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Ethicon Media Monitoring 5/2/2018

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

    Online Sources

  1. Politician warns of surgical mess dangers

    May 1, 2018 | Clydebank Post

    By Jack Thomson

    A WEST Dunbartonshire politician has warned of the dangers of surgical mesh in a House of Commons debate.
  2. Surgical mesh awareness raised in Leeton by Pauline Cregan and Eve Webb

    May 2, 2018 | The Irrigator

    By Talia Pattison

    After years of debilitating symptoms, Ms Webb was forced to quit her job in Sydney and move to Narrandera where she felt she could “hide away from the world” and not have to answer questions about why she was always sick.
  3. Analytica expands clinical indication for its unique pelvic floor exercise technology

    May 2, 2018 | Proactive Investors Australia

    By Tharun George

    PeriCoach system is now indicated for urinary incontinence, sexual wellness and pelvic organ prolapse.

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

    Online Sources

  1. Politician warns of surgical mess dangers

    May 1, 2018 | Clydebank Post

    By Jack Thomson

    A WEST Dunbartonshire politician has warned of the dangers of surgical mesh in a House of Commons debate.

    The debate, held last Thursday, focused on mesh used to treat incontinence and prolapse and the risks it could pose to women.

    Many who have had the implant were not provided with adequate information prior to the procedure and have since suffered devastating side effects.

    The use of mesh is currently suspended in Scotland, and during the debate the UK Government was urged to enforce a suspension or outright ban across the country.

    Carol Monaghan MP said: “The issue that is raised repeatedly in all these cases is the lack of information patients were given prior to the procedure.

    “Some were told it was simple, others that a little piece of tape or sling would be inserted. None were told about side effects or complications.

    “Medical devices do not go through the same level of testing as drugs, and often the effects are not experienced immediately. This is why it is so important to carry out an audit into women who have had the procedure and their current health status.

    “Mesh implants have been described as ‘the gold standard treatment’ for stress urinary incontinence and as a ‘minor procedure’ that would change lives.

    “Sadly, many found the procedure did change their lives, they ended up in wheelchairs or crippled with nerve damage.

    “And crucially device manufacturers who have marketed mesh so aggressively are making a profit on this.”

    http://www.clydebankpost.co.uk/news/16197054.Politician_warns_of_surgical_mess_dangers/

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  2. Surgical mesh awareness raised in Leeton by Pauline Cregan and Eve Webb

    May 2, 2018 | The Irrigator

    By Talia Pattison

    After years of debilitating symptoms, Ms Webb was forced to quit her job in Sydney and move to Narrandera where she felt she could “hide away from the world” and not have to answer questions about why she was always sick. 

    “It’s so hard to explain to people and often you don’t want to tell them because it does feel embarrassing,” she said. 

    Ms Webb has had a hip replacement, which she thought would assist with the pain, but it’s now a different type of pain being experienced. Both Ms Webb and Mrs Cregan were suffering from terrible symptoms, which doctors couldn’t explain or weren’t taking seriously. 

    It was only until watching a segment on The Project last year on surgical mesh and its complications that Ms Webb realised her symptoms were likely related to that. 

    For Mrs Cregan though it was too late. She missed the episode and during her surgery a short time after (which was related to an autoimmune disease) the implant was placed inside her, but without her knowing. It was only when she woke up in debilitating pain in her groin she realised something was wrong. 

    Since then she has discovered she is allergic to the mesh, which has caused her to have rashes and be in pain all day and night. It is also affecting both women’s mental health. 

    Mrs Cregan is currently on a waiting list to have hers removed and hopes it will help. 

    The pair are now raising awareness of the mesh implants, urging men and women to do their research and avoid the implants. 

    The pair have found doctors to be difficult regarding the issue, which has also taken its toil as they believe they aren’t being taken seriously. 

    Tuesday marked International Mesh Awareness Day and the women were out and about in Pine Avenue wearing purple in support of the initiative and handing out pamphlets and wrist bands. 

    The idea is to make more people aware of the implants so they don’t have to go through what Ms Webb and Mrs Cregan are. 

    An online support group brought the two women together and both believe without the NSW Pelvic Mesh Support Group the burden would be even harder to carry. 

    “There are so many women out there not just in Australia, but everywhere, who are suffering,” Mrs Cregan said. 

    “I think if we can make even just one person aware and they know about it then that’s good. 

    “We don’t want anyone else to have to go through what we are. It ruins your life.” 

    Along with the support group, Mrs Cregan said her husband Andrew had been a pillar of strength, holding her together in some of her darkest hours throughout the last 11 months. 

    What is urogynecological mesh?

    Urogynecological mesh is a permanent synthetic mesh implant, which is made from polypropylene or biomaterial like porcine. 

    It is surgically implanted into the vaginal wall and is used to treat pelvic organ prolapse or stress urinary incontinence. 

    The mesh can also be used to treat conditions for men. It is often referred to by surgeons as tape, sling, ribbon, hammock or kit. This is why some women are often unaware they have mesh.

    Mesh complications 

    Urogynecological mesh can break down, harden, erode, shrink or become entwined with soft tissue. It can even lead to organ perforation. 

    Some complications include chronic nerve pain, vaginal bleeding, sexual dysfunction and chronic UTIs as well as many more. 

    Senate inquiry

    A senate inquiry this year into pelvic mesh devices has recommended a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements” to doctors and teaching hospitals.

    The inquiry identified failures across the health system leading to “catastrophic” results for an unknown number of women implanted with devices for more than three decades. 

    The Senate report recommended mandatory reporting of adverse events by doctors, a registry for all high risk implantable devices, a more comprehensive monitoring scheme for devices approved for use in Australia, and government agency oversight of a more effective informed consent process by doctors.

    https://www.irrigator.com.au/story/5375907/mia-women-bring-pain-and-suffering-to-light-to-save-others-from-same-trauma/

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  3. Analytica expands clinical indication for its unique pelvic floor exercise technology

    May 2, 2018 | Proactive Investors Australia

    By Tharun George

    PeriCoach system is now indicated for urinary incontinence, sexual wellness and pelvic organ prolapse.

    Analytica Limited (ASX:ALT) has received clearance from the Australian Therapeutic Goods Administration for the expanded clinical indication for its PeriCoach System to assist in the conservative treatment of Pelvic Organ Prolapse (POP).

    The PeriCoach system with its patent protected force sensing technology assists women to properly perform pelvic floor exercises.

    The expanded clinical indication for PeriCoach now includes targeted resolution of symptoms for mild to moderate POP, urinary incontinence and sexual wellness.Pelvic organ prolapse is a common and serious condition

    Data suggests that 50% of women that have given birth have some degree of POP and half of women over 50 complain of prolapse symptoms.

    Estimates state women have a lifetime risk of up to 12% of undergoing a surgical intervention, with a re-operation rate of nearly 20%.

    Each surgical intervention in the U.S. is estimated to cost between USD$10,000- USD$20,000.

    As the population continues to age and awareness of the condition grows, it is projected that the number of women with POP will increase up to 46%.Potential sale of the technology to a multinational

    Analytica chairman Dr Michael Monsour said: “This clearance from the TGA is significant in that the PeriCoach system is indicated for the most common conditions stemming from a weak pelvic floor: urinary incontinence, sexual wellness, and pelvic organ prolapse.

    “No other system on the market has this capability.

    “This additional capability adds substantial value and progresses the sale of the company and PeriCoach system to a multinational”.

    http://www.proactiveinvestors.com.au/companies/news/196208/analytica-expands-clinical-indication-for-its-unique-pelvic-floor-exercise-technology-196208.html

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