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Study Confirms The More Transvaginal Pelvic Mesh The More Mess

Disintegrating J&J mesh, Sling the Mesh campaign

Mesh Medical Device News Desk, December 12, 2016 ~ A study published in JAMA Surgery confirms the  common adage among the mesh aware community, the more transvaginal  pelvic mesh present in a body, the more likely there will be complications.

The question posed by the study is – What is the association between the amount of synthetic vaginal mesh used with mesh erosion and repeated surgery after POP repair and SUI surgery?  Mesh erosion risk was seen more in patients receiving POP repair surgery with mesh and concurrent slings.

Published in November in JAMA Surgery (Journal of the American Medical Association)  the primary authors are Dr. Bilal Chugtai, MD, Weill Cornell, New York-Presbyterian Hospital, NY; Matthew Barber, Cleveland clinic and Jialin Mao, MD Weill Cornell Medical College, Department of Healthcare Policy and Research.

Based at inpatient and ambulatory surgery centers in New York State, the women had surgery for  POP (pelvic organ prolapse) or SUI (stress urinary incontinence) between January 1, 2008 and December 31, 2012. There was a one-year followup of the 41,604 women involved. The average age was 56.2.

They were divided into four groups: 

POP repair with mesh & a mesh SUI sling

POP repair with mesh and no SUI sling

POP repair without mesh but with SUI sling

Sling for SUI alone

Researchers concluded the combined use of a POP mesh and SUI mesh slings had the highest erosion and repeated intervention risk.  A mesh sling alone had the lowest erosion and complication rate.

They conclude there is a response based on the amount of mesh used for the surgery.

Reiterating what Dr. M. Tom Margolis stated about five years ago at the FDA Expert panel on pelvic mesh, THE MORE MESH, THE MORE MESS.

MAM rally in Charleston, WV in 2015

Researchers here conclude: “There is evidence for a dose-response relationship between the amount of mesh used and subsequent mesh erosions, complications, and invasive repeated intervention.”

Placing a mesh SUI sling at the same time as a POP procedure is probably a combination leading to the highest potential risks.

Dr. Chughtai reports receiving a grant from AUGS for his research, (See it here).

 

Mesh explanted after 3 mo.

Dr. Chughtai and Autoimmune Issues

Dr. Chughtai also submitted a paper to the 2016 AUGS conference – Long Term Systemic Effects of Vaginal Mesh: Seeking the Truth (here).

The objective is whether there is any potential link between the development of autoimmune disorders and synthetic polypropylene mesh repairs using national claims data.

He cites as the source a “consumer website” (Akre, 2014) assuming he means Mesh Medical Device News Desk.

Using the New York State Department of Health Statewide Planning and Research Coopertive Systems (SPAARCS) data, 2,257  women who had mesh placed between January 2008 and December 2009 were  compared to women undergoing routine screen colonoscopy or vaginal hysterectomy (without slings). The average age was 62.2 year.

Autoimmune diseases included Hashimoto’s thyroiditis, pernicious anemia, Grave’s disease, autoimmune hemolytic anemia,  multiple sclerosis, ALS, Guillain-Barre Syndrome, among others, was determined at six month, one year and five years periods. The women were followed through 2014.

Conclusion– Mesh-based surgery was not associated with an increased risk of developing autoimmune disease over the entire followup time period.

Two of the six authors reports financial relationships with Boston Scientific, Astors, Allergan. Dr. Chughtai reports nothing to disclose.

Dr. Chughtai et al may want to check with the informal, autoimmune registry data being gathered by researchers at UCLA. See the link to Mesh News Desk here.  And women, as well as men with hernia mesh, report anecdotal stories of their reaction to pelvic and hernia mesh, both made with polypropylene, on Mesh News Desk (here).

Generally scientific curiosity and the subsequent hypothesis begin with these anecdotal reports. ##

 

 

25 Comments

  1. Still Standing says:

    Congratulations for having a scientific paper that was based on your autoimmune disease focus. That is something. This was a retroactive study, meaning that they did not actively recruit women. They just accessed databases to create the study and control groups. Apparently, the data did not support increased autoimmune disorder with mesh. However, I think further study should look at women who reported complications ( erosion, pain, etc. ) compared to women who had mesh with no reported complications. I think that could be a logical path for research. Can it be that complications trigger a genetic disposition which may not have ever been turned on without the mesh trauma? It will be interesting to see where this leads.

  2. Kitty says:

    Yeh….Dr Margolis …an esteemed Dr …called a quack by some members of AUGS…Vindicated by research. FREE AT LAST free at last thank God I’m free at last

  3. Disgusted says:

    What is this study supposed to prove? I agree that more mesh is probably more mess. But I will also add, it doesn’t conform to my experience. I had a sling for SUI and I have suffered pudendal neuralgia, obturator neuralgia and many other issues. My urethra is “very damaged” as said by Dr. Raz. I believe that part of the reason I am injured like I am is the partial removal. If I would have known to see Dr. Raz first and gotten it all out in that one surgery I think I would have fared better. However, I never heard of him until after the partial removal. The doctor who did the partial removal told me there was nothing else he could do and sent me to pain management and PT. PT made me worse. Thank God I heard about Dr. Raz. Although I was 100% mesh free after seeing Dr. Raz, I still had a small piece work it’s way out of my vaginal wall. If they are trying to infer that slings are safe, I totally disagree. No mesh is better. Thanks for the hard work Jane, much appreciated!!

    • Kitty says:

      I didn’t get that. I got that there was the higher propensity for complication with pop sui etal. You are …let’s say in the 10% and a woman with pop and Sui is…let’s say..20%…just saying. Nothing to back up those numbets. You could very well have more damage than a woman with 2 or more….a woman without complications that is

    • Still Standing says:

      This study didnt prove anything. It did suggest that women who have POP mesh and SUI placed at the same time have the nighest number of mesh erosion and other complications compared to the other three groups plus the control group. Just because a study supports a hypothesis( this one asked what group of the four groups they set up has the highest risk) It did not say that those with SUI mesh only had no problems, but that in the women they studied, women with BOTH products at the SAME time had the most complications. No research can make sweeping generalizations.

      • Kitty says:

        Miralax and chocolate will not cut it. MONICA needs to hear from her attorney. Stress causes vaginal pain

        • Still Standing says:

          Kitty, Monica’s attorney cant wave a magic wand make her vaginal pain go away either. Believe me, I am living proof that getting very large sums of money for mesh injury does not get rid of pain. There are many, many things that contribute to ongoing mesh pain and we cant control many of them. Yet, there ARE things that we can do to decrease our suffering from this pain. Actually, vaginal pain due to stress is one of them. Pain from constipation is another. I really dont understand why you criticize my efforts to give positive affirmations to women who are in pain. We have all been terribly damaged by mesh. I just believe that tackling our pain from every angle is the most productive and most empowering way to live our lives as survivors, not victims. I could send you literally hundreds of articles that address the emotional and physical components of pain and how holistically adressing each and every aspect of pain can make a difference. No, it will not make the pain go away, but, taking control of the things that we can is vital if we want to have better days. Money cannot do this for us. We have to be proactive in our daily self-care. Negativitity really doesnt help.

  4. JB says:

    The hell suffered through these implantation surgeries; subsequent surgery to repair what they screwed up with 2 types of mesh implanted; who in the h_ll would let ANYONE open up their abdomen again? No on your life! Still trying to live, survive with this messed up body full of mesh.

    • Kitty says:

      Yeh…some times it
      is better to Leave well enough alone. What puzzles me is the tiers….why would a company pay more for the Incompenency of an explanting surgeon who has reached “Peters Principle”…. (level of incompetence)

      pnysician

  5. ANNA M says:

    Dear MeshDesk Editor,
    Still awaiting my TVT Mesh Settlement
    Have been informed from my attorney’s office that J&J has settled and awaiting a settlement from Biotech …
    My concern is that i need a Mesh Loan against my settlement amount…a small loan…and i need a full explanation as to why it isn’t allowed? Or maybe now, it is allowed…
    This nightmare TVT Mesh horror as not only affected my health, live in general, but also, my work …not the income i need to pay my committments as before…
    What can i do to get a TVT Mesh loan against my ‘settlement’ that is in progress?
    thank you for reply
    Anna M.

    • Jane Akre says:

      The common wisdom is if you can avoid taking a loan, avoid it. can you borrow from family since you have a settlement in the works? Do you even have any idea how much your settlement is? They have been pretty disappointing. If you could do a small loan where it is all spelled out to you in writing, that’s preferable over 39%….Check Mark Bello, who did a story on MND…. he loans small amounts only. He is a friend….

      https://www.meshmedicaldevicenewsdesk.com/lawsuit-financing-what-you-need-to-know-before-you-borrow/

    • Still Standing says:

      Anna, your attorney has to approve any settlement loan you get. They should have an idea of how much your settlement will be. For them, it is another lien on your settlement award, which will further reduce your amount. It wont change their take since they get their percentage off the top. But then you will have 25% of the total gross amount held back to pay liens and you could wait a year to have those funds released. You will probably have other liens against the money ( health insurers, medicare, medicaid, etc) and they have to take that into consideration. How much interest will you have to pay on the borrowed amount if the settlement draws out for a year? Then, there will be additional case costs deducted from your 60% as well. So, this may have confused you more, but the bottom line is that your attorney has to approve your loan. They are the only ones who can advise you on this but there are real reasons they might not approve your lawsuit borrowing.

    • Kitty says:

      You no doubt feel like a shameful crook looking for money…Begging like a street walker while taking narcotics for twisted mesh contractions. They are steady now.
      .but no baby for us

  6. Deborah S says:

    I have just spent my entire day in tears. I am so absolutely floored that my life (as I knew it) is worth a total of $22,000 to Coloplast. This just makes me want to die. What a freakin’ joke. I don’t even think I will sign the damn papers. Sure wish someone would take me seriously. I am just done……….

    • Jane Akre says:

      Of course you life is worth far more than that.. Can you ask your law firm to have it renegotiated? Do they have ALL of your medical records? You can always say no to any settlement, that is your option, if you have a reason to believe your case is worth much more, which of course it is. How much is health worth? I’m sorry.

      • Still Standing says:

        Im guessing that the law firms dont negotiate each individual case. They come to a deal about what the tiers are and how much is awarded within these for their clients. If the individual case could be renegotiated, just know that you will have to pay for those additional hours and any additional case costs out of your amount, whether or not that amount goes up.

  7. Kitty says:

    As far as loan is concermed…what skin is it off attorney’s back if u take one?. The skin is off your back . I think the interest is high.

  8. Kitty says:

    Jane…I was just reading some of previous posts
    We are on the subject of competence and tiers. I guess I have to agree with u on AUGS. If a woman hadn’t gone to an incompetent explanter.
    And gonet to…let’s say M&M…she would not have had so many surgeries..thus putting her in lower tier. Less $$ BUT..then she develops nerve damage anyway..TOO bad..Tier one for u girlie HA…these boots were made for walking

    • Jane Akre says:

      The entire premise of settlement based on number of injuries is a flawed one, in my estimation since some women cannot afford surgery. Is she less injured than a woman who has insurance and finances to afford a dozen surgeries? No of course not. So as labor intensive as it is, these cases should probably be gauged on an individual basis, in my opinion.

      • Still Standing says:

        Well, another way to look at it is that settlements do NOT award anything for punitive damages, only a calculated compensation for actual damages. A woman who has had many surgeries probably has spent more actual money on bills or lost wages. That is probably one reason behind the tiers. They look at women with one surgery and come up with an algorithm of potential actualpersonal costs and do this for each level. Women on the high end with 5+ surgeries theoretically get screwed as well because they have more out of pocket actual expenses, but they have mostly been lumped in with 4+ surgeries. Remember, they are not compensating for loss of quality of life or other intangible or hard to measure issues. And they are not admitting to any of the accusations. It is strictly a financial deal that is influenced not by corporate compassion, but a computer financial model. Sad, but true. None of us will every be compensated in a fair way because our idea of fair is not what the corporations view as fair. This system really needs to be changed, not just for mesh women, but for all of those who have fallen in the black hole of medical device litigation.

  9. Monica says:

    It’s been almost 4 years and I haven’t heard a thing about when it will settle or for how much it will settle for, I’ve had to quit my job because I’m in pain all the time and my doctor has basically told me there isn’t anything else he can do. I don’t think this will ever end. I think we’re all being lead on like sheep and frankly, I’m just tired of it all.

    • Jane Akre says:

      Monica- Do you have a doctor who can help you? There may be some avenues for you to find some relief….Just because your doc can’t do anything else doesn’t mean there aren’t others… Everyone here will be able to help supply names if you tell us where you live and if you have insurance? Thanks so much…. and I”m sorry. you can write me janeakre@meshnewsdesk.com

    • Still Standing says:

      Monica, if you are in high pain all of the time, then your doctor has not done all he/she can do. For me, eight years and 7 surgeries out, I will be honest and tell you that I know I will never be out of pain. However, there is a level of pain that I can live with ( not the pain level I WANT, which is of course zero). My doctor and I work on maintaining this level on a consistent level. It is an opioid free approach, but that is because he steered me away from that and I agreed with his recommendation. There are medications I take for muscle spasms and neuropathic pain, but there are also things I do daily that help. Rest, good nutrition( low sugar, dairy) and sleep are the things that help me the most. Take away those things and my pain goes way up. I’m my own worst enemy when it comes to overdoing, especially this time of the year. Last night I was turning to my heat and ice therapy and I will have to pull it out more over the next week for sure. I just want to encourage you to have an honest conversation with your physician about your pain and do not let him/her brush it off. It is important and they have an ethical responsibility to address pain. Also, start identifying small changes in your days that could help reduce your experience of pain. Sleep allows your pelvic muscles to relax, which is so important. Eating high sugar and dairy increases inflammation, which causes pain ( this is not easy and dont beat yourself up when you turn to comfort foods. I just polished off my granddaughters largechocolate Santa. It is family tradition that a chocolate Santa is in the toes of the stockings. Luckily, I forsaw my weakness and bought more Santas than I needed, ha) Resting is paying attention to your body’s needs and choosing good self-care. One major pain generator for mesh women is constipation. Do wht you need to do to stay regular. I take magnesium, miralax and benefiber every night and it makes such a huge difference. Ive posted many other suggestions here over time and while each one of us finds relief in different ways, it is important to realize that there are some things that we can control. Even small changes in pain can make the day better. At the end of it all, you may still have pain, but determining what level of pain allows you to still move through your day gives you some power over it and that power can have a physical and psychological impact. I am hoping that you can find your way to less painful days. It isnt easy, but it is possible.

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