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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