Ethicon Media Monitoring 3/29/2018

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

Online Sources

1. Australia investigates implants that left some women with 'rotting pelvises'

   Mar 29, 2018 | CNN

   By Marian Liu
   
   
   Like more than 100,000 Australian women, Linda Schulz had a pelvic mesh implant to treat complications from childbirth that resulted in her bowel and bladder prolapsing.
2. Controversial transvaginal mesh implants leave women with ‘rotting pelvises’

   Mar 28, 2018 | Newsweek

   By Dana Dovey
   
   
   On Wednesday, the Australian Senate recommended that transvaginal mesh, a pelvic implant used to address prolapse, only be used as a last resort.
3. Transvaginal mesh use should be suspended, health groups say

   Mar 29, 2018 | The Guardian

   By Christopher Knaus
   
   
   Health consumer groups have called for the use of transvaginal mesh to be suspended while a comprehensive audit of complications is conducted.
4. Pelvic mesh implants: Further legal action on the table after scathing Senate report

   Mar 29, 2018 | ABC News

   By Sophie Scott and Alison Branley
   
   
   Australian women who have been injured by pelvic mesh implants could be part of a second class action against the makers of the surgical devices.
5. Vaginal mesh Senate inquiry recommendations too weak, advocate says

   Mar 29, 2018 | ABC News

   A landmark Senate inquiry into the use of pelvic mesh implants in Australia has called for a major overhaul of the regulation of the medical devices and says mesh implants should only be used as a last resort.
6. A Senate Report Has Targeted The 'Payment Of Inducements' To Doctors And Hospitals Linked To Mesh Scandal

   Mar 29, 2018 | Newcastle Herald

   By Joanne McCarthy
   
   
   A SENATE inquiry 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.
7. 11 Horror Stories From The Australian Pelvic-Mesh Implant Report

   Mar 29, 2018 | Women's Health

   By Claire Lampen
   
   
   Australia is currently weathering what Senator Derryn Hinch has told the Australian Broadcasting Corporation is "one of the biggest medical scandals Australian women have ever been subjected to" after a government report found that 10,000 to 15,000 people incurred serious side effects after receiving transvaginal mesh implants.
8. Australian Women Involved in Pelvic Mesh Implant Scandal

   Mar 28, 2018 | Week Facts

   By Amanda Carano
   
   
   Like in excess of 100,000 Australian Women, Linda Schulz had a Pelvic Mesh Implant to treat complications from Childbirth that brought about her gut and bladder prolapsing.
9. Transvaginal mesh inquiry criticises Australia's medical device regulation

   Mar 28, 2018 | The Guardian

   By Christopher Knaus
   
   
   Failure to protect women receiving the mesh implants cast health professionals in ‘very poor light’, inquiry finds
10. Pelvic mesh implantation horrors

    Mar 29, 2018 | News-Medical.net

    By Ananya Mandal
    
    
    Thousands of women undergo operations to get pelvic meshes inserted surgically within their lower bodies to prevent prolapsing of the abdominal organs after childbirth complications.
11. Startling New Report Says Pelvic Mesh Implants

    | Marie Claire

    By Elle Lisbon
    
    
    Following years of horror stories and even deaths, a report into vaginal mesh implants has recommended the devices "should only be used as a last resort."
12. Australian women with pelvic mesh implants 'treated appallingly'

    Mar 29, 2018 | ABC Local

    By Sophie Scott
    
    
    A Senate committee report has been scathing in its assessment of the medical community's treatment of women who received pelvic mesh implants.
13. Australian Senate Mesh Decision is a Disservice to Women

    Mar 28, 2018 | Mirage News

    Today’s recommendation by the Australian Senate Committee Inquiry that implantation of all transvaginal mesh products should only be undertaken as a last resort has been met with bewilderment and concern by doctors treating Australian and New Zealand women for urinary incontinence and pelvic floor conditions.
14. New report recommends limiting use of transvaginal mesh as a last resort

    Mar 28, 2018 | International Business Times

    By Dan Perez
    
    
    The health system’s failure to protect females getting transvaginal mesh implants revealed failings with Australia’s regulation of medical devices and casted health professionals in “very poor light,” an inquiry has found.
15. “Torture device’ vaginal mesh only as last resort: report

    Mar 28, 2018 | NEWS.com.au

    By Matt Coughlan
    
    
    A Senate committee has recommended transvaginal mesh only be used as a last resort after victims told an inquiry harrowing stories of devastating physical and mental scars.
16. Trial testimony questions appropriateness of pelvic mesh in N.J. case against C.R. Bard

    Mar 28, 2018 | Legal News Line

    By John Sammon
    
    
    Jury trial resumed on March 26 in a woman’s lawsuit seeking damages against a medical manufacturer whose pelvic implant device used for bladder support allegedly instead led to chronic inflammation and pain and had to be surgically removed.
17. Shook Hardy Grabs Morgan Lewis Complex Litigation Partner

    Mar 28, 2018 | The Legal Intelligencer

    By Lizzy McLellan
    
    
    ... The firm already has a foothold in the region with some of those clients, having recently represented Johnson & Johnson in local talc litigation and Boston Scientific in pelvic mesh litigation that originated in Philadelphia.

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

Online Sources

1. Australia investigates implants that left some women with 'rotting pelvises'

   Mar 29, 2018 | CNN

   By Marian Liu

   Like more than 100,000 Australian women, Linda Schulz had a pelvic mesh implant to treat complications from childbirth that resulted in her bowel and bladder prolapsing.

   The mesh was meant to be a quick fix, but the aftermath was worse.

   Her right leg went numb almost immediately after the procedure, and after a few weeks the mesh was like a knife constantly cutting her up from the inside.

   "The mesh cut through my vagina wall and came through my skin," Schulz said. "Any movement, whether I moved my legs or not, felt like a serrated-edge knife was cutting me."

   In the last year, Schulz, 48, along with hundreds of women experiencing similar complications, petitioned the Australian Senate to investigate their use, hoping for an outright ban and recourse for past procedures.

   After a yearlong inquiry, the Senate released a report Wednesday, recommending that the implant be a "last resort" and raised concern that medical practitioners had not adequately informed their patients and "overused" the procedure "without considering alternative treatment options."

   The report went on to outline vital recommendations for improved treatment guidelines and medical training, prevention of financial inducements for practitioners, a registry of high-risk implantable devices and an audit of past procedures. It also outlined concern that it is not possible to identify accurately the number of women who have received transvaginal mesh implants in the country.

   "Women that have had those implants, who have those outcomes ... have been failed in a monumental way by the system and by certain people in the medical profession who they trusted," said Sen. Rachel Siewert when she introduced the report Wednesday to the Senate. "I hope that we never have to have another inquiry where we see such suffering from the witnesses."

   Senate involvement all started when Sen. Derryn Hinch heard stories such as Schulz's, and was moved to start an inquiry in February 2017.

   "I hope our report convinces them they have been listened to and more importantly they have been believed," Hinch said at the Senate meeting introducing the report.

   Hearings were held across Australia in 2017, interviewing both patients and mesh manufacturers. Hundreds wrote in to the Senate, sharing a range of stories about living with pain after the operation -- from not being able to walk, sit or drive to puncturing their partner during intercourse with a splinter that broke off the implant.

   Schulz said she hopes the report will go past recommendations into action, and she hopes no woman has to go through what she did: "It changes your whole life. You don't feel like a woman anymore. They just take everything in one fell swoop."

   'Horror stories' in consumer group's survey

   Clocking in at 20 minutes, the mesh implant is a quick fix aimed at repairing common complications from childbirth and menopause.

   The mesh is implanted to support weakened or damaged tissue to treat poor bladder control and organ prolapse. But the procedure can be risky because of the methods and materials used. According to various studies, complications can include organ perforation, infection, hemorrhage and sexual dysfunction.

   About half of women between 50 and 79 may have prolapse, according to the American Urogynecologic Society. When muscles and ligaments in the pelvic floor get too stretched, for reasons such as childbirth, they fail to hold up the pelvic organs: the bladder, rectum and uterus. The organs can drop into the cavity, making urination and sex painful.

   One in five women has incontinence, or poor bladder control, from childbirth, according to the Journal of Prenatal Medicine.

   Part of the problem in the past, Schulz said, is that there were no hard statistics and records of how many procedures are done and their effects.

   In April 2017, the Health Issues Centre -- an Australian consumer advocacy group -- conducted its own survey. After asking on Facebook for stories, it heard from 2,500 women in six weeks.

   "We heard horror stories, lives that were completely destroyed," said Danny Vadasz, head of Health Issues Centre, who also wrote to the Senate, asking for reform. "We were shocked and barely believed something like this could happen in what we considered the world-class health system of Australia."

   The Australian health care system offers universal health care insurance, paid through taxes, as well as private insurance.

   Based on his survey, Vadasz estimates that in the past two decades, there have been 120,000 to 150,000 mesh implants in Australia, and around 70% of the stories his group heard involved a lack of fully informed consent. Many women, he said, were not even told that a mesh would be implanted into their bodies.

   'Mine was badly fitted'

   "As these devices were to be permanent, we are meant to live with rotting pelvises forever," said Justine Watson, a Sydney resident who submitted her mesh photos to the Senate as part of the inquiry and joined more than 700 Australian women last year in a suit against Johnson & Johnson over claims of flaws in its mesh devices.

   In January, the pharmaceutical giant withdrew its mesh products from the Australian market. That same month, Australia's medical devices regulator, the Therapeutic Goods Administration, removed mesh products for prolapse.

   Watson's pain was so severe that she tried to take her own life after being hospitalized multiple times. Doctors didn't believe her, she said, referring her to psychiatrists instead.

   "Mine was badly fitted," said Watson, who spent her life savings to travel in October from Australia to the United States to remove the mesh that was first implanted in 2010. "It broke into the wall of my bladder and skewered my urethra."

   After giving birth to two boys, both weighing more than 8 pounds, Watson struggled with incontinence.

   But within three months of the procedure, Watson was incontinent again and after suffering multiple medical problems, such as fibromyalgia, chronic pain and fatigue, she had the mesh removed. At 47, the procedure left her with the body of an 80-year-old: unwell, overweight and unable to walk more than 100 meters.

   The need for more action

   Both Watson and Schulz said they felt that Wednesday's Senate report was full of guidelines rather than concrete rules.

   "This (report) feels somewhat ambiguous and can be interpreted several different ways. ... It's very unlikely that it'll make any difference," Watson said.

   And eight Australian pelvic mesh implant support groups agreed, saying in a joint statement: "There are a few glimmers of hope for mesh-injured women in the report - but the wording used in the recommendations are so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual. We are disappointed that the recommendations are not stronger, mandating a change in treatment, monitoring and care - especially considering that the report found that: Women are not having their mesh complications identified, or believed, by primary or specialist doctors."

   Now Schulz, along with others who have been affected, are now looking into a Royal Commission, an official investigation that they hope can fully ban the practice and even offer financial restitution.

   Schulz wants more recognition of the problem. She represents more than 1,600 women in the Australian Pelvic Mesh Support Group, an advocacy organization that warns women about the risks of the procedure.

   In response to the Senate study, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) said, "more needs to be done to protect the safety of women."

   "It was very clear in the report that women who have experienced adverse complications as a result of a mesh implant have endured long-term pain and reduced quality of life," said President Professor Steve Robson from RANZCOG, which trains and accredits doctors in Australia and New Zealand.

   Along with agreeing with the recommendation for a registry for high-risk medical devices, he added in his statement: "We support our members by offering clinical guidance and ensure that our College communications and information hubs reflect current national standards."

   A 2016 study, which compared the results of women across 35 UK hospitals who had surgery with and without mesh, concluded that there was "no benefit to women having their first prolapse repair from the use of transvaginal synthetic mesh."

   More than 1 in 10 in their study suffered complications, with 3 in 10 needing another operation, leading the study authors to recommend the more standard approach, without mesh, where organs are repositioned to their original areas and the supportive tissue surrounding them is repaired and stitched. The Mayo Clinic consistently uses this method.

   There are also less invasive treatments, recommended by some researchers, such as pelvic floor muscle training to strengthen the weakened tissue.

   But for many women, such as Schulz, no other option is given.

   A global issue

   The surgical mesh procedure is controversial and has led to many class-action suits across the United States, UK and Australia.

   In the UK, the National Health Service estimates that over the past two decades, more than 100,000 women have had surgery involving a mesh implant and 3% to 5% have had complications. But a recent study suggested higher figures, estimating that 1 in 15 women had to have her implant surgically removed in the UK.

   Edward Morris, vice president for clinical quality for the Royal College of Obstetricians and Gynaecologists, highlights that based on current evidence, the mesh may be effective to treat incontinence but is not advised for organ prolapse.

   There is still a small subset of women for whom it might be beneficial, he added, given the "appropriate information and counseling about the risks and benefits."

   The college has a mesh webpage dedicated to information and advice on mesh implants to help women be informed about the procedure.

   In December, the National Institute for Health and Care Excellence -- the UK's health watchdog -- withdrew its recommendation for the procedure to treat pelvic organ prolapse, and the Department of Health and Social Care is auditing cases dating to 2005.

   In January, New Zealand banned all vaginal mesh procedures to treat organ prolapse.

   In the United States, the Food and Drug Administration has not taken steps to ban vaginal mesh. However, in 2016, it reclassified the device from class II (moderate risk) to class III (high risk), providing the agency with more oversight over the manufacturing of mesh products.

   The FDA estimated that there are 75,000 procedures involving pelvic mesh implants each year in the United States. A 2011 report by the FDA also reported 2,874 cases of injury, death or malfunction related to the use of vaginal mesh between 2008 and 2010, including three deaths: two from bowel perforations and one from hemorrhage.

   https://edition.cnn.com/2018/03/28/health/pelvic-mesh-implant-australia-senate-intl/index.html
   

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2. Controversial transvaginal mesh implants leave women with ‘rotting pelvises’

   Mar 28, 2018 | Newsweek

   By Dana Dovey

   On Wednesday, the Australian Senate recommended that transvaginal mesh, a pelvic implant used to address prolapse, only be used as a last resort. These guidelines are similar to those already in place in the United States, and come after horror stories emerged of the wire mesh cutting through patients’ vaginal walls and piercing their organs, and even their partners’ organs during intercourse.

   In addition to recommending that the mesh be used only as a last resort, the Australian Senate's report outlined 12 other recommendations, including that any adverse effects of the mesh implants must be reported, NT News reported. The report also called for doctors to give potential patients more information on the risks of the mesh implants, and for doctors and nurses to be better trained on how to secure the implants.

   Transvaginal meshes are designed to address pelvic organ prolapse, a condition where an organ in the pelvis, such as the bladder or rectum, begins to fall into the vagina. According to the American Urogynecologic Society, nearly half of women between 50 and 79 may experience some type of pelvic prolapse.

   Dr. Marian G. Acevedo, Urogynecology Division Fellow and OB/GYN Department at Yale University told Newsweek that there are similar guidelines in the United States. Here, the mesh is also reserved as a last case scenario. Patients are also required to understand all the risks, and doctors and nurses must undergo special training to ensure they understand how to place these meshes correctly.

   “The general thought is that it [transvaginal mesh] should only be used in very specific patient populations,” Acevedo told Newsweek.

   These include patients who did not benefit from prior prolapse repair attempts and patients own tissue is not enough to prevent prolapse recurrence.

   Some of the women who have been adversely affected by the mesh, however, said the guidelines are too abstract.

   "This (report) feels somewhat ambiguous and can be interpreted several different ways. ... It's very unlikely that it'll make any difference," Justine Watson, who’s mesh cut through the wall of her bladder and sliced her urethra, told CNN.  "As these devices were to be permanent, we are meant to live with rotting pelvises forever."

   Other women like Watson who received the mesh experienced an assortment of serious injuries, ranging from bleeding and discomfort to the mesh coming through the vaginal wall and piercing other organs, or their partners, during intervourse, CNN reported. Acevedo acknowledged that the mesh has caused significant discomfort and damage in some patients, but maintained that it still has a place in medicine.

   “When it comes to mesh, I think there is a balance between being able to provide an alternative to patients with complicated prolapse repair history and minimizing the possible complications,” said Acevedo. “I think that’s where we are at now.”

   http://www.newsweek.com/rotting-pelvis-transvaginal-mesh-womens-health-864909
   

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3. Transvaginal mesh use should be suspended, health groups say

   Mar 29, 2018 | The Guardian

   By Christopher Knaus

   Alliance of six state and territory consumer bodies say full audit of complications is needed

   Health consumer groups have called for the use of transvaginal mesh to be suspended while a comprehensive audit of complications is conducted.

   The call, made by an alliance of six state and territory consumer health groups, comes as the law firm Slater and Gordon announced it was investigating a second class action against manufacturers.

   On Wednesday a Senate inquiry delivered a damning report into the use of transvaginal mesh products in Australia.

   The devices are surgically implanted to treat pelvic organ prolapse and stress urinary incontinence, common childbirth complications. It’s estimated about 150,000 women have undergone the procedure in Australia.Transvaginal mesh inquiry criticises Australia's medical device regulation

    Read more

   The devices have been associated with significant, often life-altering complications, including debilitating pain, and have prompted class actions in Australia, the United Kingdom, the United States and Canada.

   The Senate inquiry on Wednesday recommended the devices be used only as a “last resort”. It found women were often not properly appraised of less invasive and risky alternatives, such as physiotherapy, and that doctors did not acquire fully informed consent.

   The inquiry also warned it was next to impossible to tell how many women had suffered complications, because the reporting of adverse events was haphazard and voluntary. It recommended an audit be conducted of transvaginal mesh procedures by the Australian commission on safety and quality in health care. It also called for mandatory reporting of complications and a national register of high-risk medical devices.

   On Thursday a group of six state and territory health consumer groups welcomed the recommendations. But the groups also called for mesh use to be suspended until the audit is complete.

   “We are disappointed that a more cautious approach wasn’t taken, to recommend the suspension in use of all mesh until the data is in to establish their safety and efficacy,” Health Consumers Queensland’s chief executive officer, Melissa Fox, said.

   “These devices will continue to be implanted in women in hospitals across Australia tomorrow, and not one more woman should be unwittingly subjected to this high-stakes surgical intervention until we can be assured of their safety.”

   Urologists, however, have cautioned against limiting their use for urinary incontinence. The Urological Society of Australia and New Zealand said urine leakage was common after childbirth, and that nearly one in 10 women would need surgery for stress incontinence by the age of 80. Prof Vincent Tse, from the Urological Society, said the recommendation mesh be used only as a last resort was fair for pelvic organ prolapse.

   But he said: “The Urological Society strongly believes that Australian women should be given the choice to have a mid urethral sling for treatment of their stress incontinence.”

   The devices are the subject of a class action run by Shine Lawyers in the federal court. The case against Johnson & Johnson has accused it of playing down the risks, failing to properly convey warnings to surgeons and patients, not conducting proper clinical trials, and aggressively marketing the devices to surgeons. 
   

   A second class action firm, Slater and Gordon, flagged it was also investigating a class action over the mesh products. It would consider action against other manufacturers. A senior associate, Rhea Dhillon, said consideration of the class action was in its “advanced stages”.

   “This inquiry has provided irrefutable evidence of the extensive suffering of women who have received pelvic mesh implants,” Dhillon said. “What is incredibly concerning is that the risk of complication does not appear to be isolated to any one particular brand, but rather attached to the product itself. Boston Scientific and Coloplast are among the manufacturers we have been investigating.”

   The Royal Australian and New Zealand College of Obstetricians and Gynaecologists welcomed the Senate inquiry’s report. It supported developing a registry of high-risk medical devices.

   The college’s president, Steve Robson, said he supported the registry so that robust and secure data was available.

   “It was very clear in the report that women who have experienced adverse complications as a result of a mesh implant have endured long-term pain and reduced quality of life,” Robson said.

   “[The college] is not dismissive of these accounts and is profoundly sympathetic to all women who have had this experience.”

   https://www.theguardian.com/society/2018/mar/29/transvaginal-mesh-use-should-be-suspended-health-groups-say
   

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4. Pelvic mesh implants: Further legal action on the table after scathing Senate report

   Mar 29, 2018 | ABC News

   By Sophie Scott and Alison Branley

   Australian women who have been injured by pelvic mesh implants could be part of a second class action against the makers of the surgical devices.

   A scathing Senate committee report recommended the devices "should only be used as a last resort" and found some women were not properly informed about potentially serious side-effects.

   Senator Derryn Hinch, who spearheaded the inquiry, said he believed the mesh devices were, "one of the biggest medical scandals Australian women have ever been subjected to".

   Closing submissions for the first class action by Shine Lawyers involving more than 700 women against manufacturer Johnson and Johnson were filed in February.

   The judge, Justice Anna Katzmann, is yet to make a ruling, which could take up to 12 months.

   Now, Slater and Gordon lawyer Rhea Dillon said it was investigating a number of mesh manufacturers, and complications from the devices were widespread.

   "The findings of this report support our view that more clinical evidence was needed before pelvic mesh products were marketed to tens of thousands of women across the country," she said.

   Ms Dillon said the inquiry provided irrefutable evidence of the extensive suffering of women who had received pelvic implants.

   "What is incredibly concerning is that the risk of complication does not appear to be isolated to any one particular brand, but rather attached to the product itself," she said.

   She added that any woman who experienced complications and who was not in previous class actions could potentially be included in future legal action.

   The Senate inquiry was set up after hundreds of women recounted how the devices left them with debilitating pain, unable to have sex, and with recurring infections.

   Many told the ABC they felt they had not been listened to by their doctors and were told the mesh could not be the reason for their ill health.

   With growing public outrage, in November 2017 health authorities banned controversial vaginal mesh implants for use in pelvic organ prolapse.

   The director of the Women's Health and Research Institute, Dr Thierry Vancaille, gave evidence to the Senate inquiry.

   He said the Chronic Pelvic Pain Clinic at the Royal Hospital for Women in Sydney was seeing patients suffering with chronic pain after mesh surgery with increasing frequency.

   "Nerve pain is horrible — it burns, it stings, it feels like a ball stuck in the rectum and it does not go away," Dr Vancaille said.

   "In 2017, so far, we have seen 54 new patients with nerve pain after mesh surgery and, since the middle of August, we see six new patients every week."Lessons for doctors in report: AMA

   The report's 13 recommendations included introducing mandatory reporting of adverse events by medical practitioners, better education for both doctors and patients, and more surgical training so women could get the devices removed.

   The president of the Australian Medical Association (AMA), Dr Michael Gannon, said the report also highlighted some learnings for the medical profession in dealing with patients when something went wrong.

   "In a perfect world, every doctor would listen dutifully to every complaint from patients and respond to it appropriately. But doctors are human and they don't all react perfectly," he said.

   "The fact is that things do go wrong with surgery and how we respond to the complaints that patients have is a critical element of being a good doctor."

   But Dr Gannon added that not all women had problems with the devices.

   "It [the report] fails to recognise the massive number of women who have benefited from mid-urethral sling operations," he said.

   The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson, said the college had a very rigorous and extensive training program.

   "We will continue to provide the best training to our trainees, and continuing professional development to our specialists to ensure that our speciality is equipped to deliver the best care, and in turn that women are able to receive quality care," he said.

   Another of the report's recommendations was the establishment of a national registry of high-risk implantable devices.

   Medical Technology Association of Australia CEO Ian Burgess said registries could be invaluable but they were "complex and expensive".

   "We need to ensure that when we set up a registry we're very clear around what data is being collected and the extent of that data," he said.

   http://www.abc.net.au/news/2018-03-29/further-legal-action-considered-after-pelvic-mesh-report/9600286
   

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5. Vaginal mesh Senate inquiry recommendations too weak, advocate says

   Mar 29, 2018 | ABC News

   A landmark Senate inquiry into the use of pelvic mesh implants in Australia has called for a major overhaul of the regulation of the medical devices and says mesh implants should only be used as a last resort.

   The Senate Inquiry began investigating pelvic implants after hundreds of Australian women recounted how the devices left them in chronic, debilitating pain, unable to have sex and with recurring infections.

   The scandal has prompted class actions against the manufacturer Johnson and Johnson here in Australia as well as in the United States, the UK and Canada.

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6. A Senate Report Has Targeted The 'Payment Of Inducements' To Doctors And Hospitals Linked To Mesh Scandal

   Mar 29, 2018 | Newcastle Herald

   By Joanne McCarthy

   A SENATE inquiry 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 initiated by Senator Derryn Hinch and headed by Greens Senator Rachel Siewert has 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 tabled on Wednesday 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.
   

   It said pelvic mesh should be used as a “last resort” after devastating evidence from women about the severe, permanent and disabling consequences of some mesh surgery to treat routine conditions after childbirth.

   The Senate community affairs references committee called on the federal and state governments to commission an audit of all mesh devices and outcomes and establish specialist units across the country to assess and manage the long-term severe complications experienced by some women.
   

   The committee targeted financial relationships between doctors, hospitals and the device industry after evidence of the rapid take-up of pelvic mesh devices across Australia to treat incontinence and prolapse complications after childbirth, despite limited evidence of safety and efficacy.
   

   It recommended a Department of Health-led review of “systems in place to prevent the payment of inducements to medical professionals and teaching hospitals” after Australia’s college of women’s health specialists failed to declare the full range of sponsorships from pelvic mesh device manufacturers to the Senate inquiry.
   

   The Royal Australian and New Zealand College of Obstetricians and Gynaecologists denied being influenced by health industry funding.

   In a rebuke of the medical profession after decades of mesh surgery, the Senate committee called on medical colleges and specialist societies to establish “governance arrangements” requiring surgeons to be “adequately skilled” and trained to implant and remove pelvic mesh devices.

   The recommendation followed evidence to the inquiry that doctors are not subject to a central credentialing system before using the devices.

   The report documented the devastating impact of pelvic mesh device surgery for an unknown number of Australian women and criticised doctors’ groups and doctors who have repeatedly emphasised that the majority of women implanted with devices have had positive outcomes.
   

   “The committee considers that it is of no consolation to women who have lost so much to be told that they are part of a very small minority,” the report said.
   

   “The committee does not discount the successful outcomes experienced by many women. Nor does the committee underestimate the complexity of treating stress incontinence and prolapse.
   

   “However, the committee is concerned that the plight of those women who have experienced devastating impacts on their health and quality of life not be downplayed, simply because they are in the minority. Rather the committee intends that greater focus be placed on understanding why some women experience positive life changing outcomes and others experience catastrophe.
   

   “Some women have experienced nervous breakdowns that they attribute to the pain and anxiety their symptoms have produced, while others spoke of suicidal ideations.”
   

   At least one Australian woman has taken her own life because of severe, permanent and disabling mesh complications. 

   The Australian Pelvic Mesh Support Group called on the Federal Government to assist women unable to work because of pelvic mesh injuries, and state governments to “radically improve pathways for women who urgently require full pelvic mesh removals”.
   

   “We’re aware of hundreds of Australian women who are financially destroyed and unable to provide for their families, and are abandoned and unsupported by the government officials who endorsed these defective products,” group administrator Kim Blieschke said.
   

   It was offensive and farcical that women who were “broken financially, psychologically and physically” because of mesh surgery were then forced to finance mesh removal costs as well, she said.

   “Only one party wins in this situation, and it’s not Australian women,” she said.

   A survey of 1690 group members found that 44 per cent worked before pelvic mesh surgery, but only 10 per cent were now able to work full time.
   

   The Consumers Health Forum of Australia said the pelvic mesh scandal had been a failure of the regulatory, quality and safety mechanisms that exist to safeguard the general public.
   

   It called for a separate inquiry into the responsibilities, operations and funding of Australia’s device regulator, the Therapeutic Goods Administration, with “special emphasis on its failure to provide timely warnings”.
   

   Spokesperson for Australia’s state and territory-based consumer health organisations, Melissa Fox, said there was an urgent need for specialist support care for many women across the country left with devastating, permanent and incapacitating mesh complications.

   She rejected doctors’ groups that said only a small number of women were affected after the lack of data about mesh surgery was first raised in the media  and later confirmed during the Senate inquiry – including a concession by Australia’s device regulator in 2013 that there was “no way” of knowing how many women were implanted with mesh based on Medicare payments.
   

   She also backed women’s views that gender played a significant role in why the scandal went on for so long, despite serious concerns being raised about mesh device prototypes in the late 1980s.
   

   “If the gender roles had been reversed and it was doctors implanting male patients, this would not have continued for as long as it has,” Ms Fox said. 

   Hunter mesh-injured woman Teigan, who was 22 when she was implanted with a “gold standard” Johnson & Johnson TVT device in 2008, said she wanted the mesh taken out of her body after a decade of severe complications that have left her scared of the future.

   “I just don’t know what’s going on with my body,” she said after the latest round of tests showed liver abnormalities, on the back of years of pain, unceasing urinary tract infections and an inability to urinate caused by “strangury”, or the interaction between her bladder and the mesh.

   “I want this mesh out of me but my symptoms might not improve,” she said.

   Too many doctors were unaware of the severe complications caused by mesh, she said.

   The Urological Society of Australia and New Zealand backed the use of a group of pelvic mesh devices known as midurethral slings to treat incontinence, and said denying women the option to choose the slings would be a “retrograde step and out of keeping with best practice”.
   

   “The difficulties some women have experienced in relation to mid urethral sling placement has not always been a result of the technology alone and Urologists are experienced in managing such complications,” the society said.
   

   In January American pharmaceutical giant Johnson & Johnson withdrew its “gold standard” incontinence pelvic mesh midurethral slings from the Australian market after evidence from women at the Senate inquiry and a class action legal case by more than 800 women.

   http://www.theherald.com.au/story/5309813/a-catastrophe-for-some-women-pelvic-mesh-report/
   

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7. 11 Horror Stories From The Australian Pelvic-Mesh Implant Report

   Mar 29, 2018 | Women's Health

   By Claire Lampen

   Australia is currently weathering what Senator Derryn Hinch has told the Australian Broadcasting Corporation is "one of the biggest medical scandals Australian women have ever been subjected to" after a government report found that 10,000 to 15,000 people incurred serious side effects after receiving transvaginal mesh implants.
   

   Transvaginal mesh is a net-like implant inserted into the body to prevent pelvic organ prolapse (POP), or to put it another way, to keep the uterus, bladder, and rectum from sliding out of place or into the vagina.

   According to the American Urogynecological Society, pelvic organ prolapse (POP) occurs in about half of women ages 50 to 79, whether because of age, injury to the pelvic floor (like from a vaginal birth, surgery, or fractures to the back and pelvic bones), chronic straining, smoking, nerve and muscle diseases, menopause, or other reasonably common factors.

    The report comes a year after hundreds of Australian women joined in a complaint to the Senate, according to CNN. In the complaint, women alleged that transvaginal mesh caused them extreme health complications, and that doctors overused it as treatment without sufficiently informing their patients of the consequences, or exploring other routes.

   In its report, the Senate says it now wants to see mesh used as a "last resort." These 11 stories—all submissions received by the Parliament of Australia—illustrate why.

   1. "It's just pain, pain, and more pain merely to exist."

   "My life has been impacted in every way. I am in constant pain, so I cannot do what I used to do, and I must lie down horizontally every hour or so because the pain becomes unbearable. I have experienced bleeding, constant bowel and urination pain, and insomnia every night; I cannot sleep because I am in so much pain. I have always been very active, going to gym, walking, cycling, but everything is very limited now. Every movement hurts. I used to be sexually active prior to this, but now I absolutely cannot. It's just pain, pain, and more pain to merely exist." —Stella Channing

   2. "I can't sit upright in a chair for longer than 15 minutes at a time."

   "I was told by my implanting surgeon that I would be back at the gym within 10 days post-implant procedure and that I would be like a 16-year-old virgin after the implants. To this day, I can't sit upright on a chair for longer than 15 minutes at a time due to the searing pain that travels across my lower abdomen and deep into my pelvis... It took a good 14 weeks, not 10 days, post implant before I was able to get out of bed and walk again. I still, to this very day, experience the same burning pain, even after the removal of both meshes. I describe my pain as being cut open and set alight. It's a deep, burning, searing ache that intensifies with movement." — Joann

   3. 'A piece of plastic was hanging out of my vagina'

   "Add to this my personal experience of trying to teach full time with a piece of plastic hanging out of an open wound in my vagina for the last three months. I can assure you that it was not just an inconvenience or a trivial or superficial incident." — Fiona

   4. "It felt like barbed wire inside me ... I grieved my sex life for a long time."

   "The first time we tried to have intercourse it felt like barbed wire inside me. My husband could also feel the mesh. This [came] as a massive shock as my professor had told me I would be like a new woman after childbirth everything would be tighter. I grieved for my sex life for a long time as my husband and I had only been married 6 months." —name withheld

   5. "My life revolved around being close to a toilet."

   "I was completely bladder incontinent, bowel incontinent; I couldn't have sexual intercourse. I continuously had bladder infections. I developed chronic thrush because of it. I was sick for years. My life revolved around having extra clothes, pads, being close to a toilet and hoping to God that when I had a shower my bowels wouldn't release themselves on me. That was my life." —Timnat

   6. "I noticed a smell that I described as rotting flesh."

   "By 3 months post-op I was getting pain in my vagina, bleeding and there was mesh eroding out through the side of my Vagina, I noticed a smell that I described as rotting flesh, I went to my GP, who thought I had a fistula and sent me back to my specialist for review. I saw him and he said it was just a small hiccup, he would 'snip' the small bit of mesh out in his surgery, and he did OMG, it hurt so much and I left, with him telling me to take a couple of Panadol and I would feel ok. This went on for a couple of years, with 4 major surgeries for mesh erosion and multiple trims in his rooms. I was assured this was not very common." —name withheld

   7. "Making love was like sleeping with a cheese grater."

   "My husband began complaining that making love to me was like sleeping with a cheese grater. His penis would be cut when we had intercourse. The pain and embarrassment made me anxious, sick and depressed." —name withheld

   8. "I was unable to do normal things without debilitating pain and fatigue."

   "I dragged myself to work each day and on weekends I was bedridden. I was unable to do normal things like shopping, cooking and housework without debilitating pain and fatigue. My relationship with my family, friends suffered as I could not handle social activities. Not being able to care for my new grandson broke my heart. Surfing was impossible and walking the dogs or doing other light physical exercise was just too painful." —name withheld

   9. "I have spent tens of thousands of dollars out of pocket for treatment."

   "I cannot work because of my medical issues, which has caused financial problems. The costs for treatment for my pain and other symptoms is ongoing. I have spent tens of thousands of dollars out of pocket for treatment, after private health insurance claims. My last surgery cost $8000+ out of pocket." —name withheld

   10. "I now rely on medication so I can smile at my children."

   "I have attempted to keep my physical and emotional pain from the ones that I love, and I've pushed on through so hard so I always get back on track, back to being the mum that I always was and the hardworking woman I strive to be. Others cannot believe I'd end up broken, but I am. I suffer with post-traumatic stress, huge anxiety and I have recently accepted that, yes, depression is real. I now rely on medication so I can smile at my children, look at my husband and remind him of why he married me. I can't attend work anymore. I am no longer able to pretend that I am okay. The pain slowly kills your soul." —Harriet

   11. "I have pawned my wedding rings, jewelry."

   "The surgery cost [for mesh removal] is $9,600 which I haven't got yet but have pawned my wedding rings, jewelry, set up a crowdfunding page and asked my children for money to help as I am determined to have it as I need this product out of me before it causes more damage. My three children live in the United States so going through all this on my own has been very stressful." —name withheld

   https://www.womenshealthmag.com/health/a19622268/australian-pelvic-mesh-report-stories/
   

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8. Australian Women Involved in Pelvic Mesh Implant Scandal

   Mar 28, 2018 | Week Facts

   By Amanda Carano

   Like in excess of 100,000 Australian Women, Linda Schulz had a Pelvic Mesh Implant to treat complications from Childbirth that brought about her gut and bladder prolapsing.

   The mesh was intended to be a handy solution, yet the fallout was more terrible.

   Her correct leg went numb very quickly after the method, and following fourteen days the mesh resembled a Blade always cutting her up from within.

   “The mesh slice through my vagina divider and got through my Skin,” Schulz said. “Any development, regardless of whether I moved my Legs or not, felt like a serrated-edge cut was cutting me.”

   In the most recent year, Schulz, 48, alongside several Women encountering comparable complications, requested of the Australian Senate to Research their utilization, seeking after an inside and out boycott and plan of action for past systems.

   After a yearlong request, the Senate discharged a report Wednesday, prescribing that the Implant be a “final resort” and raised worry that restorative professionals had not sufficiently educated their Patients and “abused” the system “without thinking about elective treatment choices.”

   The report went ahead to plot imperative proposals for enhanced treatment Rules and medicinal preparing, counteractive action of money related actuations for specialists, a registry of high-hazard implantable gadgets and a Review of past methodology. It likewise laid out worry that it isn’t conceivable to recognize precisely the quantity of women who have gotten transvaginal mesh implants in the nation.

   “Women that have had those implants, who have those results … have been bombed stupendously by the framework and by specific individuals in the restorative calling who they put stock in,” said Sen. Rachel Siewert when she acquainted the report Wednesday with the Senate. “I Trust that we never need to have another request where we see such experiencing the witnesses.”

   Senate association all began when Sen. Derryn Hinch heard stories, for example, Schulz’s, and was moved to begin a request in February 2017.

   “I trust our report persuades them they have been tuned in to and all the more imperatively they have been trusted,” Hinch said at the Senate meeting presenting the report.

   Hearings were held crosswise over Australia in 2017, meeting the two patients and mesh makers. Hundreds sent in to the Senate, sharing a scope of stories about Livingwith torment after the activity – from not having the capacity to walk, sit or Drive to puncturing their accomplice amid intercourse with a fragment that severed the implant.

   Schulz said she trusts the report will go past proposals enthusiastically, and she trusts no lady needs to experience what she did: “It changes as long as you can remember. You don’t feel like a lady any longer. They simply take everything all at once.”

   Checking in at 20 minutes, the mesh implant is a handy solution went for repairing basic complications from childbirth and menopause.

   The mesh is implanted to Help debilitated or harmed Tissue to treat poor bladder control and Organ prolapse. In any case, the strategy can be unsafe due to the techniques and Materials utilized. As indicated by different examinations, complications can incorporate organ puncturing, Disease, drain and Sexual brokenness.

   About portion of women in the vicinity of 50 and 79 may have prolapse, as per the American Urogynecologic Society. Whenever muscles and tendons in the pelvic floor get excessively extended, for reasons, for example, childbirth, they Neglect to hold up the pelvic organs: the bladder, rectum and Uterus. The organs can drop into the hole, making pee and sex agonizing.

   One of every five women has incontinence, or poor bladder control, from childbirth, as per the Journal of Prenatal Medicine.

   Some portion of the issue before, Schulz stated, is that there were no hard measurements and records of what number of systems are done and their belongings.

   In April 2017, the Health Issues Center – an Australian shopper support assemble – directed its own Study. In the wake of approaching on Facebook for stories, it got notification from 2,500 women in a month and a half.

   “We heard awfulness stories, experience that were totally annihilated,” said Danny Vadasz, Head of Health Issues Center, who additionally kept in touch with the Senate, requesting change. “We were stunned and scarcely thought something like this could occur in what we considered the World-Class wellbeing arrangement of Australia.”

   The Australian Social insurance framework offers all inclusive human services protection, paid through charges, and also private protection.

   In view of his review, Vadasz gauges that in the previous two decades, there have been 120,000 to 150,000 mesh implants in Australia, and around 70% of the stories his gathering heard included an absence of completely educated assent. Numerous women, he stated, were not informed that a mesh would be implanted into their Bodies.

   “As these gadgets were to be perpetual, we are intended to live with decaying pelvises always,” said Justine Watson, a Sydney inhabitant who presented her mesh photographs to the Senate as a feature of the request and joined in excess of 700 Australian women a year ago in a suit against Johnson and Johnson over cases of imperfections in its mesh gadgets.

   In January, the pharmaceutical monster pulled Back its mesh items from the Australian market. That same month, Australia’s medicinal gadgets controller, the Therapeutic Goods Administration, Evacuated mesh items for prolapse.

   Watson’s agony was severe to the point that she attempted to take her own particular Life subsequent to being hospitalized numerous circumstances. Specialists didn’t trust her, she stated, alluding her to therapists.

   “Mine was seriously fitted,” said Watson, who spent her life investment funds to movement in October from Australia to the United States to expel the mesh that was first implanted in 2010. “It broke into the mass of my bladder and pierced my urethra.”

   In the wake of bringing forth two young men, both measuring in excess of 8 pounds, Watson battled with incontinence.

   Be that as it may, inside three months of the method, Watson was incontinent again and in the wake of agony various restorative issues, for example, fibromyalgia, incessant torment and weakness, she had the mesh evacuated. However, at 47, she said the methodology has abandoned her with the Body of a 80-year-old: unwell, Overweight and unfit to walk in excess of 100 meters.

   Both Watson and Schulz said they felt that Wednesday’s Senate report was brimming with rules as opposed to solid tenets.

   “This (report) feels to some degree uncertain and can be deciphered a few diverse ways. … It’s impossible that it’ll have any effect,” Watson said.

   They, alongside other People who have been influenced, are currently investigating a Royal Commission, an official examination that they expectation can completely boycott the training and even offer money related compensation.

   Schulz needs more acknowledgment of the issue. She speaks to in excess of 1,600 women in the Australian Pelvic Mesh Support Group, a backing association that cautions women about the dangers of the strategy.

   A recent report, which thought about the consequences of women crosswise over 35 UK healing centers who had Surgery with and without mesh, presumed that there was “no advantage to women having their first prolapse repair from the utilization of transvaginal engineered mesh.”

   More than 1 of every 10 in their examination endured complications, with 3 out of 10 requiring another activity, Driving the Investigation creators to suggest the more standard approach, without mesh, where organs are repositioned to their unique territories and the steady tissue encompassing them is repaired and sewed. The Mayo Clinic reliably utilizes this technique.

   There are likewise less intrusive medications, prescribed by a few Scientists, for example, pelvic floor Muscle preparing to reinforce the debilitated tissue.

   However, for some women, for example, Schulz, no other alternative is given.

   The surgical mesh technique is disputable and has prompted numerous class-activity Suits over the United States, UK and Australia.

   In the UK, the National Health Service gauges that in the course of recent decades, in excess of 100,000 women have had surgery including a mesh implant and 3% to 5% have had complications. In any case, a current report proposed higher figures, evaluating that 1 out of 15 women needed to have her implant surgically evacuated in the UK.

   Edward Morris, VP for clinical quality for the Royal College of Obstetricians and Gynecologists, features that in view of current proof, the mesh might be compelling to treat incontinence however isn’t exhorted for organ prolapse.

   Be that as it may, there is as yet a little subset of women for whom it may be gainful, he included, given the “proper Data and guiding about the dangers and advantages.”

   The School has a mesh website page committed to data and exhortation on mesh implants to enable women to be educated about the strategy.

   In December, the National Institute for Health and Care Excellence – the UK’s wellbeing guard dog – pulled back its suggestion for the strategy to treat pelvic organ prolapse, and the Department Of Health and Social Care is reviewing cases Dating to 2005.

   In January, New Zealand restricted all vaginal mesh techniques to treat organ prolapse.

   In the United States, the Food And Drug Administration has not found a way to boycott vaginal mesh. Be that as it may, in 2016, it renamed the gadget from class II (direct hazard) to class III (high hazard), giving the office more oversight over the assembling of mesh items.

   The FDA assessed that there are 75,000 methodology including pelvic mesh implants every year in the United States. A 2011 report by the FDA additionally announced 2,874 instances of damage, passing or glitch identified with the utilization of vaginal mesh in the vicinity of 2008 and 2010, including three passings: two from inside holes and one from discharge.

   https://weekfacts.com/2018/03/australian-women-involved-in-pelvic-mesh-implant-scandal/

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9. Transvaginal mesh inquiry criticises Australia's medical device regulation

   Mar 28, 2018 | The Guardian

   By Christopher Knaus

   Failure to protect women receiving the mesh implants cast health professionals in ‘very poor light’, inquiry finds

   The health system’s catastrophic failure to protect women receiving transvaginal mesh implants has caused “great cost” to victims, exposed major failings with Australia’s regulation of medical devices, and cast health professionals in a “very poor light”, an inquiry has found.

   The inquiry has called for a major overhaul of Australia’s regulation of medical devices, including the creation of a national register tracking high-risk implantable devices and forcing the mandatory disclosure of complications, so that defective products can be quickly identified and addressed.

   Roughly 150,000 women in Australia have undergone transvaginal mesh procedures, largely to treat stress urinary incontinence and pelvic organ prolapse – two common complications of childbirth.

   The devices have been associated with significant complications across the world.

   They have caused chronic and debilitating pain, made sexual intercourse impossible, and ruined relationships, careers and lives. The scandal has prompted class actions against the manufacturer Johnson & Johnson and its associated companies in Australia, Britain, Canada and the US.Vaginal mesh complications too severe to be inflicted on patients, court told

    Read more

   In the Australian class action, it has been alleged that Johnson & Johnson downplayed the risks of the product, failed to conduct proper testing, and aggressively marketed the devices to surgeons as a means of making a quick and easy profit. Women were not properly informed of the risks of the surgery, and were disbelieved when they complained of pain. The company is also alleged to have sought to avoid the scrutiny of regulators and suppress unfavourable data.

   A Senate inquiry has been probing the mesh scandal in Australia in recent months, and delivered its final report on Wednesday evening.

   The findings were damning. It found Australia’s system of reporting adverse consequences from medical devices was deeply flawed.

   There is no national register of high-risk medical devices, and reporting of problems was haphazard and voluntary. That masked problems as they emerged and allowed more and more women to suffer.

   “The committee is particularly concerned that underreporting of adverse events associated with transvaginal mesh products has provided a false indication of the safety of such devices and contributed to delays in responding to the issues identified,” the report says.

   “The committee is deeply concerned that this has resulted in more women suffering complications.”
   

   Despite exhaustive attempts, the inquiry was left unable to tell just how many women had been affected by the flawed mesh devices.

   The inquiry was also scathing of elements of the medical profession for their failure to achieve proper consent from women before surgery. 
   

   One woman told the inquiry of her horror at realising the potential complications from the mesh, after her surgery. “I felt completely doomed I put the puzzle together and started crying. How can I have not known a foreign medical device had been implanted in my body without my consent?”

   The inquiry recommended that women’s fully informed consent be obtained before the mesh devices were implanted.

   “The committee is deeply concerned by the accounts it has received of women’s experiences at the hands of medical practitioners,” the inquiry found. “Even allowing for the positive accounts provided to the committee and the fact that some accounts are recalling events of over 10 or 15 years ago, they present the medical profession in a very poor light.”

   Greens senator Rachel Siewert, the chair of the community affairs committee, urged the federal government to implement the inquiry’s 13 recommendations.

   “The inquiry heard from many women who are living with the consequences of having had these implants,” Siewert said. “It is heartbreaking that for so long the experiences of these women have been ignored.

   “These women have been let down, the system has failed them.”
   

   The inquiry recommended the Therapeutic Goods Administration and the Australian Commission on Safety and Quality in Health Care develop information sheets for patients, giving them guidance for what to do when experiencing complications.

   It called on the government to prioritise the establishment of a more comprehensive post-market monitoring scheme.

   .https://www.theguardian.com/society/2018/mar/28/transvaginal-mesh-inquiry-criticises-australias-medical-device-regulation

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10. Pelvic mesh implantation horrors

    Mar 29, 2018 | News-Medical.net

    By Ananya Mandal

    Thousands of women undergo operations to get pelvic meshes inserted surgically within their lower bodies to prevent prolapsing of the abdominal organs after childbirth complications.

    Studies including one from the Journal of Prenatal Medicine, have shown that after childbirth, there is a risk of poor bladder and bowel control in one fifth of all women. Because of the muscles and ligaments of the pelvic floor becoming weak, there is a risk of the organs prolapsing or dropping down. This makes urination, defecation and intercourse painful. These meshes are supposed to protect the abdominal organs from sagging by providing support. The mesh is inserted in a short 20 minute procedure to provide support to the pelvic floor.

    So like many other women, an Australian woman Linda Schulz, 48 too went in for a pelvic mesh implant. After the procedure however, she started feeling numb in her right leg. Within a few weeks the mesh cut into her abdominal and pelvic organs and it was painful for her to move without feeling the mesh cut into her like a knife. So she along with hundreds of other women last year petitioned the Australian Senate to look into these procedures as they were all suffering from these dreadful complications after surgery. The Senate looked into the matter and after around a year, they released their findings in a report yesterday (28th of March 2018).

    The enquiry began in February 2017 after Sen. Derryn Hinch heard the petition from the affected women. All through 2017, the Senate conducted hearings of the patients and the implant makers. The women complained of several injuries they suffered from the implants and the pain. Some of them even reported injuring their partners when they had intercourse with a splinter that had broken off from the implant.

    According to the latest report from the Senate, these implants must be the “last resort”. They raised the issues with lack of information regarding the procedure provided to the patients beforehand so that they could make an informed choice. They found that the medical practitioners had been “overusing” the procedure where there could have been other treatment alternatives. These alternative options were not informed to the patients, the report said. The report outlines several recommendations regarding the treatment guidelines for prolapse. It also outlines the training of the medical personnel in this regard and attempts to stop and prevent the financial inducements from the makers to the medical personnel. All high risk implant devices need to be recorded and a list of procedures conducted in the past also need to be provided for audit, the report says.

    Sen. Rachel Siewert spoke to the Senate while releasing the report stating, “Women that have had those implants, who have those outcomes ... have been failed in a monumental way by the system and by certain people in the medical profession who they trusted… I hope that we never have to have another inquiry where we see such suffering from the witnesses.”

    This January, Johnson & Johnson, one of the makers of these meshes, withdrew their product from the Australian market after a legal action from over 800 women who had suffered after the implant.

    https://www.news-medical.net/news/20180329/Pelvic-mesh-implantation-horrors.aspx
    

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11. Startling New Report Says Pelvic Mesh Implants

    | Marie Claire

    By Elle Lisbon

    Following years of horror stories and even deaths, a report into vaginal mesh implants has recommended the devices "should only be used as a last resort."
    

    The Senate Community Affairs References Inquiry began investigating the implants, which have been used to treat prolapse or incontinence women since the 1990s, after hundreds of Australian women complained to the senate of suffering debilitating pain and serious infections.

    Senator Derryn Hinch says the report's findings were far worse than they had been expecting, finding that 10,000 to 15,000 people incurred serious side effects and that in some cases, women were not properly informed about these potentially serious side effects.

    "I believe it was one of the biggest medical scandals Australian women have ever been subjected to and there are still a lot of questions to be answered, " he told the ABC. "Thousands of women were deformed."

    The report made 13 recommendations including mandatory reporting of adverse effects on women and better training for doctors and surgeons, SBS reports.

    "My life has been impacted in every way. I am in constant pain, so I cannot do what I used to do, and I must lie down horizontally every hour or so because the pain becomes unbearable," Stella Channing said in a submission received by the Parliament of Australia.

    "I have experienced bleeding, constant bowel and urination pain, and insomnia every night; I cannot sleep because I am in so much pain. I have always been very active, going to gym, walking, cycling, but everything is very limited now. Every movement hurts. I used to be sexually active prior to this, but now I absolutely cannot. It's just pain, pain, and more pain to merely exist."

    https://www.marieclaire.com.au/pelvic-mesh-implants-australia-should-be-last-resort
    

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12. Australian women with pelvic mesh implants 'treated appallingly'

    Mar 29, 2018 | ABC Local

    By Sophie Scott

    A Senate committee report has been scathing in its assessment of the medical community's treatment of women who received pelvic mesh implants.

    Hundreds of thousands of women had the devices implanted to address incontinence or prolapse after having children.

    But it's estimated that up to 15 per cent of those with the mesh suffered crippling side effects.

    http://www.abc.net.au/radio/programs/am/australian-women-with-pelvic-mesh-implants-treated-appallingly/9600026
    

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13. Australian Senate Mesh Decision is a Disservice to Women

    Mar 28, 2018 | Mirage News

    Today’s recommendation by the Australian Senate Committee Inquiry that implantation of all transvaginal mesh products should only be undertaken as a last resort has been met with bewilderment and concern by doctors treating Australian and New Zealand women for urinary incontinence and pelvic floor conditions.

    The Urogynaecological Society of Australasia (UGSA) says this recommendation affects women’s options for care by limiting access to the safest and most effective surgical treatment for urinary incontinence, the mid-urethral sling or MUS. “This decision is one of the most retrograde steps in the history of modern surgery” says UGSA Chair Dr Jenny King. “It simply disregards sound scientific data”.

    UGSA states lightweight, minimally invasive mid urethral slings have been used in Australia and NZ since 1998. They have been extensively studied for almost two decades with over 2,000 scientific publications. The mid-urethral sling is supported as the operation of choice for stress urinary incontinence by every /media releasewomen’s health and pelvic floor society in Europe, the United Kingdom and the USA. It is important to note that the US FDA statements on safety concerns over transvaginal mesh do not include mid urethral slings and the Australian TGA has continued to support the inclusion of these products on the Register of Therapeutic Goods.

    Just this week The Australian Commission on Safety and Quality in Health Care (ACSQH)released the hospital credentialing guidelines for MUS stating “There is robust evidence nationally and internationally to support the use of the traditional mid urethral sling for stress urinary incontinence in appropriate cases.” The Royal Australian and New Zealand College of Obstetricians and Gynaecologists also recommends the MUS as it is highly effective in the short and medium term with fewer adverse outcomes than other available major continence surgeries. “MUS have been clearly shown to be safer and more effective with a lower complication rate than our previous continence procedures”, says Dr King.

    UGSA believes the way forward lies in rigorous safeguards including ongoing audit, long term monitoring, careful surgical training and research with thoughtful patient selection and counselling. These recommendations have also been made by the ACSQH and many are included in the Senate recommendations. All will improve care for our patients.

    But UGSA also makes a plea for sensible and accurate discussion of these issues. So many women have been made unnecessarily anxious by the emotive and scaremongering coverage of transvaginal mesh that they are now waiting for something to go wrong or are just too frightened to consider a treatment which will be of real benefit.Health MARCH 28, 2018 8:45 PMShare Twitter FacebookAustralian Senate Mesh Decision is a Disservice to Women

    Today’s recommendation by the Australian Senate Committee Inquiry that implantation of all transvaginal mesh products should only be undertaken as a last resort has been met with bewilderment and concern by doctors treating Australian and New Zealand women for urinary incontinence and pelvic floor conditions.

    The Urogynaecological Society of Australasia (UGSA) says this recommendation affects women’s options for care by limiting access to the safest and most effective surgical treatment for urinary incontinence, the mid-urethral sling or MUS. “This decision is one of the most retrograde steps in the history of modern surgery” says UGSA Chair Dr Jenny King. “It simply disregards sound scientific data”.UGSA states lightweight, minimally invasive mid urethral slings have been used in Australia and NZ since 1998. They have been extensively studied for almost two decades with over 2,000 scientific publications. The mid-urethral sling is supported as the operation of choice for stress urinary incontinence by every /media releasewomen’s health and pelvic floor society in Europe, the United Kingdom and the USA. It is important to note that the US FDA statements on safety concerns over transvaginal mesh do not include mid urethral slings and the Australian TGA has continued to support the inclusion of these products on the Register of Therapeutic Goods.

    Read more:  Tanilba Bay head-on crash leaves woman seriously injured, NSW

    Just this week The Australian Commission on Safety and Quality in Health Care (ACSQH)released the hospital credentialing guidelines for MUS stating “There is robust evidence nationally and internationally to support the use of the traditional mid urethral sling for stress urinary incontinence in appropriate cases.” The Royal Australian and New Zealand College of Obstetricians and Gynaecologists also recommends the MUS as it is highly effective in the short and medium term with fewer adverse outcomes than other available major continence surgeries. “MUS have been clearly shown to be safer and more effective with a lower complication rate than our previous continence procedures”, says Dr King.

    UGSA believes the way forward lies in rigorous safeguards including ongoing audit, long term monitoring, careful surgical training and research with thoughtful patient selection and counselling. These recommendations have also been made by the ACSQH and many are included in the Senate recommendations. All will improve care for our patients.

    But UGSA also makes a plea for sensible and accurate discussion of these issues. So many women have been made unnecessarily anxious by the emotive and scaremongering coverage of transvaginal mesh that they are now waiting for something to go wrong or are just too frightened to consider a treatment which will be of real benefit.Read more:  Australia's indigenous languages have one source - study

    Our task now is to care for those women with ongoing problems and to continue to advance our treatments for those women still suffering with incontinence and pelvic floor weakness. Often the best treatment option will be a mid urethral sling – women must be able to make that choice.

    https://www.miragenews.com/australian-senate-mesh-decision-is-a-disservice-to-women/
    

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14. New report recommends limiting use of transvaginal mesh as a last resort

    Mar 28, 2018 | International Business Times

    By Dan Perez

    The health system’s failure to protect females getting transvaginal mesh implants revealed failings with Australia’s regulation of medical devices and casted health professionals in “very poor light,” an inquiry has found. The failure also caused “great cost” to victims.

    The inquiry has called for an overhaul of the country’s regulation of medical devices after victims talked about stories of devastating physical and mental scars. It includes forcing the mandatory disclosure of complications as well as the creation of a national register tracking high-risk implantable devices.

    The Senate Community Affairs References Inquiry started to investigate the pelvic implants after complaints of side effects from a number of Australian women. Senator Derryn Hinch, who led the inquiry, said the damage was far worse than the committee has expected.

    Hinch said he believes it was among the biggest medical scandals women in Australia have been subjected. He added there are still several questions that need answers.

    About 150,000 women in Australia have undergone transvaginal mesh procedures. Many decided to undergo the procedure in order to treat pelvic organ prolapse and stress urinary incontinence, which are two known complications of childbirth.

    A report into transvaginal mesh implants has suggested the devices “should only be used as a last resort.” Hinch said thousands of women were deformed, and that the committee estimated between 10,000 to 15,000 females may have suffered side effects.

    Greens senator and chair of the community affairs committee Rachel Siewert encouraged the federal government to employ the inquiry’s 13 recommendations. She said the inquiry heard from several women living with the consequences of having had these implants.

    "Many women who have had transvaginal mesh implants have had devastating complications resulting in ongoing emotional trauma, embarrassment, shame, depression, debilitating pain, recurring infection and a poor quality of life," SBS reported Siewert as saying. Siewert said the failure has to be fixed and support has to be provided for the women.

    The Senate committee’s recommendation is for transvaginal mesh to be used as a last resort when other treatment options have been considered and determined unsuitable. It was also recommended the mesh be used with fully informed consent.

    Among other recommendations are establishing a register of all high-risk devices and providing information about seeking treatment in the event of complications. It has been alleged that Johnson & Johnson failed to do proper testing and marketed the devices aggressively to make an easy and fast profit.

    http://www.ibtimes.com.au/new-report-recommends-limiting-use-transvaginal-mesh-last-resort-1566653
    

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15. “Torture device’ vaginal mesh only as last resort: report

    Mar 28, 2018 | NEWS.com.au

    By Matt Coughlan

    A Senate committee has recommended transvaginal mesh only be used as a last resort after victims told an inquiry harrowing stories of devastating physical and mental scars.

    The mesh has been used since the 1990s to treat stress urinary incontinence and pelvic organ prolapse in women, with many experiencing severe impacts.

    A report tabled in parliament on Wednesday made 13 recommendations including mandatory reporting of adverse effects on women, more information about the risks of implants and better training for doctors and surgeons.

    “Many women who have had transvaginal mesh implants have had devastating complications resulting in ongoing emotional trauma, embarrassment, shame, depression, debilitating pain, recurring infection and a poor quality of life,” committee chair, Greens senator Rachel Siewert said.

    Independent senator Derryn Hinch said the committee had heard frightening stories of complications for women who had been let down by the Therapeutic Goods Administration.

    “Having first been told there’s only a one per cent chance of an adverse reaction, they have since been treated like mushrooms,” Senator Hinch said.

    “Kept in the dark and fed bulls*** by doctors, hospital administrators, the drug companies and sadly even the TGA.”

    In 2017, Hinch described it as “the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs”.

    The committee recommended the mesh be used only with fully informed consent and as a last resort when other treatment options have been properly considered and determined unsuitable.

    Establishing a register of all high-risk devices and providing information of how to seek treatment in the event of complications were among the report’s other recommendations.

    “This should never have happened. We need to fix it. We need to be providing support for these women,” Senator Siewert said.

    Senator Hinch said the netting, which had led to relationship breakdowns, could become brittle, break away in shards and splinters to float around the body.

    “No wonder these things have been called a torture device.”

    http://www.news.com.au/lifestyle/health/health-problems/torture-device-vaginal-mesh-only-as-last-resort-report/news-story/84d5ad7c6bc656efae44124bf14a63e5
    

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16. Trial testimony questions appropriateness of pelvic mesh in N.J. case against C.R. Bard

    Mar 28, 2018 | Legal News Line

    By John Sammon

    Jury trial resumed on March 26 in a woman’s lawsuit seeking damages against a medical manufacturer whose pelvic implant device used for bladder support allegedly instead led to chronic inflammation and pain and had to be surgically removed.

    Plaintiff Mary McGinnis, 62, of North Carolina, sued C.R. Bard, a New Jersey marketer of the implant device Avaulta that was used in her 2009 surgery allegedly without proper background studies or warnings of the risks of the device. The device reportedly caused intense pain in the vagina and rectum.

    McGinnis eventually had to journey to California at her own expense, according to her attorney Adam Slater, to undergo vaginal reconstruction. Slater is with the firm Mazie, Slater, Katz & Freeman in Roseland, New Jersey.

    The device is a clear plastic-looking polypropylene mesh with long connecting arms. The plaintiff's attorney contended the device was too large, causing McGinnis’ body to form scar tissue in efforts to reject it and that it also constricted, causing intense pain.

    Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.            

    Monday’s testimony in New Jersey Superior Court in Bergen County centered on the plaintiff’s contention that traditional, less-risky surgical procedures should have been used to treat McGinnis instead of the implant device. 

    Dr. Anne Weber, an expert in urogynecology and a researcher and teacher on the subject of female pelvic disorders, appeared as a witness for the plaintiff.

    Slater cited a study, “Risk Factors for Reoperation of Surgically Treated Pelvic Organ Relapse,” he said supported the idea conventional surgery would have been a more-effective way to treat McGinnis’ bladder prolapse.

    “Why is this important?” Slater asked Weber.

    “The big push behind the marketing of mesh was that there was this perceived high rate of re-operation for prolapse with traditional native tissue repairs, and that’s not the case,” Weber answered.

    Weber said it was unproven whether the use of mesh in this case provided enough benefit to outweigh the risks associated with it.

    The “Risk Factors for Reoperation of Surgically Treated Pelvic Organ Relapse” study, over a 20-year period, compared groups of women who had to have re-operations for their conditions as opposed to those who did not.

    According to the report, approximately 94.4 percent did not need an additional operation with more traditional (suture) methods.

    Because of the risk involved with mesh, Weber said it should only be used to manage prolapse in the most severe cases, considered stage three or stage four conditions. McGinnis’ level was estimated at stage two.

    Slater asked Weber if, in her opinion, McGinnis would have met the criteria to use mesh?

    “No,” Weber answered.   

    Under cross-examination, defense attorney for C.R. Bard, Lori Cohen of Miami-based Greenberg Traurig LLP, asked Weber if she agreed prolapse was a vexing problem?

    “Yes,” Weber responded.

    “It can’t be made safe under every circumstance, true?” Cohen asked.

    “That’s right,” Weber responded.

    When asked if she thought McGinnis had primary stress urinary incontinence (SUI) and if an implant doctor should do what he or she thought best, Weber responded “as long as they have adequate information.”

    Cohen referred to an earlier medical report Weber had collaborated on in which it was stated “TOT (bladder mesh) sling has become one of the most-popular and effective surgical treatments for female SUI worldwide.”

    It was also stated in the report the effectiveness of such treatments was high.

    “These were your words,” Cohen said.

    “Yes,” Weber responded.

    The report said complications from such procedures were common, but serious complications uncommon.

    https://legalnewsline.com/stories/511370766-trial-testimony-questions-appropriateness-of-pelvic-mesh-in-n-j-case-against-c-r-bard
    

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17. Shook Hardy Grabs Morgan Lewis Complex Litigation Partner

    Mar 28, 2018 | The Legal Intelligencer

    By Lizzy McLellan

    Thomas Sullivan has joined the Kansas City-based litigation firm after 14 years at Morgan Lewis.

    Kansas City, Missouri-based Shook, Hardy & Bacon has added to its Philadelphia office, bringing on a litigator from Morgan, Lewis & Bockius.

    Thomas Sullivan is the 10th lawyer to join Shook Hardy’s Philadelphia location, which opened in 2012, according to the firm’s website. Morgan Lewis has nearly 300 lawyers in Philadelphia, where it was founded, and over 2,200 worldwide, according to the firm.

    Sean Wajert, Shook Hardy’s managing partner in the city, said Sullivan adds bench depth in Philadelphia, where the firm is looking to grow.

    Sullivan focuses on complex litigation, including class actions and mass torts. He also handles cases alleging fraud in state and federal health care statutes, as well as legal ethics and professional responsibility matters. His work has focused largely on the life sciences and food and beverage industries.

    “I’m going to be hitting the ground running with this premier litigation firm and its outstanding trial and appellate lawyers,” Sullivan said in a statement.

    Sullivan’s clients, according to federal court records, have included Rite Aid, Ward Manufacturing, Auxilium Pharmaceuticals and Urban Outfitters. He represented Urban Outfitters in a consumer class action over the collection of customer zip codes for marketing purposes in Massachusetts—an issue on which he has represented several national retailers.

    “We’ve known Tom for a while. He’s got a great reputation in town and we’re excited in particular because his practice focus and his practice mix is such a wonderful fit for what we do and what we’re trying to do here,” Wajert said in an interview.

    In a statement, Shook Hardy chair Madeleine McDonough said Sullivan will help lead the development of the firm’s practice with health, life sciences and food and beverage clients.

    The firm already has a foothold in the region with some of those clients, having recently represented Johnson & Johnson in local talc litigation and Boston Scientific in pelvic mesh litigation that originated in Philadelphia.

    Sullivan spent more than 14 years at Morgan Lewis, which has nearly doubled in size since he joined in 2003.

    Shook Hardy had a total head count of 467 and gross revenue of $350.7 million in 2017, Legal affiliate The American Lawyer has reported.

    Wajert said Shook Hardy currently has 13 timekeepers in Philadelphia.

    “We don’t have a magic number, but I would think when we get to about 20 or so we’ll take a breath and assess what’s next,” Wajert said.

    A spokeswoman for Morgan Lewis said the firm wishes Sullivan well.

    https://www.law.com/thelegalintelligencer/2018/03/28/shook-hardy-grabs-morgan-lewis-complex-litigation-partner/
    

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