TOT Has Twice the Risk of Re-Operation of Transvaginal Tape

//TOT Has Twice the Risk of Re-Operation of Transvaginal Tape

TOT Has Twice the Risk of Re-Operation of Transvaginal Tape

Harvard Patient Education

Mesh Medical Device News Desk, January 11, 2017 ~ Transobturator tape used to treat incontinence, has twice the risk of re-operation as transvaginal tape, according to Danish researchers. 

Danish researchers find that the risk of a re-operation with a TOT or transobturator tape was twice the risk in that country when compared to transvaginal tape (TVT).

TOT mesh was introduced in Denmark in 2003 and two years earlier in the U.S.

Both TOT and TVT are also called “tape” are are made of polypropylene, affixed to support the urethra as a treatment for incontinence. The TVT tape ends exit in the abdomen while the TVT-O passes through the obturator foramen and exits through the groin.

The TVT-O has been found to be defectively designed in at least two pelvic mesh trials..

Both meshes are a permanent implant, despite what a woman maybe told by her doctor when she expresses reservations.

 

THE DANISH STUDY

Transobturator mesh, from Scottish Pelvic Floor Network

A population-based study was presented last year at the International Continence Society in Montreal, (Foss Hansen M, Lose G, Kesmodel US, et al. Reoperation for urinary incontinence: a nationwide cohort study, 1998–2007. Am J Obstet Gynecol 2016;214:263.e1-8.)

In this Danish study, a total of 8,671 women who were enrolled in the Danish National Patient Registry, were included who had undergone surgery to treat urinary incontinence between 1998 through 2007, with no prior incontinence surgeries. Among the initial group, 888 women were re-operated on within five years, making the rate of re-operation 10.2%.

Researchers were trying to determine the rates of re-operation within five years of various surgeries for stress urinary incontinence.  Other types of surgery, besides TVT or TOT, include urethral injection therapy and Burch colposuspension.

The median time for the re-operations was one-year for sling surgery, two years for a Burch colposuspension and six-months for urethral injection surgery.  Most re-operations occurred before the two-year mark after initial implant.

Factors such as body mass, severity of symptoms and skill of the surgeon were not analyzed. The study does not specify the definition of re-operation, that is, whether it was for pain, mesh removal, or to treat incontinence.

Aaron Horton and Linda Batiste, her TVT-O trial determined product was was defectively designed

The transvaginal tape obturator (TVT-O) has been shown to be defectively designed in at least two product liability trials.

And still it remains on the market.

A study previously published (Cochrane Database Syst Review October 2009 and July 2015) found no significant difference between a TVT or TOT but was a small patient base of 7,476 women and lasted for one-year post-implant.

The Danish researcher, Dr. Foss Hansen, MD, suggests ideally more data should be derived from randomized, controlled trials.

Since TOT mesh was marketed by manufacturers such as Boston Scientific, Johnson & Johnson, and C.R. Bard, thousands of product liability cases have been filed against seven pelvic mesh manufacturers who who were not required to do long-term studies before marketing their products.

This study is notable because it is one of the few on the TOT surgery and it is considered long-term. Most mesh studies are short term, 12-months or less. ###

By | 2017-01-16T13:04:14+00:00 January 11th, 2017|News|30 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

30 Comments

  1. Kitty January 11, 2017 at 2:34 pm - Reply

    I remember the day that Aron braced Linda who seemed so alone and humiliated

  2. Joleen Chambers January 14, 2017 at 6:25 am - Reply

    Linda Batiste died 8/2015. The $1.2M verdict was appealed. Her heirs settled. This is not justice: the decision of the jury was not observed. http://mobile.reuters.com/article/idUSL2N18K1VD

  3. Stopmeshimplants January 16, 2017 at 4:23 am - Reply

    It might be helpful to list products that are TOT’s and which are TVT’s. I know that the Monarc TOT sling, made by AMS, is the one I had implanted in my body. Many women are still learning which implants they have and are trying to understand what is happening to their bodies. Because these manufacturers, doctors and nurses complicate things by saying tape instead of mesh women think they are safe and nothing will happen to them after surgery. It was years before my complications occurred and no one would use the word mesh when my pain began. It was only after going to three other Urogyneocologist that I learned the truth. Thank you Jane for the information in this study.

    • Jane Akre January 16, 2017 at 7:17 am - Reply

      Excellent idea, thank you Stop.

  4. jade January 16, 2017 at 6:56 am - Reply

    I’d like to know “Where is Your Implanting Doctor NOW?” It would be interesting to track IF these “jump-on-the-wagon” doctors back in 2009 so eager to implant without any testing are still doing as well as they were back then. Let’s share any info we have, so we can determine how these doctors survived the negative press and where they are now! Dr. Jim Ross – “those sheep are expensive”; Dr. Goldstein of BSC; Dr. Patrick J. Culligan “mesh-monger” & “Expert Witness” for BSC???? Let’s put out a report on where they are NOW and how this affected their life and careers.

    • Jane Akre January 16, 2017 at 7:16 am - Reply

      Wow Jade, excellent idea….. do they still use mesh? I’ve heard some have backed away because of litigation and fear they will be brought into a med mal in state court. They slam the lawyers and some of you do too. Why do you think some docs stopped doing mesh if not for the fear of litigation?

      • Still Standing January 16, 2017 at 6:24 pm - Reply

        My implanting doctor retired early about two years after my implant. She was a preceptor for the manufacturer yet she swore she had no other patients who had complications. She refused to do a deposition and had to be subpoenaed and attornies had to fly to LA for the deposition. This woman who had been my trusted physician for a decade totally threw me under the bus, even though her words to me were that I was so healthy she would just do the posterior and anterior at the same time. How convenient. I would not cross the street to spit on her shoes.

        • jade January 17, 2017 at 7:50 am - Reply

          I understand your anger, as I too, feel the same. Even IF I were to get a million dollars, I would still want my doctor to be at the least apologize and at the most be punished for what he did to me and my family! But I do believe that most of the doctors just employed a “cut and run” philosophy and laid low until the storm passed??? I’m a spiritual person and I know this is where “forgiveness” come in, but as my doctor never even admitted his wrong doing, how do I begin? I just feel all of these doctors should NOT be allowed to just continue on with their lives unless they make restitution to their victims and pay for their crime.

          • Jane Akre January 17, 2017 at 9:20 am

            If any of you happen to have that conversation with your implanting docs, can you get back to me…. I’d love to hear how they feel today… thank you.

          • Kitty January 17, 2017 at 12:33 pm

            Hi Jade. Was thinking about u recently. …your art work og the tortured woma. It is so fitting without any vulgarity. Most recently there I’d a group of wome. That are stating a womens
            Ovement to promote ewuit and their icon is a woma.s torso with the VJJ shaded. I found it Vulgar

          • jade January 18, 2017 at 7:14 am

            Thank you, Kitty. What I draw is what I feel should be communicated – honestly.This tragic and horrific implantation encompassed MORE than just our torso or pelvis – it screams for relief and justice. I’d like to make a listing of all known implanting doctors – so, let’s begin here and then we can move forward. Jane, possibly we can do a story/bios on each of them – some will come out in the public eye better than others – but ALL will be exposed. This could be a good documentary, but we need the funding as always.

          • Kitty January 19, 2017 at 7:03 pm

            You cannot forgive someone who has not apologized……but u can move on. We are all trying to move on and hopefully we will when justice is served

  5. Still Standing January 18, 2017 at 2:18 pm - Reply

    Other than personal revenge, what good will come out of doing a hit piece on every implanting doctor? I imagine that many of them have changed their views about mesh as scientific evidence has come out. Most of them have distanced themselves from transvaginal mesh. Perhaps some have not. Who is going to check the facts on every doctor and who is going to fact check the bios for accuracy and what they currently believe? Hopefully , some doctors read this website to try to see the patient side, to develop a bettering understanding and empathy toward the mesh women they treat. How willing will they be to do this if they come here and see names published with no specific reason. If you went to the ACOG website and someone posted a list of every woman with mesh who had filed a lawsuit with labels such incompetent, uneducated, a smoker or overweight or sedentary or whatever reason they could think of, would you continue to read that site? We have to remember that the medical community is where our best chance of figuring out what to do for mesh complications lies. This should become a meeting of the minds, a coming together to find the best solutions. Not going to happen if we get mired in the mud.

    • Jane Akre January 20, 2017 at 3:14 am - Reply

      On the issue of doctors, I have mentioned the names of implanting doctors in the context of a trial and I feel that is the proper context for Mesh News Desk as a publisher.

  6. jade January 19, 2017 at 7:13 am - Reply

    It’s never going to come together with these doctors – like Adam Slater said the ONLY way they will listen is if you hit them where it hurts – their pocketbooks and in the case of these docs – their egos. I do appreciate your sentiment, but these, what I consider, “criminal” docs did implants for the money and fame. They ignored the “patient” side then, and will ignore you NOW! Not one of them will EVER “come together” with us without pressure because they are guilty of a crime and they know it! These players MUST be exposed and brought to trial in the eyes of the public for what they are. That is what they fear most. That is “why” most of them have either retired or “cut and run”. Getting together, holding hands and singing kumbaya sounds great – but it is a fantasy! Doesn’t it enrage you that most of us are getting through our lives on expensive drugs which do not cure the problems we are having; becoming immobile because it hurts too much to move; losing our families and friends because they have grown tired and frustrated?? While these docs are making money as usual; going out to dinners; enjoying their families riding around in limos – and, engaged in conversations with close colleagues about how “they got away with it” because most of the settled cases had joined them on the Plaintiff’s lawsuit – so, when the manufacturer settled it just went away for them?

    • Still Standing January 19, 2017 at 2:05 pm - Reply

      I have done much work advocating for pain policy changes on the government level, working to educate people who live with pain about being the best they can be despite pain, much as a volunteer. I have been putting in place a way to fund the critical medical needs of mesh injured women. It is planned even past my death. My children know how important this legacy is to me. Mesh women, however have to do what they can right now to stay as functional as possible. It is not easy. We need to physically move around (yes it hurts) we need to eat right a good bit of the time, we need to develop an emotional resiliency. In the end, we arent the only people who have been hurt in life. We must bend, but not break. I spent more than 20 years walking with hundreds of hospice patients through their final days of life. Maybe that is why I have a different perspective than yours. I dont remember hearing one dying person say that life was unfair. I watched children, teens, young mothers and fathers , young and old, face death with courage and grace even though they had such tremendous physical and emotional pain.

      So, here are my questions for you. Are the quotes you have attributed to physicians real quotes.? Did you actually hear doctors say these things? How many physicians do you see running around town in limos. This is the trouble throwing stuff out on the internet that is conjecture. It just stays out there, forever, no matter if it is true or partly true or completely false.

      We all must cope with this tragedy in our lives in our own way. If this is the stand that you think will make you feel better and Jane is willing to put her journalism credentials on the line, have at it. But, please, do not infer in any way that how I have intentionally chosen a life with purpose in spite of all of this is inferior to choosing to react with anger and hate.

      • Stopmeshimplants January 20, 2017 at 4:35 am - Reply

        I remember his words exactly. And my husband was there to validate my physician’s comments. I also remember asking how long the implant would last and he said 5-10 years. When asked what we would do next after that time period he said whatever the next latest and greatest fix was at the time. Yes, I was stupid for going ahead with the surgery after hearing his responses. I neglected to ask all of these questions until I was being prepped for surgery just before I was given the medications. I did not want to postpone the surgery because so many people had gone to so much work for me. Biggest, most regrettable action of my life.

    • Jane Akre January 20, 2017 at 3:33 am - Reply

      Jade, physicians I’ve known don’t ride in limousines, they drive family cars like you and I …. and I’ve not heard anyone say how they “got away with it…” Making them part of a grand conspiracy may not apply to all doctors, in fact, I think some have come to realize that they were “sold” on a procedure and product to their and their patient’s detriment. That realization is way too slow in coming but among some doctors, it is there, from what I got out of attending AUGS. Please be careful in painting with too broad a brush here… just because you are a member of AUGS doesn’t make you a bad doctor.

      • Kitty January 21, 2017 at 6:06 am - Reply

        Jade. I wish you could go to DC with your logo. I am unable to get there today. I wish we could be there. I do have family there for future reference..so we would have help getting places and have a place to stay. It is expensive.

    • Kitty January 23, 2017 at 7:11 pm - Reply

      Yes even to.say to an ignorant woman…”mesh?….what mesh?….it’s gone. I

  7. jade January 19, 2017 at 7:25 am - Reply

    http://www.augs.org/p/cm/ld/fid=549

    Here we go: Let’s start with this list of doctors – obviously, most of us know quite well some of these names and are able to contribute info on where they are today?

    • Kitty January 20, 2017 at 11:58 am - Reply

      It is very helpful to potential patients…for example friends get together and tell horror stories of bad back hip or knee surgeries gone bad. But Jane…I understand if u don’t want names. I

  8. Kitty January 19, 2017 at 7:11 pm - Reply

    Naming names could be a way to move on..but then we jeopardize our ability to obtain justice. The names will come out slowly..one by one
    SS has given us a name..although it’s only a first name.

    • Jane Akre January 20, 2017 at 3:10 am - Reply

      You all know when there is a trial and the implanting doctor is named, MND reports on it. I feel more comfortable naming names in that context.

      • Kitty January 20, 2017 at 11:53 am - Reply

        You have been able to recently mention “Nancy” ….your implanting g MD and tell us of her unforgiveable behavior……because u are moving on. Some of us have not received justice and are unable to move on and give names and examples their behavior toward us.

  9. jade January 21, 2017 at 10:34 am - Reply

    There will be no justice unless it is bravely sought after by victims. Time may pass without discovery and the guilty will hide behind it. This passage will fog their recollection of their crimes and be rationalized in own mind. In order for any healing to take place for the victims, the puppet doctors of mesh manufacturers need be exposed. I for one refuse to believe that they did NOT know what they were doing. They knew it and, now, most of them want to believe that they got away with murder, literally.
    Michael_Hayssus
    “You can run and you can hide, but you can never get away from your conscience, it will find you when you are most vulnerable and slowly consume you from the inside out.”

    If you believe this sentiment, we’d be doing these docs a favor by exposing who they are!

  10. Lynne D January 2, 2018 at 4:24 am - Reply

    Culligan the “mesh monger” . OMG he is my uro gyn. I’m bringing my pad and showing him his rep!

  11. Lynne D January 2, 2018 at 4:27 am - Reply

    He didn’t implant but is treating my rare bacteria aeroccus urinae (bladder). Offers me Premarin to enhance good bacteria. Aye! Quack, Premarin is a famale hormone for menopause. Wants to know if I want it in the ring or cream?….

    • Jane Akre January 2, 2018 at 11:59 am - Reply

      Lynne- I’m about to announce a new partnership that may help your infection. It is d-mannose by Superior Labs… you can purchase it on Amazon and have it shipped to you. Put in code SUP0DMAN (that all caps s-u-p-zero-d-m-a-n) and the price drops! This is the only sale Superior Labs offers and its thru MND! I’m about to announce it but please, d-mannose is a sugar that does not allow bacteria to lodge on in the urethra/bladder…. very effective. Please try it… we need to get the word out because it may be the solution. Certainly it is an alternative to antibiotic use. Go to Amazon.com and set up your account, which including your shipping address and credit card to pay. Price drops to $19.51 from nearly $23.!!! SUPERIOR LABS version only which has no GMO, no metals, no Magnesium Stearate and is verified by a third party certification.

      Premarin comes from pregnant mares and is not very animal friendly…. but it is effective in thickening the vaginal tissue. Personally, I have trouble with the animal issue.

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