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Ethicon Media Monitoring 1/18/2019

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

    Online Sources

  1. Mesh complications linked to greater depression, self-harm risk

    Jan 17, 2019 | Reuters (in MD Linx)

    By Anne Harding

    Women who suffer from transvaginal mesh complications are at increased risk of new-onset depression and self-harm, according to new research.
  2. Gold Coast to host service dedicated to women affected by pelvic mesh

    Jan 17, 2019 | New Zealand Doctor

    The Palaszczuk Government will open Australia’s first specialised service for women with pelvic mesh complications on the Gold Coast in the first half of 2019.

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

    Online Sources

  1. Mesh complications linked to greater depression, self-harm risk

    Jan 17, 2019 | Reuters (in MD Linx)

    By Anne Harding

    Women who suffer from transvaginal mesh complications are at increased risk of new-onset depression and self-harm, according to new research.

    "There is evidence that women with transvaginal mesh complications do have a degree of psychiatric distress associated with them, and that's something that should be taken into account when managing patients with surgery and with nonsurgical options," Dr. Blayne Welk of Western University in London, Canada, the study's lead author, told Reuters Health by phone.

    The mid-urethral mesh sling procedure is the gold standard for treating women with stress incontinence, Dr. Welk and his colleagues write in JAMA Surgery, online January 9, 2019. "However, regulatory warnings about transvaginal mesh complications, lawsuits, and media scrutiny have resulted in substantial public doubts about their safety," they add.

    About 2% to 3% of women experience these complications, Dr. Welk noted, which can include chronic pain where the mesh is located, mesh erosion or exposure, and changes to voiding. "For many people you can rectify them, but definitely some patients have chronic problems that we can't really fix," he said. Patients with transvaginal mesh complications who came to his clinic were often very distressed, he added.

    "Judging from their presentation I felt like it would be reasonable to look at whether there would be demonstrable psychiatric complications associated with the years of looking for treatment and trying to find a resolution to their symptoms," Dr. Welk said. He and his colleagues analyzed data from Ontario's universal health care system on more than 57,000 women who underwent a midurethral mesh sling procedure in 2004–2015, 2.8% of whom required surgery to treat complications of the procedure.

    The study's primary outcome of presenting for treatment of depression was more common overall in women who developed complications, although the increase was only statistically significant among women under 46 (absolute risk increase, 5.18 percentage points; adjusted hazard ratio [aHR], 1.38; P < 0.01). Complications were also significantly associated with self-harm in women under 46 (aHR, 1.68) and in those aged 46–66 (aHR, 2.36).

    "The age-dependent interaction is potentially a result of a stronger association between transvaginal mesh complications and intimacy among younger women," Dr. Welk and his team write. "When managing women with complications, surgeons should be aware of the potential serious psychological implications of these complications."

    https://www.mdlinx.com/surgery/top-medical-news/article/2019/01/17/7553654

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  2. Gold Coast to host service dedicated to women affected by pelvic mesh

    Jan 17, 2019 | New Zealand Doctor

    The Palaszczuk Government will open Australia’s first specialised service for women with pelvic mesh complications on the Gold Coast in the first half of 2019.

    Health Minister Steven Miles said the Queensland Pelvic Mesh Service would comprise a team of medical, nursing and allied health specialists, offering expertise in surgery, continence care, chronic pain management and counselling.

    “This is the first service to be co-designed with clinicians, Health Consumers Queensland and consumer representatives to ensure it meets the needs of affected women.

    “There are many women who are experiencing significant health problems caused by pelvic mesh devices, and their stories have been heart-wrenching,” Mr Miles said.

    “The Queensland Pelvic Mesh Service will include an initial comprehensive interdisciplinary assessment, resulting in a plan developed for each woman that meets her needs and recovery goals.

    “This care may include medical and nursing treatment and procedures, continence care, chronic pain management, counselling, psychology, social work support and physiotherapy.”

    Member for Gaven Meaghan Scanlon said the specialist team would be based on the Gold Coast but that women from across the state would have access.

    “This highly specialised interdisciplinary service will be delivered here on the Gold Coast, meaning all the expertise in caring for and treating women with pelvic mesh complications is available at the one site.”

    “The Palaszczuk Government is committed to providing specialised care and treatment for women, whether they live in rural, remote, regional or metropolitan Queensland. Which is why the Queensland Health Patient Travel Subsidy Scheme will subsidise travel and accommodation costs for eligible women across the state.”

    “Due to the complexity of mesh complications, each woman will have very different needs.”

    “Based on the interdisciplinary assessment and in consultation each woman, care and treatment will be offered relevant to their personal recovery needs,” Ms Scanlon said.

    Queensland Health will provide $3.14 million annually to the Gold Coast Hospital and Health Service to operate the new service.

    In 2018, the Therapeutic Goods Administration (TGA) restricted the sale of transvaginal mesh products designed solely for the treatment of pelvic organ prolapse and single incision mini-slings used to treat stress urinary incontinence.

    The action was taken after a TGA review determined the risks of using transvaginal mesh for pelvic organ prolapse outweighed the benefits to women.

    Queensland Health’s Clinical Excellence Division Deputy Director-General, Dr John Wakefield, said the new state-wide service will partner with women to develop individualised care and recovery plans.

    “The co-design with consumer representatives and clinicians has been central to the development of the Queensland Pelvic Mesh Service,” Dr Wakefield said.

    Melissa Fox, Chief Executive of Health Consumers Queensland said, “Mesh affected women have been strong advocates for the care that they need. We are pleased that Queensland Health has listened and co-designed a service that we hope will be responsive to their needs.”

    Ms Fox said, “Health Consumers Queensland look forward to continuing to support the ongoing partnership between Queensland Health and consumers.”

    Dr Wakefield said, “Acknowledging the impacts of mesh complications in daily life is essential, as is responding to the needs of women suffering from pain.”

    “We offer our sincerest sympathies to these women and their families.”

    “We understand each of these women has different complications and health needs, so our services will be holistic and personalised to ensure each patient receives the precise care they require.”

    The Queensland Pelvic Mesh Service is anticipated to open the first half of 2019.

    Women seeking to access the service will require a referral from their general practitioner.

    https://www.nzdoctor.co.nz/article/undoctored/gold-coast-host-service-dedicated-women-affected-pelvic-mesh

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