Updated: 4th February 2012
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Lorraine Evans
Email: lorraine@tvt-messed-up-mesh.org.uk
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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
Direct link to their website News and Press:
www.rosenblatt-law.co.uk/news/details-rosenblatt-lawyers-bring-hope-to-thousands-of-women-11982 >>>
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
THE NEW THALIDOMIDE
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.
DO YOU FEEL LUCKY?
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 >>>
17 May 2011
NEW 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 >>>
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www.tvt-messed-up-mesh.org.uk/petition.pdf >>>
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