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Ethicon Media Monitoring 8/17/2017

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. 'I’ve been on the brink of suicide but my kids kept me going': Mother reveals how her sex life, career and relationship have been destroyed after having a vaginal mesh implant fitted

    Aug 17, 2017 | The Daily Mail

    By Alexandra Thompson And Stephen Matthews

    A mother-of-three has revealed she was on the brink of suicide after suffering agonising pain from a vaginal mesh implant she had fitted.
  2. Opinion The Guardian view on vaginal mesh implants: trust data and patients Editorial

    Aug 16, 2017 | The Guardian

    The numbers tell their own tale. Thousands of women have undergone surgery to have vaginal mesh implants removed after suffering complications.
  3. Women left in agony after routine removal of vaginal mesh implants

    Aug 16, 2017 | EveningStandard

    By Chloe Chaplain

    Shocking figures have revealed the number of women left in pain, unable walk or have sex after undergoing vaginal mesh surgery to help with incontinence.

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. 'I’ve been on the brink of suicide but my kids kept me going': Mother reveals how her sex life, career and relationship have been destroyed after having a vaginal mesh implant fitted

    Aug 17, 2017 | The Daily Mail

    By Alexandra Thompson And Stephen Matthews

    ·  EXCLUSIVE 

    ·  Janette Nelson, 43, relies on her children to wash, dress and catheterise her

    ·  Her boyfriend left her when she was unable to have sex due to the crippling pain

    ·  Ms Nelson can no longer work because she cannot stand or control her bladder

    ·  She blames strong painkillers for causing her to accumulate £10,000 in debt

    A mother-of-three has revealed she was on the brink of suicide after suffering agonising pain from a vaginal mesh implant she had fitted.

    Janette Nelson, 43, from Newtownards, Northern Ireland, said the only think that kept her going was her children, but she still battles guilt every day as she depends on them to help her wash, dress and even catheterise after the procedure left her unable to control her bladder. It is a ‘humiliating’ experience for Ms Nelson. 

    The former hairdresser also blames her implant for the breakdown of her relationship as her boyfriend left her when the pain was too severe for her to have sex. Unable to work, her career has also been destroyed and she has been left debt-ridden.

    Vaginal mesh implants are offered to women suffering from stress urinary incontinence or pelvic organ prolapse, yet more than 800 are suing the NHS and the implants’ manufacturers after suffering crippling pain.

    The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention. 

    Here MailOnline reveals the story of Ms Nelson as we back calls for a suspension to the controversial procedure.

    Ms Nelson had the most common type of mesh, known as TVT, fitted in March 2012 in an attempt to cure her urinary stress incontinence.

    She said:‘Immediately once my tape was fitted I woke up with excruciating pain in my groin; its indescribable.’

    Ms Nelson was unable to pass urine after the procedure, however, doctors simply fitted her with a catheter and assured her the problem would pass within the next few days.

    Yet, her bladder control only got worse, resulting in Ms Nelson wetting herself while out shopping with her children around a week later.

    Five years on, her urine control is no better and Ms Nelson relies on her 17-year-old daughter to help her fit her catheter every day.

    She said: ‘My eldest helps me catheterise, which is so humiliating for me.

    ‘My children help me get dressed, get into the bath, do chores around the house.’

    Ms Nelson had the implant partially removed in the summer of 2012, however, the mesh had already eroded into her vagina and organs, meaning surgeons were unable to remove it in its entirety.

    A second removal attempt in March 2013 was so invasive that Ms Nelson has been left with severe nerve damage in her groin and legs. Fragments of the implant still remain in her body.

    There are no surgeons capable of carrying out total removal procedures in Northern Ireland, which forces women to pay to travel to England and have private consultations.

    Due to the excruciating pain of the mesh, Ms Nelson has been forced to rely on her mother and sister to help her raise her children.

    She said: ‘My children lost their mummy. I’ve been on the brink of suicide. 

    ‘My kids say “why are you no fun anymore?” They can’t see a broken bone or cast so they don’t know its sore.

    ‘My kids kept me going. I was useless as a mum but I’m still their mum. It’s all been about me for the past few years.’ 

    As well as affecting her as a parent, Ms Nelson also blames the implant for the loss of her love life and career.

    She said: ‘I had a boyfriend when this started but the sex was excruciating, neither of us could cope with it. My boyfriend left me because of it.

    ‘I used to work as a hairdresser; always on my feet, always very confident, but now I can hardly walk and I can’t control my bladder so I can’t work. It’s really knocked my confidence.’ 

    Ms Nelson, who relies on a wheelchair when travelling long distances, receives government financial support and disability living allowance payments, but still struggles to make ends meet as a single mother.

    The pain also meant she used to rely on strong doses of morphine every day until weaning herself off the medication last year.

    She blames the painkillers for making her brain not ‘work right’ and causing her to spend beyond her means.

    Consequently, Ms Nelson has accumulated debts of around £10,000, which she is struggling to pay off.

    After having the implant fitted, Ms Nelson felt her complications were swept under the carpet, with doctors dismissing them as just ‘unfortunate’. 

    She said: ‘Surgeons just said it hadn’t take to my body and was unfortunate but it happens sometimes.

    ‘No one would tell me what went wrong, they spoke to me like I was stupid. 

    ‘Women doctors are treating women like dirt, we’ve been pushed to the side and they hope we don’t complain.’

    Ms Nelson is applying to have her case reviewed by an NHS board, who will decide whether she is eligible for a mesh removal operation in London.  

    As of last week, the Department of Health agreed to send one patient to England to meet with a surgeon, however, it is unclear if more women will be deemed eligible.  

    Ms Nelson said: ‘I just want to be fixed a little so I can go back to work. 

    ‘My future is not good and I don’t expect it to be, but I want a glimmer that it might get better.’

    http://www.dailymail.co.uk/health/article-4792912/Mother-considered-suicide-vaginal-mesh-implant.html

     

     

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  2. Opinion The Guardian view on vaginal mesh implants: trust data and patients Editorial

    Aug 16, 2017 | The Guardian

    The numbers tell their own tale. Thousands of women have undergone surgery to have vaginal mesh implants removed after suffering complications. Around one in 15 of those fitted with the most common type of mesh have required operations, according to NHS data obtained by the Guardian. In short, the problems are much more widespread than previously acknowledged. The removal rate was previously estimated at less than 1%.

    But numbers are not enough. Each case is a woman with a disturbing story; and listening is as important as tallying them. Carolyn Churchill had to give up work after she was left in agony, with persistent bleeding. Yet she said she was made to feel like a baby for complaining. Others describe being left unable to walk or have sex – and of being assured that the implant was not responsible. So even this data under-represents the problem. Women may not be referred for removal, or may decide against it given the risks.Guardian Morning Briefing - sign up and start the day one step ahead

     Read more

    The implants have been adopted widely as a simple, less invasive alternative to traditional surgical procedures for women suffering from incontinence and prolapse, often after childbirth. That the procedure saved the NHS a good deal of money no doubt helped. But doctors believed it was in the interests of their patients. In most cases, they were right. In too many, they were not.

    The approval process for medical devices is poorly regulated in comparison to drugs: no large-scale, randomised controlled trials are required, and products can be introduced to the market rapidly – while complications may emerge only months or years later. It is time to consider a tighter regime. In the meantime, requiring long-term follow up studies to identify problems down the line could save patients suffering, without in any way holding back innovation.

    But those shortcomings do not fully explain why such severe effects, reported by so many, in several countries, have gone under the radar for so long. Some of those may be procedural – the specialists implanting the mesh saw the successes, but were often not the ones removing it when things went wrong. But it is also clear that many sufferers simply were not listened to.

    Of course, patients of both sexes can be brushed aside by doctors who think they know best. And many medical staff – both male and female – have been fighting for those affected: one recently compared the issue to the thalidomide scandal. But it echoes a pattern we have seen more broadly where women’s reproductive systems are concerned, such as in the extraordinary neglect of endometriosis. Women find that severe suffering is not taken seriously, or is misdiagnosed not once, but serially.

    Authorities are at last starting to listen. The Scottish government has asked health boards to suspend the use of mesh devices; the US Food and Drug Administration has issued safety warnings about the risks. Meanwhile, an NHS review last monthacknowledged that some women have suffered severe and life-altering complications, and called for patients to be fully informed of the benefits and risks of the procedure. But it concludes that the use of the implants is safe. This would be more convincing if it did not also call for more data – apparently oblivious to the evidence in its own records. The unearthed figures tell a more complex story, and so do the patients.

    https://www.theguardian.com/commentisfree/2017/aug/16/the-guardian-view-on-vaginal-mesh-implants-trust-data-and-patients

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  3. Women left in agony after routine removal of vaginal mesh implants

    Aug 16, 2017 | EveningStandard

    By Chloe Chaplain

    Shocking figures have revealed the number of women left in pain, unable walk or have sex after undergoing vaginal mesh surgery to help with incontinence.

    NHS figures show that one in every 15 women fitted with the vaginal mesh implants in the past ten years has had it removed.

    The implant – known as trans-vaginal tape (TVT) – is a small mesh support used to treat urinary incontinence or prolapse occurring after childbirth.

    Removal of the tape can cause serious long-term complications for some women who are left in chronic pain, requiring invasive surgery to have the mesh removed.

    According to figures released by NHS Digital, between 2006 and 2016, more than 75,000 people had the TVT implant fitted.

    And, in the same period, more than 4,900 procedures were carried out to remove them – equating to 6.5 per cent.

    Sohier Elneil, a consultant at University College Hospital told the Guardian the figures were a “scandal” and others called for a public inquiry into the use of the treatment.

    The implants have become a popular method of treating post-birth complications as a less invasive alternative to traditional approaches.

    But removing the mesh, which is designed to embed itself in the surrounding tissue, can require long and complex surgery and risks damaging nerves and nearby organs.

    The surgeon would have to perform the operation by entering both through the vaginal opening and the patient’s stomach where they have to “chisel” out small sections of the mesh.

    Ms Elneil said that many patients expect a “simple and easy fix” but stressed the removal “is a completely different story”.

    The mesh treatment has been the centre of a suspicion after NHS meeting minutes, obtained by the Press Association from 2016, revealed bosses plotted to “avoid media attention” about complications.

    When the minutes were published, authorities were accused of covering up the true risks of the treatment.

    And these latest figures do not tally up with those published in a 2014 government report, which estimated the removal rate for TVT was just 0.9 per cent, sparking more accusations that the complications relating to the treatment is being played down.

    The Medicines and Healthcare products Regulatory Agency (MHRA), who published the report conceded that no device was without risk.

    But, in a statement, it added: “In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of evidence which would lead to the conclusion these devices are inherently unsafe if used as intended.”

    And Johnson & Johnson, the leading manufacturer of the meshes, released a statement saying: “We empathise with those patients who have had complications associated with pelvic mesh procedures, but we believe it is important to recognise that their experiences do not speak for the vast majority of women whose lives have been improved through treatment with pelvic mesh devices.”

    https://www.standard.co.uk/news/health/shocking-figures-reveal-1-in-15-women-are-unable-to-walk-or-have-sex-after-vaginal-mesh-surgery-a3613301.html

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