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The Voices Today on Messed up Mesh (TVT Mum)
Help and support to both men and woman who have had the medical device TVT Retropubic, TVT-Secur, TVTO and TOT, synthetic polypropylene mesh for hernias, prolapse, stress incontinence and bladder and bowel disorders. You're not alone!

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United Kingdom and Europe
Press and Media

press and media in the UK woman reading newspaper

25th October 2012
New webpage:
The Telegraph and the BMJ
Faulty medical implants investigation:

FIFTEEN articles and videos to watch, The MHRA Statement and the European Commission Revision of the medical device directives
Please click on the link below to view all the investigations:
www.tvt-messed-up-mesh.org.uk/the-telegraph-uk-bmj-faulty-medical-implants-investigation.html >>>

25th October 2012
Press statement:
MHRA statement on European regulatory system for medical devices

Date: 24 October 2012
Time: 15:00
Subject:Following stories in the Daily Telegraph about their joint investigation with the British Medical Journal into the European regulatory system for medical devices, the MHRA have released the following statement:
Please click on the link below to read more:
www.tvt-messed-up-mesh.org.uk/latest-news-from-the-mhra.html >>>

24th October 2012
The Telegraph - UK
By Claire Newell and Holly Watt
9:56PM BST 23 Oct 2012
Faulty medical implants investigation:
'We can help you label it European so China is not on packaging'

Firm tells reporters posing as representatives of hip implant maker how to bend the law. For the female executive from the Hungarian firm which is authorised to approve medical devices throughout Europe, the brochure outlining a proposal for a new “metal-on-metal” hip implant should have rung alarm bells. The two people purporting to be executives from a Chinese firm called “Changi” should politely have been told that such a product could be risky and certification might be a problem.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/healthnews/9629307/Faulty-medical-implants-investigation-We-can-help-you-label-it-European-so-China-is-not-on-packaging.html >>>

24th October 2012
The Telegraph - UK
By Holly Watt, and Claire Newell
10:14PM BST 24 Oct 2012
Faulty medical implants investigation:
'We’re paid by manufacturer so want deal to succeed'

The shiny office block in a business district of Seoul is not the most obvious place to find an organisation offering to authorise a medical product for use in patients throughout Europe. But, earlier this month, in a meeting on the 14th floor of the building in South Korea, two undercover reporters from The Daily Telegraph posing as representatives from a Chinese company were discussing just such a licence. As the air conditioning hummed in the background, the four smartly dressed Korean men began their presentation — in reality, a sales pitch about how they would effectively be able to guarantee that a metal-on-metal hip implant which should be banned could soon find its way legally into British operating theatres.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/healthnews/9632006/Faulty-medical-implants-investigation-Were-paid-by-manufacturer-so-want-deal-to-succeed.html >>>

24th October 2012
The Telegraph - UK
By Holly Watt, and Claire Newell
10:14PM BST 24 Oct 2012
Faulty medical implants investigation:
Patients failed by poor implant regulation, say surgeons

Patients are being “failed” by the poor regulation of artificial hips and other medical devices, which is potentially allowing dangerous products to be used in Britain, the Royal College of Surgeons warns. In a letter to The Daily Telegraph, the Royal College and the British Orthopaedic Association (BOA) warn that this week’s revelations about the system are a “stark reminder” of the “urgent need to address the regulatory flaws”. A joint investigation by this newspaper and the British Medical Journal discloses that the regulation of European medical products is also being “sub-contracted” to questionable Asian firms.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/healthnews/9631974/Faulty-medical-implants-investigation-Patients-failed-by-poor-implant-regulation-say-surgeons.html >>>

24th October 2012
The Telegraph - UK
10:00PM BST 24 Oct 2012
Another article and video
South Korea firm offers 'one stop shop' for licencing medical implants

In a joint investigation by The Daily Telegraph and British Medical Journal into the regulation of artificial hips and other medical devices in Europe met with firms which offered to be a 'one stop shop' for authorising a medical product for use in patients across Europe.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/healthnews/9631655/South-Korea-firm-offers-one-stop-shop-for-licencing-medical-implants.html >>>

24th October 2012
The Telegraph - UK
9:50PM BST 23 Oct 2012
Another article and Video
European regulator explains how to mask the real origin of a medical implant

Slovakian firm offers undercover reporters from The Daily Telegraph and BMJ 'marketing' advice about how to conceal the country a dubious medical implant really comes from.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/healthnews/9629268/European-regulator-explains-how-to-mask-the-real-origin-of-a-medical-implant.html >>>

23rd October 2012
The Telegraph - UK
By Holly Watt
6:55AM BST 23 Oct 2012
Faulty medical implants investigation:
Patients treated 'like guinea pigs’

European patients are being treated like “guinea pigs” because of lax rules governing medical devices, a senior American regulator claimed last year.
For years, concerns have been raised about Europe’s system for approving hip replacements, artificial knees and other products which have undermined the health of thousands of Britons. In America, a government agency, the Food and Drug Administration (FDA), assesses whether companies should be able to market a device.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/9626920/Faulty-medical-implants-investigation-Patients-treated-like-guinea-pigs.html >>>

23rd October 2012
The Telegraph - UK
By By Claire Newell and Holly Watt
6:55AM BST 23 Oct 2012
Faulty medical implants investigation: 'Sometimes we cross the line'

Slovakian firm tells undercover reporters it is happy to approve faulty hip implants in the EU.
The offices of the firm in a former Communist town in Slovakia were lined with burnt-out kettles and toasters, testimony to the “safety” tests which take place in the building. EVPU is one of the private companies given the task of assessing, on behalf of the Slovakian government, whether electrical products are safe to be sold throughout the European Union. But the company’s activities are not restricted to licensing domestic appliances to see if they blow up when plugged in. Under European rules, the firm is also authorised to license medical implants such as artificial hips and knees.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/healthnews/9626911/Faulty-medical-implants-investigation-Sometimes-we-cross-the-line.html >>>

23rd October 2012
The Telegraph - UK
By Carl Heneghan
Faulty medical implants investigation:
'A system in disarray that favours manufacturers at the expense of safety'

6:55AM BST 23 Oct 2012
The role of medical devices in health care is essential. Yet a number of recent high-profile failings have prompted serious concerns about the current system of regulatory approval, says Carl Heneghan. In terms of regulation, the role of the European Union is to ensure the highest level of patient safety. But what has been found out by the Telegraph and the BMJ’s investigation now puts this claim in serious doubt.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/9626921/Faulty-medical-implants-investigation-A-system-in-disarray-that-favours-manufacturers-at-the-expense-of-safety.html >>>

23rd October 2012
The Telegraph - UK
By Telegraph View
8:04PM BST 24 Oct 2012
Patients before profits

Medical implants should be subjected to rigorous clinical trials The inspiration for this newspaper’s investigation into the regulation of hip and other implants – carried out jointly with the British Medical Journal – was the PIP scandal. How, we asked, could tens of thousands of women have received breast implants filled with shoddy materials?
Please click on the link below to view the full article:
www.telegraph.co.uk/comment/telegraph-view/9630804/Patients-before-profits.html >>>

23rd October 2012
The Telegraph - UK
By Jeremy Hunt, Health Secretary
9:57PM BST 23 Oct 2012
Jeremy Hunt: I will not tolerate British patients being put at risk

Like many people, I was shocked and appalled to read in The Telegraph that a regulator in Europe said that it was “on the side of the manufacturer” when it comes to licensing products — such as hip replacements — for use in British patients
www.telegraph.co.uk/health/healthnews/9629323/Jeremy-Hunt-I-will-not-tolerate-British-patients-being-put-at-risk.html >>>

23rd October 2012
The Telegraph - UK
By Claire Newell and Holly Watt
9:57PM BST 23 Oct 2012
Faulty medical implants investigation:
Regulators’ trail of deception has been exposed, says chairman

Andrew Miller, the chairman of a parliamentary select committee investigating the sub-standard regulation of medical devices in Britain, has said that a “trail of deception” has been exposed in the system.
www.telegraph.co.uk/health/9629337/Faulty-medical-implants-investigation-Regulators-trail-of-deception-has-been-exposed-says-chairman.html >>>

23rd October 2012
The Telegraph - UK
By Claire Newell and Holly Watt
9:50PM BST 22 Oct 2012
Article with video
Faulty medical implants investigation:
Patients’ health put at risk by unscrupulous EU regulators

British patients’ health is being put at risk by unscrupulous European regulators who are prepared to license potentially dangerous medical implants for sale in this country, The Telegraph discloses.
Please click on the link below to view the full article:
www.telegraph.co.uk/health/9626756/Faulty-medical-implants-investigation-Patients-health-put-at-risk-by-unscrupulous-EU-regulators.html >>>

17th October 2012
Daily Mail - UK
Don't be caught short: From botox jabs to a plaster on your back, the treatments that can fix a leaky bladder

By Carol Davis
PUBLISHED: 16 October 2012
Please be sure to read the submitted comments end of the article, to view the article click on the link below:
http://www.dailymail.co.uk/health/article-2218230/Incontinence-Dont-caught-short-From-botox-jabs-plaster-treatments-fix-leaky-bladder.html >>>

13th February 2012
Press Release
For Immediate Release:
Monday, February 13, 2012
End our ‘human guinea pig’ hell

A TIRELESS campaigner is calling on surgeons to stop treating incontinent women as medical guinea pigs.

Currently, medics aim to cure stress urinary incontinence (SUI) by inserting a device known as trans-vaginal tension free tape (TVT), or trans-vaginal tape obturator (TVT-O and TOT), but both have left thousands of women, partially disabled and struggling to rebuild shattered lives.

Lorraine Evans, founder of support group, TVT Mum, insists there ARE alternatives to surgery, and that surgeons are keeping sufferers in the dark when it comes to spelling out potential dangers.
To read more please click on the link below:
www.tvt-messed-up-mesh.org.uk/13-feb-2012-press-release-end-our-guinea-pig-hell.html >>>

4th February 2012
Published Jan. 5, 2012 9:51 AM ET
France eyes EU move amid breast implant scandal
JAMEY KEATEN, Associated Press

PARIS (AP) — France wants the European Union to stiffen its rules on authorizing medical devices amid a breast implant scandal involving a French company and affecting tens of thousands of women worldwide, the health minister said Thursday.

Xavier Bertrand called for "an unprecedented change" in EU rules to put authorizations for medical devices, including silicone breast implants, on a par with rules already in place for prescription medicines.

The implants, made by now-defunct French company Poly Implant Prothese, were pulled from the market last year in several countries in and beyond Europe due to fears they could rupture and leak silicone into the body. France has recommended that the estimated 30,000 women in France with the implants get them removed after more than 1,000 ruptures, and agreed to pay for the procedure.

The whereabouts of the company's former director, Jean-Claude Mas, are unclear — and he is being sought by authorities.

The scandal has put pressure on French health authorities for allegedly not doing enough to vet the quality of a product used by untold thousands of women both in France and abroad.

Jean-Yves Grall, France's top doctor as head of the national health directorate, was holding a closed-door meeting with industry players and top health officials on Thursday.

"We need new rules ... and this modification needs to happen at the European level," Health Minister Bertrand told LCI TV. He said he planned a conference call on the matter with EU counterparts.

Frederic Vincent, spokesman for EU Health and Consumer Policy Commissioner John Dalli, said Brussels had already planned to revise its directive on medical devices — which covers some 10,000 items, as varied as bandages, contact lenses and hip replacements — in the first half of 2012. It would strengthen national regulators and improve information-sharing.

Vincent acknowledged that "traceability is an issue" and said that at the moment each member government is responsible for tracing medical devices used by patients in its country.

France's Health Safety Agency has said the suspect PIP implants appear to be more rupture-prone than other types. Investigators say PIP sought to save money by using industrial silicone — whose potential health risks are not yet clear.

But Wednesday, Australia's medical watchdog said health officials had found no evidence that the PIP implants had an increased risk of rupture in Australian women, and said lab testing of the silicone gel used indicated that it was non-toxic to the tissue around the implant even if it did rupture.

Authorities in places such as Britain and Italy have asked hospitals and private clinics to track down women who received the implants. Several countries, including Colombia and Venezuela, have agreed to use state money to pay for the removal of the suspect implants. In some other countries, recipients have demanded to have their governments pay for replacements, too.

PIP's website said the company had exported to more than 60 countries and was one of the world's leading implant makers. The silicone-gel implants in question are not sold in the United States.

According to estimates by national authorities, over 42,000 women in Britain received the implants, more than 30,000 in France, 9,000 in Australia and 4,000 in Italy. Nearly 25,000 of the implants were sold in Brazil.

Please click the link below to view the full article:-
www.businessweek.com/ap/financialnews/D9S2VF100.htm >>>
Message to M Smit - Holland, thank you for your watchful eye and sharing your find with us.

12th January 2012
BBC Radio 4 Medical device regulation 'putting patients at risk'
Health secretary Andrew Lansley is to make another statement in the Commons about what the NHS can do to help women who had PIP breast implants and are worried about the risk of rupture.

Dr Richard Horton, editor of the Lancet medical journal, details an editorial in which concerns are raised over regulation of all medical devices.

"We have a smokescreen of device regulation which is, unfortunately, putting patients and surgeons at risk," he said.
Please click on this external link direct to the BBC:-
news.bbc.co.uk/today/hi/today/newsid_9675000/9675434.stm >>>
Message to Kath, thank you for your watchful eye and sharing your find with us.

12th January 2012
BBC Radio 4 Inside Health
New Series: Dr Mark Porter demystifies the health issues that perplex us and separates the facts from the fiction. He brings clarity to conflicting health advice, explores new medical research and tackles the big health issue of the moment revealing the inner workings of the medical profession and the daily dilemmas doctors face.

This week Mark Porter looks at the regulation covering medical devices and implants - everything from artificial joints, to pacemakers and heart valves - and explains why more needs to be done to protect the general public who are often unwitting guinea pigs for untried technology.
Please click on this external link direct to the BBC:-
www.bbc.co.uk/programmes/b019c8kt >>>
Comment on the above BBC radio interviews: THE MANUFACTURERS DIDN'T DO ANY HUMAN TRAILS FOR TVT/MESHES TOO! WE HAVE BEEN TELLING THE MHRA FOR YEARS! Our Voices will be heard! We have been used as guinea pigs too! Where is the action for TVT/Meshes considering the Medicines and Healthcare products Agency (MHRA) are supposed to be carrying out an investigation and have released a Public Notice showing on their website. Please view latest updates on the MHRA on the link below:-
http://www.tvt-messed-up-mesh.org.uk/news-from-the-mhra.html >>>
Message to Kath, thank you for your watchful eye and sharing your find with us.

20th September 2011
Rosenblatt Lawyers bring hope to thousands of women
Sorry Rosenblatt no longer accepts Mesh Claims.

20th September 2011
Letter: TVT Mum and the work achieved since July 2008
I started my research on TVT medical devices back in July 2008 this is when I discovered I had mesh erosion from the TVT and I was absolutely devastated to find out I had been lied to for years concerning my health as they all knew from the start of my surgery back in October 2005 it was the TVT causing me so much bad health all along. It has been extremely difficult for me to keep the work and the support group going whilst I am in ill health myself with TVT mesh problems plus I have other serious health issues since having this TVT implant, the NHS has left me permanently disabled.
To read more www.tvt-messed-up-mesh.org.uk/tvt-mum-and-the-work-achieved-since-july-2008.html >>>

20th September 2011
Thalidomide was initially a very successful drug, which was launched as a sedative for pregnant women, with an outstanding safety record if children took an overdose of their mother's pills as compared to barbiturates. You may recall the great irony of the original adverts which showed a young child standing on a stool and reaching into the medicine cabinet with the accompanying slogan about safety in children.

Here it is - www.bonkersinstitute.org/medshow/thalidomide.html >>>

There was no doubt that the drug was beneficial and a breakthrough and successful in many women.

There had only been short term animal studies and no long term studies in humans Unfortunately, the not so long term side effect of congential limb defects then became apparent.

The drug was withdrawn and the scandal led to legislation and far grearer controls over the introduction and licensing of new drugs into clinical practice.

In similar fashion, it is possible that the mesh problems ( including the other recent concerns over hips and pacemakers as well as the Dispatches programme and BMJ article ) may be a watershed moment and lead to far greater and stricter control in the UK and Europe so that these are regarded as Class III Medical Devices subject to the same controls and rigour that the MHRA applies to new drugs.

Certainly, there are probably more mesh victims than thalidomide victims. It may be just as debilitating, although it would be far less emotional in the eyes of the general public who are far more affected by pictures of children with limb defects that women with bladder problems.


It is suggested a mesh procedure is a bit like Russian roulette. We know that it is a reasonably successful procedure in many women but we also know that it has a relatively high risk of serious complications in a significant number of women. Overall, it may maybe unreasonable to use the products for a benign non-urgent condition unless women are fully aware of this. The dilemma is that mesh procedures may be more successful than older procedures such as anterior repair but there is no doubt that the complications are far more serious and difficult to manage. In many previous cases, products with a reasonable success rate, used for benign non-urgent indications, but a significant risk of major complications have been withdrawn e.g. the well known case of the Dalkon Shield IUCD and the less well known case of Intragel for adhesions. Many drugs have been withdrawn for exactly the same reason; they are reasonably successful in many patients but have unacceptable high risks of complications.

The problem is that whatever the skill of the surgeon and whatever the degree of the pre-operative counselling, it is almost impossible to predict whether an individual will be the unlucky one to suffer a serious complication of a mesh procedure. A 5 - 10% chance of serious problems is like saying ' is there a bullet left in the gun? '. Hence - Do you feel lucky?

All the Latest News
www.tvt-messed-up-mesh.org.uk/latest-news.html >>>

Daily Mail Article
Title: It was a simple implant to cure an embarrassing problem... The incontinence operation that's ruining women's lives.

It was a simple implant to cure an embarrassing problem... The incontinence operation that's ruining women's lives
By Lois RogersUPDATED: 23:04, 15 August 2011

Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems following childbirth. As a result the NHS is now facing a crisis on a par with the compensation claims for leaking silicone breast implants in the Nineties.
To read more please click on the link below:
www.dailymail.co.uk/health/article-2026354/It-simple-implant-cure-embarrassing-problem--The-incontinence-operation- thats-ruining-womens-lives.html >>>
Also you can view the same article on the website >>>

17 May 2011newNEW WEBPAGE regarding the Channel 4 programme aired on Monday 16 May 2011 with the link to watch the full video and to view our comments. Please click here www.tvt-messed-up-mesh.org.uk/dispatches-the-truth-about-going-under-the-knife >>>
Channel 4 Monday 16 May at 8pm - Investigations question safety regulation of medical devices, click for full information.
www.channel4.com/info/press/news/investigations-question-safety-regulation-of-medical-devices >>>

United Kingdom Press Releases
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Scotland Press Releases
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Medicines and Healthcare Regulatory Agency (MHRA) Latest News
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Worldwide Press Release and Latest News
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There are many people who have signed our online petition and some have shared their stories. 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 >>>

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