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Ethicon Media Monitoring 10/29/2018

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

    Online Sources

  1. Scottish government apologises to victims of mesh implant scandal

    Oct 26, 2018 | Medical Plastics News

    By Callum Little

    Jackson Carlaw, MSP for Eastwood spoke on Thursday 25th October during First Minister’s Questions at the Scottish Parliament in Holyrood and voiced his support for women whose lives have been irreversibly affected by the mesh implant scandal.
  2. Mesh scandal: conflict of interests in review confirmed by investigation

    Oct 26, 2018 | Holyrood

    By Tom Freeman

    A 2017 review into the use of transvaginal mesh implants has been discredited because it contained conflicts of interest, a new report has found.
  3. Mesh implants investigation suffered from ‘Systematic failures’

    Oct 26, 2018 | Edinburgh Evening News

    By Chris Green

    The official investigation into the use of mesh implants in Scotland was so badly executed that it left several members of the panel “traumatised”, an independent review has found.
  4. Series of systematic failures found in conduct of mesh review

    Oct 26, 2018 | Express and Star

    An investigation into the independent review on mesh implants has uncovered a series of systematic failures in the way it was conducted.
  5. Euan McColm: Jackson Carlaw’s turn to deal with Tories’ usual suspects

    Oct 27, 2018 | The Scotsman

    By Euan McColm

    The Scottish party leader’s deputy steps forward at a critical time for maintaining the tolerant, progressive image fostered by Ruth Davidson, writes Euan McColm.
  6. Say hello to the vagina gym. Tone your muscles for £2,000

    Oct 27, 2018 | The Times

    By Victoria Woodhall

    In one 28-minute session, I'm getting the equivalent of 11,000 pelvic floor ... neck or inserting tape or vaginal mesh [which was stopped this year because of ...

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

    Online Sources

  1. Scottish government apologises to victims of mesh implant scandal

    Oct 26, 2018 | Medical Plastics News

    By Callum Little

    Jackson Carlaw, MSP for Eastwood spoke on Thursday 25th October during First Minister’s Questions at the Scottish Parliament in Holyrood and voiced his support for women whose lives have been irreversibly affected by the mesh implant scandal.

    Carlaw who is also deputy leader of the Scottish conservative Party, was standing in for Scottish tory party leader Ruth Davidson, who is on maternity leave, and used his FMQ debut to call on the Scottish government to say sorry.

    Carlaw referred to the mesh scandal as the ‘greatest self-inflicted health scandal since Thalidomide in the 60s’ and continued to press the issue with the First Minister Nicola Sturgeon, saying “First Minister, just how badly let down have the thousands of Scottish women fitted with a Mesh device been?”

    He added, “Will the First Minister now, on behalf of the Scottish Government, apologise to all the women in Scotland who have suffered?”

    The mesh implant scandal refers to a controversial procedure where surgeons implanted mesh medical devices to treat pelvic organ prolapse and incontinence in women, these conditions can occur after childbirth.

    Nicola Sturgeon addressed Carlaw’s concerns, and said, “Let me say today on behalf of the Scottish Government I apologise unreservedly to any woman who has suffered because of mesh procedures.”

    Sturgeon continued, “In terms of the women affected, I have deep and very profound sympathy for what they have gone through and the position that they have found themselves in”

    The MSP for Eastwood also called for women in Scotland affected by the mesh implant scandal to be given access to the blue badge disability scheme.

    Carlaw said, “Many of the women whose mobility has been impaired by Mesh are currently simply not eligible (for the blue badge scheme). To them, access to the Blue Badge scheme – those in wheelchairs and on crutches – would be a hugely welcome and practical advantage.”

    Their use of mesh implants was suspended in 2014 by NHS Scotland amid safety concerns, after a request from the Scottish government to allow proper investigation into mesh devices as a result of some women reporting to be suffering from side-effects.

    Some of the reported side-effects included severe and contestant abdominal and vaginal pain post-surgery. Numerous women reported infections and bleeding and others have complained that their incontinence symptoms have persisted, despite the mesh being implanted.

    A number of women have been left unable to walk properly following the procedure and are forced to use crutches or wheelchairs when they need to walk due to impaired mobility.

    The Blue Badge scheme enables holders to access parking bays situated closer to where they want to go, for example, their place of employment or the shops. Badge holders are exempt from certain parking restrictions across the UK.

    https://www.medicalplasticsnews.com/news/scottish-government-apologises-to-victims-of-mesh-implant-sc/

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  2. Mesh scandal: conflict of interests in review confirmed by investigation

    Oct 26, 2018 | Holyrood

    By Tom Freeman

    A 2017 review into the use of transvaginal mesh implants has been discredited because it contained conflicts of interest, a new report has found.

    Last May the three-year safety review was branded “a whitewash” by campaigners after it was significantly altered before the final draft was published, recommending that the controversial procedure should be reinstated in Scotland, albeit not “routinely”.

    Then health secretary Shona Robison ordered an investigation into the way the review was conducted.

    Professor of medical law at Glasgow Caledonian University Alison Britton, who led the investigation, has now concluded the original review was “ill-conceived, thoughtlessly structured and poorly executed”.

    The report details that conflicts of interest were not declared or even discussed in the review. These included members being paid by big pharmaceutical companies, members who were being sued and members who were suing others.

    One of the clinicians involved was actually the surgeon who had operated on another member of the review.

    “Involvement in litigation, or a doctor patient relationship, has the potential to compromise the independence of any review,” Britton’s report said.

    “We believe that it was a major failing that these were not declared and discussed. The credibility or accessibility of outcome tends to determine public perception of independence.”

    Mesh is a synthetic implant used to treat pelvic organ prolapse and stress urinary incontinence. While the majority of women have suffered no side effects, complications can be severe.

    In September chief medical officer Catherine Calderwood wrote to health boards to immediately halt the procedure after the implant was listed as a factor in the death of a woman in West Lothian.

    SNP MSP Alex Neil, who ordered the original review, Scottish Conservative Jackson Carlaw and Scottish Labour’s Neil Findlay have campaigned on the issue and questioned the integrity of the Medicines and Healthcare products Regulatory Agency (MRHA), who authorised the products.

    Britton has made 46 recommendations of how future government-ordered reviews can avoid the issues, including establishing a “test of impartiality” from the outset.

    “It is important to be honest about our past failures,” she said in her foreword to the report. “But it is equally important to learn lessons from the past and to shape the future in light of those lessons.”

    https://www.holyrood.com/articles/news/mesh-scandal-conflict-interests-review-confirmed-investigation

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  3. Mesh implants investigation suffered from ‘Systematic failures’

    Oct 26, 2018 | Edinburgh Evening News

    By Chris Green

    The official investigation into the use of mesh implants in Scotland was so badly executed that it left several members of the panel “traumatised”, an independent review has found.

    It concluded that the original inquiry into the issue was characterised by “systematic failures”, including in-fighting among its members and a failure to declare conflicts of interest. It is now time for the SNP government to completely ditch this discredited review Neil Findlay MSP An investigation into what went wrong with the review was ordered by ministers after three of its members resigned before it concluded, describing its report as a “whitewash”.

    The original review was set up in 2014 to investigate the use of transvaginal mesh implants, after dozens of women told MSPs that the surgery had ruined their lives and left them in chronic pain. The implants were linked to the death of a 75-year-old woman earlier this year, prompting the Health Secretary to call a halt to their use in Scotland’s NHS last month.

    The new investigation, led by Professor Alison Britton of Glasgow Caledonian University, said the original review had been “ill-conceived, thoughtlessly structured and poorly executed”.

    “Negative factors including irreconcilable differences of opinion of review members [and a] lack of agreement on the interpretation of evidence,” it added. Her review also said several members of the initial inquiry had failed to declare potential conflicts of interest, with some being paid to conduct research in the area they were investigating.

    It added that most members were “totally unprepared” for the level of public and political scrutiny they received, with one recalling: “It was terrible, terrible, terrible”.

    Some said they felt “traumatised” when the report was finally published, while others said they wished they had never taken part and would never contribute to a similar exercise again.

    Prof Britton said that while she was satisfied that nobody involved in the original review had acted in “bad faith”, it had ultimately failed due to a lack of oversight and proper guidance. Her report made 46 recommendations to ministers.

    Earlier this week, Nicola Sturgeon issued a formal apology on behalf of the Scottish Government to the thousands of women across Scotland who suffered as a result of having mesh implants.

    Scottish Labour MSP Neil Findlay said: “This report that reveals the SNP’s original mesh review was a complete white wash. “It is now time for the SNP government to completely ditch this discredited review and immediately pledge to deliver a thorough and truly independent inquiry.”

    Scottish Conservative interim leader Jackson Carlaw said there were “very serious lessons to be learned” for the Scottish Government. “The recommendations of Professor Britton must be accepted in full,” he added. 

    A Scottish Government spokesman said: “We will now carefully consider all of her recommendations in relation to the establishment and operation of future reviews.” 

    https://www.edinburghnews.scotsman.com/news/politics/mesh-implants-investigation-suffered-from-systematic-failures-1-4820729

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  4. Series of systematic failures found in conduct of mesh review

    Oct 26, 2018 | Express and Star

    An investigation into the independent review on mesh implants has uncovered a series of systematic failures in the way it was conducted.

    Professor Alison Britton said the review was “ill-conceived, thoughtlessly structured and poorly executed”.

    She was tasked by the Scottish Government with examining how the Scottish Independent Review of Transvaginal Mesh Implants was carried out following widespread criticism of its final report.

    Her year-long investigative review has made a series of recommendations which may be applied to similar independent reviews in the future.

    The Scottish Government said it would consider her findings.

    The original mesh review was commissioned by ministers after a number women spoke out at Holyrood on their experiences of being treated with the medical devices.

    Many experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence.

    The review group was set up in 2014, but its final report was not published until March 2017.

    Prior to publication, the first chair of the group and three members resigned.

    There were claims the report was a “whitewash”, with key parts warning of the risks of mesh implants removed.

    Porf Britton’s report states: “Having reviewed the evidence, we have concluded that the mesh review and the process leading up to the publication of its final report were characterised by systematic failures.

    “We found that the Mesh Review was ill-conceived, thoughtlessly structured and poorly executed.

    “Negative factors including irreconcilable differences of opinion of review members, lack of agreement on the interpretation of evidence, unhelpful political and media influences and pressure to complete the report only served to magnify the failures in the process.”

    It continued: “Whether the mesh review was independent was a recurring concern.

    “The independence of any investigation is the spine which gives it credibility and legitimacy. Our investigation identified a number of problems with how the mesh review solicited, monitored and reported relevant declarations and conflicts of interests by members of the review group.

    “We record a number of criticisms on how the Mesh Review was conducted. Some of these criticisms have informed our recommendations.

    “However, we were satisfied that no one involved in the Mesh Review was acting in bad faith.”

    Her 46 recommendations include setting up a dedicated unit to support commissioned reviews, and the application of a test of impartiality to allow a review group member’s prior knowledge or involvement in a subject to be disclosed and evaluated.

    Scottish Labour MSP Neil Findlay said: “This report that reveals the SNP’s original mesh review was a complete white wash.

    “It is now time for the SNP government to completely ditch this discredited review and immediately pledge to deliver a thorough and truly independent inquiry.”

    Scottish Conservative interim leader Jackson Carlaw said there were “very serious lessons to be learned” for the Scottish Government.

    “The recommendations of Professor Britton must be accepted in full,” he added.

    A Scottish Government spokesman said: “We thank Professor Britton for her investigative review into the process of establishing, managing and supporting independent reviews. We received this yesterday (Thursday) and have published it today.

    “The Scottish Government commissioned Professor Britton’s analysis in order to ensure any forthcoming reviews operate on the firmest possible footing. Not least in ensuring any conflicts of interest are avoided.

    “We will now carefully consider all of her recommendations in relation to the establishment and operation of future reviews.”

    https://www.expressandstar.com/news/uk-news/2018/10/26/series-of-systematic-failures-found-in-conduct-of-mesh-review/

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  5. Euan McColm: Jackson Carlaw’s turn to deal with Tories’ usual suspects

    Oct 27, 2018 | The Scotsman

    By Euan McColm

    The Scottish party leader’s deputy steps forward at a critical time for maintaining the tolerant, progressive image fostered by Ruth Davidson, writes Euan McColm.

    Opponents and members of the public (the usual contemptible exceptions who cannot bloody help themselves aside) were full of warm words, bombarding Davidson on social media with their congratulations.

    “Many congratulations to you both,” tweeted First Minister Nicola Sturgeon, “I wish wee Finn a lifetime of happiness.” For this rare moment of happy comradeship in these rancorous times, young Finn, we are in your debt.

    The day before Davidson gave birth, her deputy, Jackson Carlaw, participated in his first session of First Minister’s Question Time as acting leader of the Scottish Conservative Party.

    The broad consensus was that he acquitted himself well enough, asking a question about the use of vaginal mesh implants that had Nicola Sturgeon agreeing to look at whether blue-badge parking permits might be made available to women affected by their use.

    But one decent FMQs does not a leader make. For several months to come, the sideman will take centre-stage at a critical moment for his party and it is how he responds that will give us the measure of the man.

    With Brexit chaos ongoing and the ever present threat of a second referendum, Carlaw has busy times ahead. Until now, a fairly obscure figure, his profile is about to soar.

    The big question is whether he can sustain – and even build – on the momentum Davidson has created since taking over leadership of her party seven years ago.

    Davidson’s decision to appoint Carlaw as her deputy was greeted with surprise. She was on a mission to detoxify the Scottish Conservatives, not just rebranding but refocusing the party, and he seemed to epitomise the sort of Tory Davidson was keen to erase from memory.

    A privately educated former chairman of the Young Tories whose stomping ground was the affluent Eastwood constituency south of Glasgow, Carlaw was decidedly old school when compared with his boss. The Tory spin at the time went that Carlaw had a connection with the party’s grassroots that would be invaluable to Davidson, then a johnny-come-lately who’d been in the party just a few years.

    A sceptic might have listened to this version of events then looked at the Scottish Tories’ Holyrood group and concluded that – no offence to Carlaw – Davidson’s decision had been shaped by her lack of choice.

    Carlaw, it turned out, was not quite the old-fashioned right-wing Tory of caricature (though, having been a local newspaper reporter three decades back when Carlaw was chairman of the Eastwood Tories, I would contend that he once filled out that suit very well).

    Surprisingly socially liberal and focusing on issues one might not have expected – the mesh implants scandal being an excellent example – Carlaw might still have looked the part of the ruddy-faced Tory boy, but it turned out he was more in tune with Davidson than had been suspected. One Tory source says that Carlaw had been uncomfortable with his party’s social illiberalism under previous leaders for some time.

    “You might not have looked at Ruth and Jackson and seen very much in common between them,” says one colleague. “In fact, I’m not even sure that Ruth saw it, but it turns out that on the big equality issues like gay marriage, he’s absolutely passionately in favour.” But if Carlaw is a more modern Conservative than a first glance might have suggested, the party’s transformation is far from complete.

    During a debate on inequality at Holyrood last week, Tory MSP Michelle Ballantyne declared “fair” the idea that people on benefits could not simply have as many children as they wished. Ballantyne’s remarks revealed the sort of mean-spirited view of those struggling at the bottom of society that would have been considered too extreme for a 1980s Thatcherite city trader in all his coked-up pomp.

    Carlaw – privately seething about Ballantyne’s remarks (the idea the state could dictate how many kids you’re allowed to have is about as un-Tory as you can get,” one Conservative MSP told me) – was swift to issue a statement in which he described his colleague’s words as clumsy and implied that knuckles had been rapped.

    Beyond Holyrood, Scottish Tory MP Ross Thomson and three others – a third of the Scottish Conservatives at Westminster – have aligned themselves with MP Jacob Rees-Mogg’s right-wing European Research Group, placing themselves at the deeply unappealing No Deal end of the Brexiteer spectrum. With his rising profile, Thomson has the power to seriously tarnish the Davidson brand. He is the sort of Tory loathed by central belt Scots (and I’m sorry, rural Tories, but if you want to win power, you need those voters on board).

    How Carlaw keeps the right of the Scottish Tories in check has yet to be seen, but make no mistake, tensions now exist between the acting leader and a number of those who follow him. Until now, the rise of the Scottish Tories has been greatly aided by the existence of the independence question.

    Yes, Davidson is a skilled politician with a likeable presence but it was her clear opposition to a second referendum that gave the Tories fuel in the most recent Holyrood and Westminster elections.

    The Scottish Conservatives have wrung a lot out of this position, but if the party is serious about winning the next Holyrood election (and this remains, in my opinion, the longest of long shots) it will have to do more than stand against something.

    Davidson’s Tory Party is policy light. We know what they wouldn’t do in power (hold a referendum on independence) but it’s not at all clear what they would do.

    So, an easy few months ahead for Jackson Carlaw. All he has to do is keep in check his party’s Brexit extremists, ensure the half-wits among the Tory ranks at Holyrood don’t speak their minds about anything, and come up with a policy agenda fit to topple Nicola Sturgeon.

    That should be a breeze, shouldn’t it?

    https://www.scotsman.com/news/politics/euan-mccolm-jackson-carlaw-s-turn-to-deal-with-tories-usual-suspects-1-4820778

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  6. Say hello to the vagina gym. Tone your muscles for £2,000

    Oct 27, 2018 | The Times

    By Victoria Woodhall

    Prrrrp! There’s an unmissable thrum between me and the seat beneath me that feels like a cross between a Trimphone and a whoopee cushion. What I’m sitting on has been nicknamed the “Kegel throne” and it’s an electromagnetic chair that could revolutionise everyday life for the millions of British women with issues caused by a weak pelvic floor.

    The Emsella chair, which is new to the UK, is zapping my nether regions with thousands of electric pulses. In one 28-minute session, I’m getting the equivalent of 11,000 pelvic floor contractions. All women are supposed to do these exercises themselves after childbirth, but let’s be honest, who even remembers what day it is when you have a newborn?

    Dr Victoria Manning, who with her colleague Dr…

    Access to full text unavailable – subscription required.

    Story can be found here: https://www.thetimes.co.uk/article/say-hello-to-the-vagina-gym-tone-your-muscles-for2-000-hmkxl8p7v


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