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Ethicon Media Monitoring 8/30/2018
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11th Circ. Says Mesh Sling Suit's Injury Notice Beat Time Limit
Aug 29, 2018 | Law 360
By Rick Archer
The Eleventh Circuit on Tuesday revived a woman’s claims that she was injured by a Johnson & Johnson unit’s defective pelvic mesh implant, saying her report of her symptoms did not toll the statute of limitations because she had no reason to blame them on the alleged defect. -
Falkirk MSP backs petition to ban medical mesh
Aug 29, 2018 | Falkirk Herald
By James Trimble
The Falkirk East MSP is backing a petition is calling on the Scottish Government to suspend the use of controversial medical mesh devices. -
Transvaginal Sling Procedures for SUI in Decline Following Warnings
Aug 29, 2018 | Renal and Urology News
By Jody A. Charnow
Use of transvaginal sling (TVS) procedures for stress urinary incontinence (SUI) has been in decline following warnings from the FDA and Health Canada about complications associated with transvaginal mesh, investigators reported at the International Continence Society's 2018 annual meeting. -
Hernia mesh can shrink, harden and degrade and complications are becoming more common, says leading surgeon
Aug 29, 2018 | Cambs Times
By Kath Sansom
The polypropylene material used for hernias is the same, albeit of different fibre size and weight at times, as that used for women’s pelvic mesh implants which were suspended across the UK in July after a senior Tory peer said she was appalled at the tragic risks.
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11th Circ. Says Mesh Sling Suit's Injury Notice Beat Time Limit
Aug 29, 2018 | Law 360
By Rick Archer
The Eleventh Circuit on Tuesday revived a woman’s claims that she was injured by a Johnson & Johnson unit’s defective pelvic mesh implant, saying her report of her symptoms did not toll the statute of limitations because she had no reason to blame them on the alleged defect.
In an unpublished opinion, the panel said Patricia Perryman’s claims could go to the jury despite the fact that she filed suit more than seven years after her Mentor Worldwide LLC-made ObTape transobturator vaginal sling was removed, saying it was questionable when she noticed because the symptoms that led to the removal were not out of line with the side effects she was warned could happen if the product worked as intended.
“Plaintiff never suspected that ObTape was defective or that a specific defect in her ObTape implant had caused her injuries until she saw a commercial in 2013 that reported the existence of vaginal sling defects,” wrote U.S. Circuit Court Judge Julie Carnes for the panel.
Perryman’s claims are part of an MDL filed against Mentor over the ObTape implant. The plaintiffs claimed Mentor failed to adequately test the device before introducing it in 2003, and that it caused the erosion of internal bodily tissues, resulting in complications that included infections and pain.
According to the opinion, Perryman, a Florida resident, was implanted with an ObTape sling in May 2005. She claimed she was informed the surgery carried risks of infection, pain and tenderness, and that her body might reject the implant, the opinion said.
After the surgery, she reported infection, pain and protrusion of the mesh, and had it removed in February 2006, according to the opinion. The panel said she filed suit in September 2013, claiming she realized her injuries were not merely a side effect of the procedure or the mesh after seeing a television commercial about ObTape’s alleged defects.
Mentor moved for summary judgment, arguing Florida’s four-year statute of limitations had tolled when the implant was removed in 2006, and the district court agreed.
But the Eleventh Circuit disagreed, saying it was a question for the jury when notice occurred.
Citing a 2017 Eleventh Circuit opinion on one of many defective vaginal mesh claims against Boston Scientific Corp., the panel said under Florida case law the statute is not tolled until the plaintiff has notice of “an injury distinct in some way from conditions naturally to be expected from the plaintiff’s condition.”
They said in this case Perryman’s symptoms were in line with what her physicians told her might happen after the surgery, and by her account at the time she blamed the symptoms on an infection or an allergic reaction to the implant.
“In other words, such symptoms could arise from a nondefective mesh that had been implanted through surgery that was properly performed,” Judge Carnes said.
Counsel for Perryman and Mentor did not immediately respond to requests for comment Wednesday.
Circuit Court Judges Julie E. Carnes and Gerald B. Tjoflat and District Court Judge Lewis A. Kaplan sat on the panel for the Eleventh Circuit.
Perryman is represented by Erik B. Walker of Justinian & Associates PLLC, and Douglass A. Kreis of Aylstock Witkin Kreis & Overholtz PLLC.
Mentor is represented by John Q. Lewis, Dustin B. Rawlin and Benjamin C. Sassé of Tucker Ellis LLP.
The case is Perryman v. Mentor Worldwide LLC, case number 16-16645, in the U.S. Court of Appeals for the Eleventh Circuit.https://www.law360.com/lifesciences/articles/1077777/11th-circ-says-mesh-sling-suit-s-injury-notice-beat-time-limit
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Falkirk MSP backs petition to ban medical mesh
Aug 29, 2018 | Falkirk Herald
By James Trimble
The Falkirk East MSP is backing a petition is calling on the Scottish Government to suspend the use of controversial medical mesh devices.
Holyrood’s public petitions committee has been considering evidence on the issues highlighted by the document lodged in April 2014 by Elaine Holmes and Olive McIlroy on behalf of the Scottish Mesh Survivors’ Hear our Voice campaign.
The petition was brought forward after women experienced debilitating and life changing complications after undergoing the procedure.
Urogynaecological meshes are used to treat stress incontinence and pelvic organ prolapse.
While most short-term clinical trials have found high efficacy and low complication rates for the most common mesh implants used for incontinence, there is a growing body of evidence that efficacy is lower and complication rates are higher for pelvic organ prolapse.
The procedure has now been temporarily banned in England.
Falkirk East MSP Angus MacDonald MSP, depute convener of the Scottish Parliament’s Public Petitions Committee, is backing the ban on mesh until the findings of the independent review set up to examine the controversial procedure are available and examined in full.
Mr MacDonald said: “I am grateful to the petitioners, Elaine Holmes and Olive McIlroy, for bringing forward this petition and I commend their courage and commitment in the face of their trauma.
“Seeing and hearing the experiences of the many women we have heard from during our consideration of this petition was incredibly emotional, with the physical and mental impact plain to see.”
https://www.falkirkherald.co.uk/our-region/falkirk-district/falkirk-msp-backs-petition-to-ban-medical-mesh-1-4791545
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Transvaginal Sling Procedures for SUI in Decline Following Warnings
Aug 29, 2018 | Renal and Urology News
By Jody A. Charnow
Use of transvaginal sling (TVS) procedures for stress urinary incontinence (SUI) has been in decline following warnings from the FDA and Health Canada about complications associated with transvaginal mesh, investigators reported at the International Continence Society's 2018 annual meeting.
Joseph R. Labossiere, MD, and colleagues at the University of Toronto identified 120,999 women who underwent SUI surgery from 1994 to 2016. From 2000 to 2009, annual rate of TVS procedures increased from 19 to 129 per 100,000 population. The annual rate declined after 2009 to 60 procedures per 100,000 population in 2016.
“These data suggest that the regulatory warnings had a significant effect on how patients and physicians approach surgical management of SUI,” Dr Labossiere's team concluded in their study abstract.
In other study findings, the annual rate of any SUI procedure from 1994 to 2000 was 95 procedures per 100,000 population. From 2000 to 2009, annual rates of any SUI procedure increased from 95 to 147 procedures per 100,000 population. After 2009, annual rates of any SUI procedure declined to 64 procedures per 100,000 population.
https://www.renalandurologynews.com/ics-2018-coverage/transvaginal-sling-procedures-for-stress-urinary-incontinence-in-decline-following-warnings/article/791967/
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Aug 29, 2018 | Cambs Times
By Kath Sansom
The polypropylene material used for hernias is the same, albeit of different fibre size and weight at times, as that used for women’s pelvic mesh implants which were suspended across the UK in July after a senior Tory peer said she was appalled at the tragic risks.
The plastic can twist, harden, shrink, cut, erode or degrade once implanted, which has been confirmed in nearly 500 mesh explants.
But the British Hernia Centre (BHC) claims the material and their implanting method to fix hernias is safe and the problems only affect women’s pelvic mesh with issues originating mainly in America.
Canadian surgeon Robert Bendavid said the claims are “preposterous” and the UK has been more effective than America in raising the issues.
Meanwhile, American surgeon Kevin Petersen says he has received calls from former patients of the British Hernia Centre suffering pain.
Dr Bendavid, who pioneers a non mesh hernia repair called the Shouldice Method, said: “Knowing the march of events of mesh hardening, stiffening, erosion, degradation, it is difficult to understand why surgeons use it so freely and without reservation, when an alternative is available and is just as effective.
“It only demands knowledge of basic anatomy.
“In the last two years there have seen several studies with nearly a million patients to prove the point.
“Studies from the Mayo Clinic and the University of Toronto being the largest. In the latter of 216,000 patients with a 16 year follow-up, the mesh repairs were seen to have five times the recurrence rate of the Shouldice repair by experts of the Shouldice Hospital.
“The Shouldice Hospital was unaware of the study which was carried out independently by the Institute for Clinical Evaluative Sciences (ICES), and independent and outstanding statistical team of the University of Tornto.
“The BHC statement is dubious and defies statistical happenstance as well as logic.
“It relies on ignorance of the public. The complication of hernia mesh pain is becoming more common and is forcing us to consider expansion of our mesh removal service.”
Sling The Mesh campaign, with more than 6,500 members, has a growing number of people join suffering life altering pain from hernia mesh.
In America there are 100,000 cases in courts associated with women’s mesh issues, while 50,000 court cases involve hernia mesh repairs, Dr Bendavid said.
However, a BHC spokesman strongly denied it was a problem and said: “We need to make it perfectly clear that the mesh we use and the open techniques we employ are in no way implicated or involved in these matters.
“It needs to be understood that in hernia repair, using our technique, the mesh should not come into contact with anything significant other than the muscle and tendon tissue that has herniated within the abdominal wall structure.
“The internal organs, contained within the peritoneal cavity, are not even touched in the normal course of this procedure. This applies to both genders.
“It is important to distinguish between the two types of surgery and to recognise that the claimed problems do not apply at all with hernia repair.
“The British Hernia Centre bases its opinion on our experience of many tens of thousands of cases over three decades and not a single case suffering these complications.”
Dr Bendavid said their claims might be more believable if supported by an editorial in a surgical journal or the Royal College of Surgeons, but above all by verifiable statistics from the BHC.
“The BHC techniques means the mesh is in contact with organs, the bladder, the distal portion of the fallopian tubes in women, the femoral or iliac arteries, veins and all nerves nearby, as well as creating a foreign body response,” he said.
“In time, the very peritoneum that protects the internal organs at first, becomes adherent to the mesh and eventually to internal organs.
“In the long run the method used by the BHC namely, the preperitoneal space, is the very space where one finds the genito-femoral nerve, and invariably the femoral branch of the genito-femoral nerve, which is often implicated in chronic post-operative pain.
“No mesh technique is devoid of the possibility and likelihood on time, of complications. Our longest recorded case lasted 24 years before mesh removal.
“Importantly for men the mesh is in contact with the vas deferens whose muscular coating is non existent in the pre-peritoneal space.
“Many men suffer mesh shrinking and eroding into their vas deferens causing excrutiating pain and loss of sex life, that it is referred to in the European Hernia Society’s International guidelines as dysejaculation (3.1-4 per cent) and sexual pain (10.9 per cent) in men.”
http://www.cambstimes.co.uk/news/hernia-mesh-shouldice-1-5670965
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