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

Pelvic Surgical Mesh: "Living in Hell"

Western Australian pelvic mesh victims criticise government response to scandal

Joanne McCarthy

21 Jul 2017, 1 p.m. FiDA highlight

• Women call on WA Health Minister to order investigation into mesh surgery research

Women allege they were used as guinea pigs in pelvic mesh trials in WA public and private hospitals

SUE Turner and Jeanette McKinnon are the Western Australian women implanted with pelvic mesh devices in public hospitals who refuse to be regarded as unfortunate statistics.

They have made submissions to a Federal Parliament Senate inquiry into pelvic mesh – with a public hearing in Perth on August 25 – listing serious, permanent and life-altering consequences of their surgeries more than a decade ago.

They want answers from WA Health Minister Roger Cook about mesh research allegedly conducted in public hospitals, and whether they are included in mesh trials for which they say they did not consent.

They are scathing of Mr Cook’s commitment to “make some enquiries” about the alleged mesh research trials, in response to questions from Fairfax Media, and have called for a full investigation into whether women were used as “mesh guinea pigs” in public health facilities.  

“Something awful happened to me in 2004 and 2005 after I had mesh put into me. My world’s just so small now,” said Mrs McKinnon, who was 46 in 2004 when she was implanted with an Australian-developed pelvic mesh device at Bentley Hospital.

“It’s like living in hell. I’m dying a very slow and agonising death.”

Victorian Senator Derryn Hinch in February successfully argued for a Senate inquiry into how some pelvic mesh devices for women’s incontinence and prolapse problems after childbirth were cleared for use in Australia over the past two decades. He compared pelvic mesh products to Thalidomide, the drug that led to birth defects in babies in the 1960s.

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(Video on link.) Senator Derryn Hinch calls for a Senate inquiry into pelvic mesh.

The aggressive marketing of many mesh devices in Australia from 2003, without sufficient evidence of their safety and efficacy, led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” Senator Hinch said in a speech to Parliament.

Nearly 200 Western Australian women have responded to a survey conducted by Victorian consumer health advocacy group, Health Issues Centre, for a submission to the inquiry representing the experiences of more than 2200 Australian women implanted with pelvic mesh devices.

More than 700 women are part of a current class action against major pelvic mesh manufacturer, Johnson & Johnson, in the Federal Court in Sydney.

Sue Turner, of Perth, has sought legal advice about a class action against an Australian manufacturing company, after she was implanted with an Australian-developed pelvic mesh device at Armadale Hospital in 2007.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial.

- Sue Turner, who had pelvic mesh surgery in 2007.

”

“I had a prolapse. I just trusted the doctor and our health system when he told me it would be a pretty easy fix,” Mrs Turner said.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial. If I was told there was a risk that if things went wrong I would never have a sex life again, or live a life of sometimes unendurable pain, or be left with mesh and anchors in my body that have moved and embedded into tissue very close to major blood vessels and nerves, I would never have consented. But I wasn’t told.”

In a statement to Fairfax Media Mr Cook said he would ask the Department of Health to “make some enquiries into the research undertaken, and the cases where the implants have been used”, after two senior Western Australian doctors released a series of papers from 2005 about trials in Western Australian public and private hospitals, including Armadale Hospital, using the Australian-developed pelvic mesh device.

In a statement by a WA Health Department unit, Fairfax Media was advised there are no records of research approvals for trials involving surgery on women at public hospitals using the Australian-developed pelvic mesh device.

Mrs Turner and Perth-based Australian Pelvic Mesh Support Group founder Caz Chisholm were angered by Mr Cook’s statements that the “WA Government understands the concern this has caused for some patients”, but “there have been very few complaints received by WA Health and the Health and Disability Complaints Office”.

“What are we? Guinea pigs?” Mrs Turner said.

“I want this stuff out of my body but my doctor’s told me the surgery could be life-threatening. This isn’t about numbers. It’s about how our health system allowed these devices onto the market, and how these doctors were allowed to do this surgery in public hospitals without telling us of the risks.”

Ms Chisholm said the lack of complaints was a consequence of women being told for years that their chronic problems, including often debilitating pain, repeated serious infections, and erosion of mesh into organs including the bladder and bowel, were not linked to mesh surgery, or not being told they were implanted with mesh.

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause.

- Australian Pelvic Mesh Support Group founder Caz Chisholm

”

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause. It is only because of recent media attention about stories of women's pain and complications that women are realising their own complications are identical to the media stories,” Ms Chisholm said.

“The minister says there have been very few complaints by women, but what about the doctors treating the women? Obviously doctors aren’t reporting complications either, and are they supposed to?”

Mrs McKinnon has spent more than a decade on antibiotics.

“I came out of hospital not very well in 2004 and had my first urinary tract infection shortly after that. Then it was one urinary tract infection after another. If I come off the antibiotics I get a urinary tract infection,” she said.

She had another four major surgeries over the following year to relieve the pain and address mesh erosion into organs. 

In 2009 Mrs McKinnon was diagnosed with the auto immune condition lupus, requiring steroid treatment.

“I was normal, healthy and fit before I had that surgery. I’m only 59 and I feel like a 100-year-old. I thought all these years it was just me. It’s just the nightmare that you live.”

In a statement in June the Royal Australian College of Obstetricians and Gynaecologists said the majority of women treated with mesh for incontinence or prolapse had “a good long-term result” but “in a small number of cases the complications have been very serious”.

In a submission to the Senate inquiry Victoria’s Health Issues Centre chief executive Danny Vadasz has criticised mesh debate “framed in terms of the good outcomes of the many outweighing the unfortunate experiences of a few”.

“Our health system is built on values such as equity and a universal duty of care, not on a cost/benefit analysis that accepts the unavoidability of collateral damage,” he said, in a Health Issues Centre submission arguing Australian regulators have been “asleep at the wheel” on pelvic mesh.

Do you know more? Email jmccarthy@fairfaxmedia.com.au

http://www.theherald.com.au/story/4804268/its-like-living-in-hell/

Thalidomide & Failed Implants-Egregious Harm

German Drug Maker Apologizes to Victims ofThalidomide

By JOHN F. BURNS

Published: September 1, 2012  New York Times  (FiDA highlight added.)

LONDON — Decades of campaigning by victims of thalidomide, a morning sickness drug, have taken a new turn, with the first apology in 50 years to the victims and their families by the drug’s German manufacturer — and an incensed rejection of the apology as too little and too late from many of those it was intended to placate.

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The apology was issued Friday by Harald Stock, chief executive of the Grünenthal Group, a family-owned pharmaceutical company that marketed the drug in the 1950s and early 1960s. It was withdrawn in 1961 after it was linked to birth defects, including shortened arms and legs, and in some cases no limbs at all, that campaigners say affected 10,000 babies around the world, mostly in Australia, Canada, Europe and Japan.

The apology came in a speech Mr. Stock delivered in the Rhineland town of Stolberg, the company’s base, at the unveiling of a thalidomide memorial, a bronze statue of a limbless child.

Addressing the victims and their families, he said the company wished to “apologize for the fact that we have not found the way to you from person to person for almost 50 years.

“Instead, we have been silent, and we are very sorry for that.”

According to an English translation of his remarks that appeared on Grünenthal’s Web site, he added, “We ask that you regard our long silence as a sign of the shock that your fate caused in us.” As for the company’s delay in moving beyond its previous expressions of regret for marketing the drug to a direct apology to the victims, he said that in recent discussions with victims and their families, “we learned how much it is publicly desired that we express our deep regrets to those affected by thalidomide.”

Although thalidomide was never approved for use by pregnant women in the United States, some victims are American.

One is Berrisford Boothe, 51, an associate professor of art at Lehigh University in Bethlehem, Pa., who described himself in a telephone interview as one of 26 known American thalidomide victims. He said he had been born with severe disabilities in both hands and one arm, and described his life as a “long and isolated journey.”

Now, he said, Grünenthal, shaken from a half century of denial by a class-action lawsuit in Australia, had made “some kind of statement that they are emotionally connected to our suffering. They’ve had 50 years to make billions of dollars while we struggled and our parents committed suicide. And now, they’re apologizing for not saying anything. How dare they do that and think it’s going to be enough?”

Mr. Stock said the company had carried out all the tests on thalidomide before it was marketed that were possible given the scientific knowledge available in the 1950s.

But the storm of protest the apology provoked from thalidomide victims and groups that represent them suggested that it had done little to assuage the anger and hurt accumulated over decades of campaigning for a full acknowledgment of thalidomide’s harm, and for more generous compensation.

“It is over 50 years on since the thalidomide tragedy — why now?” said Freddie Astbury, chief consultant at Thalidomide U.K. Agency, which represents people in Britain, where nearly 500 victims survive. He said British victims had received some compensation from the government and from distributors of thalidomide, but not enough.

Mr. Astbury, 53, who was born with no arms and no legs, said he believed that one reason for Mr. Stock’s speech was greater global awareness of issues affecting the disabled, manifested by the success of the Paralympic Games in London.

He pointed, too, to the Australian lawsuit, which legal experts say can result in new compensation awards for thalidomide victims running into tens of millions of dollars.

“We are glad the apology has been made,” he said. “But when you are disabled, it costs a lot of money. We are in our 50s, we need care. We need adaptations in our houses and cars, for starters. So if they’re serious, let’s get around the table and talk financial help.”

He added: “We didn’t ask to be born this way.”

Sandy Macaskill contributed reporting.