Vaginal Mesh Implants: Experimental! NICE

Vaginal mesh operations should be banned, says NICE

By Anna Collinson

Reporter, Victoria Derbyshire programme

• 27 November 2017  FiDA highlight
  

Draft guidelines from NICE say the implants should only be used for research - and not routine operations.

Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.

One expert said it is highly likely the NHS will take up the recommendation.

However, the organisation is not compelled to act on findings it receives from NICE.

Both NHS England and NICE declined to comment.

'Life-changing consequences'

In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".

It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".

One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.

"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.

"These can last from two to six hours at a time and is like having a heart attack," she said.

Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.

She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.

The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through"

The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.

They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.

The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".

He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.

But he said it had come too late.

"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."

He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.

In April, the BBC learned more than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants.

The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.

About one in 11 women has experienced problems, the data suggests.

The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.

In Scotland, former Scottish Health Secretary Alex Neil requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed hundreds of operations have been performed since.

A number of Scottish health boards have stopped using mesh implants altogether.

The mesh is also used routinely in hernia repair despite concerns it is leaving many patients in chronic pain.

The Department of Health declined to comment.

Watch the Victoria Derbyshire programme on weekdays between 09:00 and 11:00 on BBC Two and the BBC News Channel.

http://www.bbc.com/news/health-42110076

Surgical Mesh Scandal: Worse Than Thalidomide. Truth.

Vaginal mesh 'disaster' could be 'worse than Thalidomide', experts warn

Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history.

16:40, UK,

Saturday 30 September 2017

The vaginal mesh that was fitted to tens of thousands of women, leading some to suffer pain

By Charlotte Lomas, Sky News Correspondent and Aubrey Allegretti, News Reporter

An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.

Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".

Speaking about the scale of the scandal, he said: "I think this is the worst one that we'll ever see in my lifetime because of the scale of the number of women affected."

More than 75,000 women in England had the procedure - known as TVT - between 2006 and 2016, according to NHS data.

One in 15 have had the implant removed.

The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.

While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.

The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.

Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.

She is now registered disabled, is in chronic pain and survives on benefits.

Image:

Lesley Elder has had 13 operations to repair damage caused by the fitting of the mesh

"I'm not the woman I used to be," she told Sky News. "I feel like a helpless no-hoper. I think I'd be better off dead; I don't want to live like this. I want my old life back."

Professor Heneghan, from the University of Oxford, said Lesley's case is not unique, and warned that the UK is heading for a "major disaster".

"Every young woman I have talked to has not been told about the adverse consequences," he told Sky News.

Professor Heneghan said the NHS was not offering the operation to patients based on "need" but on what manufacturers with a commercial interest wanted.

The mentality, he said, was: "Get people through the system - in and out."

Image:

Ms Elder says she has to take a cocktail of drugs after having the procedure

One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.

Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.

David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a "significant" medical case.

Total compensation, he claimed, could "run into the billions of pounds, which would make it the largest medical case in UK history".

A spokesperson for Johnson & Johnson told Sky News implantable mesh was "backed by years of clinical research" and that "Ethicon is confident in its products".

They said the use of pelvic mesh devices is "supported by medical experts around the world".

The spokesperson added: "Ethicon is defending lawsuits concerning the use of our pelvic mesh products.

"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."

http://news.sky.com/story/vaginal-mesh-legal-action-could-be-bigger-than-thalidomide-11060083

Regulators favor implant manufacturers over patient safety.

Faulty medical implantsinvestigation: 'A system in disarray that favours manufacturers at the expenseof safety'

By Carl Heneghan     The Telegraph  (FiDA highlight added.

6:55AM BST 23 Oct 2012

 Carl Heneghan is director of the Centre for Evidence-Based Medicine, University of Oxford

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.

To put it bluntly, device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is sub-standard, and individuals supposedly representing the regulatory system are conflicted and in many cases under-qualified.

This all means that the system now heavily favours manufacturers at the expense of patient safety.

Notified bodies are organisations authorised to grant a CE mark in the EU. A company is free to select any notified body it sees fit to undertake certification of a new device.

An application for a metal hip should raise significant alarm bells, particularly given the worldwide alerts that exist to its problems. A Google search immediately retrieves “compensation”, “implant failure” and “could cause cancer”. But, in this case it did not raise concerns among eight of the contacted notified bodies.

It gets worse. In the evidence document submitted for application, the device was based on two previous recalled devices and a number of deliberate errors were inserted into the document: tests for corrosion didn’t add up, the hip data showed it wore at a very high rate and the data implied the hip would literally “fall out”.

Basically, it couldn’t be any worse for the device. But some notified bodies seem to want a device to get through at any cost. One said that they would provide a “solution for certification, somehow”.

European regulations state that companies should submit clinical data at the time of device approval, yet this can be as little as an evaluation of the scientific literature. This data is supposed to relate to the “safety, performance, design characteristics and intended purpose of the device”.

The investigation informs us that submitted data can be wrong, refer to previous recalled devices and not demonstrate safety at all. To date, no one adequately knows the make-up of notified bodies, their qualification or their skills.

But in this investigation they were certainly not equipped to deal with this case. Indeed, they had never dealt with a hip implant.

There have been many unsubstantiated reports that companies shop around for the best deal. As the Telegraph/BMJ investigation shows, the notified body does not need to see the device, clinical data can be sub-standard and wrong, the organisation with oversight of the device approval process does not need to reside in Europe, and they certainly do not need relevant skills. And despite all this you can access the European market, for an implantable device, without a single patient ever having received it.

The current situation needs urgent remediable action. At a minimum, and as a quick fix, there should be a requirement for new devices to have published clinical data.

The investigation has revealed appalling loopholes in the current system that could allow defective devices onto the European market. What is needed is transparency.

None of the regulators has a register of approved devices and none of them get to see the submitted data for the device. This can’t be right.

http://www.telegraph.co.uk/health/9626921/Faulty-medical-implants-investigation-A-system-in-disarray-that-favours-manufacturers-at-the-expense-of-safety.html

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