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Ethicon Media Monitoring 6/28/2017
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Biker’s despair after botched vagina op destroyed her sex life and marriage – and left her jobless and disabled
Jun 27, 2017 | The Sun
By Hayley Richardson and Kelly Strange
LIZZY Ford, 54, from Innerleithen, Scotland, had a routine operation in June 2010 to cure stress incontinence, where a mesh sling was inserted to lift her bladder and stop it leaking -
AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process
Jun 28, 2017 | Regulatory Focus
By Zachary Brennan
Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer. -
Mesh implants action law firm says op ruined some of its clients' lives
Jun 27, 2017 | Belfast Telegraph
By Michael Sheils McNamee
The lives of some women who have undergone vaginal mesh implants have been "devastated" by the procedures, a solicitor has claimed. -
Women Left ‘Scarred’ by Vaginal Mesh Treatment
Jun 28, 2017 | Slater and Gordon Lawyers UK
By Jack Bowman
Women in Northern Ireland are taking legal action after being physical and mentally scarred by vaginal mesh implants.
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Jun 27, 2017 | The Sun
By Hayley Richardson and Kelly Strange
LIZZY Ford, 54, from Innerleithen, Scotland, had a routine operation in June 2010 to cure stress incontinence, where a mesh sling was inserted to lift her bladder and stop it leaking
A BIKER mum has told of her despair after a routine operation to cure her stress incontinence ruined her sex life, destroyed her marriage and left her jobless and disabled.
Lizzy Ford, 54, from Innerleithen, Scotland, was forced to swap her beloved motorcycle for a mobility scooter just weeks after the disaster operation that she says ruined her life.
The mum-of-one had suffered from stress incontinence when she coughed and laughed since giving birth to her daughter, Rachel, in 1989.
Her GP had suggested having a mesh sling called a transvaginal tape (TVT) inserted to lift the prolapsed bladder and stop it leaking.
She went through with the op in June 2010, but afterwards was left in agony.
Lizzy went from being a biker to using a mobility scooter in just three months, but initially doctors refused to link the throbbing pain between her legs with the TVT surgery.
In 2014, after begging her consultant to remove it, she was told the operation was classed as permanent because of the way the mesh knits into the vaginal tissue.
Lizzy refused to give up and was eventually referred to a surgeon who extracted the mesh in February this year.
She is now part of Scottish Mesh Survivors and Sling the Mesh, campaign groups aiming to raise awareness and connect victims of the surgery, which has already been suspended in Scotland but is still offered to women in England.
Lizzy is keen to share her story to warn other women of the risks.
She said: “I went from being an active biker to being reliant on a mobility scooter.
“Nobody told me about the risks of the mesh – that it can erode into your body causing agony and pain and that because it’s permanent it’s very difficult to reverse.”
Lizzy recalled how the 20-minute operation sounded like a quick and easy fix to her stress continence and she went through with it, supported by her second husband Bob, whom she married in 2008.
But afterwards, every step she took left her in agony.
When she tried to ride her 500cc Kawasaki, it send red hot pains searing through her groin and leg.
Her sex life disappeared and she was forced to give up her job at a supermarket.
But doctors were baffled and insisted the mesh was not to blame, despite the fact it had also failed to cure her stress incontinence.
Lizzy tried attending her beloved biker events on her scooter, but said it was humiliating and a painful reminder of what she had lost since the surgery.
As a result of their dwindling sex life, she told how she and her husband began to grow apart and eventually decided to separate.
Lizzy began doing some research and was shocked to discover that thousands of women were taking legal action after the plastic mesh used to lift the bladder caused horrifying complications – like the ones she was suffering.What is a transvaginal tape (TVT) procedure?
People with stress incontinence leak small amounts of urine, sometimes when coughing, laughing, sneezing or doing exercise.
For women, tape procedures may be recommended to stop the problem by providing support to a sagging urethra.
In TVT surgery, a mesh tape is placed under your urethra like a sling or hammock to keep it in its normal position.
The tape is inserted through tiny incisions in your abdomen and vaginal wall, with the procedure normally taking around 30 minutes.
Around 13,500 women have the operation annually on the NHS and it’s the most common way to treat stress incontinence.
However, there has been an increase in the women coming forward with post-op problems.
The surgery was suspended in Scotland two years ago, where around 400 lawsuits are ongoing.
The mesh is also used in hernia operations, so men are also at risk from feeling the adverse affects.
Finally, still in chronic pain, her consultant agreed to remove the mesh – but warned her of a low success rate because the operation is permanent; something Lizzy said she was not told.
“They told me it would be like getting chewing gum out of hair because the mesh embeds into the tissue,” she explained.
The mesh was eventually removed this February, and Lizzy said she “felt better straight away”.
“The relief to know it was out was incredible,” she admitted.
“To go from motorbike to disability scooter in months was soul destroying. I wish with all my heart I had never had the operation.
“They said it would change my life and it did, but not in the way I had hoped. It ruined it.
“It’s too early to know if I’ll ever be able to swap my mobility scooter for a motorbike again.
“But hopefully I can stop other women from being injured.”
https://www.thesun.co.uk/living/3891710/biker-mum-botched-vagina-op/
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AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process
Jun 28, 2017 | Regulatory Focus
By Zachary Brennan
Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.
In an amicus curiae brief filed with the nation's top court last week, AdvaMed takes issue with a decision from the US Court of Appeals for the Fourth Circuit, which upheld a $3.27 million jury verdict against Johnson & Johnson subsidiary Ethicon.
The CaseThat case, known as Ethicon v. Huskey, was brought by Jo Huskey, a woman implanted with an Ethicon transvaginal mesh device in 2011 to treat stress urinary incontinence but which caused severe pain. Huskey and tens of thousands of others have filed lawsuits because of pelvic mesh device issues.
But AdvaMed is taking issue with the Fourth Circuit's decision to affirm the district court's decision to exclude all evidence of the Ethicon device's 510(k) clearance, despite "Congress having mandated that principles of safety and effectiveness underlie every 510(k) review," AdvaMed says.
"The Fourth Circuit discarded FDA's own view that principles of safety and effectiveness underlie the 510(k) process, rejecting FDA's statements as ‘[b]ald assertions,'" AdvaMed writes.
The court reasoned that the 510(k)-clearance information "was of minimal probative value as to whether the TVT-O [the device] is safe because ‘the 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only "tangentially" examines the safety of the product going through the process,'" AdvaMed says.
In addition, the group says the court's reasoning is from a 1982 decision and AdvaMed cited FDA publications from 2014 and 2017 that "contain many statements confirming the importance of safety and effectiveness in a 510(k) review."
FDA's "consistent position" since the Safe Medical Devices Act was enacted in 1990 is "that principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review," AdvaMed claims.
SCOTUS ClarificationAdvaMed is calling on the Supreme Court to take up the case, not only because there are about 60,000 pelvic mesh cases pending, but because it believes the court should "clarify the bounds of its previous statements on the 510(k) process."
In addition, the organization wants the Supreme Court to clarify whether a device manufacturer can be barred from citing FDA's clearance of the device to defend against claims that the device is unsafe, and to "elucidate the limits as to when a court may disregard an agency's characterization of its own processes," among other issues.
http://raps.org/Regulatory-Focus/News/2017/06/27/27984/AdvaMed-Urges-Supreme-Court-to-Take-Up-Case-on-510k-Review-Process/
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Mesh implants action law firm says op ruined some of its clients' lives
Jun 27, 2017 | Belfast Telegraph
By Michael Sheils McNamee
The lives of some women who have undergone vaginal mesh implants have been "devastated" by the procedures, a solicitor has claimed.
Joanne Kerr, who is handling the case for Belfast-based negligence solicitors Thompsons NI, said it is still too early to tell how many could potentially have been impacted.
"It has devastated some of the women that we have spoken to. It has absolutely devastated their lives," Ms Kerr told the Belfast Telegraph.
A number of affected women have already come forward, and others are being urged to seek legal advice.
Procedures involving the use of the mesh are used to treat issues like pelvic organ prolapses and stress incontinence. According to the legal firm, some of the women it is acting on behalf of have reported "pieces of the mesh appearing through the tissue wall, causing extreme pain and discomfort, and in some cases mobility problems".
The time frame for the development of the case is unclear, with Ms Kerr saying that it is "only really at the start of the process".
"It depends on a number of factors that we can't determine at the present time," she said.
"It depends on the attitudes of the defendants etc, about how long it might take to come to conclusion."
The Department of Health said: "It is recognised that women who have undergone these procedures may experience complications, as is the case with any surgical procedure, and these symptoms can be distressing.
"Any woman who is experiencing distressing symptoms that are related to having undergone this procedure should, in the first instance, seek advice from their GP."
Between 2007/2008 and 2015/16 a total of 5,575 of the mesh implants were carried out here.
It is anticipated that action will be taken against various health trusts in Northern Ireland.
The women can pursue either a product liability claim, or a standalone clinical negligence claim.
"We will pursue the avenue that we feel is most beneficial to the individual woman," Ms Kerr added.
http://www.belfasttelegraph.co.uk/news/northern-ireland/mesh-implants-action-law-firm-says-op-ruined-some-of-its-clients-lives-35868386.html
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Women Left ‘Scarred’ by Vaginal Mesh Treatment
Jun 28, 2017 | Slater and Gordon Lawyers UK
By Jack Bowman
Women in Northern Ireland are taking legal action after being physical and mentally scarred by vaginal mesh implants.
The implants are the ‘recommended method’ for treating a pelvic organ prolapse and incontinence after childbirth.
Almost half of those who have received mesh implants are at risk of developing chronic pain, according to an investigation by the BBC's Victoria Derbyshire programme.
Peter Jones, a former general surgeon from Kent, told the BBC he spent much of his career removing mesh implants from hernia patients. He said: “At least half of patients who have a mesh repair will have a smooth recovery but in my opinion the risks of a poor outcome are so bad, I wouldn't want to take that risk”.
The UK's medical products regulator said the current evidence showed the devices are "acceptably safe" if used "properly and as intended."
More than 800 women across the UK are taking legal action against the NHS and the makers of vaginal mesh implants, it was revealed in April.
Between April 2007 and March 2015, over 92,000 women had vaginal mesh implants fitted in England.
The Department of Health told the BBC it is "recognised that women who have undergone these procedures may experience complications, as is the case with any surgical procedures and these symptoms can be distressing".
"It is essential that clinicians that conduct these operations carry out audits to ensure they are performing to the highest possible standards."
Ian Cohen, a clinical negligence specialist at Slater and Gordon, said: “We are seeing an increasing number of clients who have been left with very debilitating conditions as a consequence of vaginal mesh.
“Many of these clients believe they did not provide fully-informed consent as they were either not warned of the known risks of complications arising out of using vaginal mesh, or in many cases, they should never have been offered a TVT or TOT operation in the first place.
“The real concerns we have with surgical mesh- in particular ‘sling’ surgeries- are many women were not appropriate candidates for such surgery in the first place and the regulator accepts mesh should only be used ‘as intended’.”
https://www.slatergordon.co.uk/media-centre/industry-news/2017/06/women-left-scarred-by-vaginal-mesh-treatment-35814/
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