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Ethicon Monitoring 10/17/2018
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Australia And Britain Have Stopped Vaginal Mesh Implants — California Should, Too
Oct 18, 2018 | San Francisco Chronicle
By Alicia Mundy
... Currently, tens of thousands of women living in California are suffering every day from severe, often permanent, injuries due to implants of transvaginal mesh. -
J&J Wants $20M Pa. Mesh Award Axed Over Alleged Time Bar
Oct 17, 2018 | Law 360
By Matt Fair
A $20.2 million verdict against a Johnson & Johnson unit in a pelvic mesh injury case came under fire on Wednesday as a Pennsylvania appeals court heard arguments that the lawsuit that led to the award had been filed outside of the two-year statute of limitations. -
I wanted to have my vaginal mesh implant removed – but it left me PARALYSED
Oct 17, 2018 | The Sun
By Anna Roberts and Rob Eveleigh
Former This Morning model and mum-of-two Gemma Mulcahy, 35, thought her vaginal mesh was going to help her - but it tore her life apart
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Australia And Britain Have Stopped Vaginal Mesh Implants — California Should, Too
Oct 18, 2018 | San Francisco Chronicle
By Alicia Mundy
Dear Gov. Brown,
Here’s a question for you: What’s a vagina worth?
That’s probably not an issue you have spent much time pondering, but you should.
Currently, tens of thousands of women living in California are suffering every day from severe, often permanent, injuries due to implants of transvaginal mesh.
They were among some roughly 2 million women in America who received mesh implants to repair conditions that affect some 30 percent women after childbirth or as they age: pelvic organ prolapse and stress urinary incontinence. The mesh is supposed to support the vaginal wall, bladder and uterus.
But those mesh implants were not tested first in vaginas, thanks to loose regulations demanded by the medical device lobby. These women were guinea pigs.
This is one of the biggest scandals in the modern women’s health care. Dr. Tom Margolis, a Burlingame pelvic surgeon and an expert on pelvic mesh, warned the Food and Drug Administration in 2011 that vaginal mesh implants were unsafe. His mesh removal surgery wait list stretches to mid-2019.
Injuries and deaths have led other countries including Australia, Ireland and Scotland to stop such implants. Earlier this year, the United Kingdom shut down these operations to conduct a long-term study of mesh damage.
However, in the United States, companies that make vaginal mesh continue to advertise and gynecologists continue to implant it. Why is this happening?
Money. The mesh implant makers have amassed billions of dollars in sales over the past decade, and they don’t want to lose this lucrative revenue stream. Nor do the ob-gyns who were aggressively recruited by mesh marketers’ sales reps, with promises of wealth. Sales reps even helped train the doctors in the implant procedure.
It is time for California to stop vaginal mesh surgery in-state while it reviews the extent of tragic results. This can be part of your legacy, Gov. Brown.
California saw more vaginal mesh implants than other states — perhaps as many as 100,000, according to mesh experts. It is estimated that 10 percent of the women will need partial or complete mesh removal to pull the plastic from organs it has cut. In my reporting, doctors and patients told me that implant surgeries cost about $3,500 but the removals are in the range of $50,000. The British health system says mesh removal surgeries are costing it millions of pounds.
The Food and Drug Administration says serious problems with vaginal mesh are “NOT rare.” Thousands of women across America endure repeated emergency room visits for chronic urinary tract infections, unrelenting pain, and difficulty walking.
A group of those women, several in wheelchairs, came to Chicago last week to rally before pro-mesh doctors at the annual medical conference on women’s pelvic disorders.
Among them was a woman from Colorado who has had five surgeries at UCLA since 2015 for mesh removal and pelvic repair. Mesh had caused inversion of her small intestine, which was hanging out. Her vagina was so damaged by mesh that it was removed and reconstructed, to a point. Not surprisingly, she calls mesh deterioration “genital mutilation.”
In 2016, the California Attorney General — then Kamala Harris — paved the way for California to stop these implants. In 2016, she announced that California was suing Johnson & Johnson for deceptive marketing. Harris said, “Johnson and Johnson put millions of women at risk of severe health problems.” The company sold 787,232 devices nationally from 2008 to 2014, more than 42,000 in California. And Johnson & Johnson was only one of four companies selling mesh in California.
This summer, Netflix’s documentary “The Bleeding Edge” and CBS’ “60 Minutes” showed damage done to women’s internal organs by plastic mesh “migration” (as it’s politely called).
The company that manufactured the polypropylene used in mesh warned that it was not intended as an implant in humans. A clinical trial in the United States was halted in 2009 because of the shocking 15 percent complication rate among patients within three months. Mesh-maker executives have said under oath that they knew this plastic could shrink, move and perforate organs.
But companies sold billions of dollars of vaginal mesh anyway.
I’ll bet their investors know what a vagina is worth.
People tell me they’re “uncomfortable” discussing vaginal mesh. Katrina Spradley of Georgia, who organized the rally for Mesh Awareness in Chicago, can discuss the “cheese grater” that her mesh felt like. Spradley has also had removal surgery at UCLA. She talks freely about the incident before her repair operation, when a piece of mesh that pushed through her vaginal wall unexpectedly scratched her husband’s penis during sex.
Now that is uncomfortable.
If California acts to halt these mesh surgeries, other states will follow.
As one of your last official acts, Gov. Brown, show that California is still first in protecting women’s health.
https://www.sfchronicle.com/opinion/openforum/article/Australia-and-Britain-have-stopped-vaginal-mesh-13315968.php
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J&J Wants $20M Pa. Mesh Award Axed Over Alleged Time Bar
Oct 17, 2018 | Law 360
By Matt Fair
Law360 (October 17, 2018, 8:16 PM EDT) -- A $20.2 million verdict against a Johnson & Johnson unit in a pelvic mesh injury case came under fire on Wednesday as a Pennsylvania appeals court heard arguments that the lawsuit that led to the award had been filed outside of the two-year statute of limitations.
Alicia Hickok, an attorney with Drinker Biddle & Reath LLP representing J&J subsidiary Ethicon Inc., told a three-judge Superior Court panel in Philadelphia that plaintiff Peggy Engleman should have realized she had a potential claim against the company after she began experiencing complications with her mesh implant a month after receiving it in June 2007.
Instead, Hickok said, Engleman only filed suit in April 2014 after seeing an advertisement on television soliciting potential mesh claims.
“She didn’t think to sue anybody until she saw an ad seven years after the fact,” Hickok said. “Fortuitously, there was this advertisement that told her there might be able to be a lawsuit against a manufacturer.”
According to court records, Engleman was implanted with Ethicon’s so-called TVT-Secur mesh to relieve symptoms of urinary stress incontinence, but within a month she began experiencing pain after the implant eroded into her vagina.
She underwent a second surgery in September 2007 to remove the portion of the mesh that had become exposed in her vagina, but she said she continued to experience “constant throbbing pain” in the area.
Most — though not all — of the mesh was removed during a third operation in February 2008 during which she was implanted with a new device that court records said resolved her incontinence.
After she continued experiencing intermittent pain over the intervening years, Engleman underwent a fourth surgery in December 2013 in which a doctor removed an additional section of the leftover TVT-Secur, which had once again eroded into her vagina.
A jury ultimately awarded her $20.2 million in damages last April, including $17.5 million in punitive damages against Ethicon.
As part of the verdict, the jury rejected arguments from Ethicon that Engleman should have realized she had a claim, at the earliest, when her treating physician told her that a portion of the implant had eroded in the month after she received it in 2007.
But Hickok argued on Wednesday that Engleman didn’t need to have the possibility of a legal claim against Ethicon laid out explicitly for her in an advertisement to realize she might have had a case against the company.
“You don’t need to know everything that happened to you, you don’t need to know the full extent of your injury, you do not have to know what went into causing the injury in terms of all the details that might have given rise to it, and specifically you do not need to know that you have a cause of action,” she said.
Judge Alice Beck Debow, however, suggested that the jury had already grappled with the issue and decided in favor of Engleman.
“Everything you’re telling us now, the jury heard that and they found there was no statute of limitations violation,” she said.
Chip Becker, an attorney with Kline & Specter PC representing Engleman, said that his client’s physicians had given her no reason to think that the problems she experienced weren't simply a result of her body rejecting the mesh as opposed to a latent defects with the product.
“She didn’t have any understanding of what was happening to her,” he said. “Her physician did not inform her that what was going on was not just a bad reaction, but was actually a failure of the device.”
Engleman is represented by Charles “Chip” Becker, Ruxandra Laidacker, Lee Balefsky and Christopher Gomez of Kline & Specter PC, Bryan Aylstock, Daniel Thornburgh and James Barger of Aylstock Witkin Kreis & Overholtz PLLC, Stefanie Colella-Walsh and Martin Schrama of Stark & Stark PC, and Benjamin Anderson of Anderson Law Offices.
Ethicon is represented by D. Alicia Hickok, William Carr and Molly Flynn of Drinker Biddle & Reath LLP, Stephen Brody of O'Melveny & Myers LLP, and Julie Callsen of Tucker Ellis LLP.
The case is Margaret Engleman v. Ethicon Inc. et al., case numbers 3320 EDA 2017 and 3400 EDA 2017, before the Pennsylvania Superior Court.https://www.law360.com/pennsylvania/articles/1092353/j-j-wants-20m-pa-mesh-award-axed-over-alleged-time-bar
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I wanted to have my vaginal mesh implant removed – but it left me PARALYSED
Oct 17, 2018 | The Sun
By Anna Roberts and Rob Eveleigh
Former This Morning model and mum-of-two Gemma Mulcahy, 35, thought her vaginal mesh was going to help her - but it tore her life apart
LOOKING into her newborn son Niall’s eyes, Gemma Mulcahy was smitten.
The former model and mum-of-two - who showcased clothes on This Morning as a teen - briefly forgot the “really tough” pregnancy and “horrific birth” she’d just endured.
“My hips were in agony and by 37 weeks it was so bad I could barely walk and had to be induced,” Gemma, also mum to Mhairi, six, recalled. “His birth was horrific. Things didn’t go to plan and I begged the nurses for an epidural… but it was too late.”
Four-year-old Niall's extraordinarily painful arrival had a significant impact on Gemma, now 35, from Newport, South Wales.
Virtually immediately afterwards, she developed stress incontinence and a bladder prolapse. This is when the top of the bladder slips down from its normal position and bulges out of the vagina.
It is relatively common after childbirth, according to the NHS – but can be painful and make urinating difficult.
So when Gemma’s doctor at a private hospital in south Wales suggested she have a vaginal mesh fitted – to solve the issues – she agreed.
She didn't realise at the time that meshes are a hugely controversial topic - with around 800 people taking legal action in relation to them, having been left unable to have sex, in pain and incontinent.
Now Nice has issued its latest draft guideline on the management of urinary incontinence and pelvic organ prolapse in women, with formal guidance expected in April next year.
The draft document states that women should try a range of techniques before mesh is even considered.
In 2017 the BBC reported that more than 100,000 women have had meshes fitted - and a Sky News investigation into hospital figures suggestion around 10 per cent of these women suffer problems afterwards.
Sling The Mesh founder Kath Sansom, who set up a campaign highlighting these problems reported women had been left suicidal as a result of having meshes implanted.
"One in seven have lost their marriages because of mesh," she warned. "One in seven have lost their sex life. Eight out of ten suffer pain so great it affects their daily life."
She added: "More than half suffer ongoing urinary infections. Unsurprisingly many are suicidal and six in ten are on anti-depressants.''
Gemma, who had a hysterectomy as a consequence of her mesh, told how it triggered in her a catalogue of devastating problems.
“Niall was a gorgeous baby, absolutely perfect, but giving birth to him took a real toll on my body,” she explained. “My issues afterwards were so bad that at times I couldn't even sit on the loo.
“It’s hard enough when you’re a new mum, but on top of everything else I was back and forth to the hospital.
“I just had to get on with it. You put the children first and just keep pushing through.
"The mesh sounded gruesome but I really thought it would be the end of my embarrassing troubles."
Even when the procedure was described to her she wasn't deterred.
“The doctor explained how this piece of plastic tape would be inserted surgically [at the top of the vagina] and would act like a sling to support the organs in my pelvis,” she said.
A few weeks late the mesh was fitted.
A small cut is made in the vaginal or abdominal wall, and the surgical mesh is implanted and held in place by sutures or tissue fixation devices.
The idea is that tissue will grow into the pores of the mesh.
But almost instantly Gemma started to feel “excruciating” pain.
She developed bleeding and her incontinence, rather than improve, worsened.
Then – in addition to a bladder prolapse – she developed a bowel prolapse.
Gemma, who runs a dance school with her twin sister Philippa, having previously worked at Disney Worlds in Tokyo and Paris, continued: “I suffered constant, excruciating pain because of my implant.
“I had constant abdominal pain, suffered a bowel prolapse and I bled almost constantly for an entire year.
“The mesh did nothing to help my incontinence – if anything it made it worse. I was told I had an ‘overactive bladder’ and doctors gave me Botox injections on my bladder to try and remedy that."
Affected by incontinence she could only wear dark clothes. "Incontinence affects every aspect of your daily life," she explained. “If was going somewhere I’d have to think ahead about how long it would take to get there, where the loos were, and whether I’d be close enough to them.
“Gone were the days when I could sling a little handbag over my shoulder like a normal person and just take off – I’d have to pack a change of clothes wherever I went.”
A few years ago Gemma was offered a hysterectomy in the hope it would relieve her symptoms. Desperate to feel better, she agreed to it.
“I talked it over with my husband Patrick and we both felt our family was complete with two children so, in an act of desperation, I had the operation."
But it failed to cure her so, a few weeks ago, she had the implant removed.
Gemma’s operation was carried out at the private Spire Hospital in Bristol.
She said: “The spinal anaesthetic meant I was numb from the waist down when I came round from the operation.
“I was recovering on the ward and gradually regained the feeling in my right leg, but couldn’t feel anything in my left.
“I was trying to wiggle my toes but there was just nothing there. I started to panic – the first thing that came to my mind was dancing. I was lying there thinking, ‘What the hell am I going to do?’
“I was in floods of tears, but no one at the hospital seemed to be in much of a panic.
“The nursing staff eventually contacted a consultant. He was as shocked as I was – he just couldn’t understand what had happened.
“Patrick came in to visit and tried to reassure me. He told me it was going to be OK, that we’d get through it together, because we always do.
“But the hospital didn’t have any answers – and still don’t.”
Gemma says she was told she may have Functional Neurological Disorder (FND), a poorly understood condition that can result in paralysis even if there is nothing physically wrong with the body.
Spire advised her to have rehab treatment – but warned that her private health scheme would not cover the cost.
She was transferred to St Woolos NHS hospital in Newport.
She says she had a daily physio session lasting between 10 and 20 minutes at St Woolos, but claims she was never seen by a consultant, and she discharged herself after five days.
Gemma had advice from a private neuro rehabilitation centre – the Morrello Clinic in Langstone, Newport.
She is now having physio there and is on the waiting list for treatment at Wales’ flagship NHS spinal injury rehab centre, the Rookwood Hospital in Cardiff.
Meanwhile her pupils are raising £8,000 to pay for her £300-a-week rehab sessions, and a £2,500 wheelchair.
She said: “The Morello believe the nerve is intact but they think I’ve suffered some spinal cord damage, and there’s no timescale for recovery.
“I’ve got to take each day as it comes. It’s heartbreaking to go from being so active before an operation to being left like this.
"Everything is more difficult - getting up in the morning, getting the kids ready for the school run, getting the wheelchair in and out of the car everywhere we go.
“I try to push it to the back of my mind and just get on with it. I haven’t really accepted it – because that would mean accepting I might never dance again.”
“I’ve danced since I was three, it’s always been what I wanted to do.
“I performed around the world and I came home to set up the dance school from scratch with Philippa."She continued: “The school is my life and I don’t want to let my students down - for now I’m teaching them from my wheelchair, but it doesn’t look great when new students arrive and see me stuck in a chair.
“I’m itching to demonstrate new moves but can’t – I have to talk them through it.”
A spokesman for Aneurin Bevan University Health Board, which administers St Woolos, commented: “We’re sorry to hear that Ms Mulcahy has concerns about the care she has received. We would ask that she makes contact with us directly so we can look into her claims.”A spokesman for Spire Healthcare said: “As Ms Mulcahy is continuing to receive care from us, it would be inappropriate to discuss the details of her treatment.
"However, in view of the fact that Ms Mulcahy has not raised any concerns with us directly, we would kindly ask her to contact the hospital or her treating consultant if she has any issues regarding her surgery that she would want addressed.
"We are committed to delivering the very highest quality of care for our patients whilst admitted and also following discharge. "
Gemma is raising funds for her rehabilitation. Donate here.
We previously told how a mum was left with a "deadly vagina" that "BIT" her partnerduring sex after surgery for stress incontinence went wrong.
In June we reported how a biker's botched vagina op destroyed her sex life – and left her jobless and disabled.
https://www.thesun.co.uk/fabulous/7515906/i-wanted-to-have-my-vaginal-mesh-implant-removed-but-it-left-me-paralysed/
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