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Urogyn Society Opposes Restrictions on Surgical Uses of Mesh

Prolene mesh

Prolene mesh

March 26, 2013~  Today, the American Urogynecologic Society (AUGS) issued a position statement strongly opposing restrictions that ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA).

The AUGS position states that it is essential for patients and their surgeons to have access to a full range of both non-surgical and surgical options.  Additionally, AUGS recently developed two credentialing guidelines to encourage hospitals and health systems to establish processes to credential and audit surgeons who perform these types of urogynecologic procedures.

I wanted to touch base with you to see if you would be interested in speaking with Dr. Anthony G. Visco, president of AUGS and Division Chief of Urogynecology at Duke University Medical Center in Raleigh-Durham, NC, about the new statement and the credentialing guidelines for surgical training and ongoing maintenance of skills.

Please let me know if you are interested in this opportunity.  I’ve included a full press below for your reference.

Best,

Melissa Hoefel

*EDITORS NOTE*   I have asked for an interview with Dr. Visco, Jane Akre 2:05 pm March 26, 2013

AUGS ISSUES STATEMENT OPPOSING THE RESTRICTION OF SURGICAL OPTIONS

FOR PELVIC FLOOR DISORDERS

 

Recommends Preserving All Surgical Options Including Transvaginal Mesh for Pelvic Organ Prolapse and Adopting Recently Published Credentialing Guidelines

Here is the statement. Below is a Press Release

 

WASHINGTON, DC – March 26, 2013 – The American Urogynecologic Society (AUGS), the leading professional organization dedicated to the treatment of pelvic floor disorders, issued a position statement today strongly opposing restrictions that ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA). Individualized treatment decisions should be made between patients and their surgeons, with the goal of providing the patient with the best, most effective therapy based on each patient’s specific clinical need.

POP is a condition that occurs when the normal support of the vagina is lost, resulting in sagging or dropping of the vagina, uterus, bladder and rectum. As the prolapse of the vagina and uterus progresses, women can feel bulging tissue protruding through the opening of the vagina. The FDA first cleared the use of transvaginal surgical mesh for the treatment of POP in 2002. During such surgeries, a piece of synthetic mesh is implanted through the vagina to support the prolapsed organs.

In July 2011, the FDA released a safety communication and white paper on transvaginal surgical mesh to highlight the potential benefits and risks associated with this therapy. Since that time, a few groups including a state medical organization, a healthcare system and a malpractice insurance company have considered restricting or have banned its use.  Such restrictions were never the intent of the FDA safety communication nor do they represent the findings of the FDA Advisory Panel.

“Women should have all treatment options made available to them.   The decision of what surgical option is right for a patient should be left between the patient and her surgeon without outside interference or limitations,” said Anthony G. Visco, M.D., Division Chief of Urogynecology at Duke University Medical Center in Raleigh-Durham, N.C., and President of AUGS.  “A ban on mesh would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women.”

The AUGS position statement notes that it is essential for patients and their surgeons to have access to a full range of both non-surgical and surgical options and to have an open discussion during the informed consent process regarding the likely benefits as well as the potential risks of all options.  In some instances, transvaginal mesh for POP may be the most appropriate surgical option, such as in high-risk patients with recurrent prolapse or those with medical conditions where a more invasive and lengthier procedure may be more dangerous.

AUGS is the leading professional organization dedicated to the treatment of pelvic floor disorders, especially POP and stress incontinence, and its members are working closely with the FDA, the National Institutes of Health (NIH) and the American College of Obstetrics and Gynecology (ACOG) to develop robust mechanisms to continue to monitor the safety and effectiveness of transvaginal surgical mesh.

AUGS recently developed two credentialing guidelines for POP procedures, one for transvaginal mesh surgery and the other for sacrocolpopexy.  These guidelines encourage hospitals and health systems to establish processes to credential and audit surgeons who perform these types of urogynecologic procedures. To achieve the best clinical outcome, it is important that surgeons are properly trained in these procedures. The AUGS credentialing guidelines provide specific recommendations for surgical training and ongoing maintenance of skills.

In addition to adopting the credentialing guidelines at the local and state levels, AUGS recommends the following over-arching strategies:

·         Establish a broad group of trained pelvic floor reconstructive experts to review cases and complications of both mesh and non-mesh prolapse repair.

·         Ensure appropriate resources and patient management systems are implemented to identify and manage both mesh and non-mesh related complications.

·         Track both surgeons and specific products being implanted, as these may each influence efficacy and complications.

·         Mandate a standardized informed consent process for mesh placement.

About AUGS

The American Urogynecologic Society (AUGS), founded in 1979, is the premier non-profit organization representing more than 1500 members including practicing physicians, nurse practitioners, physical therapists, nurses and health care professionals, as well as researchers from many disciplines, all dedicated to improving female pelvic floor disorders. As the leader in Female Pelvic Medicine and Reconstructive Surgery, AUGS promotes the highest quality patient care through excellence in education, research and advocacy. For more information, visit www.augs.org.

 

 

20 Comments

  1. Carmel Berry says:

    I am fearful for the women in these 522 sanctioned ‘trials’. I have to wonder how fully ‘informed’ they will be, and if they would be required to waiver future claims against mesh manufacturers or the implanting surgeons.

  2. Carmel Berry says:

    I am fearful for the women in these sanctioned ‘trials’. I have to wonder how fully ‘informed’ they will be, and if they would be required to waiver future claims against mesh manufacturers or the implanting surgeons.

  3. Ruth says:

    “A ban on mesh would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women.” I am chilled to the core reading these words. What has happened to professional ethics? When did the “advancement of science and future innovations” become a justification to torture women? A far more ethical approach would be to do retrospective studies on women who already have been unfortunate enough to have received these implants, and follow the impact on their quality of life at 5, 10, and 20 years.

    I fully agree that there should be open discussion between physician and patient. Unfortunately, surgeons typically do NOT offer non surgical options and women are often told that mesh is their only option.

  4. Ruth says:

    Focusing on the discussion between doctor and patient is meaningless when the recognized and trusted expert, the doctor, either is misinformed about the true rate and severity of complications, or, like the AUGS, chooses to ignore them.

    When compared with the horrors of mesh, the lofty-sounding goal of “innovations that could significantly help women” is ludicrous. Most mesh injured people I know would take back their original problems in a heartbeat if they could turn back the clock to 60 seconds before going under anesthesia, to be rid of the 24/7 excruciating, permanent, life-destroying problems that mesh introduces.

    I would have hoped that the AUGS would proactively take the lead in researching this problem and it’s horrific effects on unsuspecting women with pelvic floor disorders, and proactively take steps to change current practices that cause patient harm. Unfortunately it seems they have chosen to wait for the outcomes of lawsuits to force changes. Shame on them!

  5. tvtinfo says:

    “A ban on mesh would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women.” This statement shows a very blinkered view!

    Is mesh the only way to advance science? More likely that mesh is actually stifling innovation as most of the major research is being funded and targeted at mesh surgery and not much else.

    “The decision of what surgical option is right for a patient should be left between the patient and her surgeon without outside interference or limitations……..In some instances, transvaginal mesh for POP may be the most appropriate surgical option”

    The trouble with this statement is that (a) the patient does not really know if mesh is the best option or whether the surgeon is pushing mesh because he/she prefers it as it is easier/quicker and (b) the surgeon keeps his freedom to select patients who are more supposedly more suited to mesh, but as well all know the surgeon could easily extend this choice to a an ever increasing range of patients to suit his own purposes too. Patient selection turns out to be somewhat of a myth.

  6. Kathy says:

    Spot on,tvtinfo… So I guess we need to yell a little louder, unite world wide and advance warning other innocent women. This force to continue mesh also protect them from lawsuits and them having to face what has been done to us. It can only be the manufacture at fault to a certain point.

    Dr. Raz, Dr. Rodriquez, Dr. Peterson, please speak up, loud and clear with us!

  7. Ruth says:

    I just can’t get over the arrogance in the “without outside interference or limitations” statement, and the insult this implies to US, the victims who are tirelessly advocating, yelling as loudly as we can to warn everyone. The very “few groups” asking for a ban are the only ones who are listening to US. How dare they dismiss US as “outside interference” when we have the most intimate, excruciating, inside knowledge of anyone!!!

  8. George says:

    Jane and Friends,

    The AUGS website that has a comment section below the presidents memo, has deleted posts questioning his stance. Hard to respect the group that filters communication.

    G

    • Jane Akre says:

      Ruth- Excellent point. George- I did not see that comment screen, yes trying to get through as “outside interference” would incite a much-needed conversation at least. Apparently you must be a member of AUGS to make a comment.

    • Ruth says:

      George and Jane: I too had left a comment under the president’s memo which was deleted quite quickly. It seems the comments must have been too much to handle so the comment section has been disabled.

      • Jane Akre says:

        Ruth- Please explain… only I can remove comments but I don’t edit unless profane. thank you.

        • George says:

          Jane,

          Ruth and I wrote comments on the AUGS website directly below the Prez Blurb within a day or so of the posting.

          Yes, AUGS deleted the text and then locked the area to the public.

          From my view as an on-going hernia mesh victim (8 surgeries to date and more looming), a biologist, friends/family that are MDs, mesh device manufactures lawyers that talk with me regularly; plastic used for medical devices with its dozens of applications has the entire FDA/Medical staff /Manufacturing triad very worried. It is as if they knew they were getting away with less than sound science and practice, but carried on anyway. Of course groups like AUGS will deny a problem, which we all know is the universal tact when caught – deny, deny until forced to admit an error and only then make the correct adjustments – no more plastic implants of any kind.

          Thanks Jane for your tireless efforts!! G

  9. Betty says:

    I just found a Dr. online that say’s he does non-mesh repairs. I called him for a friend and went with her. He wrote in her record that her friend vehemently opposes mesh. Even though he will do the non-mesh repair, he say’s there is a new bio-compatible mesh on the market that dissolves within 2 years. The pamphlet he gave her had all the side effects of the other procedures except their own. That was on the 2nd to the last page. I was not surprised to see the same complications listed. He fought with me and said he’d love to talk to me more. He said the old meshes were bad, but the new one is great. He had told me I was very well read on the subject and obviously intelligent. They are on a “learning curve and science knowledge is increasing”, to which I answered, “yes, and we are the guinea pigs.” He said “no, you’re not guniea pigs – they tested.” Then he left. I had lots of answers to that one, thanks to Jane, others and just plain research. He also believes “technique” is the key. Does anyone know of a women who had erosion and was actually helped by estrogen cream? I”ve heard Dr.’s say this. I saw it in court testimony. But have yet to hear it from any woman. We really need “a guide to get well, after mesh implant complications”. This Dr. also said he believes the lawyers are the reason there are so many plaintiffs, that there weren’t that many until the commercials came out. DUH!! We were being lied to, “it’s not the mesh” the commercials woke us up. God help us all. We are living in a very corrupt era.

    • Jane Akre says:

      Hi Betty~

      I don’t know what NEW mesh he’s talking about.. Does it have a name? Bio-compatible sometimes is a composite synthetic and pig skin or cow so bio-compatible may be a bit misleading. They tested? Who tested? Good question about estrogen cream. As far as the lawyers- really? Does that mean all of these women are hypochondriacs? Why can’t doctors and lawyers communicate, the reasonable ones at least, for the benefit of the patient?

  10. linda says:

    Women are and will continue to be mislead by new descriptions rather than new products. New women have come forward who have complications who were told it is not the old mesh. Mesh is mesh. More women will be injured because they do not understand exactly what is being put into them. Same dance, different tune, done by the smae doctors. They should rethink the process altogether. “Stop pushing mesh’ are the cries of thousands of injured women.

  11. Betty says:

    I heard an argument, supposedly relating to mesh, that said the first 10 patients for bone marrow transplants died. What a justification. The bone marrow transplants, are over life and death situations. It was well known the patient wouldn’t make it otherwise. In contrast to this, we’re talking about organ prolapse or even just leaking urine. Although uncomfortable and even life limiting at times, it is a far cry from a life or death situation. It is mesh that has made it a life or death situation. I’ve lost my life to mesh and struggle with pain and ordinary life daily. We have all gone mad. With our worship of youth, and wanting life to be easy we are allowing Dr.’s to convince us that it won’t happen to us. We used to say that the youth of our country “thought it would never happen to them”, I think that has changed. The one’s in the know are interested purely in the dollar and not the patient. They will word their products in such a way that makes it believable that this is in our best interest. It is not only the transvaginal mesh world that is affected, it’s medical device wide and corruption is at every level in our country. This will change when honesty, integrity and a mans word means something again.

  12. Mary Pat says:

    I didn’t see this post until now. I have had 3 surgeries for mesh removal. Before the mesh eroded into the vaginal vault for the third time, I had an old schooled doctor who wanted to perform the Burch urothropy on me for the incontinence. When the mesh eroded again, that surgery was put on hold until I could travel to Seattle, WA for the mesh removal surgery first. Although my surgeon in Seattle is a urogynecologist with a speciality in pelvic floor and he has been trained to remove mesh, he does not do the Burch urothropy and doesn’t know how to do it. When I asked him if he could perform the Burch on me, he said “no, you would have to see one of my associates for that procedure”. He is a young doctor who was in training and assisted at my second mesh removal surgery a few years ago. The point is, the new urogynecologists are only being trained to use slings to correct SUI and prolapse. No wonder AUGs doesn’t want mesh restricted. The Burch Urothropy was the gold standard prior to mesh. Only highly skilled urologists with advanced training could perform the burch. My old schooled doctor who lived in my city closed his practice and moved away. I saw another urologist in my city to see if he could do the Burch. When I asked him what I should do about the incontinence, he grinned and said we fix that with mesh and you don’t like mesh so you will have to live with it. When I told him my previous urologist suggested the Burch, this new doctor went ballistic and started screaming at me. His ranting started with “why are you bothering me……”. He hollered for a few minutes before he left the exam room. I couldn’t leave because I was wearing a paper top with a paper towel to cover my lower half. Point is, my young, freshly trained urologist only knows how to repair SUI with slings (he, too, says “the new mesh is better, they no longer use the old abrasive mesh”) and the URL that screamed at me obviously has very strong feelings about using mesh and despising mesh victims. The doctors who support AUGS have job security at risk. I am sure they are screaming to AUGS to keep mesh on the market. No doubt the pharma companies are pressuring AUGS as well. It is simply money. We, mesh victims past, present and future have lost our health, our sexuality and in some cases our jobs, and our lives as we knew them, so others can make and continue to make money. Shame on the greedy doctors and pharma companies. That’s all I can say SHAME ON THEM ALL.

  13. Mary Pat says:

    I have been thinking about Dr Visco’s comments and AUGS’s position to keep mesh on the market so women will have choices. In keeping with that line of thinking, he really should get silicone breast implants back on the market so women can choose silicone over saline. How on earth did silicone ever get banned? AUGS certainly would not have allowed that, after all, women deserve choices no matter how harmful they might be according to Dr Visco and AUGS!

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