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Survey: Transvaginal Mesh Advertising Frightens Patients

Michelle Koski, MD

Michelle Koski, MD

May 28, 2013 ~ Medscape Medical News reports that all of those ads you see on television warning about the complications from transvaginal mesh are worrying women and raising a red flag about whether it is a viable option, but not scaring them away.  Story is here.

Women from two urology and urogynecolocy clinics were surveyed and  asked where they are receiving most of their information.

The answer- personal injury law firms. 

Dr. Michelle Koski says “It’s a vulnerable population and they are getting all of this misinformation.”

Dr. Koski, a urologist, presented the results of her survey at the American Urological Association 2013 Annual meeting in San Diego, California. Their website is here.

Ninety-nine women completed a questionnaire from clinics at Louisiana State University and the Medical University of South Carolina.  The results showed that although the information about mesh had come from law firms, three-quarters of women surveyed were still open to considering mesh as an option to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP).

In fairness, it is not just law firms warning of the complications of surgical mesh for women.  In July 2011, the FDA issued a safety communication stating that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare.”

The FDA added that “transvaginally placed mesh in pelvic organ prolapse repair does not conclusively improve clinical outcomes over traditional nonmesh repair.

Nonmesh repair includes native tissue using just sutures to stitch up falling organs, or using muscle and tissue from the woman’s own body to create a sling.

It was that word from the FDA that was the spark that began the lawyer advertising you see today and the thousands of lawsuits that name primarily five mesh manufacturers in product liability lawsuits.

As far as mesh used in the treatment of stress urinary incontinence (SUI), the FDA said it, “continues to evaluate the effects of using surgical mesh to repair stress urinary incontinence and will communicate these findings at a later date.”   There has been no further word from the FDA on SUI mesh.

Informed Consent

Dr. Koski says she gives women a copy of the FDA warning and spends time talking about the lawsuit ads. She tells Medscape News, POP mesh has “positive aspects for certain patients.”

She speaks more favorably about slings used to treat incontinence.The transurethral sling has always been lauded for incontinence, but it’s getting dragged into this mess by people who don’t have any medical knowledge,” Dr. Koski said.

Dr. Koski reports she is not working on a study funded by American Medical Systems Inc., as Medscape reports.  AMS is one of the five primary mesh manufacturers that, at last count, was named in 6,781 lawsuits filed in federal court in West Virginia alone. Many more are filed in state courts around the country. #

 

The AUA Guideline for the Surgical Management of Female Stress Urinary Incontinence: 2009 Update

http://www.auanet.org/common/pdf/education/clinical-guidance/Incontinence.pdf

 

AUA 2013 Annual Meeting

http://www.aua2013.org/

 

 

22 Comments

  1. linda says:

    Sadly the problem is that doctors constantly tell patients they do not use THAT mesh. Instead they should check out the stats from cases filed. Are we a crazy/ No we are all mesh injured.

    • Jane Akre says:

      Linda – I never understand what “that mesh” means! Question for patients to ask: Is it polypropylene mesh? If the answer is yes, then it is the same mesh. After talking to Dr. K, she is upset that pelvic mesh in kits, which is a lot more mesh, is being put into the same class as slings, which is less mesh. But the polypropylene material is the same. Many of you have also have severe problems with slings and certainly with their removal.

      If women are told “that mesh” has been recalled- only the ProteGen mesh was recalled in 1999. Four meshes were voluntarily removed by Ethicon from the market last June. Kugel mesh for hernia repair was recalled but was re-issued later.C.R. Bard stopped selling the Avaulta mesh kits around the time of the Christine Scott $5.5 million verdict and Mentor Ob withdrew that mesh in March 2006. Other than that, they remain on the market to my knowledge. Anyone else? My question might be – how many kits remain on the market?

      • jade says:

        I’d like more info on Indy Journalsim seeking a reporter to cover CR Bard trial.

        I am a seasoned writer with a personal interest in this venue.

  2. Terri says:

    Women should be scared and run for their lives!! If I had known for a split second that mesh (although I never even knew it was mesh back then,-my surgeon referred to it as a small hammock -was going to destroy my life as I knew it and a life with so much agonizing pain I would have ran so fast and never looked back. I would wear a giant diaper if I had to than suffer like this everyday.

  3. Nonie Wideman says:

    well my knowledge of SUI slings comes from personal experience !!!! so does Dr. Koski know what mesh erosion feels like? into your urethra and bladder? mesh is mesh with all its faults no matter where you stick it !! the arrogance of some doctors makes me so angry, I am beginning to think the wrath of women should fall onto doctors who keep implanting mesh after all the warnings!! I am glad our American sisters can sue doctors also for malpractice …

  4. a nurse says:

    As a nurse practitioner who had one of the “new and improved” SUI TVMs and whose life as she knew it was utterly destroyed by this TOT, I assure Dr Koski that complications from SUI TVMs are NOT easily “manageable”, as described by the OB-GYN Panel that advises the FDA on TVMs. In a 2009 AUGS Webinar for it’s members, it was said that “even with thorough anatomical knowledge, there will be complications” from TVM “because it is a BLIND procedure”. That was then and this is now, so what’s the difference? It’s still a blind procedure! The OB-GYN Panel at the Sept 2011 meeting did not discuss neuromuscular pain and other complications relating to nerve injury in any detail, so therefore; the problem remains greatly undiagnosed today. The complications from SUI TVM are severe and I know a young lady, in her thirties, who has yet to urinate on her own, without catheters, for almost a year now, ever since her TVM surgery. She supposidely went to one of the best uro-gyns in her state, and her mesh has already been removed. So why has she not urinated yet? A urologist she was sent to afterwards, told her that her feelers weren’t feeling and her squeezers weren’t squeezing. Sounds like nerve injury to me. Thanks a lot! All this young lady wishes for is to be able to urinate normally again! Ever since the FDA, in 2011, declined to issue increased warnings with SUI TVM like they did with POP TVM, it seems like more and more younger women, of child-bearing years, still with their uteruses, are having SUI TVM implanted. It seems like all of the doctors have said, “Well, the FDA says that SUI TVM is ok and the complications are manageable, so…..”. I heard not long ago about a young pregnant lady in awful pain since her mesh, and with vaginal erosion, who was told that nothing could be done about her mesh problems until after her baby was born. She has young children and her husband is away in the service. Can you even imagine being in that predicament? What will happen with her pain level as her baby grows and her belly expands? And she shouldn’t be taking any pain medications. I googled pregnancy after TVM and found only TWO items. In one, the woman had a healthy baby by c-section. Are pregnant women with TVM able to deliver vaginally or must delivery be by c-section? Has this been studied? Is it fair that these women and their unborn babies be guinea pigs for industry? Years ago, a woman with vaginal mesh pain and erosion was coded under vaginal or pelvic pain or something else because there was no insurance code for vaginal erosion. It only became a code after time went on and it was being seen more often in doctor’s offices. Doctors (and industry) are learing about TVMs as we go along. I, and many others, deserve to have had informed consent, which is impossible when we are the guinea pigs and these complications are not known about ahead of time….

    • Another medical professional says:

      I agree with the post here especially. I too am in the medical field and know what informed consent is and the informed consent I was given had no talk of FDA warnings…no talk of the mesh is virtually impossible to come out…no talk of the kind of things that could happen if things went wrong. In fact, it was quite the opposite. Two different doctors failed to give me proper informed consent, not just one! So I know that there are more doctors than not who are not informing their patients properly. It isn’t good medicine dear Dr. Koski that the FDA has mesh implants cleared at a level of clearance where there doesn’t have to be an ounce of randomized double blind studies confirming that the risks are low..that the implants are more successful than traditional procedures…that the materials that are used are not harmful to the women they are used on in any way. This is clearly yet another case of an unchallenged medical establishment who thinks that it’s patients are its experiments. Isn’t that nice ladies that we get to pay our hard earned money to be experimented on. Think about it seriously before you do it. And Dr. Koski…put mesh in you…see how it feels and then you can comment on what it is really like to have its complications.

    • Melynda says:

      I got pregnant (an unexpected blessing) with a baby four hears after I had a full mesh kit put in (POP mesh). She was delivered at 37 weeks via c-section as my doctor, a professor at VCU medical school, deemed it too risky to deliver vaginally even though my local ObGyn group were going to allow me to attempt a vaginal delivery. The doctor who delivered my baby took the time to really research my situation and could not find ANY information – not ONE published article or conference presentation on how to manage pregnancy after mesh. NOT ONE!!! She made her decision on her gut feelings of what would be the safest for both me and my daughter.

      Fast forward three years to three weeks ago when I had the full mesh kit removed. When I received and read through my surgical notes, I saw how risky a vaginal delivery would have been. The mesh had infiltrated the uterine artery, the tissue and vessels around the cervix, and the vaginal cuff. If my ObGyn had not followed her gut and taken my baby via c/section at the earliest possible time she ethically could but rather allowed me to deliver vaginally, both my daughter and I would have most likely died from any number of complications. Thank God she did or my husband would have been left without a wife and my other children without their mother.

      Doctors MUST be warned. Women MUST be warned. The public MUST be made aware of the dangers of mesh, even in the hands of a skilled surgeon.

      • Carol says:

        Hi Melynda,

        I’m happy you and your child are safe.

        I saw a post from you (can’t find it again since I’ve read and ‘searched’ so many forums) you mentioned you had gone to UCLA for your mesh removal.

        I had inserted in 2006 due to uterine prolapse. A sacrocolpopexy was done along with a bladder sling. I did “fine” until 2012 at which time the mesh eroded into the colon. I returned to Atlanta to the person who had put in the mesh. He told me it was not a ‘procedure’ for him to do but that ‘any’ colo-rectal surgeon could sew up the fistua I had developed and suggested I return home to have it done. (800 miles to Kansas City, Mo) I didn’t give up and asked him to refer a surgeon in Atlanta. When I visited with her she said she would repair the fistua but needed to do a colonoscopy. Only minutes into the procedure it was halted as the image showed a ‘wad’ of mesh in the colon. She did agree to do the surgery with the gyno doc also present. This surgery was Dec. 2012.

        Following the operation the ‘mesh’ doctor told me, “I got out as much of the mesh as I could.”

        I returned home after a 5 day hospital stay. In a few weeks I developed an incisional hernia. I had no desire for more mesh and all the docs I could find wanted to do the repair with mesh. I searched until I found Dr. Kevin Petersen in Las Vegas. NO MESH. This man is wonderful.

        I have developed another fistula. I contacted Dr. Petersen for a referral—-he suggested I go to UCLA.

        I phoned and can’t get an appointment until Oct. 1.

        I apologize for the long post. I saw that you had multiple erosions and wondered if you could share any more of your experiences at UCLA with your mesh removal and repairs done there.

        All comments, suggestions would be appreciated. : )

  5. MarieAnn says:

    Why would someone even consider a surgical implant for something as benign as stress incontinence with all the evidence out there? It is NOT safe! Also, as a woman who was in my forties when I had my first mesh implanted, I wasn’t told about erosions, and possibly having to MANAGE my private parts for the rest of my life, like lathering vaginal estrogen inside to try to heal an erosion or prevent one. ALL women go through menopause, and the vaginal tissues are going to change no matter how much estrogen you use! This is what has now happened to me with a supposedly safe TVT placed seven yrs ago with my hysterectomy, just INCASE I was incontinent! The larger mesh that was placed 4 yrs ago, eroded in eight weeks postoperatively. It was completely removed within a year. Now I’m dealing with the TVT, that at the time did not present with any issues, then all of a sudden it started eroding and is to be removed soon. This SUI, TVT mesh, for me, had a lifespan of seven years! There is no warranty on these devices! Surgeons need to learn true surgical skills and stop leaning on these mesh kits! I know a woman who had the MMK procedure which used sutures for SUI. She had the procedure in the 1980s and she is 90 now and has no leakages, is very active, washes her own car, just amazing. Meanwhile I am decades younger than her and will never be able to wash my car, etc! So much for advances in medical sciences!

  6. Michelle Koski says:

    I am the author of the study discussed. Based on the comments made here, I feel like I should clarify the intent of my research. There is no discussion in the study whatsoever on whether mesh, in any form, is beneficial or not. The goal of this study was to see where patients obtain information about transvaginal mesh, and whether the information they have access to is factually correct. I believe that patients need to have access to well written, accurate information from an unbiased source. Ideally, medical information that is published on television and the internet should be factually correct and unbiased – unfortunately, this is not always the case.

    I am not advocating for or against transvaginal mesh in this forum or any other forum. I am advocating for the availability of information for patients. Please note that the Medscape news remarks are taken from a conversation without context, and that I am not working on any studies for American Medical Systems.

    As a physician who treats patients with mesh complications, I certainly understand and sympathize with the viewpoints of many of the commentators.

    • Jane Akre says:

      Dr. Koski~

      Thank you so much for your comments and clarification on the AMS association. As this issue evolves it will take doctors with a true commitment to patient care to change the dialogue and outcomes. Thank you speaking up.

  7. Kathy says:

    It is so difficult and painful to think that any doctor is still implanting mesh into women that. Only have a bit of leakage. We injured mesh patients need doctors to step up and help us. We are frightened from our lack of medical care.We are hurting deeply and it is as if no one really cares at all.

  8. Jaque says:

    Hi,

    I have two replies here, one to Kathy, I too have received no help from my primary doctors, no one in the medical proffession does care about us, we have been used like lab animals and thrown away. They use mesh because its easy to. Implant because the majority of these people would be out of work if they had to do a proper job using a fascia sling as they simply do not have the surgical ability or skill to perform the gold standard, without the mesh gravy train what would the majority do for a living? I have had mesh pain now from 2006 to present, each year has got worse, what a life of daily torture, had I been a lab animal at least I would have been put down. Of course all surgeons know what they are putting in you, they are not stupid and know exactly what damage it’s going to cause for you and yet they keep on hurting new patients every day, what kind of monsters are these surgeons?

    The other question is for Marie Ann, could you tell me where you got your mesh completely removed?

    • Jane Akre says:

      Jaque-

      I just wanted to say you express yourself so well, especially about the failure of the system to allow those without surgical skills to experiment with a woman’s most sacred area ( as someone said). What is even worse is when it is allowed to continue and those surgeons delay and deny, even today with all of the information out. I notice you are in the UK- do you need to seek a doctor there? Liz Reece ( see her profile, put in a search) lives in the UK and had a successful surgery. Just a thought…. please stay in touch… ja

      • LizR says:

        Hello Jaque,

        I empathise with what you write and agree entirely. I just don’t understand why mesh continues to be used – none of us had any information prior to implantation and now have life-long consequences. Having had my mesh removed 2 years ago I am about 95% back to where I was, the 5% being residual nerve pain and problems from a cyst that formed near my groin when the mesh was in.

        Jane is amazing making links between information and people, and I’ve not been on the site for a couple of weeks but am following up her recommendation to check out my story. It might give you hope.

        Do check out tvt.wordpress.info.com which is a fantastic blog by another successful TVT removed patient of the same fantastic urogynaecologist who removed my mesh. There is lots of information about mesh removal on that blog, and also about reporting your complications to the MHRA (not much value but important to do).

        Natalia Price in Oxford has removed close to 40 TVTs and there is another excellent surgeon that I know of, Sohier Elneil in London who can remove TOTs and does many mesh removals.

        I hope that you get this and can follow up. Liz

  9. Betty says:

    I cannot for the life of me understand why this is still on the market. Dog food poisons 7 and it makes national news. People respond and throw out or take back the food. To me we are being tortured by our own country with no protection. Doctors do not know how to handle any of these complications. Pain can be severe with mesh complications, but no Dr. knows exactly what to do. I went with a friend to a local pain clinic, and found out I would never be helped by them. My closest Dr.’s are 200 miles away! Please study the effectiveness of this product, with unbiased reporting. I don’t care what perceptions are. Why does that matter? Women are being lied to. I have SUI mesh and the complications are anything but manageable. I want my health back, not a big settlement, as has been suggested by some on other websites. If it helps restore my health than so be it. As far as the lawyers “capitalizing” on this problem, it’s hogwash. I found it very hard to find a lawyer to take my suit, and I have a solid case, with only one mesh. I wish a good Dr., like Dr. Raz or Margolis etc. would write a paper for the ER on how to handle mesh pain complications that they could post at the nurses’ desk. I know too many who go to the ER are drugged and sent home. Also, there needs to be training classes on complications paid for by the pharmaceutical corporations for all Dr.’s who buy and use this crude product. Perhaps some would drop it if they saw what it really can do. It is so hard to believe that we live in a world where “care” and “greed” are synonyms. This has gone so far now, that it’s obvious that there are complications with all mesh at some % level. It isn’t unreasonable to expect that it is covered with the Dr.’s using it. Perhaps some lawyer could add this into the suits.

    • Jane Akre says:

      Betty- Your words are so powerful. It is difficult to believe that dog food is recalled, and it should be, when it kills dogs, yet we don’t have the same sort of early warning system in place that at least slows down the rush to the latest and greatest medical procedure. Doctors don’t want to be thought of as behind the times, their sales reps enforce that and unfortunately many doctors are not involved in ongoing education. I believe (personal opinion) that is why we see so many who say “I’ve never heard of this.”

      Betty- anytime you would like to write for MDND it would be an honor to have you.

  10. Janet says:

    As a woman who has had her life completely ruined by a mesh sling, I beg to differ with the author. I would much rather have received my information from tv advertising from lawyers than the way I actually did receive it. Which was not receiving any information at all. At least women today have some clue about what they might be getting themselves in to. And after seeing warnings on TV, they have something to ask their doctor about when he/she recommends a mesh procedure. In 2010 when my mesh sling was recommended for a light case of sui (doc said he would ‘throw it in’ along with a cystocele repair surgery), there were no tv ads. And because my urologist gave me absolutely no warnings about what could happen with mesh, other than the generic surgical complication information that goes with all surgeries, I didn’t question him. I have learned my lesson the hard way. Because of that sling, I can no longer sit at all. No longer have sex with my husband of 23 years. No longer work. No longer go 4 hours without popping yet another pain pill. And that’s after the sling was removed – it was even worse with it in. I had to self-cath. I had this abrasive pain around my urethra, like having steel wool wrapped around it. I could not get out of bed, or touch my legs together. I almost died. I am not exaggerating. It was horrific. If I had known that there was even a small chance, a 1% chance, that I would be in lifelong pain and disability, I would NEVER have consented to this. So to say that women getting their information from TV ads is wrong, well, I disagree. If the author had the kind of pain that so many of us have due to mesh complications, she would welcome the TV ads as at least one method that women can learn the truth about what mesh could do to their lives.

    • Jane Akre says:

      Janet you bring up a very good point. With FULL INFORMED CONSENT a woman would understand what could happen to her, to the extent it is known which really, it is not. In fact, this entire web site is informed consent because it is what can happen… In what percentage of the cases and when? Nobody really knows. If roughly 30 percent of procedures go awry- is that a percentage you are willing to take? Even 20 percent? How about 5 to 10 years down the road? Thank you for the story suggestion- Informed consent- what does it mean and what do we know now? Jane a.

  11. I DO NOT KNOW HOW ANYONE CAN SAY THAT THEY ARE 95% CURED WHEN THIS MESH PLAYS HAVOC WITH YOUR LIFE FOR YEARS AND YEARS.

    I AM NOT CURED AND WILL PROBABLY NEVER BE.

    As for the surgeon in Oxford UK Natalia Price she does not even report the mesh removals to The MHRA UK as their adverse incidents are very very low and this just proves that surgeons in The United Kingdom are not reporting the mesh removals.

    Also the very surgeon Natalia Price in Oxford is still putting transvaginal mesh into women for all the problems she sees with meshn removals.

  12. Bejah says:

    Had it not been for one of those TV ads finally getting through to me and prompting me to ask for a copy of my surgery file I would never have known or thought it possible that I had been a victim of this mesh. I am thankful for these ads and I hate advertising but thank GOD it exists. It reaches us.

    I am not represented by counsel that advertises on TV but I am very thankful to those advertisers.

    I am also stunned at the arrogance of the writer of the piece that suggests that I am so simpleminded that those ads scare me. How dare she! She exlemplifies part of the problem: The disconnect between physicians and the people they have vowed to serve. It is very sad to see a woman physician, especially, make such a blanket statement about women. It is as pitiful as it is offensive. She also does a disservice to law firms that have an exlemplary record of service in defense of the people, and are willing to take cases where representation would otherwise be unaffordable.

    No doubt the defendants in these cases are fairly certain that very few patients victimized by these products will be able to afford legal representation and I suspect they are also fairly certain that the US Governement will be more protective of corporate interests than the interests of its own people, if recent history is any indication. Our mandate is to ensure that there is a just resolution in all cases and that products that are dangerous are banned PERIOD.

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