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Use of Vaginal Mesh for Pelvic Organ Prolapse Causes Concern for Doctors

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Physicians are growing more and more concerned over the potential risk of problems with vaginal mesh used to treat pelvic organ prolapse (POP), leading some to consider the use experimental until consistent data is available about long-term follow-up and possible complications. 

In a Letter to the Editor published by the American Journal of Obstetrics & Gynecology on November 29, Dr. Anne M. Weber of Pennsylvania wrote that there is so little sound information on the health risks of pelvic organ prolapse vaginal mesh that it is impossible for patients to give truly informed consent for the surgery. As a result, Weber suggests that all use of surgical vaginal mesh implants should be governed under the same rules as experimental medical procedures.

A pelvic organ prolapse occurs when organs such as the bladder, uterus, bowel or rectum drop and push against the wall of the vagina. This happens when the muscles holding the pelvic organ in place become weak or stretched, often due to childbirth or surgery. Vaginal mesh may be used during prolapse surgery to support the muscle.

However, side effects of vaginal mesh for pelvic organ prolapse have been linked to a number of severe complications, including reports of infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. Some women have also reported recurrences of the prolapse and the need for additional surgeries to attempt to remove surgical mesh that had eroded into the vagina.

In October 2008, the FDA issued a warning about vaginal mesh complications when used to treat pelvic organ prolapse and stress urinary incontinence. The agency indicated that more than 1,000 people have reported experiencing problems with vaginal mesh made by at least nine different manufacturers.

The FDA recommended that physicians obtain specialized training for various placement techniques and that they closely monitor patients for problems after vaginal mesh surgery. The regulatory agency also stressed that patients should be informed about the vaginal mesh risks, so that they understand that complications could seriously impact their quality of life.

In response to an article published in the American Journal of Obstetrics & Gynecology in August 2010, which stressed the importance of documenting informed consent in the face of the FDA warnings and mounting vaginal mesh lawsuits filed throughout the United States, Dr. Weber wrote that informed consent cannot be obtained for the use of vaginal mesh. She said patients should be made to understand the absence of data and the medical community’s uncertainty over the effects of vaginal mesh, and their consent should be a conscious decision to proceed anyway and reflected in their medical records.

“Sufficient data do not yet exist regarding the use of vaginal mesh procedures for pelvic organ prolapse,” Weber wrote. “Therefore, the use of vaginal mesh for prolapse should be treated as experimental, and patients should provide consent on that basis.”

The manufacturers of several different types of vaginal mesh face mounting litigation from patients who allege that they failed to adequately research their products or warn about the risk of complications.

In 2006, the Mentor ObTape vaginal mesh was removed from the market by Mentor Corporation just three years after it was introduced when a large number of women experienced severe problems. A number of Mentor ObTape lawsuits have been filed by women who alleged that the complication rate associated with the vaginal mesh could be as high as 17% to 18%. Earlier this year, Mentor ObTape settlements were reached in many of these vaginal mesh lawsuits.

C.R. Bard, Inc. also faces a number of lawsuits over problems with Bard Avaulta vaginal mesh. The Avaulta Anterior and Posterior Biosyntetic Support System, which is used to treat pelvic organ prolapse, has been linked to severe internal injuries, urinary problems, erosion and other complications. All federal Bard Avaulta vaginal mesh lawsuits, which allege that the implant was defectively designed, are currently consolidated for pretrial litigation as part of an MDL (multidistrict litigation) in the U.S. District Court for the Southern District of West Virginia.

Lawsuits over Ethicon Gynecare vaginal mesh have also been filed as a result of similar allegations. Most of the complaints have been centralized in New Jersey state court.

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20 comments

  1. Leslie Reply

    I had the inital surgery in 1998, numerious complication arose. I had repeated surgeries afterward, last dated 2001. To this date I am still having problems, continued pain, unable to move certain ways and urinary problems. I’ve contact my doctors so many times, but they say they can not help me, live with the pain. I live in tears and pain daily. Is their any help?

  2. Deborah Reply

    3 years ago I had and A&P surgical procedure done, they placed two vaginal MESH slings in me….I have had nothing but trouble, pain, infection after infection Kidney and Bladder….Recently I have had surgery to remove the mesh as it was coming out of me where I could see it, and feel it …….I have come to find out that this Mesh was not FDA approved for this procedure….I have suffered all of this time because of the MESH…I had to wear a diaper at night because my bladder would empty without any feeling…I would wake up and be soaking wet, my potassium would drop..All I can say is it is awful…Like I said I have recently had surgery and they removed the Vaginal Sling that was supporting my bladder….I am posting this because if you have had the Vaginal Mesh sling procedure and are in pain and having constant bladder and Kidney infections, consitpation, cramping, lower back pain, and swelling to the point your rings dont fit or your ankles are gone you may have what I do….This is very serious and can be life threatening…. My life has come to a almost complete stop…I can not lift anything over a gallon of milk, I can not stand for long periods of time, I am still in pain as I still have the posteril Mesh…I can’t hold my grandchildren, I cant be a lover to my husband…….I do not want anyone else to suffer…I pray that knowone else has to go through this.

  3. Tracie Reply

    Hello,i also had a TVT mesh implanted in me 10Nov 2010,and it has been the worst nightmare of my life,obviously it had eroded more or less straight away,maybe put in by an inexperienced consultant..Partial removal on Jan11 2011 still pain discomfort aches and numbness,it actually feels like theres two meshes now,and proberly more procedures…This device should be banned and any woman offered the TVT mesh look into it please….No one should be suffering because of this cheap nasty device…We are not lab rats….

  4. Carol Reply

    I was told today that i needed to have a mesh sling put in because of my bladder an also my bowel, after reading all that women have been through I definitely will do lots of research before i have surgery. I had surgery in Dec. 2009 to fix the prolapsed bladder but a few months later it was back so the doctor now says i need another surgery and I need to have a mesh sling. I am scared to have anything done now after reading all the comments made by other women and how their lives are forever changed and the fact they have had to have so many other surgeries.
    I have a lot of allergies and I worry about having a reaction to the mesh.
    Guess i will put off the surgery until i have good answers to all my questions from the doctor, not ready to just trust what the doctor says. I will do a lot of praying also before doing anything also get a second opinion maybe a third.

  5. Deborah Reply

    I first posted on this web-site in January…and at that time had, had surgery to remove the mesh from the bladder area…now as of today I have had 3 surgeries to remove the Mesh from my bladder area….with each surgery my body and my mental state are effected….the back pain is still there, the cramps are still there….I can not sit on a hard chair, I can not stand for long periods, I can not hold my grandchildren, I can’t go to the store and grocery shop….I am so upset and I don’t know if it will ever end…just when I think it may be the last surgery its not. It seems this Mesh keeps working its way down….The pain is like sitting on Barb wire, and when standing the Barb wire pulls and pokes and stabs….the pain medication doesn’t even touch it….when will this stop? Why was I not told anything when they did the intial 1st surgery of putting this Life destroying Vaginal Mesh in me????? The Doctor that is taking care of me now says they can not go back in and remove it all because it can cause more serious problems that would be permenent, life altering…and could even cause death…..I have been in contact with an advocate for woman that have had this done to them….so many woman, so many lives that are changed….Because of what was supposed to be a simple procedure…..My husband has been very supportive through all this, but I have seen the tears in his eyes when I have been in so much pain, and he can not help me….it has been 7 days since my last surgery, removing more of the Mesh that is eroding through the vaginal area….I pray each night for the next morning the pain would be less, that I would be able to make the bed, anything….but no releif yet…The ladies at the Advocate for woman with this Mesh erosion have sent me cards, and been very kind, very thoughtful…as I have become a shut in due to the Vaginal Mesh Slings…any woman suffering from this needs to contact a good Doctor and be examined….re-acuring bladder infections, back pain, urinating when you lie down, swelling, painful sex, preassure, or a discharge with a very bad oder, or blood in your urine…and constipation…its all part of the Vaginal Mesh….seek help don’t wait, because it won’t get bettter. My prayers go out to anyone suffering from this, and I ask for prayers for myself.

  6. Sharee Reply

    This is unreal. I had the sling inplanted in early 2002. After 1 year, the leaking started to reoccur. I have re-occurring bladder infections, sharp pains in my pelvic area, back pains, leakage, discharge with an odor and constant constipation. I did not know where these problems were coming from but now I know. I ask my doctor could the mesh be removed and he said no. This is horrible.

  7. Danni Reply

    This will be the first board I have commented on. My Gynecare TVT bladder sling was put in on Aug.,10, 2009. The uro-gyno told me this was the greatest product ever to be in the medical world!! She pressured me into the procedure, while promising the saftey of TVT!! Well, she lied!! 1st, they let my leg fall out of stirrup during the FIVE AND 1/2 HOUR surgery!!! I have had low back, numb, tingling leg, can’t cross leg, can’t sit for long (not able to do my sit down job!) can’t stand too long or lay on my stomach or my right side! I also wake during the night to find a wet bed! Some days I have to self cath! My pubic bone is in constant pain and I was recently diagnosed with osteitis pubis! My bladder hurts all the time and there’s a nasty smell! I’ve been constipated entire time and must use laxitives! Uro-gyno SWEARS that sling has nothing to do with ANY of these problems!! NEVER HAVE THIS SURGERY DONE!! The hospital I had my surgery is in TN. and Ethicon (who makes Gynecare) dumps tons of money into it to promote thier products!! Oh, by the way- sex is no longer a part of my life!!!! Every doc and every med company should be held accountable for the damage these things cause!!!!

  8. Tammy Reply

    I am 44 years old and had my surgery of cystocele and rectocele prolapse with the Prolift Gynecare done on Nov 17,2010. I too was tricked by my gyno that this was going to be the best thing in my life and all these horror stories on-line that I read about are only a very few women with inexperienced doctors. WELL, it is now April 13th, 2011 and I am still having extremely severe stabbing and pulling pain., My husband and I have tried to have intercourse from the 13 week of post-op until now about 10 times. It feels like I am being ripped and having a something huge rammed into me. My husband is not a large guy (Thank God) and he really has been gentle. Bless his heart. The pain is unbearable. I usually take pain well. This is why I have tried 10 times thinking I just need to keep trying. I really loved sex before! I am see a Specialist (Urologist) tomorrow. I hope he can help me. Heaven help us women from these fools!

  9. Tammy Reply

    I am 44 years old and had my surgery of cystocele and rectocele prolapse with the Prolift Gynecare done on Nov 17,2010. I too was coershed by my gyno that this was going to be the best thing in my life and all these horror stories on-line that I read about are only a very few women with inexperienced doctors. WELL, it is now April 13th, 2011 and I am still having extremely severe stabbing and a pulling pain., My husband and I have tried to have intercourse from the 12 week of post-op until now about 10 times. It feels like I am being ripped and having a something huge rammed into me. My husband is not a large guy (Thank God) and he really has been gentle. Bless his heart. The pain is unbearable. I usually take pain well. This is why I have tried 10 times thinking I just need to keep trying. I really loved sex before! I am seeing a Specialist (Urologist) tomorrow. I hope he can help me. Heaven help us women from these doctors that are fools!

  10. donna Reply

    I am 50 years old and had my first surgery at age 42, then again at 44 for a cystocele and rectocele prolapse, I had the TVT sling . I STILL have a huge prolaspe and can sometimes not even walk because of the bulge between my legs, it not only hurts but I have a terrible discharge. When the sling was first put in the Dr. thought that I was allergic to it, I broke out in a rash and could not stop itching and we almost removed it then. I also wake up some nights and have wet the bed , unable to control my bladder, my sex life is almost gone because of the pain, the longer I stand on my feet the larger the prolaspe gets, I also have pain going up and down my legs and my ankles swell something horrible. What do I DO????

  11. GEANINE Reply

    i had mesh inserter 16 yrs. ago and now i am getting pancreatists, pain in my abdomon enlarged stomach, bleeding constantly, lumps breaking out on my arms and legs, my ankles are always swollen and different infections…. I’ve been to nine gyn’s and no one will help me. And also a dropped uterus and i had three c-sections… two after the mesh wall were inserted. i can’t live anymore with the pain and constant fear….
    Does anyone know a Dr. out there that would help me??? i’m desperate… i live in south jersey, but willing to go wherever…..
    Please help me….. Thank you

  12. Therese Reply

    Well I had the procedure done in October 2008 and almost immediately things felt wrong. I felt like someone had my bladder in a vice grip and a strange discharge started within the first 3 months but it wasn’t from my vagina! I told my doctor and he asked me if I was sure the smell and discharge wasn’t from my vagina???? Well I am a 50 year old woman with 4 children and I am pretty familiar with my lady parts, so I assured him it was not normal. I also started wetting the bed. If I have anything in my bladder and turn a certain way while sleeping the urine just comes out! As for the pain…it’s ridiculous! I am a thin woman so I like wearing lower cute jeans and such… Well I can’t do that without severe pain in my bladder area… I can’t sit for long periods of time, I feel like my kidney is failing. I have to rock back and forth on the toilet to have a bowel movement… and the list goes on and on! I have seen 4 specialist and they all say there isn’t much that can be done. I had a series of pain injestions in my vaginal wall (yeah, that was pleasant) but that is only temporary! I am currently in a class action lawsuit, but those usually don’t go anywhere, so I’m stuck without health insurance and I’m scared because I truly feel like my insides are slowly dying! any advice would be welcome!

  13. angela Reply

    Is it possible that they could implanted the mesh during c section and not told me cause my husband said he saw them putting something in me and they didn’t take it out please if anyone can let me know it would be very helpful

  14. Kristen Reply

    I too would like to know if the doctor uses this after a c-section. If they were to use something like this they would be required to inform the patient right? I have had four c-sections, I had to have major repair on my uterus and stomach during the last c-section. I have had nothing but problem scene. Reoccurring infections, bowl problems, pain during intercourse…. I have spoke to my doctor and he assures me that it is part of the healing process and prescribes a different antibiotic or pain pill. Something just doesn’t seem right.

  15. kristine Reply

    This makes me so sad. I’m a mesh victim. My life has been turned upside down no joke. I first noticed my hip leg and thigh pain two weeks after surgery. I can not lay down on my left side at all. My leg cramps are pretty bad. The pelvic groin pain is no joke. I get up from sitting and I feel it pulling on me. Its like I was stabbed. No amount of pain meds work . I pace the floor at night praying for the pain to stop. I’ve developed odd rashes on my thighs inner and outer, on my hips and legs. I think I’m allergic to the mesh. I’m allergic to tape all kinds . Medical and regular tape. I walk really slow now. I cannot stand the butt pain its horrific its like . I have small pins poking me and ripping my skin. I recently had two rectal infections from what and have had several pelvic infections. I noticed I have this foul smell like my skin is rotting. Its never ending. I’m waiting to see the surgeon. Sex is out of the question. I could go on and on and I’m a happy go lucky person with four older children and a husband. Life is not the same for me as it was before this surgery. I wish these people who said its safe and made thisproduct could put this crap mesh in their body and see how it feels. Bastards. No joke. I pray for all suffering from mesh . I’m right their with you. God bless you all.

  16. Catina Reply

    I had a baby by C-Section March 2012, afterwards I haven’t had a periodand not sure if the used the vvaginal mesh on me. I have had so pain and discomfort but lately I have been peeing on my self without knowing at nightI don’t know if they used one one me but would love to know.

  17. Joni Reply

    Exactly 8 months ago I had a c-section (Sept 12 2014) and in Oct I had what I thought was a uti, and I’ve been on 7 antibiotics since with no answers as to why I’ve been peeing blood, blood clots, and have severe pain when urinating, not urinating and during intercourse. Well I’m currently seeing a urologist who went in this past Friday with a camera intoy bladder. He said it was really red and infected. And asked if I’ve had any surgeries I said yes, only a c section. He said nothing for your bladder? I said no. He said it looks as if I’ve had surgery on my bladder or had a bladder sling put it. Which if I did I was never told about. And for the past 8 months I’ve been in nothing but pain and misery. Please tell me if this is even possible?? Why was I never told?!

    PS I’m going for a ct scan this Thursday, may 14 2015.

  18. Emily Reply

    Hi, just wondering if any of those who have commented that have had a cesarean went on to find out if mesh was actually used or not? I’m in so much pain post cesarean and would love to hear back from anyone. I’m so desparate.

  19. terri Reply

    Has anyone ever developed hives after having the transvaginal mesh? I had the mesh put in in May 2015 and in October started getting bouts of hives. I went to the allergist and after 140 shots it was determined that it was all outdoor, trees, plants, pollen, dust mites (isn’t everyone) etc. I never had outbreaks like this. The only thing I can think of is can I be allergic to the mesh?

  20. robin Reply

    I had transvaginal mesh and I too developed hives about 1 month post surgery. I have been to several dermalatolgists and no one knows why. I tot believe it might be the mesh as I never had hives before the surgery. My hives are primarily in my abdonimal and trunk areas.

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