister was to accompany her to one of the many medical visits to her surgeon to discuss her health problems after the implant of the mesh medical device transobturator tape .

    The impression I have come away with is that surgeons are only interested in the success of the operations they perform. The quality of the device they insert into a woman or the exactness of the procedure they carry out is not their main priority.

    The surgeons must be made aware that this procedure is barbaric and life threatening. The ‘blind’ operation they perform to implant this foreign body causes latent problems. They should be made to accept that they are partly to blame for ruining the lives of women because they continue to perform these operations.

    So to all you surgeons out there I would say learn to listen to the patients in distress.

    • Dear Anne

      Yes you have been their at my consultations many times as an observer and not a sufferer like myself.

      It is really interesting to hear your view on what consultants really think about these mesh devices.

      I am really glad that you have been able to be with me and listen also at these consultations because as Lyn says in her post these people were also telling me at one time that I was a rare case.

      Unfortunately you do think you are alone and “rare” and it can play havoc with the mental side of things as well as the physical health side.

      These consultants I feel have been playing mind games and unfortunately that is the way some people are they try to play around with your head.

      Unfortunately we have worked it out over the years and we are in no doubt that we are not rare cases regarding transvaginal mesh complications.

      Teresa Hughes

  7. karen newman says:

    I still can’t believe these aweful things are being put in! It defies belief that a device that can do so much harm is put in by those that swear an oath to first do no harm! What hipocrits! keep the good work up Teresa

    • Dear Karen

      I have talked to many consultants about this mesh operation. While they admit they have not had robust clinical trials they try to defend by saying that for 80% of women it works.

      Well what about the other 20% of women that are suffering and have no life.

      The are also not even reporting the adverse incidents to The Medicine Health Regulator about the mesh removals they are performing.

      The consultants in The United Kingdom need to be open and transparent and stop hiding the evidence that is there for all for to see in the figures I received back from parliament. via my member of parliament Shaun Woodward.

      The Medicine Health Regulator UK need to grow a backbone along with the consultants and start working together and listen to the women who are suffering on a daily basis.

      Please keep on top of getting a reply back from the MHRA UK when you report the adverse incident.

      Teresa

  8. Lizzy Blanch says:

    Theresa is doing a fantastic job to highlight the misery that mesh sufferers are experiencing. Many feel alone and isolated and very frightened at what is happening to them and lives are changed forever. Once the realisation and suffering starts life is not the same with continual worry about the future and drugs to over come pain. How dare the medical profession ignore the findings and the evidence and let it be sidelined. Carry on campaigning Theresa we are right behind you and whatever you need and we can help with let us know.

    Even throughout her own suffering Theresa is relentlessly helping other women and campaigning that not one more woman be maimed by this barbaric operation.

  9. Lizzy Blanch says:

    I’m not sure if my last comment got through as it seemed to crash! Theresa is doing a fantastic job of highlight the suffering of mesh sufferers, It is disgusting and disgraceful that the knowledge is falling on deaf ears while the pharma companies are still making rich pickings on the suffering of women fitted with these barbaric devices. If a few politicians wives mothers and girlfriends had them or even maybe some of the royal family someone might take some notice!! Keep going Theresa you are an inspiration to all of us and speak for those who now have the knowledge of what the mesh can do and the voice of those who are still in ignorance.

  10. Linda Gregory says:

    I thank the day I found Tereasa and the Meshies site I was suffering alone thinking it was just me but now I know I am not imagining this insufferable pain.

    Well done

    • Dear Linda

      I also thak the day that you found Meshies United Group UK.

      I know that you felt so alone and isloated but not anymore as you have our group and our terrific supportive members to talk to and contact when ever you need our help.

      Love Teresa

  11. Kate R says:

    Well done Teresa on highlighting the under-regulated use of mesh in women. There are many surgeons fitting a wide range of these devices, many of whom are inexperienced and who do not seem to care about the permanent damage done to us and the effect on our families. Thjs situation has to change because patient welfare should be the top priority.

    • Hello Kate

      Maybe when I have my visit and chat to see Professor Christopher Chapple Chair of European Urology we may find a way forward to work together on lobbing Europe about changing the law about how these mesh medical devices are put out onto the worlwide wide market.

      Teresa xx

    • Hello Kate

      Maybe when I have my visit and chat to see Professor Christopher Chapple Chair of European Urology we may find a way forward to work together on lobbying Europe about changing the law about how these mesh medical devices are put out onto the worlwide wide market.

      Teresa xx

  12. jo read says:

    well done to teresa for showing us the way , i have reported my adverse incident and never heard a thing , why are they putting these devices into us and not helping us with our pain and suffering .
    my life has not been the same since this time last year when i had the toto put in

    • Dear Jo

      Please contact The Medicine Health Regulator once again about what has or is happening regarding information of your adverse incident.
      This seems to be rather a long time with no contact or communication back to you.

      My past dealings with The Medicine Health Regulator is they would rather say nothing and ignore people.

      This establishment need a kick up the backside because they are failing the public at large in The United Kingdom

      Take care. Teresa

  13. Karen Hughes says:

    Teresa has tirelessly worked to give us all hope & comfort in her website, these surgeons that use mesh & then are unable to put right the complications need to be held to account.
    All issues surrounding mesh & it’s devastating effects need to be in the open so people know the risks.
    Thank you Teresa & her team fo all the campaigning.

    • Dear Karen

      As you say the serious issues/complications related to this transvaginal mesh operation should be out into the open and more transparent.

      The surgeons who perform the operation now have more data from previous years and so does The Medicine Health Regulator in the UK but still they continue to ignore the statistics and facts.

      I found out the other week when I spoke to 2 women who had recently had this operation and were suffering almost immediately, that there are still surgeons out there offering women this operation as a tape nothing is explained in detail.

      They are also not even telling them or listing on the consent forms about the groin and leg pain which is a well known factor.

      Even today with the information that is out there about complications that certainly surgeons must read about they are still not doing there duty of care in listing all risks.

      Teresa

  14. lyn says:

    I have been in contact with Teresa for 3 years now.
    I often think back to the days when I felt so alone,I was made to believe I was a rare case the words said to me “Its rare almost unheard of for complications regarding this procedure” those words will stay with me for the rest of my life.
    During those early days I was so alone,after all I was a rare case….Well i was told I was!
    i managed to contact another sufferer, this being Teresa. I could not believe I had someone who was suffering as I was.
    I have been in contact,and have visited local women who have suffered dreadful complications regarding this so called simple operation that we were all made to believe.
    Teresa has given me encouragement to carry on supporting women,it is not easy when we are all suffering so much,not only ourselves but our families and partners.
    Teresa you are an absolute star.
    You find out so much information and make us all aware.
    You always have time to talk and help other women.
    You spend so much of your time,even though you must really struggle at times because of your health,going to places like Downing Street. MHRA.
    Most importantly getting the meshies united support group up for us.
    Teresa you are one hell of a women,you have helped so many women like myself and many others.
    One day all this will come to light.It will just be a matter of time.
    The MHRA cannot ignore our complaints far too many women are being harmed.
    Clearly someone is not doing the job they are being paid for.
    We cannot be ignored for much longer.
    I thank you again Teresa for everything you do, your determination and guts and hard work helps us all so very much.
    Lyn

    • Dear Lyn

      I remember it was early 2009 when we first contacted one another over this mesh medical device and the complications and cause of our suffering.

      The contact was through my Petition in 2008 to ask the government in England about the serious complications that where occuring with this mesh medical device.

      How time has flown by and how we have over the years found out a lot more research and moved forward with trying to get recognition of the serious complications brought about by this mesh.

      Over the last 3 and half years there is a need for you be recognised for the work you have done in the background.

      I know that you have met and talked tirelessly to many women who are suffering complications of transvaginal mesh and have helped and supported them as best that you can.

      Please keep up the good work.

      Teresa xx

  15. anurse says:

    From the USA, thank you for keeping up the fight overseas. We women, everywhere, will speak out about this travesty of justice. We will not be kept silent.
    Transvaginal mesh (TVM) was allowed on the market in the USA by the FDA’s faulty and antiquated (per the Institute of Medicine) 510(k) process. This process says a medical device can be “cleared” (not “approved”) for use if it is shown to be “substantially equivalent” to another device already on the market… Even if that device has been removed because it was deemed by the FDA to be “misbranded and adulterated”. For example, the ProteGen was recalled by the FDA but can still be used and has been used as the initial “predicate” for other transvaginal meshes, including the TOT. This makes sense?
    The American Urogynecologic Society (AUGS), in a 2009 educational “Webinar” for it’s members, said that even in surgeons “with thorough anatomic knowledge, complications will occur” from TVM surgery because it is a BLIND procedure. Mesh “kits” are pretty much “one-size-fits-all”. The same kit is used in a woman who is 5’1″ and 100 pounds as for a woman who is 6 feet tall and 250 pounds. We are different and do not have the exact anatomy! NO effort is made to avoid important pelvic nerves by using monitors during the surgery as is done in other surgeries where damage to nerves is a possibility, and then, to make matters worse for the poor patient, nerve damage frequently goes undiagnosed by the ones (doctors) who are causing it. This says nothing about the severe local and systemic auto-immune-type reactions that are seen in many with mesh. Papers and studies are showing that mesh is not inert, as has been reported for years.
    Once again, thank you for all of your hard work! We will keep it up on this side of the pond!

  16. Thank you so much for putting into words the horror, the pain and the suffering endured by 1,000′s of women worldwide who have had this barbaric transvaginal medical device inserted.

    The history also of how it evolved and was allowed to come onto the market worldwide is invaluable.

    We have to keep the momentum going both in The United Kingdom and Overseas.

    Some days this is a very hard task to do as we are all people who are suffering on a daily basis.

    In The United Kingdom it would appear that The Mhra, The Department of Health and The Government think that we will just disappear.

    I am afraid that will not happen. If anything we are more determined than ever to have our voices heard.

    I am so glad of your input and thank you so much for your comments.

    We will continue to highlight our plight in The United Kingdom and wish you all good luck in America as you continue to do the same.

    Teresa
    meshies united group

  17. Jane Akre says:

    Teresa- Thank you so much for keeping us updated in the U.S. – Sometimes we forget this is a global problem. I’m curious how your court system differs from the U.S. to allow for product liability or negligence lawsuits against the manufacturers. We have barriers to getting to court but I know it is not much better in other places.

    thanks again for all you do!

    • Dear Jane

      Clinical Negligence is one route that I went down in England.
      To the ordinary lay person the legal system is baffling.

      They talk about Duty of care and Breach of Duty these are some olf the area’s that are looked at as to whether the Consultants are negligence is these instance.

      Cl.inical negligence timescale is 3 years in England from when you find out that you have a problem caused by whoever or whatever.

      Then there is the route to go down and looking and finding a medical expert who will write a good and honest report after accessing many years of your hospital records.

      It has to be noted that this person can be called to court to take an oath that what they are saying is the truth.

      This in itself cost me £1,800 with no guarantee so this is dead money before you start depending how your case is funded. Then the hospital records cost around £350 pounds this is also dead money depending how your case is funded.

      There are quotes from past court cases reference: The Chester v Afshar decision.

      The House of Lords decided that in the Chester v Afshar case that doctors should treat us as adults and properly explain the implications of a particular operation so that if a patient decides to go ahead with it they did so knowingly fully what was involved.

      Also there was no court finding in this case as to what level of compensation for the failure by the doctor to peoperly advise should amount to.

      These are some of the area’s that I have come across myself.

      Teresa

  18. Ingrid Z. says:

    As fellow sufferers we need to stay “united” in our cause. As the problems are now aired more widely – more websites and other means of supplying information will come to the forefront. This cannot be halted. We need all the publicity we can get.
    However, we need to be grateful to the original sites and their founders and members, who are all working tirelessly to further the cause.Two petitions to No 10 Downing Street in short succession of each other is a remarkable achievement – well done!! It really does not matter who got to No. 10 Downing Street first. It mattered that it really happened! They know themselves, who they are!
    We all must for ever be grateful and as a Christian I thank God, my Lord and Maker that I was able to find these websites and their founders. Because without the web I would still be in agony and still in a state of panic and helplessness and utter despair.
    Let’s work to one aim only – to save other women (and men) from the suffering that mesh implants cause.
    Support those who need the moral support at the time of their journeys, and this means give freely points of contacts, so that the seeker can move forward with the correct information. Let’s not keep anyone in the dark.! Surely this is why we have all suffered in the first place L A C K of knowledge and lack of honest disclosure from the skilled professionals we all trusted, initially! Let’s help any new comers and lead them towards better understanding their problems and the opportunity of making an informed choice so they could move forward by making a choice to have this tape removed. So they may be fortunate to have this tape removed, successfully, as I have. Let’s pray that we find more surgeons who are willing to devote their skills and care to removing the tape by Laparoscopy.
    Please keep going, stay focused and s t a y u n i t e d. It is worth taking a stand against things that are wrong.
    “Power to our elbows and force to our pens” Please do your bit in your corner of the globe by raising awareness to the problems of surgical mesh implants. I Z

    • Ingrid

      Thanks very much for your support and input.

      Teresa

      • In The United Kingdom there does seem to be the publicity about the dangers of transvaginal mesh either in the media or television or advertising from solicitors.

        I wish it was more like America and the discussion is more transparant.

        At least The Fda gave out Health Publications. What do we have in the UK a Medicine Health Regulator who bury their heads in the sand like an ostrich.

        It is a hard slog to even try to get this serious issue out in the open.

        Women in the United Kingdom do not seem as pro-active as the women in America.

        For all the talking they do on websites they need to more pro-active and set about having their voices heard instead of sitting and suffering in silence.

        Once again I reiterate that The Dept of Health, The government in England and Members of Parliament, The Health Select committee and especially The Medicine Health Regulator UK are failing the public at large by not even having discussions on such a serious issue.

        The answer I keep getting back is that they are having discussion and have not reached a conclusion.

        Over one year has passed since March 2011 when they said they where looking into transvaginal mesh medical devices complications.

        They have since then had another meeting in March 2012 and have not printed the minutes of the meeting that took place.

        Apparently under The Freedom of Information Act they do not have to release the minutes of their meetings until they wish to do so.

        What a load of tripe. Why are they hiding away and why have they not answered the question about nearly 3,000 mesh removal operations that have not been recorded as adverse incidents according to the hospital statistics in English Hospitals.

        I am ashamed to live in this country England. it is a disgrace in the way that they treat people regarding health problems when the public ask questions. It is like going backward in time and living in a third world country.

        They send you around in circles and direct you to another department somewhere else and by the time you have finished no one has answered the question and you are back where you started with no answer.

        These people in charge are not doing the job they are employed to do and radical changes need to be made.

        Teresa Hughes
        Meshies United UK

        • Caitlyn says:

          I completely agree, Teresa.

          I sent the MHRA an email with a simple enquiry in plain English about the TVT device – asking when it was appproved, who approved it and on what grounds. I received a reply which was complete gobbledygook and, as you described, directing me to other departments and websites which were also very technical and difficult to navigate.

          Reading between the lines, I think they just didn’t have the answers! What kind of organisation responsible for ensuring the safety of the public from medical devices would not be able to answer these sort of questions?

          I don’t know what the answer is, Teresa. I think we need some key figures on our side because the MHRA seem like a toothless organisation which, as you point out, is in need of a radical shake up.

          Caitlyn

  19. Caitlyn

    The MHRA in the United Kingdom are a toothless watchdog.

    I would really like someone to define what they actually do in the way of protecting the public health.

    I feel that when sufferers try to ask The MHRA questions that require an answer they do not appear to have the professional capabilities of how to reply.

    i WOULD LIKE TO KNOW WHY IT TAKES THEM 20 DAYS TO REPLY BACK AND THAT IS IF THEY DO REPLY AT ALL.

    Teresa

  20. This is what this transvaginal mesh has done to me.

    I now require 2 major operations.

    After 6 years this mesh has eroded into the urethra.

    I am now being told that I require excision of transvaginal mesh and macroplastique and utheral diverticulas and also a lump in the urethra and interposition of a martius fat pad.

    They want to take tissue from the labia to fix the urethra.

    Why in the name of God are they using this mesh and destroying our lives

  21. Vincent Argent says:

    Gynaecological and urological surgeons rarely report the complications with vaginal mesh procedures.

    Thay are very common and very severe.

    The serious complication rate is about 5%. This is highly significant for a procedure performed for a benign, non life-threatening condition.

    Women are very poorly infomed about the risks of these procedures during the consent process.

    The MHRA has been asked to set up a National Register of all mesh insertion and removal procedures. Following the breast and hip implant scandals, the MHRA needs to urgently address this issue.

    Vincent Argent FRCOG
    Consultant Gynaecologist

    • Amy G says:

      You bring up a good point at the FDA hearing on synthetic slings for the treatment of SUI. The FDA presented the reports of serious adverse events received between 2008-2009 (the FDA has already acknowledged that underreporting exists estimating the reports represent only 1-10% of the true problems)

      Of 1,367 reports only 91 of the reported events came from physicians and surgeons. 1,276 came from industry. Industry is apparently doing their own monitoring. None of the voluntary reports by patients suffering with mesh complications are included in their analysis.

      • Amy G says:

        I meant to say 2008-2010

        • I took a petition to 10 Downing Street England the Prime Ministers residence in January 2012.

          I also had talks at Westminster London with my member of parliament Shaun Woodward who asked The Secretary of State for Health to reveal the number of tape insertions and removals for the last 8 years.

          The response back revealed that 64,000 operations to insert tvt and tot took place from 2006 to 2011, they kept no Data before 2005. This is for England alone. The statistics also revealed that nearly 3,000 mesh removals had taken place amongst the same years. These where from the NHS Source hospitals.

          The MHRA HAVE only HAD ONLY 107 ADVERSE INCIDENTS RECORDED TO THEM

          The MHRA have said that they did not know about these stats, and also shall we say at this moment in time think maybe it is incompetent surgeons putting them in and not the medical device itself.

          I say that nearly 3,000 mesh removals in NHS sources excluding the private sector and for England alone is a rise of 4.6%. These stats are still not registered with the MHRA nad this needs to be addressed urgently

          Teresa.

    • Dear Vincent

      Thank you so much for your input and comments. I have recently met with The Medicine Health Regulator in July 2012. I have tried to prevent this disastorous mesh ruining my quality of life and have been failed by 2 hospitals one in Merseyside and one

      • Dear Vincent

        Thank you so much for your comments and input on this issue.

        I have recently met with Dr Susanne Ludgate at The Medicine Health Regulator UK and spoke about my complex surgery and transvaginal mesh tapes.

        There needs to be more transparancy where the patients need multiple surgery and it is not fully explained and for this reason I have told Mr. Julian Shah at London University College Hospital that I do not want him to operate on me.
        Mr Julian Shah did not have the decency to reply back to me with how many mesh removals he has done.

        Plus I need lots of questions answered about this mesh and the surgery I now require. The guidelines out there now say “ask your consultant how many operations has he undertaken and the success rate” is anyone abiding by this when you ask the question.”No they are running scared”.

        Teresa

    • Liz Reece says:

      Vincent,
      Thank you so much for your input on this valuable site. I am one of the case histories that Jane has included and am one of the lucky women who had the TVT safely removed and am back to a very happy and active life. But I continue to research and campaign against this mesh.
      It seems that UK medics are completely blind to the situation of mesh complications, and the cases finally coming to justice in the USA. You are an exception and I do know of a few others. But you are rare.
      My next letter is to the Royal College of Obstetricians and Gynaecologists whose on-line leaflet on SUI states that complications for TVTs are:

      “About 4 out of every 100 women initially have problems with fully emptying the bladder, but does not
      seem to be a long term problem. 3 to 15 in every 100 women pass water very often, or get little
      warning of needing to go to the toilet or have trouble getting to the toilet in time.”

      Then they include an entry for synthetic slings. I am not clear what the difference is between the ‘synthetic sling’ and a TVT but they include a more accurate set of complications listed for this type of surgery:

      “More risk of extra problems than natural tissue slings. For up to 16 in every 100 women the sling material moves into the vagina. Up to 11 in every 100 women may have problems in fully emptying the bladder. About 2 in every 100 women need a long term catheter. May reduce quality of life.”

      This completely ignores the statistics that Ethicon themselves include in their clinical data which is freely available on line here: http://www.ethicon360.com/products/gynecare-tvt-retropubic-system-tension-sup-incont

      19% erosion reported after 5 years for TVTs. WHAT!! How can that go without serious comment on the dangers of this product. 5% erosion at 6 weeks is cause for alarm.

      Yet women are repeatedly being ignored with serious complications – in part because it seems that the consultants do not know what they are looking for or have any idea of the devastation of mesh. They need educating! How can we do this in the UK, Vincent?

      Warm regards,
      Liz Reece

    • Caitlyn says:

      Vincent

      You have hit the nail on the head and it is very brave of you to speak out and tell the truth about synthetic mesh.

      As you point out, women are very poorly informed about the risks when they have this surgery and then when they have experienced problems and write to different authorities afterwards expressing their concerns, they receive ‘cut and paste’ replies remarking that all surgery has risks. This is very dissmissive of their issues.

      Many organisations have called for a national register of all implants but the MHRA seem to be doing nothing. I have even heard that they have put their Independent Review of meshes on hold. There seems to be no sense of urgency.

      Given the growing controversy surrounding mesh, It’s incredible that mesh is still promoted as the only surgical option when women are going for consultations.

      Caitlyn

  22. MarieAnn says:

    Teresa, How accessible is your queen? Since she is a woman, maybe she will sympathize with you as to what damage is being done by TVM and the NHS and health dept in their ignoring statistics. I suppose she visits NHS hospitals, have you hand delivered a petition to her? I’m just wondering from across the pond. Praying the *hit is hitting the fan over here. As the saying in America goes, “Women are the heart of the home”, and we are being destroyed world-wide by this travesty.

    • Dear Marie Ann
      The Queen is not accessible at all although, maybe a letter to her wont go amiss.
      She did team up with James Bond at The Olympic opening ceremony and jumped out the helicopter into the olympic stadium. Who knows!

      I have written to every Tom Dick and Harry in this country about this issue.

      I beleive that they have amber alerts out on me now wherever I turn up. (That is a fact) Not to worry it will soon be turning to red alert.

      I am so glad that the women in America are keeping this issue going because it certainly needs more media coverage.

      I’ll send the quenn of england a letter about this mesh and see if I get a response back.

      Take care Teresa

  23. David says:

    @ Teresa We need to go to the next level there are several of us groups and we should team up and go to the INTERNATIONAL level. It seems your country nor ours is listening and the madness has to stop and women need help as most have no means of treatment health insurance due to loss of their jobs etc. Watch http://TVTNO.org for regular updates as we have tons in the works!

    • Dear David

      I am all for going International in some way.
      This would be a huge undertaking.
      I would not rule it out in the future.
      Maybe we could talk sometime properly about a way forward
      I am about to start having a number of surgeries due to this dreaded mesh medical device but will still carry on trying for justice for all who have been maimed.

      Teresa

  24. I have just had urgent surgery to have my gallbladder removed last week it was full of infection and had adhered itself to other organs.

    It makes you wonder about this mesh as mine has shattered like shrapnel who knows where it will appear next

    What a nightmare! then I received a call to have mesh removal 26 September it’s like waiting for a bus and 2 come along.

    The mesh removal cannot happen for at least 6-8 weeks. I’m looking forward to that like a nail in the head.

    So it’s mesh removal next, urethra reconstruction after that, then removal of utheral diverticulum from bladder neck and who knows after that.

    But I will not be beaten by this dreaded mesh and neither will my members as we continue with our plight in The United Kingdom to get this out into the public domain.

    Good luck to all of you overseas in raising awareness about this dreadful mesh,

    Teresa Hughes meshies united group uk

  25. cathy munsey says:

    i am having mesh problems too. i have cancer on top of that so i most likely will never have it removed. it will probably help kill me along with the cancer. anyway, i have written the fda also and they have responded. but they need to do something now, not years later when it will be too late for some of these women. we cannot all afford to get this surgery done. we need help from our government! i am so ashamed of our government too for letting these doctors put this mesh into women. i remember asking my doctor if this mesh was safe and he said yes it was. i trusted him with my life! and now he has retired and moved out of this area. that is most likely the reason for he wasnt even old. i hear he is practicing in the plano, texas area but not in gynecology. but you can bet i will find out why he left here. i am determined.

  26. Hello Cath

    Thank you for your input. The government in the united kingdom as well as other countries should be ashamed of themselves. They are absoloutely useless when it comes to talking or doing anything regarding the complications of this dreaded mesh and helping women.

    It would appear that you had enough to deal with without this mesh inside you. These surgeons these days they seem to retire early and disappear.of the planet.

    I admire your determination to find him and ask questions of him. Please take care.

    Teresa

  27. Rita Bridgman says:

    Teresa please contact me as soon as you can – I’m going in to have mesh removed that may have cut through to my bowel. But I also have a second operation to repair a prolapse with mesh but apparently not the same mesh as was used 3 yrs ago 2009). I need your advice.

  28. Dear Rita

    I do not know if I missed this post but please contact me at the website http://www.meshiesunitedgroup.co.uk and then we can speak to one another.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.