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

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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.

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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.

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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