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A Scottish Health Board Votes to Suspend Sales of Transvaginal Mesh Implants

Elains Holmes testifies

Elains Holmes testifies

After an effective campaign where women spoke directly to a Scottish Parliamentary Committee, a Scottish Health Board has decided to ban the use of transvaginal mesh implants used as a treatment for pelvic organ prolapse.

This is the first board to suspend the plastic mesh implants reports the Sunday Mail’s reporter Marion Scott here.

The board’s medical director has called for a halt to the use of polypropylene transvaginal mesh as a treatment for prolapse and has called for a review of surgical “tape” or TVT (transvaginal tape) used to treat stress incontinence.

Dumfries & Galloway is the first board to make that decision.  NHS (National Health Service) serves a population of 148,190 inside a 2,400 square mile area says its website here.   In Scotland the publicly funded healthcare system the NHS is overseen by the Cabinet Secretary of Health and Well-being who is currently Alex Neil.  There are 14 geographically-based NHS Boards in Scotland.

Marion Scott, reporter Sunday Mail

Marion Scott, reporter Sunday Mail

Last week women told their stories of pain and permanent injuries.  (background story is here). You can watch the link to the hearing here. 

Marion Scott, a reporter for the Sunday Mail, has run  a fearless series of reports on the victims of transvaginal mesh and her front page stories have gathered attention to the health crisis.

As many as 30 percent of women who are implanted with transvaginal mesh suffer chronic pain, infections, mesh migration and perforation of organs, nerve damage and a host of other complications. The U.S. mesh manufacturers are facing about 70,000 lawsuits in the U.S. where the majority of transvaginal meshes  remains on the market.

The Scottish women women had petitioned the government (here) asking for a registry of mesh injuries and asking that the procedures be suspended until questions can be answered and improved safety consent forms can be written so women have a complete understanding of the complications that potentially accompany the use of transvaginal tape.

They also requested that doctors be required to report adverse events instead of the voluntary system that exists in Scotland, similar to what occurs in the U.S.

Dr. Angus Cameron, the board’s medical director, tells the paper “It is obvious from national and international studies that the rate of long-term severe complications is relatively high and we feel that the benefit/risk ratio that is now apparent does not support the use of meshes.”

Health Secretary Alex Neil will not mandate sales of transvaginal tape be suspended because of concerns of lawsuits by manufacturers.  He will explain before a Public Petitions Committee on Tuesday.

Scottish Mesh Survivors Karen Neil says “this is the breakthrough we have been waiting for.”

See their Facebook group here.

Adam Slater, Mazie Slater Katz Freeman

Adam Slater, Mazie Slater Katz Freeman

 

Attorney Adam Slater, who represented Ethicon mesh victim Linda Gross a who was awarded an $11.1 million by a New Jersey jury last year, says he wants to go to Scotland at his own expense and present evidence to the Scottish Parliament.

Slater said: “In the course of investigating mesh cases over the past six years, I have amassed new evidence which I believe has not been made available and will be unknown by those presenting testimony to the committee.”

He believes mesh complications are much larger than what has been reported in the States and elsewhere. He told the paper he has documentation showing mesh makers paid for the non-reporting of complications by the inventor of transvaginal tape.

Slater says the mesh manufacturers continue to influence professional organizations such as the American Urogynecologic Society (AUGS) and the American College of Obstetricians and Gynecologists (ACOG) through financial conflicts of interest.

In the U.S. the FDA has opened up a 90 day period for public comment reclassifying transvaginal mesh for pelvic organ prolapse as “high-risk” requiring studies and clinical trials to assure safety before it can be sold. Critics say the mesh makers understand their products will not survive clinical trials and that will end any innovation.

The comment period and reclassification does not include transvaginal “tape” used to treat stress urinary incontinence.#

 

19 Comments

  1. Carmel Berry says:

    Fantastic coverage of a brave battle. Heros!

  2. stopmeshimplants says:

    Perhaps their suffering and hard fought battle to bring all this information to light will help us in some small way. It is mind boggling to think that no government officials in this country cares enough to stop this mesh madness. Thank you for sharing this!

  3. msm says:

    A shining example of a country ahead of the USA in caring for the health AND ”Well-being” of its citizens. Mandatory reporting is a no-brainer unless device manufacturers have influence over that policy which they apparently do in the USA. If true, Mr. Slater has evidence of deeply rooted CRIMINAL activities. There should be a Congressional hearing on this. A hearing was held for GMs neglect so why not all of the mesh manufacturers. If one is guilty, then everyone of them that used 501(k) to get their product cleared is guilty as well. Hats off to Scots and to Mr. Slater.

    • pam says:

      I have beg and pleaded with senators, congressmen, governors, reps and more in the state of Tennessee to do something, and all they do is NOTHING. I said I have been lied on lied to and I am sick of what I have gone through, read records where the truth was not told, and lied saying I was not to be seen again, PURE HELL, because in Tennessee and I am sure most states follow colleagues and lies and cover up. Medical runs Tennessee. If slater say he does not stand on lies of those in law like his colleagues have done, it would shock me, because they too have had their part in women and men suffering with mesh. A TRUE TRUTHFUL AND HONEST PERSON THAT DOES THE BEST OF THEIR ABILITY TO THEIR PROFESSION, i am sure would also learn what is like to be put through hell by their own colleagues, BUT THOSE THAT DO GET THE REPUTATION OF 1 THAT EARNS CLIENTS , PATIENTS AS 1 OF AMERICA’S BEST TOO MANY LIE AND COVER UP, FOR FAVORS OF MONEY AND GREEDY, . I call it blood money, gotten from those evil for greed of power and money that would do this and those in power that do nothing are just as guility, but states also won’t to take blood money from people that have suffered and will die from those that did this, women suffering for years because a sorry scum doctor thought it funny and lied to them that say they can get by with murder knowing those in power have them covered in lies. HOW LITTLE 11, 000 MILLION OF ALL THE ONES AND POWER AND MEDICAL, AND INVESTORS, AND POLITICAL LEADERS THAT GOT RICH AND NO CONSCIOUS TO KNOWING IT WAS NOT FIT TO BE PUT IN HUMANS , THAT IS AS DIRTY AS ANY ONE IN BIG BUSINESS, , POWER, LEADERSHIP TO DO NOTHING. AS HAS BEEN DONE IN THE USA. PUTTING MORE PAIN AND SUFFERING ON WOMEN , LYING, AND PROVOKING WOMEN SUFFERING TO ANGER,

      i hope other countries follow what scotland has done, banning mesh, it should have been done first in america, but news media and leaders with FDA , stopped any info to be told in truth, THIS IS NOT LIVING , NOT KNOWING 1 DAY TO ANOTHER , WHAT WILL BE NEXT, BUT FOR THOSE BEFORE MINE, THEY KNOW HOW LONG WOMEN HAVE LIVED BET ON IT!

  4. msm says:

    Interesting FYI:

    no ICD-9 Code existed for mesh complications until 2011. How long after that update was it used by the majority of practitioners and institutions? I had one procedure coded as removal of a foreign body. I can’t imagine what diagnosis code they used! It was all done by a coder with no formal medical training who reads the notes and uses the first code that might suffice to receive the max reimbursement. I’m going back and looking at the last five years of coding for treatment of my mesh complications. If coding was done correctly, it would be easy to compile stats on complications without MAUDE system which has never worked and never will.

    • Jane Akre says:

      MSM- Please explain further the ICD-9 code… is that the medical billing designation for mesh? Would it be the same for all meshes and all facilities? What can people look for on their own medical bills? ~ Thank you.

      • charles says:

        Jane what she ks saying about icd coding is that the fed gov assigns a code to all procedures to facillitate reimbursment to doctors and hospitals. The thing is to match a code to a procedure that wont be denied by the fed so any code that is liklynto not be denied can be used . Ususally it is a person called a mds coder. Generally there will be several codes that will fit any diagnosis so a good mds coder will know which codes to assign to recieve maximum reimbursment. But there can be so much ambiguity. For example , the code for foreign body removal may be different from mesh removal , so the surgeon who know he has a legal problem looming can tell his coders to use codes that have nothing to do with mesh but will accomplish the same objective

      • msm says:

        I am not a coder, but I have fought my insurance company and hospitals over many coding errors over the years.

        Here are some of the CPT codes you might see. The first 2 are the ones that are supposed to be used starting 10/2011 according to the following update:

        http://www.augs.org/p/cm/ld/fid=83

        **62931 Erosion of implanted vaginal mesh and other prosthetic materials to surrounding organ or tissue

        **62932 Exposure of implanted vaginal mesh and other prosthetic materials into vagina

        99630 Mechanical complication of unspecified genitourinary device, implant, and graft

        99639 Other mechanical complication of genitourinary device, implant, and graft

        99665 Infection and inflammatory reaction due to other genitourinary device, implant, and graft

        99676 Other complications due to genitourinary device, implant, and graft

        E8782 Surgical operation with anastomosis, bypass, or graft, with natural or artificial tissues used as implant causing abnormal patient reaction, or later complication, without mention of misadventure at time of operation

        ————–

        Here are some of the ICD-9 codes you might see:

        7050 Repair of cystocele and rectocele

        7051 Repair of cystocele

        7052 Repair of rectocele

        7053 Repair of cystocele and rectocele with graft or prosthesis

        7054 Repair of cystocele with graft or prosthesis

        7055 Repair of rectocele with graft or prosthesis

        7061 Vaginal construction

        7062 Vaginal reconstruction

        7063 Vaginal construction with graft or prosthesis

        7064 Vaginal reconstruction with graft or prosthesis

        7078 Vaginal suspension and fixation with graft or prosthesis

        7079 Other repair of vagina

        7091 Other operations on vagina

        7095 Insertion of synthetic graft or prosthesis

        7179 Other repair of vulva and perineum

        718 Other operations on vulva

        719 Other operations on female genital organs

        9823 Removal of foreign body from vulva without incision

        5759 Open excision or destruction of other lesion or tissue of bladder

        5781 Suture of laceration of bladder

        5789 Other repair of bladder

        Notice there is no diagnostic code for repair of a complication of graft or prosthesis.

        • msm says:

          Also:

          With the advent of electronic health records (EHR’s), patients aren’t receiving “charge sheets” showing the codes when they check out from an appointment. I have needed these sheets almost everytime I have had to dispute a bill. SOOOO… not matter how mad they get, do not leave an appointment without a printout of the services provided and the specific codes used!!!!

        • msm says:

          HOWEVER*** (I’m getting way off the original topic. Sorry)

          AMS says on their website to use the following:

          “CPT 57288(Sling operation for stress incontinence, e.g., fascia or synthetic) is the most commonly billed code for use with the AMS sling systems. If a revision or removal of the sling is performed, it would be appropriate to use CPT 57287(Removal or revision of sling for stress incontinence, e.g., fascia or synthetic).”

          americanmedicalsystems.com/DAM_public/2013-FAQ-Female-Sling-Systems-AMSUS_HCA-00527.pdf

          So, does this mean that the code for “removal or revision” (57287) could be used in place of the code for erosion/extrusion (62931, 62932) thus skewing statistics? Again, I’m not a coder so someone else might have more insight.

          • charles says:

            It means the codes are all a giant labyrinth to expose or hide anything or claim ” i didnt know” the doctors or hospitals know exactly when and how to be truthful and/or vauge according to the circumstance . The best we can hope for is a judge who knows the medical and legal terminology game and will call the mesh makers to task. The mesh will continue to deteriorate and cause multiple problems in at least 30 to 40 % of people with susceptible immune systems. I would love to see a definitive diagnostic blood and tissue test developed to detect byproducts of polypropolenne. Definitive proof will be required to combat endless vauge excuses from endless talking heads . In more simplistic terms any dam fool should know not to put unsterile plastic inside your body. How can mesh be implanted thrugh the vagina sterilly? Vaginal bacteria will be introduced into sterile pelvic cavity and grow uninhibited thus why so much ecoli and bladder bacteria shows up in cultures from cysts and fistulas

  5. All Meshed Up says:

    I notice that the article points out Polypropylene. I would hope that our Government would take notice of that and take a serious look at PP as a dangerous implant product no matter which mesh. But I doubt it very seriously that they will. After all this time with as much information available and given to the FDA, the possibility that they will do anything substantial is very remote, given their past history with Hernia Mesh.

    As far as billing codes go, I believe that an investigation will reveal that the Medical community has been hiding the exact nature and reason for removals with these codes. They did with my removal by coding it as a foreign body removal because of rejection. Which then bares the question as to why then implant another mesh product? But the Dr. did do just that………

  6. Aaron Leigh says:

    Great news! Please remember how #LindaBatiste and her bravery here in Texas contributed to the worldwide success we are all making. We are one community and we are making so much progress! Congrats to our Scottish Survivors and their Families! AMAZING! http://www.dailyrecord.co.uk/news/scottish-news/campaigners-renew-calls-end-mesh-3408119#.U58bSA52bGF.facebook

  7. msm says:

    Amen, Charles. If this wasn’t expected to become more of a problem, why would the new ICD-10 codes to be used by the World Health Organization list these 6 codes instead of the current 2 codes:

    T83711A Erosion of implanted vaginal mesh and other prosthetic materials to surrounding organ or tissue, initial encounter

    T83711D Erosion of implanted vaginal mesh and other prosthetic materials to surrounding organ or tissue, subsequent encounter

    T83711S Erosion of implanted vaginal mesh and other prosthetic materials to surrounding organ or tissue, sequela

    T83721A Exposure of implanted vaginal mesh and other prosthetic materials into vagina, initial encounter

    T83721D Exposure of implanted vaginal mesh and other prosthetic materials into vagina, subsequent encounter

    T83721S Exposure of implanted vaginal mesh and other prosthetic materials into vagina, sequela

    I definitely agree with your statements concerning infection as I will see an GYN infectious disease specialist in a few days to determine the extent, strain, and treatment of the infection. If all of it can’t be removed, the infection lives on affecting every hour of every day. If she doesn’t have an answer, I don’t know how I will continue to hold out hope and live like this.

  8. pam says:

    I ‘D LIKE TO HEAR FROM THOSE FROM OTHER STATES THAT HAVE ALSO CALLED LEADERS IN THIER STATES AND GOT NO WHERE . SURELY MORE HAVE MADE CALLS, more than me, to their stat leaders, that would not do anything.

    I have called health boards and more.

    • Kitty says:

      Hello all and especially those J&J mesh victims. was just listening to a news program about the IRS e mails that have been deleted and several I T specialists–including Charles Krauthammer insist that E mails cannot be completely deleted. There are back up systems and back up systems with Back ups. The I T specialists say that No file can ever ever be totally deleted. There is something sinister and someone must get to the bottom of it Wasn’t this given to Eric Holder Is he doing something about this?

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