Preview Newsletter
Ethicon Media Monitoring 7/11/2018
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30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many
Jul 10, 2018 | Mesh Medical Device News Desk
By Jane Akre
Pelvic Organ Prolapse (POP) polypropylene mesh, that has injured so many, has just suffered another blow. -
*Breaking News* Incontinence Mesh Use Suspended in Great Britain Pending Govt. Review
Jul 10, 2018 | Mesh Medical Device News Desk
By Jane Akre
SUI Mesh use will be suspended in England after regulators listened to stories of horror from mesh-implanted women. -
Surgical mesh for stress urinary incontinence to be halted immediately in England
Jul 10, 2018 | British Medical Journal
By Jacqui Wise
The use of surgical mesh for stress urinary incontinence is to be suspended immediately following a recommendation by the Independent Medicines and Medical Devices Safety Review. -
As vaginal mesh procedures are suspended, why did it take so long for women's pain to be taken seriously?
Jul 10, 2018 | The Independent
By Harriet Marsden
“It’s the end of mesh,” said Labour MP Owen Smith on the Victoria Derbyshire show today. Well, not quite. -
Pause in surgical mesh use to be extended to Northern Ireland
Jul 10, 2018 | BBC News
By Catherine Smyth
The chief medical officer is to write to health trusts calling for a halt to the use of surgical mesh for urinary incontinence in Northern Ireland. -
Ethicon applicants asked to weigh in on UK ruling on defective
Jul 11, 2018 | Lawyerly
By Cat Fredenburgh
The judge overseeing a class action against Johnson & Johnson over allegedly defective vaginal mesh products has asked the applicants to weigh in on a recent UK High Court ruling that found there must be an abnormal risk in order for a product to be considered defective. -
Vaginal mesh is barbaric and I won’t rest until it’s banned for good
Jul 10, 2018 | Metro
By Yvette Greenway
Hundreds, probably thousands of women across the UK, will be celebrating today’s important announcement that vaginal mesh is suspended with immediate effect. -
Belfast solicitor welcomes NHS England suspension of mesh operations
Jul 10, 2018 | Irish Legal News
A Belfast-based solicitor specialising in civil litigation has welcomed a decision by NHS England to suspend surgical procedures using vaginal mesh devices over safety concerns. -
Vaginal mesh surgery ‘paused’ for some treatments
Jul 11, 2018 | The Press Association (In The Times)
Vaginal mesh surgery is to be “paused” for some treatments in England, officials have announced. -
As Vaginal Mesh Surgery Is Banned In The UK, WH Asks: Is It The Biggest Health Scandal Of Our Time?
Jul 11, 2018 | Women's Health
By Roisin Dervish-O'Kane and Ally Head
Vaginal mesh surgery has been halted by the Government with immediate effect. -
NHS England to put immediate curb on mesh operations
Jul 10, 2018 | Health Business UK
NHS England has accepted the advice of a new review looking at harm reported by women who received mesh operations for stress urinary incontinence and is placing an immediate curb on the treatment.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many
Jul 10, 2018 | Mesh Medical Device News Desk
By Jane Akre
Pelvic Organ Prolapse (POP) polypropylene mesh, that has injured so many, has just suffered another blow. After an initial announcement and a 30 month waiting period, finally this month, the FDA has officially reclassified POP mesh as “high risk,” requiring proof of safety and efficacy, the strictest requirements of the agency be met before it can be sold.
The FDA move may be too little, too late. Few POP meshes remain on the market following years of legal challenges prompting an industry retreat.
But while the reclassification comes too late for many women who live with the permanent implant, it may save countless others from being implanted with the large, problematic polypropylene in the future.
She sits in a downtown Atlanta apartment. “Mandy” is 71 years old. She was implanted with a Prolift, made by Ethicon, a division of Johnson & Johnson, a decade ago. Mandy (who is involved in litigation and can’t use her real name) tells MND she rarely leaves her home. She is in constant pain which is treated with her constant companion, morphine. At least it keeps the pain bearable and allows her some interaction with her family.
The date would come too late for Mandy and thousands of others implanted with transvaginal mesh to treat pelvic organ prolapse (POP).
The date was January 5, 2016.
The U.S. Food and Drug Administration announced mesh for POP would be officially reclassified as class III, reserved for high-risk devices or questionable devices that nonetheless might be needed to sustain life.
POP mesh, a larger plastic mesh made of polypropylene (PP) and implanted through slices in the vagina (transvaginally), had proven to deliver at least as much harm as good. Complications were “not rare,” the FDA concluded in 2011, an about-face from three years earlier when the agency called transvaginal mesh complications “rare.”
“It is not clear that transvaginal POP repair with mesh is more effective than tradition non-mesh repair,” said the FDA on July 13, 2011.
In regulatory language, the FDA said “the risk-benefit profile of surgical mesh for transvaginal POP repair is not well established.”
FDA’s Dr. William Meisel
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, in a news release.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
Industry reaction was swift.
Even though the announcement gave mesh makers 30 months to act, POP mesh makers – Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, and C.R. Bard, quickly and quietly moved to voluntarily recall their POP meshes from the market.
In doing so, they could evade the imposed vigorous premarket approval (PMA) process reserved for drugs, and class III devices, costing manufacturers millions in research and clinical trials.
July 2018 marks the end of 30 months! Polypropylene mesh used to treat POP is now officially classified as High-Risk, its use restricted for transvaginal implantation unless industry can prove through years of costly clinical trials its mesh is safe and effective.
Doctors or hospitals can no longer exhaust the supply they might have had on their shelves, though an FDA spokesman says the agency does not have the authority to check doctor’s use of the mesh.
Polypropylene mesh used for stress urinary incontinence, also known as a “sling,” or a “ribbon,” or “hammock,” is not only still on the market but is heralded as the Gold Standard by one medical society, AUGS.
ARE ANY POP MESHES STILL ON THE MARKET?
Pelvic organ prolapse meshes are generally larger than mesh used to treat incontinence, and have arms that anchor them into deep tissues, muscles and ligaments. Mesh removal experts consider them particularly difficult to remove.
Tens of thousands of product liability lawsuits since 2012 may have already delivered a death knell. One by one, POP mesh has disappeared from the market.
Pinnacle Pelvic Floor Repair, a POP mesh kit made by Boston Scientific was taken off the market May 10, 2011 in an “URGENT MEDICAL DEVICE RECALL – IMMEDIATE ACTION REQUIRED.” The device “may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement,” said the company.
Prolift and Prolift +M were quietly removed by Ethicon (J&J) in June 2012, as was Prosima Pelvic Floor Repair System. C.R. Bard took its Avaulta mesh off the market in 2012.
Elevate and Apogee, made by American Medical Systems, went away when the company was sold to Endo, which later closed its women’s health division.
Restorelle by Coloplast is still used for POP repair.
AUGS, the American Urogynecologic Society, convened a POP Mesh Consensus Conference in 2016 to promote its patient advocates who advocate the continued used of mesh as a treatment for pelvic organ prolapse. POP mesh proponent, Sheri Palm of APOPS is among them.
But as of today, POP mesh is essentially gone, unless it is used overseas or implanted through the abdomen.
A search of the FDA’s PMA database shows no new applications for pelvic organ prolapse mesh, however an application may not be public.
The FDA cannot reveal if there are any pending applications for POP mesh. It’s held under wraps as a trade secret and/or confidential commercial information, but you can check the PMA new application field in the FDA website, after the mesh is approved.
MND has made a request for information to mesh makers. We are still waiting a reply.
Yet, researchers are optimistic.
Multiple “White Papers” conducted by researchers (for profit) predict the pelvic implant market will reach $300 million in a decade with use rising in China and third world countries.
THE LOOPHOLE
There is a loophole for manufacturers to continue to use POP mesh and it doesn’t require a PMA. Any device implanted abdominally can still be used for such application exclusively.
The FDA reclassification only covers transvaginal implantation. Abdominal application remains class II, moderate risk.
An FDA spokeswoman says the agency does not have regulatory power to check doctor’s offices, nor would it do so.
“Mesh placed abdominally for POP repair appears to result in lower rate of mesh complications compared to transvaginal POP surgery with mesh,” the FDA concluded in a 2011 patient safety warning. Some surgeons agreed abdominal sacral colpopexy (ASC)”is an excellent procedure for treating POP,” according to a surgeons working group in response to the suggestion to reclassify.
And there might be another avenue to skirt the new rules.
The FDA has not responded to an inquiry whether post-approval monitoring studies the FDA required of manufacturers in January 2012 might suffice as evidence of a device safety.
THE FDA
As part of the Federal Food, Drug and Cosmetic Act, established in May 1976, three categories of devices were established, with class I as the lowest risk devices such as a wheelchair or Band-Aid, class II such as a defibrillator, and class III for higher risk devices requiring pre-market approval.
One might surmise that a permanent implant should automatically fall into a high-risk category, but that didn’t happen.
When transvaginal mesh hit the market in the late 1990s and early 2000’s, it was classified as class II and entered the market with an exchange of paperwork under the 510(k) approval process – approved for marketing – no clinical trials required.
All an applicant had to do was name another marketed mesh – the “substantial equivalent” – as a “predicate” as part of the paper exchange.
It didn’t matter if that predicate had been removed from market for being defective.
ProteGen served as a predicate device for about 60 different pelvic meshes, according to researcher Suzanne McClain. But ProteGen, one of the first pelvic meshes on the market in 1996, was taken off three years later. It does “not appear to function as intended” and led to a higher rate than expected of vaginal erosion and wound rupture at a surgical incision. Never mind.
Mentor, Ethicon, American Medical Systems, Gyne Ideas, Tyco, Caldera all either named ProteGen as their direct or indirect predicate (substantial equivalent). But there is no mechanism within the FDA to trigger a review of devices that named ProteGen as its predicate, even though there is an FDA presumption and reasonable assurance of safety and effectiveness for the predicate device.
Industry knew this and liked the 510(k). A 510(k) application might create a wait time of 90 days and cost a few thousand dollars. With that easy- breezy opening, mesh makers, mindful of competition, entered the market in droves.
A report in the BMJ on POP meshes found 61 devices whose approval relied on claimed equivalence to Mersilene Mesh and ProteGen. There were no clinical trials evidence for those 61 devices at the time of approval.
After receiving nearly 4,000 reports of mesh-related complications, including deaths, in September 2011, the FDA convened its first expert panel on transvaginally-placed polypropylene mesh implant. It left with the conclusions that incontinence mesh should stay on the market but POP mesh raised some troubling questions and should be reclassified.
No action was taken by the agency until January 2012.
After receiving even more reports of mesh-related complications, including organ perforation and bleeding, vaginal mesh exposure, pelvic pain, mesh shrinkage, painful sex and infection, the FDA issued orders for post-market surveillance studies to 33 manufacturers of urogynecologic surgical mesh for POP. Seven manufacturers of incontinence slings were also ordered to undergo three-years of post-approval monitoring of pain, infection, painful sex, vaginal scarring and shrinkage, vaginal bleeding and discharge, fistula formation, and the quality of life, among implanted patients.
The FDA recommended randomized clinical trials or prospective cohort study design. Over the next three years, industry would be required to submit quantifiable assurances to the FDA that their POP implant were safe and effective, now requiring some heavy lifting. Instead, POP meshes quietly disappeared.
The FDA today says that in most cases, POP can be treated successfully without mesh, “thus avoiding the risk of mesh-related complications.”
According to the agency doctors should warn their patients that:
“Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.”
Why not a complete ban? In 2011, the FDA concluded there was insufficient evidence to support the ban or recall of POP mesh, even as one mesh opponent, Lana Keeton, commented to the Federal Register:
“Up-classification from Class II to Class III is not the solution. Only complete and immediate removal from the market will stop the use of the life-threatening medical device, synthetic surgical mesh, by skilled and unskilled surgeons alike who choose their own convenience and profit over the safety and well-being of their patients.”
Dr. Antonio Pizarro submitted:
“Until we can prove that the benefits of mesh repair over non-mesh repair outweigh its significant risks, we should abandon the use of these problematic materials in the care of women with prolapse. There exists a danger that if the FDA does not ban mesh, surgeons will continue to rationalize the available data and obfuscate the plain reality facing us as surgeons—that mesh provides no proven advantage to women suffering from prolapse over repairs not using mesh. This obfuscation will lead to the continued use of mesh if we allow it to do so.”Surgeons signing onto a working group on POP mesh advanced, “We are deeply concerned that the current process could, as an unintended consequence result in a major setback to those core goals for many providers successfully utilizing mesh and observing high rates of satisfaction and superior outcomes.”
With the final reclassification, advocates and opponents may not be satisfied, but the reclassification creates one more hurdle for industry to scale. Proving safety of devices with a long, troubling history may be impossible and economically foolish to try.
Mesh for stress urinary incontinence (SUI) remains on the market, in a class II status with seamless entry into the market even though the majority of defective product cases currently filed involve SUI polypropylene mesh.
The reclassification comes too late for Mandy, Carleen, Linda, and countless other women who live with a permanent polypropylene POP mesh and whose lives are forever changed.
https://www.meshmedicaldevicenewsdesk.com/30-months-is-up-pop-mesh-is-officially-high-risk-too-late-for-many/
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*Breaking News* Incontinence Mesh Use Suspended in Great Britain Pending Govt. Review
Jul 10, 2018 | Mesh Medical Device News Desk
By Jane Akre
SUI Mesh use will be suspended in England after regulators listened to stories of horror from mesh-implanted women. A full review should be concluded next March to determine if the suspension becomes permanent.
The use of mesh for incontinence has been suspended in Great Britain ending a review by the government. The procedure will be halted until five strict conditions, campaigners insisted on, have been met.
Kath Sansom, founder of campaign group Sling the Mesh, which represents those affected by mesh implants, said the announcement came “out of the blue” today.
“This is incredible news. It is a testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result and I am delighted.”
There are 6,100 members of Sling the Mesh group that campaigns to have mesh taken off the market until its safety can be assured.
Sansom brought campaigners to Parliament and led to an internal investigation by the National Health Services and debates in the House of Commons.
In February, a review of mesh implants was announced by Health and Social Care Secretary Jeremy Hunt. The final recommendation should be publicized next year, but in the meantime
Baroness Julia Cumberlege, who led the review and wants to add rectopexy mesh used to treat rectal prolapse to the suspension.
The Daily Mail quotes her:
‘We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.”
‘We had to act now. My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.’
A ban will not be enacted at this time, but a halt to procedures until five conditions are met.
* The conditions are that surgeons only undertake a SUI operation if they receive appropriate training and perform surgeries regularly.
* Surgeons must report every procedure to a national database.
* A registry of surgeries will be maintained to note the type of procedure and the woman involved.
* Complication reports to the MRHA must be linked to the register.
* Specialized centers must be identified and accredited that deal with complications and removals.
Like the U.S., mesh proponents said only prolapse surgeries should be banned, but health regulators acknowledge that three-quarters of pelvic mesh surgeries are done to treat SUI and they account for most of the stories.
In the UK, an estimated 130,000 patients have had a SUI or POP procedure in the past decade. Complication rates have been found up to 42% with 30% reporting a lost or reduced sex life and urinary infections reported at 22% with bladder perforation in 31 percent of cases.
This is part of a global push back on mesh, Scotland has also addressed government directly and got a suspension on the SUI mesh in 2014 after a consistent verbal campaign and extensive media coverage by reporter, Marion Scott.
New Zealand and Australia have also suspended the use of mesh for prolapse but New Zealand expanded the suspension to include incontinence mesh. Hundreds of women are currently locked in litigation against Ethicon in Australia over its controversial mesh implants. A judge is expected to issue her conclusion sometime this year.
Sansom says the announcement today to suspend the use of mesh for incontinence was surprising.
“We were not expecting this at all because they just started their review. They’ve only had one formal meeting with women in London and have had a teleconference with campaigners, with only one formal meeting the stories they’ve heard are so horrific with lives damaged beyond repair that they’re calling a halt to these implants until March 2019.”
At that time a final report should be issued. It is unclear at this time whether a ban will become permanent.
Sansom, a reporter for CambTimes says, “I think the really positive thing about the suspense is the government is finally listening to us and realizing just how awful it is when these mesh implants go wrong.”
Sansom says that is the positive. On the not so positive side, they are not suspending the use of mesh for rectal prolapse which shows similar complications. Sansom says they would like to see those suspended as well. The same plastic is used for hernia repairs and they are starting to get the same complications, pain loss of sex life, autoimmune conditions.
Hopefully this review will be the spring board to put in place a permanent suspension of mesh used for hernia repair since all are made of polypropylene, she says.
https://www.meshmedicaldevicenewsdesk.com/incontinence-mesh-use-suspended-in-great-britain-pending-govt-review/
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Surgical mesh for stress urinary incontinence to be halted immediately in England
Jul 10, 2018 | British Medical Journal
By Jacqui Wise
The use of surgical mesh for stress urinary incontinence is to be suspended immediately following a recommendation by the Independent Medicines and Medical Devices Safety Review.1
The review was announced by the government in February after pressure from campaigners and the all party parliamentary group on surgical mesh implants.23 An increasing number of women have reported complications after mesh surgery including debilitating pain, infection, inflammation, loss of sex life, and mobility problems.
The announcement comes just days after the review began to take evidence from women affected by mesh injury. Julia Cumberlege, who chairs the review, said she was “appalled at the seriousness and scale” of the stories she had heard from women and their families.
She said: “We must stop exposing women to the risk of life changing and life threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment.” She said that the review had not seen evidence on the benefits of mesh that outweighs the severity of suffering caused by mesh complications.
Cumberlege has said surgical mesh should not be used for the treatment of stress urinary incontinence until a set of conditions to mitigate the risks of injury are met and these should be in place by March 2019. The Department of Health and NHS England have accepted her recommendations.
The conditions include:
● Surgeons should only undertake the operations for stress urinary incontinence if they are appropriately trained and if they do them regularly
● All procedures should be reported to a national database
● A register of operations should be maintained and the woman identified who has undergone the surgery
● The reporting of complications through the Medicines and Healthcare Regulatory Agency should be linked to the register
● Specialist centres should be identified and accredited for mesh procedures, removal procedures, and other aspects of care.
The move follows guidance in 2017 from the National Institute for Health and Care Excellence that mesh for vaginal wall prolapse should only be used in the context of research.4 The recommendation does not apply to mesh for rectopexy procedures, which will be considered separately by the review.
The British Society of Urogynaecologists (BSUG) said they were strongly opposed to the decision to suspend the use of surgical mesh for stress urinary incontinence. BSUG chair, Jonathan Duckett, said: “This decision is not based on any scientific logic. This is the single most researched incontinence procedure in the world and to place a suspension on its use contradicts all the research, evidence, and guidance issued by national bodies.” He added: “This procedure has been the mainstay of surgical treatment for women with stress incontinence over the past 20 years. Good quality data suggest 95% of women remain free from any complications after this surgery and the majority have markedly improved continence. Other surgical procedures have higher risks and complications.”
BSUG said it has already fulfilled the criteria set out by Cumberlege, including only having trained surgeons undertaking incontinence procedures.
Owen Smith, chair of the all party parliamentary group on surgical mesh implants, said: “Baroness Cumberlege should be applauded for making this definitive statement just days after her review began taking evidence from women affected by mesh injury. She has obviously been left in no doubt—as those of us who have listened to women injured by mesh are in no doubt—that the risks far outweigh any benefits.”
He added that he hoped that Wales, Scotland, and Northern Ireland would follow England and halt the procedure.
Kath Sansom, founder of the campaign group Sling the Mesh which has lobbied hard for the change, said: “We now hope that Baroness Cumberlege adds rectopexy mesh to the suspension. This is used when patients suffer faecal incontinence after a rectal prolapse. This is even more taboo than urinary incontinence.” She added: “The same plastic material is used for hernia repairs and is causing grave problems for members of our support group.”
Hundreds of women are taking legal action against the NHS and the makers of the implants. Linda Millband, from Thompsons Solicitors who are supporting some of the affected women, said. “There will also be legitimate questions as to why procedures, such as rectopexy for bowel patients, have not been included in this ban. Any mesh, wherever it is used, is dangerous, destructive, and, in some cases, deadly.”
https://www.bmj.com/content/362/bmj.k3035.full
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Jul 10, 2018 | The Independent
By Harriet Marsden
“It’s the end of mesh,” said Labour MP Owen Smith on the Victoria Derbyshire show today. Well, not quite.
NHS England has accepted a recommendation to temporarily suspend vaginal mesh implants for the treatment of stress-urinary incontinence (SUI) until March 2019. It is hoped that Wales, Scotland and Northern Ireland will follow suit. This joins last December’s recommendation from the National Institute for Health and Care Excellence (NICE), to ban vaginal mesh as a treatment for pelvic organ prolapse (POP).
It’s been hailed as a great victory by campaigners and the thousands of women affected by the devices, over what politicians have called “the biggest health scandal since thalidomide”. The insufficiently tested and poorly regulated plastic mesh devices have been shown to erode and disintegrate, slicing through organs and vaginal walls to cause paralysis, chronic pain, sepsis, loss of sex life and even organ failure.
In December, New Zealand became the first country to ban all vaginal mesh procedures, after Australia banned procedures to treat prolapse. And Chrissy Brajcic, an anti-mesh campaigner from Ontario, Canada, became the first woman known to die from complications relating to a mesh device.
In January, the Department of Health and Social Care committed to reviewing every vaginal mesh implant case since 2005 to determine the true extent of complications.
So we’re definitely getting somewhere. Like strides made in the treatment and awareness of polycystic ovary syndrome (PCOS), endometriosis and vaginosis, women’s pain is finally being acknowledged and investigated, empowered by a collective refusal to suffer in silence any longer.
When campaigner and mesh victim Kath Sansom first set up the Sling The Mesh Facebook group, there were only a handful of members. Now there are more than 6,000: victims, family members and doctors, led by a core group of indefatigable women.
Members share tips and information, compare symptoms and treatment, and participate in collective activism: writing, tweeting, attending parliamentary debates and lobbying for results. The group also functions as an emotional support network: members comfort each other when in pain, when demoralised and even when suicidal.
Without this incredible network of mutual education and empathy, I doubt the lid would ever have been blown off this scandal. Every step taken against mesh is a testament to their resilience.
I look back to the women’s health movement of the 1960s and the Boston Women’s Health Book Collective of the 1960s and 1970s, which rose out of a context of stigma, ignorance, and Freudian theories of frigidity and hysteria.
Women felt their pain was ignored and dismissed by a patronising medical profession, suffering “pseudoradical infantilism”, in Betty Friedan’s words. Those women began to collectivise and self-educate, empowering each other to gain autonomy over their own bodies and challenge doctors, culminating in the seminal work Our Bodies, Ourselves.
Considering what those women did, starting with just a few hand-distributed leaflets, imagine what they might have done with Twitter.
This is what female-led activism can lead to: results. They made enough of a “fuss” that they couldn’t be dismissed any more.
But they shouldn’t have had to. I’m disheartened at the slow rate of progress between then and now, and the level of noise that women still need to make before anybody listens. Reading the stories on the Facebook group is heartbreaking: women still dismissed, women still ignored, women still sneered at and patronised. I wonder what the women of the Seventies would make of how far we haven’t come.
So the news that procedures have been suspended is a great victory, but it’s only a start. The All-Party Parliamentary Group on Surgical Mesh Implants, founded by Owen Smith, is still calling for a full investigation and retrospective audit of mesh surgery. This is absolutely vital in order to establish the true rate of complications.
Mesh used to treat rectal and abdominal prolapse, as well as to repair hernia in men and women, should also be suspended pending full investigation. All planned mesh sling operations in private hospitals must be cancelled, and doctors must be trained in the (already existing) alternative, safer procedures.
What’s next is compensation, and support for the hundreds of thousands of women already in litigation in the UK and US. No amount of money can repair bodies, broken families or bring the dead back to life – but it can offer quality of life, and in many cases help pay for the extensive treatments and repair surgeries necessary to survive.
Compensation is more than money: it’s priceless. It’s public vindication that someone should have listened to you and taken you seriously, and that someone will be held to account.
Speaking of money, we need to follow it. The medical device industry is a business like any other, and people have made a (figurative) killing on pushing these devices, that were known full well to be unsafe and unregulated.
There has been evidence of cover-up, corruption and conflicts of interest in this scandal, all allowed by a criminally negligent medical device regulatory system and facilitated by our chronically underfunded health system. We need urgent reform, and we need justice for the unknown number of innocent victims that have suffered and died already – and many still might.
For Chrissy Brajcic and the others, the fight is over. But for the rest of us, it’s only just begun.
https://www.independent.co.uk/voices/vaginal-mesh-scandal-procedures-suspending-women-pain-doctors-a8440616.html
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Pause in surgical mesh use to be extended to Northern Ireland
Jul 10, 2018 | BBC News
By Catherine Smyth
The chief medical officer is to write to health trusts calling for a halt to the use of surgical mesh for urinary incontinence in Northern Ireland.
Dr Michael McBride is "advising that a pause in mesh surgery be introduced".
The announcement comes after NHS England said it was putting an immediate curb on operations after safety concerns.
It accepted the advice of a new review looking at harm reported by women who received the treatment.Case studies: Mesh led to 'excruciating pain'Hundreds suing NHS over vaginal implantsWhat's the issue with mesh implants?
The campaign group Mesh Ireland said: "The mesh injured do not benefit from today's news; they take comfort that injury to more unwitting women has been prevented.
"Stopping the next cohort of mesh injured is the right thing to do. Now an action plan must be put in place for the twenty-year legacy of those injured by the "quick fix" mesh tapes."
In February 2018, Health Secretary Jeremy Hunt announced the Independent Medicines and Medical Devices Safety Review in the House of Commons.
Mr Hunt said it would examine how the healthcare system had responded to concerns raised by patients on three issues - including surgical mesh.'Appalled'
Baroness Julia Cumberlege, who chaired the review, said she had been "appalled at the seriousness and scale of the tragic stories that women and families" including some from Northern Ireland had recounted.
As a result, the review team said they felt a pause to the procedure was necessary until a set of conditions to mitigate the risks of injury are met.
That is expected to take place in March next year.
In 2014 the Scottish government put in place a suspension in the use of mesh for stress urinary incontinence.
Last year, BBC News NI revealed that some women in Northern Ireland were left 'physically and mentally scarred' after having mesh implants.
A spokesperson for the Department of Health in Northern Ireland said: "The chief medical officer Dr Michael McBride will be writing to trusts advising that a pause in mesh surgery be introduced similar to that being put in place in England."
https://www.bbc.com/news/uk-northern-ireland-44772354
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Ethicon applicants asked to weigh in on UK ruling on defective
Jul 11, 2018 | Lawyerly
By Cat Fredenburgh
The judge overseeing a class action against Johnson & Johnson over allegedly defective vaginal mesh products has asked the applicants to weigh in on a recent UK High Court ruling that found there must be an abnormal risk in order for a product to be considered defective.
Justice Anna Katzmann asked the applicants to le a note on the UK judgment — Gee v DePuy International Limited [2018] EWHC 1208 — which the judge said was referred to in Johnson & Johnson’s submissions on “Scientific Knowledge at Time of Supply”.
The UK High Court issued the ruling in May in a group action brought against DePuy over its Pinnacle hip implants, funding the plaintiffs had failed to prove the products were defective. The judgment, which provided a detailed analysis of the meaning of “defect” in product liability matters, said the inherent tendency of hip implants to shed debris could not be considered a defect just because the shedding caused an adverse reaction in some patients.
Products must pose an abnormal risk in order to be considered defective, the UK judgment found, saying safety was “inherently and necessarily a relative concept, because no product, and particularly a medicinal product, if effective, can be absolutely safe”.
Plaintiffs in the class action are awaiting judgment in the case, after closing submissions concluded February 22. The class action seeks hundreds of thousands of dollars in compensation from J&J Medical Australia and subsidiary companies Ethicon Inc. and Ethicon Sarl.
In April, the applicants won court approval to expand the size of the class and seek an order blocking the sale of devices that don’t include a proper warning.
Over objections from Johnson & Johnson, Judge Katzmann granted the request by the applicants, lodged after the 89-day trial concluded, to expand the class definition to include women implanted with the device after the case was led and those who were implanted earlier but only suffered complications after the case commenced.
The applicants, represented by Shine Lawyers, wanted to set the end date for class eligibility for whenever the court delivered its judgment or a settlement was reached, but Judge Katzmann said it was “inappropriate and impractical” to use an uncertain date for the cut-o, and instead chose July 3, 2017, the day before trial commenced, as the end date.
The judge shot down Johnson & Johnson’s argument that extending the eligibility period would alter the claims it faces, saying there would be no material change to the claims and that all the relevant evidence had been introduced at trial. “There is no reason to believe that the respondents would have conducted their case any differently if the group members included women who had received implants and suffered complications after the commencement of the proceeding,” Judge Katzmann said.
The applicants also won approval to seek a declaration that Johnson & Johnson engaged in misleading and deceptive conduct by marketing the devices without the “proper warning”, as described by the applicants, and to seek an injunction of devices that do not include the proper warning.
Judge Katzmann disagreed with Johnson & Johnson’s argument that the applicants were trying to usurp the powers of the Therapeutic Goods Administration by prescribing what the proper warning should include and seeking the injunction.
“The contentions that the job of regulating the sale of the products should be left to the regulator and that any such order could not be made without adding the regulator as a party are spurious. The TGA does not have an exclusive role in protecting the safety of consumers,” Justice Katzmann said.
The judge also granted the applicants’ request to add a claim that Johnson & Johnson failed to provide adequate warning that those with autoimmune or soft tissue disorders could suer inammation when implanted with the devices.
The case already includes more than 1,000 Australian women who allege one or more pelvic mesh implants surgically inserted since 2005 for stress incontinence or pelvic organ prolapse caused catastrophic injuries to their internal organs and ruined their sex lives.
Shine Lawyers represents the lead applicants in the class action. Clayton Utz represents Ethicon Sarl, Ethicon Inc and Johnson & Johnson Medical Pty Ltd.
The case is Kathryn Gill & Ors v Ethicon Sarl & Ors
https://lawyerly.com.au/ethicon-applicants-asked-weigh-uk-ruling-defective-products/
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Vaginal mesh is barbaric and I won’t rest until it’s banned for good
Jul 10, 2018 | Metro
By Yvette Greenway
Hundreds, probably thousands of women across the UK, will be celebrating today’s important announcement that vaginal mesh is suspended with immediate effect.
Today’s news from NHS England, who’ve accepted the advice of the review team led by Baroness Cumberlege, is a positive step in the right direction, but in my opinion, it still doesn’t go far enough.
I will not shut up or put up until there is a complete ban on an implant that is designed to be permanent and has shown, in far too many cases, that it is unstable with severe flaws that can cause life-changing conditions to those affected, and their families.
Mesh has a very nasty characteristic: it can become brittle and erode, and its sharp, exposed edges can slice through nearby organs quicker than Freddy Kruger on a rampage.
Its permanency means there are only a handful of surgeons in the UK with the competency required to even attempt to remove it and removal carries huge risks and no guarantees of health improvement.
Were the recipients told about the dangers? Did we make an informed choice to have the implant? Would anyone choose this option if they were presented with all the facts? The answer to all of these questions is a resounding no.
There is a discriminatory element in today’s announcement from Dame Sally Davies, England’s Chief Medical Officer. She says that ‘carefully selected patients’ will still have access to the procedure and there is no suspension for mesh used in hernia or bowel surgery.
Let’s be quite clear. Mesh is mesh. How is it possible to say that mesh can be implanted into some people for certain procedures but not others? The flaws of the implanted unit do not simply vanish because of who it’s implanted into or why.
In December 2017, when NICE announced a ban on the use of mesh for vaginal prolapse operations (except for research purposes), those whose bodies had been barbarised – and their minds traumatised – felt that they were, at last, being listened to and rejoiced. They felt a justifiable sense of vindication.
https://metro.co.uk/2018/07/10/vaginal-mesh-barbaric-wont-rest-banned-good-7699049/
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Belfast solicitor welcomes NHS England suspension of mesh operations
Jul 10, 2018 | Irish Legal News
A Belfast-based solicitor specialising in civil litigation has welcomed a decision by NHS England to suspend surgical procedures using vaginal mesh devices over safety concerns.
Nicholas Quinn, solicitor at Ó Muirigh Solicitors, told Irish Legal News that the decision “will be welcome news to those affected by it”, though it was not yet clear if the decision would be extended to Northern Ireland.
An immediate end to the procedures was a key recommendation of a review group chaired by Baroness Julia Cumberlege.
Mr Quinn added: “It is important to keep in mind that the review body have recommended that the procedure be halted, as opposed to banned, until March 2019, if certain conditions are met.
“What is objectively clear is that the mesh device in question has been the source of significant life changing injuries to thousands of women in the UK. It will be the subject of many hundreds, if not thousands, of defective medical product claims.”
Mr Quinn is involved in similar ongoing litigation concerning the use of the Essure sterilisation device in women.
Like the vaginal mesh devices, the Essure device has been the subject of “adverse medical and scientific criticism”, he said.
Mr Quinn said it remained unclear “whether or not mesh manufacturers will withdraw this medical product from the market and/or the NHS will implement a ban in respect of same in due course”.
He said: “The widespread media coverage will hopefully make patients explore other options before electing for the mesh procedure.
“It also raises major issues concerning whether or not proper information was imparted to patients by doctors on the risks v. benefits of the mesh in order for them to give fully informed consent, given what the NHS would have known at the relevant time about its problems.”
https://www.irishlegal.com/13258/belfast-solicitor-welcomes-nhs-england-suspension-of-mesh-operations/
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Vaginal mesh surgery ‘paused’ for some treatments
Jul 11, 2018 | The Press Association (In The Times)
Vaginal mesh surgery is to be “paused” for some treatments in England, officials have announced.
Ministers have accepted a recommendation from the nation’s chief medical officer, who asked that “a pause in the use of vaginally inserted mesh to treat prolapse and tape/sling used to treat stress urinary incontinence is implemented through a high vigilance programme of restricted practice”.
The recommendation comes after an official review into the use of vaginal mesh called for an “immediate pause” in the use of surgical mesh for the treatment of stress urinary incontinence.
The Independent Medicines and Medical Devices Safety Review is yet to announce its terms of reference, but its chairwoman made the recommendation after gathering initial evidence from women and their families affected by surgical mesh procedures.
The review was announced by Health and Social Care Secretary Jeremy Hunt earlier this year.
England’s Chief Medical Officer Professor Dame Sally Davies said: “For some patients mesh has had unwanted and serious consequences, which is why guidance has been issued to ensure the right patients are offered the procedure, properly informed and operated on by expert surgeons.
“However, until we are clear this guidance is being properly implemented, ministers have accepted my recommendation to pause its use to ensure patients are receiving a high quality and consistent service.
“This will still be a treatment of last resort for some, so carefully selected patients will continue to have access to the operation in discussion with their consultant.”
Kath Sansom, founder of campaign group Sling The Mesh, said: “This is incredible news and vindication for more than 6,100 members of Sling The Mesh who have been maimed by this operation and then ignored, some for years.”
The news comes after review chairwoman Baroness Julia Cumberlege advised the Department of Health and Social Care and NHS England that surgical mesh should not be used for the treatment of stress urinary incontinence until a set of conditions to “mitigate the risks” of injury are met.
“We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively,” she said.
“We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.
“I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly.
“Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now.
“My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment.”
In February Mr Hunt said a review had been launched into patient concerns about hormone pregnancy test drug Primodos, vaginal mesh and sodium valproate.
He said the review will examine how the NHS responds to safety concerns raised by patients about medicines or medical devices.
In particular it will look into concerns raised about the three health issues.
It will also consider whether any further action is required, including whether a full investigation or a public inquiry is necessary.
The review’s recommendation does not apply to mesh for rectopexy procedures – usually for external rectal prolapse – which will be considered separately.
http://www.times-series.co.uk/news/national/16343873.vaginal-mesh-surgery-paused-for-some-treatments/
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As Vaginal Mesh Surgery Is Banned In The UK, WH Asks: Is It The Biggest Health Scandal Of Our Time?
Jul 11, 2018 | Women's Health
By Roisin Dervish-O'Kane and Ally Head
Vaginal mesh surgery has been halted by the Government with immediate effect.
The ban, which will occur in all NHS hospitals across the UK, is to prevent any further “life-changing and life-threatening injuries” to women and follows health secretary Jeremy Hunt's independent enquiry into the scandal earlier in the year.
Until last year, government guidelines on the matter stated that the surgery was "safe and effective." But the same year, The Guardian uncovered that one in 15 women with the implant later had to have it removed, with many suffering from life-changing injuries.
But why, as the vaginal mesh complications threaten to become one of the biggest health scandals of the 21st century, has this happened? And how has a tiny piece of plastic become synonymous with a scandal so devastating and far-reaching doctors are calling it 'bigger than thalidomide'?
WH reports on the female health crisis of our time. What exactly is vaginal mesh surgery—and why is it used?
Doctor Sohier Elneil is having a hectic morning. The urogynaecology consultant is striding through the corridors of University College London Hospital where, for 16 years, she has performed complex vaginal mesh surgery.
A typical day might involve the delicate and difficult removal of a genital growth or helping to restore bladder control in victims of female genital mutilation. She’s also one of the few specialists in the UK with the skills to extricate small pieces of plastic from vaginas, rectums and bladders. And right now, she is busier than ever. ‘This week, we’ve removed nine,’ she tells WH, stepping out into a corridor to take our call. She is talking about polypropylene netting. Mesh.
You’ve probably never imagined what sensation a cheese grater would cause if it were inserted somewhere in your lower abdomen. Or how it might feel to sit on razor blades. Or to take every step carefully, wary of disturbing a jagged piece of glass lodged somewhere deep inside your vagina. Yet that inconceivable, goosebumps-just- thinking-about-it pain is what thousands of British women are living with right now. The term ‘mesh scandal’ – as it’s become known in the press – fails to convey the everyday agony and the path of destruction that these pieces of plastic have wreaked. They have shattered self-confidence, careers, marriages. They’ve ruined lives.Why are so many people talking about vaginal mesh surgery?
The story begins in the early 2000s when gynaecologists started implanting TVT (tension-free vaginal tape) meshes into the vaginas of women struggling with incontinence following childbirth. ‘Before this, surgeons’ standard procedure was a “hitch and stitch” operation; where stitches are made either side of the vagina, lifted and then stitched to the bone to stop the bladder from moving when a woman coughs or sneezes,’ explains Dr Wael Agur, urogynaecologist and clinical senior lecturer at the University of Glasgow. The highly technical procedure could be personalised to fit the needs of each woman, but it cost an overstretched NHS time – and money.
The newer mesh procedure? Four could be done in the time it took to perform one hitch and stitch. ‘Using keyhole surgery, surgeons make a small incision inside the vagina and thread a piece of plastic tape around the tube carrying urine out of the body,’ explains Dr Agur, who fitted meshes for over a decade. ‘The middle of the tape holds the urethra up in the correct position and the two ends are threaded through two small incisions in the lower abdomen or the groin.’ The end goal was that the female body would naturally produce scar tissue around the area, holding everything in place.
Patients were able to forgo hitch and stitch recovery times of up to six weeks, the first three days of which would need to be spent in hospital, for a turnaround time of mere hours; women had the mesh inserted mid-morning and would be sleeping in their own beds that night. Early evidence suggested that mesh worked – and the procedure soon became surgeons’ default.
It was a similar story with pelvic organ prolapse (a bulge in the vagina caused by sagging of pelvic muscles and organs after childbirth). ‘Prolapse procedures work in much the same way as those for incontinence, except that a larger sheath of mesh is used,’ explains Dr Agur. ‘To repair prolapse in the front, the mesh is positioned underneath the bladder. Prolapse in the back requires the mesh to be fitted between the back wall of the vagina and the rectum, to keep it in place.’ By 2010, mesh procedures accounted for a quarter of all prolapse operations. Mesh was a safe, practical, efficient answer to some of the most common gynaecological problems affecting adult women. Until it wasn’t.So, what are the vaginal mesh surgery complications? And how many have their been?
As the number of operations grew, so too did reports of complications – a word that is, in fact, one hell of an understatement. Infection, urinary problems, pain during sex – in some cases, the mesh was reported to have cut so far through the vagina that it sliced the penises of women’s partners during intercouse. In November 2017, a Canadian woman died from sepsis which she attributed, via a social media post in her final days, to complications with TVT mesh.But why? Why are vaginal mesh surgery complications happening?
It was a procedure billed as safe, simple and cost-effective – so what happened? ‘Surgeons thought the mesh would be fine, as similar products had been used to treat hernias for years. But when you’re treating a hernia, you’re aiming to stop an organ protruding – it’s a bit like blocking a door,’ Dr Elneil explains. ‘Vaginas are different. They are fibrous, muscular tubes, which things move in and out of. They require flexibility, and what we know now is that these meshes induced non-flexibility.’
Indeed, while data suggests meshes don’t move once in the body, they can contract in on themselves, something that wasn’t taken into account when the procedure was soaring in popularity. ‘Think about what happens to a plastic bag if you put it next to an oven for a few days,’ Dr Elneil explains. ‘It becomes brittle and starts to shrink in on itself. In some women, that’s what happens with the mesh.’ with the mesh.’ She believes that the widespread use of mesh was problematic because it failed to account for how different women’s bodies might react. ‘Doctors didn’t consider that introducing a prosthetic material could induce a chronic inflammatory response, causing pain, discomfort, recurrent inflammation and infection.’
It’s still unclear just how far-reaching the fallout is. NHS data reveals that 92,000 women have had vaginal mesh fitted in England alone. But reports on the scale of the damage vary hugely. While the Medicines & Healthcare Products Regulatory Agency has put the complication rate at just one to three per cent, doctors aren’t legally required to report every issue, and leading experts we contacted estimate that the number is much higher.Real-life stories of vaginal mesh surgery
As the true scale of this crisis unfolds in the headlines, women are living through this nightmare – and the reality is horrifying. Kate Langley, a 42-year-old former recruitment consultant from East Sussex, had a TVT mesh implant inserted in 2012 to treat the stress incontinence she suffered after the birth of her second child. ‘My surgeon described it as a quick fix: a same- day operation, safer than any of the “old- fashioned” procedures they used to do,’ she recalls. But Kate’s mesh eroded through her vaginal wall and urethra and is now embedded in her bladder. Six years and 50 hospital admissions later, the bitter irony of this breezy consultation isn’t lost on her.
‘I’m at the mercy of the pain; it can hit at any time, and when it does, it can be so severe I have to call an ambulance. I take a cocktail of painkillers, suppositories and antidepressants just to get through the day, and I can’t have sex with my husband without triggering stabbing pains, which can last weeks. I grit my teeth and smile most days. But the mesh has ruined my life.’
Kate’s reaction, naturally, was to get this thing the hell out of her body. Her surgeon managed to remove the majority of the mesh, but is now struggling to find a way to extricate the final piece lodged inside Kate. She believes it is dangerously close to major veins and arteries – which, if cut, could be fatal – and is cautious about removing it. She has called on the expert opinion of another surgeon, who has won awards for his bomb shrapnel removal in Syria and Iraq, and who could be Kate’s last hope. Now all Kate can do is wait, knowing that, even if they do manage to get it out, the permanent nerve damage already caused by the implant could mean her pain is a lifelong reality.
Such is the case for Kath Sansom. Before being fitted with a TVT mesh for incontinence in March 2015, Kath could often be found high-board diving or mountain biking. Two weeks after the operation, she was bent double over the bathroom sink at work, the pain in her groin and legs so unbearable she couldn’t stop crying. After googling ‘TVT gone wrong’, she uncovered so many stories that she returned to her doctor and asked that the mesh be removed. Seven months later, it was – but the damage was far from undone. ‘I’m better than I was before and, compared with so many women, I am fortunate. I can still walk, I can still do my job,’ she explains. But her voice begins to crack as she recalls her former life. ‘Exercise used to be my therapy. But the amount of damaged scar tissue means the pain is irreversible. I can’t cycle for more than a mile on a flat road without triggering the pain. I’ll never be the woman I was before the mesh.’Why did it take so long for people to find out about the vaginal mesh surgery complications?
It seems strange that a story with so much visceral, toe-curling detail took so long to break. Why, if thousands of women were mutilated by a ‘simple’ operation, did they take years to speak up? One word comes up often in accounts of the victims: shame. Especially the kind we attach to the complicated internal system that shoulders the messy business of being a woman. Data from gynaecological cancer charity The Eve Appeal reveals that nearly a fifth of women have delayed seeing a doctor about symptoms of gynaecological cancers, like ovarian cancer, such as abnormal vaginal bleeding or spotting between periods – a third of whom said they did so because they deemed their symptoms ‘not serious enough’. When you consider this, the slow, muffled way in which the wider public became aware of such complications starts to make sense.
Stephanie Mills*, 40, from Staffordshire, recalls her shame all too well. The mother of two lived with a persistent ‘tugging’ sensation after her first mesh operation for uterine prolapse in 2012, during which a mesh sling was fitted from her coccyx to her cervix to hold up her uterus. Because it wasn’t out-and- out painful, she accepted it as ‘one of those things’.
But 12 months ago, Stephanie was informed that her bowel and bladder had also prolapsed and that she would need another operation. In 90 minutes, a second piece of mesh was fitted to hold up her bladder, and a third to support her bowel. ‘The discomfort never went away after the operation. It feels as though a sharp pin is being scratched along the side of my... [she pauses, uncomfortable] vagina.’ One year on, the pain has become so debilitating that Stephanie can no longer work. And yet, she is still second-guessing herself. ‘I’m worried that if I go back to my GP, they’ll think I’m exaggerating or jumping on some media bandwagon.’
But stigma is only part of the story. The message from countless women we spoke to isn’t just that they feared their pain would be dismissed, but that it actually was. Kate recalls telling ambulance staff that something was cutting her from the inside, only to be later told by a doctor that she was ‘being silly’. And on a separate occasion, when she raised similar concerns with a surgeon, she was told to ‘avoid hysterical women on the internet’. This feedback isn’t just anecdotal; it’s a wider conclusion drawn by a 2017 report from the All Party Parliamentary Group on Women’s Health. MPs found that 40% of women needed to visit their GP 10 times before they were diagnosed with common gynaecological complaints.
And this appalling situation isn’t just a UK problem. In a landmark review of studies in this area, The Girl Who Cried Pain, University of Maryland researchers found that, compared with men, women were more commonly prescribed sedatives instead of painkillers after an operation, and more likely to have their pain characterised as ‘emotional’ or ‘psychogenic’.How can we stop disasters like the vaginal mesh one happening again? And what does this mean for you?
We know doctors aren’t monsters; they’re medical professionals with their patients’ best interests at heart. So why are reports from devastated women stacking up against the NHS? ‘I denied that their pain could have anything to do with the mesh,’ says Dr Agur. ‘I even performed a hysterectomy on a woman who didn’t need one because there was no other explanation for her symptoms. Of course, I regret it now. But there was no mention of chronic pain as a side effect on the instruction leaflet, so as far as I was aware, any complications were unrelated to the mesh.’
Indeed, mesh manufacturers have faced legal challenges that they didn’t test the implants rigorously enough before bringing them to market. Meanwhile, the regulatory framework has also come under fire; EU legislation dictates that medical devices must have clinical trials or ‘equivalence’ – similarity to an already-approved device – in order to be used on patients. Which essentially means that to be approved as medical devices – even when they’re designed to go inside your vagina – they didn't necessarily need to be tested.
‘The device doesn’t even have to be seen by the people who approve it as fit for purpose. All they approve is technical documentation – the same as you would for a wheelchair,’ explains Dr Carl Heneghan, director of the Centre for Evidence-Based Medicine at Oxford University, who has likened the use of mesh to the thalidomide birth defects scandal in the 1960s and is calling for a registry of all devices going forward to match the system we have with drugs. 'I originally made the analogy between vaginal mesh and thalidomide because the latter marked a turning point in drug regulation requiring clinical trials. And I think the damage done by vaginal mesh implants could see a similar shift in how invasive devices are regulated.’What's next for those who have suffered?
While the politics play out, British women are still giving birth, their pelvic floor muscles are still slackening and their wombs are still prolapsing. So what now? The medical community is divided. Some surgeons dismiss the notion that meshes in particular cause harm by pointing out that all gynaecological surgeries carry risk. Dr Agur isn’t convinced. ‘In the absence of long-term clinical trials comparing the impact of treatments with
and without mesh, we can look only at the numbers available to us. In Scotland, where I practise, 500 people have sued after having mesh procedures. For non-mesh procedures, the number is zero. The women themselves are the evidence in this case, and they need to be listened to.’ And they're beginning to be: Just today, the Government has announced that vaginal mesh surgery has been banned nationwide, as Baroness Julia Cumberlege, chair of the Independent Medicines and Medical Devices Safety Review, advised the NHS that there “must be an immediate pause” in the use of it.
But this might not go far enough for the many women who's lives have been altered irrevocably. After Kath had her mesh removed in 2015, she founded a campaign group called Sling The Mesh, and is working with a cross- party group of MPs with the aim of banning the use of all pelvic mesh implants. Sling The Mesh also aims to empower women to talk freely about stigmatised issues like incontinence and prolapse. ‘If I’m proud of anything, it’s that over the past six months “vagina” has been said so frequently on daytime television that it no longer sounds shocking,’ she says, laughing. ‘The taboo women feel about their own bodies may be just one part of this scandal, but it’s a toxic one that we need to change.’
Stealing a moment before she performs another mesh removal surgery, Dr Elneil finds cause for hope. ‘I feel heartened by the fact that there is a strong group of galvanised women who are not going to have their pain explained away,’ she says. ‘Many of the women I see have never viewed themselves as feminists, but now those ideals are driving them on. They’re not afraid to speak out about their bodies – and they’re not going to stop.’
http://www.womenshealthmag.co.uk/health/female-health/8720/vaginal-mesh-surgery/
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NHS England to put immediate curb on mesh operations
Jul 10, 2018 | Health Business UK
NHS England has accepted the advice of a new review looking at harm reported by women who received mesh operations for stress urinary incontinence and is placing an immediate curb on the treatment.
Chaired by Baroness Julia Cumberlege, the review said that it was ‘appalled at the seriousness and scale of the tragic stories’ that the team has heard, with many women reporting implants causing them agony by cutting into tissue and some being left with life-changing injuries.
The health watchdog NICE has already recommended that vaginal mesh operations for treating organ prolapse should largely be stopped in England. A number of Scottish health boards have already stopped using mesh implants altogether, and in Wales the procedures are seen as a 'last resort'.
NHS England says that most patients suffer no ill effects, but it is estimated that more than 100,000 UK women have had a mesh fitted. Professor Dame Sally Davies, England's Chief Medical Officer, said that mesh would remain a treatment of last resort for some ‘carefully selected’ patients.
http://www.healthbusinessuk.net/news/10072018/nhs-england-put-immediate-curb-mesh-operations
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