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  1. ‘It was like being stabbed with a shard of glass’: Woman left in a wheelchair after controversial incontinence surgery that’s destroyed thousands of lives

    Mar 16, 2016 | The Sun

    By Hannah Ferrett

    A WOMAN was left needing a wheelchair for months after suffering severe side effects from incontinence surgery. Karen Griffiths, 51, began suffering problems with her bladder after she had children. The mother opted for a transvaginal tape (TVT), which is a mesh that is put below the bladder to help keep the internal organs in place so aiding stress incontinence.
  2. New soft material could reduce complications for women suffering from urinary incontinence

    Mar 16, 2016 | Medical Xpress

    Researchers at the University of Sheffield have developed a novel implantable material which could reduce the number of debilitating side-effects that occur as a result of using a material that is too rigid for surgical treatment of incontinence.
  3. Full Text of Stories Below

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

    Online Sources

  1. ‘It was like being stabbed with a shard of glass’: Woman left in a wheelchair after controversial incontinence surgery that’s destroyed thousands of lives

    Mar 16, 2016 | The Sun

    By Hannah Ferrett

    A WOMAN was left needing a wheelchair for months after suffering severe side effects from incontinence surgery. Karen Griffiths, 51, began suffering problems with her bladder after she had children. The mother opted for a transvaginal tape (TVT), which is a mesh that is put below the bladder to help keep the internal organs in place so aiding stress incontinence.

     

    Far from helping her situation the treatment left her in severe pain, with claims TVT is flawed.

     

    The tape can come apart, with segments of it making their way into tissue in the body.

     

    This has been dubbed "the cheesewire effect" thanks to the harsh cuts that are caused internally, and it's what happened to Karen. She said: "It was agony and I can only compare the pain to being stabbed with a piece of glass.

     

    "I could not walk and it was clear it had to come out. But at that point I thought I had just been very unlucky and my situation was a one-off."

    Karen couldn't stand up or walk and was forced to have surgery so some of the mesh could be taken out.

     

    She has two daughters and believes the two-hour labour she experienced with her youngest, who is 21, could have caused her bladder to prolapse.

     

    Following the birth she had some incontinence issues, but they worsened five years ago. She was nervous about exercising and being around people - even coughing or laughing could leave her needing a change of clothes.

     

    So she visited her GP who explained the procedure to her.

     

    She said: "I didn’t ask many questions, I just trusted the advice I was being given by professionals that is was safe and that it would improve my situation."

     

    Initially things went well, but after six weeks Karen developed infections and started to feel pain. The lacerations inside her body left her needing a wheelchair, and she was forced to have another operation after two months. She was also left so swollen she looked "eight months pregnant".

     

    It took time for Karen to be able to walk again after the ordeal. She was left depressed and it affected her relationship, which is why she has now made it her mission to inform others of the bloating and painful side effects which can come with TVT.

     

    Many women have suffered the same plight, leaving them with pain and infection. On top of this, in some cases incontinence can become an even bigger issue and women's sex lives can be impacted.

     

    She said: "It has been horrendous. I wish every day that I had not had it done but women are still being offered this procedure and are not fully aware of the consequences.

     

    "I want to share my story to reach out to them so they can at least consider the implications. I wish I had been given that chance.

    "I had no idea this surgery had caused so many problems for so many women."

     

    Around 13,500 women have the operation annually on the NHS and it's the most common way to treat stress incontinence. As many as one in 10 of those are thought to experience some of the problems Karen went through.

     

    The mother-of-two is now backing a campaign called Sling The Mesh, which is the brainchild of Kath Sansom who wants use of the mesh stopped too.

     

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  2. New soft material could reduce complications for women suffering from urinary incontinence

    Mar 16, 2016 | Medical Xpress

    Researchers at the University of Sheffield have developed a novel implantable material which could reduce the number of debilitating side-effects that occur as a result of using a material that is too rigid for surgical treatment of incontinence.

    In the UK, it is estimated between 3 and 6 million people suffer with some degree of urinary incontinence. Stress urinary incontinence is the leakage of urine when there is pressure on the bladder, such as through sneezing, laughing or exercise, often as a result of childbirth, surgery or menopause.

    The research at Sheffield, with two separate papers published in PLOS ONE and the Journal of Urology, provides evidence for using a softer and more elastic material to support the urethra. This comes as a new study shows that the long-term impact of vaginal childbirth delivery is associated with an almost twofold increase in the risk of stress urinary incontinence.

    Current treatment for the condition uses a rigid woven polypropylene mesh device, implanted under the urethra to repair damaged or weakened tissue. The material used in this device was originally designed for hernia repairs but was rapidly repurposed in the mid-1990's for use in urinary incontinence surgery, for which it is now used worldwide.

    The majority of women with the condition elect to undergo surgery, with the NHS carrying out around 13,500 operations each year in the UK to treat urinary incontinence or pelvic organ prolapse. However, over the last decade, thousands of patients have developed complications from the use of the current material after stressurinary incontinence surgery. Serious complications, including chronic pain, infection, failure or erosion of the implant are estimated to occur in around 15 per cent of women.

    Sheffield's Centre for Biomaterials and Tissue Engineering Group, working with international collaborators in Europe, have constructed a novel implantable device using elastic polyurethane which replicates the natural recoil of a healthy pelvic floor.

    Professor Sheila MacNeil, Department of Materials Science and Engineering at Sheffield, who is leading the research, said: "In younger women, the organs of the pelvis have a strong and elastic pelvic floor, supported by a combination of connective tissue, muscles and ligaments that provide 'a well-sprung floor', much like a trampoline.

    "Unfortunately, one of the consequences of pregnancy is that there is often damage and weakening to the tissues of the pelvic floor, as it becomes further stretched, with a resulting loss of elasticity."

    "After 6 years of product development and pre-clinical testing, the elastic polyurethane material we have rigorously tested is neither too strong nor too brittle, it does not weaken over time and aims to avoid the complications that currently occur with using polypropylene mesh.

    The team have implanted the device in physiologically relevant animal models through a European collaboration with colleague Professor Jan Deprest in Leuven. This is an important aspect of pre-clinical assessment to ensure that the implanted material is compatible. This demonstrates that their device becomes well integrated into tissues and is associated with much less of an inflammatory response than the current polypropylene mesh used.

    The research at Sheffield could mark the beginning of a clinical testing phase of this new device, to end the pain and misery for thousands of patients worldwide.

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