Mentor ObTape Vaginal Sling Lawsuits
Last Updated: October 2008 • 31 Comments
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Women who have received a bladder sling to treat stress urinary incontinence may be at risk of severe and debilitating injury if the Mentor ObTape Vaginal Sling was used. The defective design of the device could lead to infections, erosion and other painful complications.
STATUS OF OBTAPE SLING LAWSUITS: Cases have been filed throughout the United States for women who received the Mentor Ob Tape Sling. Lawsuits filed in federal court will likely soon be consolidated in an MDL, and ObTape sling lawyers are continuing to review new cases.
>>REVIEW AN OBTAPE LAWSUIT WITH A BLADDER SLING LAWYER<<
MANFACTURER: Mentor Corporation
OVERVIEW: The Mentor ObTape is a transobturator vaginal sling which was used in thousands of women between 2003 and 2006 to treat Stress Urinary Incontinence (SUI).
The bladder sling is designed to provide support to the vaginal wall, reinforcing the muscles that control the flow of urine. Stress urinary incontinence affects approximately 14 million women, where the pelvic muscles that support the bladder and urethra are weakened. This could result in involuntary leakage during coughing, laughing, sneezing and similar actions.
The Mentor ObTape Sling contains a “nonwoven” design, which has been found to block essential nutrients and oxygen, leading to a substantial number of serious and debilitating complaints from women treated with the bladder sling.
OBTAPE SLING PROBLEMS: Over 35,000 women worldwide received the defectively designed Mentor ObTape bladder sling between 2003 and 2006. Some estimates have suggested that complications from the vaginal sling could impact over 17% to 18% of these women.
Women treated with the ObTape have suffered severe pain, vaginal extrusions, urinary tract erosion and infection.
Symptoms of Ob Tape problems could include:
- Vaginal or Pelvic Pain
- Bloody Discharge
- Pain During Sex
- Vaginal Infections
- Severe Pain in the Back, Hips and Legs
In many cases, Mentor ObTape Sling complications have required multiple surgeries to remove the bladder sling. Even after surgery, women may be left with permanent and debilitating injuries.
Although Mentor Corporation never issued a formal vaginal sling recall, they stopped selling the ObTape Sling in 2006, just three years after it was introduced.
A study published in the October 2006 issue of the Journal of Urology outlined a number of bladder sling problems suffered by women who received the ObTape sling. Researchers evaluated 67 cases of women treated with the Mentor ObTape. More than 13% of the women developed vaginal extrusions. In adddition, 8 women developed chronic vaginal discharge and 1 developed an abscess on her thigh.
The study also analyzed the cases of 56 women who were treated with another vaginal sling and concluded that none of those women experienced the urinary incontinence sling complications.
OBTAPE RECALL CORRECTION NOTICE: The original article posted on this page contained the sub-headline “Mentor Vaginal Sling Recall” based on an article in the Journal of Urology which indicated an ObTape recall was issued due to a high erosion rate. At the request of Mentor, the Journal published a retraction notice in 2007 correcting that there has not been a vaginal sling recall. Rather, Mentor stopped manufacturing and marketing the ObTape sling in about March 2006, three years after the product was introduced.
Pingback by Motion Filed to Consolidate Mentor ObTape Sling Lawsuits : AboutLawsuits.com on 21 October 2008:
[...] currently faces Ob Tape Sling lawsuits that are pending in 12 different federal district courts on behalf of 95 plaintiffs. The product [...]
Pingback by FDA Warns About Complications of Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence : AboutLawsuits.com on 22 October 2008:
[...] 2006, a type of surgical mesh used for stress urinary incontinence, known as the ObTape Vaginal Sling, was removed from the market by Mentor Corporation just three years after it was introduced when a [...]
Pingback by MDL Panel Arguments on ObTape Bladder Sling Lawsuit Consolidation Set for Next Month : AboutLawsuits.com on 28 October 2008:
[...] has scheduled oral arguments on Mentor Corporation’s motion to consolidate and centralize all ObTape bladder sling lawsuits for November 20, 2008 at the Hollings Judicial Center II in Charleston, South [...]
Comment by Eva on 30 November 2008:
This was the worst torture device ever made. My life is forever damaged by this. 3 surgeries later to try to repair the damage from the 1St surgery where the TOT sling and I still suffer bladder leakage, pain, nerve damage, pelvic and vaginal pain, terrible Pain During Sex, leg pain and numerous other problems.
There should be some kind of help for all of us who have had this procedure. It has changed the quality of my life for the worse not the better.
Comment by Norma on 1 December 2008:
I had the mesh sling surgery for bladder suspension. The surgery was done in 2003. I have had constant pain with sex ever since. I have no medical insurance and am not quite sure how to proceed. If anyone has any ideas forward them to my email. My husband has a poking sensation when we have sex this is an ongoing pricking sensation that hurts him.
Pingback by Mentor ObTape Lawsuits Transferred to Georgia : AboutLawsuits.com on 5 December 2008:
[...] Judicial Panel on Multidistrict Litigation has ordered that all federal lawsuits involving the Mentor ObTape Transobturator Sling be consolidated in the U.S. District Court for the Middle District of Georgia for pretrial [...]
Comment by Robin on 19 December 2008:
I too had a bladder sling put in around 2005. I have had nothing but pain during sex and my husband has scars from it poking him. I have continued to dribble, incontinence and have pain in my legs constantly. My sex life is null and void since the surgery due to pain during and afterwards. I had a second opinion and it had to be replaced since it was protruding through the vaginal wall. This has been hell for the last 3 years. Hopefully my new surgeon got it right. He subscribed a cream to use daily to help with healing wihich my first dr never did. Not sure if this was the Mentor OB tape or the Protegen sling that was recalled but no one ever recalled the ones who already had it inside of us. This is a disgrace!
Pingback by ObTape Bladder Sling Lawsuits Continue to be Filed as Mentor Wins First Verdict : AboutLawsuits.com on 7 January 2009:
[...] least 32 lawsuits have been filed against Mentor Corp. involving problems with their ObTape vaginal mesh used during bladder suspension surgery, and additional cases are expected to be filed in the coming months now that a federal MDL has been [...]
Pingback by Trials in ObTape Lawsuit MDL Could Begin in February 2010 : AboutLawsuits.com on 4 February 2009:
[...] first trials in the federal ObTape lawsuit MDL are scheduled to begin early next year for women who have experienced problems allegedly caused [...]
Comment by kathi on 10 February 2009:
I had a miniarc sling put in August 2007.I am so afraid of what could be going on with this sling inside me.The doctor told me it was very SAFE.He stated no problems had happened with the sling so of course I trusted it was safe.
If anyone has any advice for me please respond.
Comment by jami on 16 February 2009:
had the tot surgery 3 weeks after having vaginal hyster. did well for 3 weeks upon resuming intercouse I’ve had chronic bladder infections, bladder pain, frequentcy and urge to go, with very little voiding. my doctor has basically abandon me. I live in a small town. looks like I’m going to have to travel out of town to fix this problem?
Comment by Peggy on 2 April 2009:
I had the bladdar sling put in in September 2007. My doctor said my bladdar and rectum had fallen and I needed this sling to correct the problem. My second surgery to remove “erosion” of the sling was just preformed and my doctor told my husband if this does not work that I would need to see a specialist. I live in a township in Southern Arizona and I am the second person in our area to have the erosion after this surgery. I have complained of intercourse pain, leg pain, back pain, lack of urination and I too have a very discusted husband over this situation.
Comment by Martha on 4 April 2009:
I cannot remember exactly when I had the TOT done, but it was within 2003 and 2006. I do not know what brand it was, and my gynecologist has yet to respond to my request for that information–and I am an RN that has worked in surgery! My friend scrubbed the case, and she will let me know as soon as things calm down–there has been a death in her family. I am going to go to Medical Records and get a copy of my Operative Report and find out what was said in that. I am not sexually active. I am a widow and don’t believe in sex outside of marriage, so I cannot say anything about pain in that regard. My legs and hips hurt a lot as well as my back. I attributed my back pain to my line of work. I am just getting over a VERY severe bladder infection. It began with the feeling that a noose was tightening on my urethra. Cipro is helping with the infection. I had a severe infection after the procedure that required two rounds of antibiotics. I hand picked the staff that took care of me, so I know that asceptic technique was not broken. If I don’t get any answers soon, I will go see a Urologist.
Comment by KELLI on 23 April 2009:
THE MENTOR BLADDER SLING HAS BEEN A NIGHTMARE FOR ME MY WAS DONE IN SEPT 2005. THE PROBLEMS DID NOT REALLY COME TO A HEAD UNTIL SEPT 2008 I HAD AN ABCESS THAT RUPTURED IN MY VAGINAL WALL, FROM THEN ON PROBLEMS JUST GOT WORST THE BACK ,LEG AND HIP PAIN MULTIPLIED X10 THE BLEEDING AND DISCHARGE WAS UNBEARABLE. I WENT TO THE ER 2X AND WAS TLD I HAD YEAST INFECTIONS AND VAGINOSIS ONLY AFTER DOING ALOT OF RESEARCH DID I COME ACROSS THAT I NEEDED A CONSULT WITH A UROGYNECOLOGIST
I NOW KNOW I HAVE MESH EROSION IN MY VAGINAL WALL I HAVE BLOCKAGE IN MY BLADDER I HAVE INFECTED OBTURATOR MUSCLES WITH ABCESSES. I WILL BE HAVING THE FIRST SURGERY IN 2 WEEKS TO TRY TO REMOVE THE MESH AND FIX THE EROSION THEN I WILL BE ON ANTIBIOTICS FOR 6 WEEKS TO CLEAR UP THE CHRONIC INFECTION I HAVE THEN ON TO THE NEXT SURGERY PELVIC RECONTRUCTION. STILL THERE COULD BE MORE DAMAGE ON THE INSIDE THAT IS NOT VISABLE. I HAVE BEEN UNABLE TO WORK AS TO THE CHRONIC PAIN SEX IS NOT EVEN CONSIDERED. I FEEL FOR MY SPOUSE! CHRONIC DEPRESSION HAS TAKEN OVER MY LIFE.
Comment by wilma on 13 May 2009:
in Nov 2008 I was diagnoised with stress incontenance. In feb 09 had the vaginal taping procedure \.
since the surgery my life has been hell. i have a very stream when I urine. The only way I can urine is that I drink coffee, soda or tea alone with water. I f I drink plain water it feels as if I have a UTI and the pain is unbearable. its as though my bladder cant pass plain waterI have had a severe yeast infection that I have been on oral mediction twice and it helps a little then flares back up it has never gone away completely. I have only had sex once because the first time the pain was so unbearable felt like i was being cut with a knife, i have never been in this much pain before. my life isnt normal anymore i have to constantly drink water to pass urine, the i have to drink some type of stimulant to make me pass urinre it has affected me so badly on my job becase i have to stay by a bathroom, I have to constantly drink water and soda, and prior to this surgery i didnt drink soda. I have a doctors appointment this wk with the gynecologist that performed my surgery, and i am going to demand that this mesh be removed I cant live like this anylonger.
Comment by Joanie on 28 May 2009:
I had the TOT sling procedure done Mar. 27, 2009, when I had my hysterctomy. Its only been 9 weeks and the mesh from the sling has already eroded its way through my vaginal wall and is visible. I’ve been having vaginal pain for a few weeks, severe at times. My doctor will be scheduling surgery in a couple of weeks to put the mesh back in and repair the damage. Bad thing is, I don’t have insurance to cover the surgery!
Comment by Pam on 16 June 2009:
I had a partial hysterectomy and bladder sling surgery in December 0f 2006. I don’t know the manufacturer but it was a TOT. He put it in wrong in the first place, but I have all of the symptoms that I am reading here. My life was ruined by the surgery. Everything I used to do easily or enjoyed doing is gone now. I lost most of my sexual function, even if I could bear to have sex. I can’t sit, stand, lay down without severe pain. I have a neurostimulator but it only takes about half of it away. The pain pills get me by now. I have had four surgeries that had their own drama. I had a pretty good month, but it ended a couple weeks ago. That was the longest I have had when I felt close to normal. I pray for all of us.
Comment by JOANIE on 17 July 2009:
I posted here recently about the tot sling mesh erosion. I had the second surgery to repair the damage from the vaginal erosion from the mesh about 4 weeks ago. Well once again the mesh has eroded through my vaginal wall and is again visible. The pain is almost unbearable at times. Not sure what the doctor is going to do this time. My advice….DO NOT GET THE TOT SLING!!!!
Comment by Joelle on 22 July 2009:
I am posting this in hopes that I will find someone out there with the same situatioin I am in right now. I am 42 years old. I had a total hysterectomy performed by my GYN and my urologist put the mesh bladder sling. I have been so sick since then. So many antibiotics (literally 30-40 bottles) for UTIs and constant yeast infections. In the last 3 months I have had 3 CATSCANS and MRIs and Urodynamics etc. They put a catheter when I could no longer pass any urine. I wore that for 7 weeks. The surgeon determined that there was a blockage of some sort. I had surgery almost 2 weeks ago and the doctor removed the mesh sling because”it was twisted on the end” and not allowing me to pee. I need to know if anyone else went thru this? My timeframe isnt very long for them to remove that sling. After reading things on the internet I question if I should want to have my bladder stable (and not falling out) or is it just too dangerous? I had cancer 2 years ago so my health has been poor for awhile. I sure would appreciate some input. Thanks
Comment by Joelle on 22 July 2009:
I am sorry I forgot to mention that I had all that done February 28,2008. Both of the surgeries were done then. Just 2 weeks ago was the sling removed by a different surgeon.
Comment by Lynn on 6 August 2009:
I had to have a full hysterectomy when I had the “TOT” sling surgery performed on me for incontinence in Jan. 2005. I immediately got pneumonia and “influenza” as they called the ‘rare’ infection I contracted just out of the hospital 4 days. I was in the ICU w/heart failure due to the ‘infection’ and almost died. The first time my gynecologist saw me after the surgery and post op illness, he said he saw “tape” protruding and showing inside the vagina. The urologist then performed two more ’surgeries’ in his office to “adjust” the tape. Then in Oct. 2006 I felt like my thigh had pulled a ham string, deep pain inside and I was diagnosed with “celluitis” since you couldn’t “see” anything but reddening of the skin. THen on June 22, 2007 I went to the ER w/a huge boil on the inside of my groin/upper inside thigh and had it drained. It drained for 12 WEEKS while I worked as a Realtor wearing a bandage in my groin, no underpants under my clothes and ‘oozing’ all the time. I was on major antibiatics including two courses of an I.V. drug. I wore the ‘portable’ needle in my arm for two weeks, and gave myself the I.V. meds each night. I continued to work and see numberous doctors at the ‘wound care’ center of our hospital. Since it wouldn’t heal, they thought I had diabetes. Then finally a plastic surgeon was called in to go in surgically and see where the canal led. It led 3-4″ deep into my thigh and he pulled out “foreign material”. Now we assume that was the first piece of ‘the tape”, from the bladder sling. Following a second surgery after it began to heal to repair the area, It healed and seem to be gone. THEN ON JUNE 22, 2008; ONE YEAR TO THE DAY AGAIN……..I felt that deep pain in my RIGHT thigh and w/in 48 hours the inside of my thigh began to turn black. By Monday, I went into ER and was rushed into surgery. The infection had eaten the tissue of my thigh from the inside out! The surgeons did three surgeries in three days trying to get all the dead, infected flesh out of the wound, and save my leg, my ham string and my life. They all said I was very lucky! I spent the next 11 days in the hospital w/a vacuum type machine w/a huge patch over the opening to help it heal and keep clean to regrow new tissue. Finally when I was sent home w/a 13cm” long and very deep open wound, I had to leave the machine at the hospital, because I had become “low income” over not being able to work as a Realtor and had to go on public assistance for the medical relief. Thank GOD I qualified! I know the bill was at least $100,000 for this second bout. Now I have a horrible scar, 6″ long on the back of my leg, but I just call it my ’shark bite’. I’m just happy I lived through it, and have been wanting to warn other women about these complications. The second bout ended in late August 2008 when the original surgeon went in to follow the canal again to find the source of the infection, and he pulled out a piece of ‘blue fabric’ both doctor’s described as possibly part of the blue ‘draping’ material they lay over the patient during surgery. Plus more’ foreign material’. The gynocologist assisting the plastic surgeon, looked in vagina and bladder and said there was no sign on any bladder sling left in or around my bladder. Hmmmm, Heck no, it came out in pieces and ruined two years of my life. Luckily I had two great doctors who would swear the sling caused all the problems, and the MRI that was last performed in 12/08 showed no pockets of infection left in my lower body! Hallelujah!
Comment by Stephanie on 14 August 2009:
I had a partial hysterectomy in/around 2003 and had my bladder sling placed then. Did wonderful for about a year then I had to start to cath myself and was told by a urologist after many painful test that it was from nerve damage from a previous back injury and to live with it. After about a year of cathing myself I found another wonderful urologist that discovered it was my bladder sling and replaced it. Again I did great for alittle while and I experienced urinary retention again and had to go back to cathing. So this time I went back to the OB/Gyn that did the orginal surgery. He placed a new sling in and I have done wonderful for several years as far as urinating. My husband is not so happy as far as the sex life is concerned because ” it is not the same”, but now I am experiencing severe hip and inner thigh pain all the time and during all this time I did have another back surgery and the leg pain is on the opposite side. I am not sure where the pain is coming from because I have not gotten insurance yet through my new employer to go to the doctor.
I do not know which sling was used on me any of the times. All of this has been a big problem in my life and I guess you could say my husbands.
I am a nurse and I would have never thought a simple procedure could have turned out with such bad results………..
Comment by Jeanne on 28 August 2009:
anybody having trouble with Mentor Corp Aris Tape? I have same bad results with this,and need people with this also for a lawsuit.
Comment by Shannon on 2 December 2009:
I had the OBtape procedure in 2005. Starting in 2007, I starting having horrible vaginal pain, pressure, infections, drainage, UTI’s and this has been non stop for 2 years. I just stumbled on the FDA’s health notice last night. My OB and my Urologist just keeping passing me back and forth like its something the other needs to fix. I no longer live in the state were I had the procedure done. I can’t live like this! Does anyone know any doctors in VA that are not scared to remove the mesh. For two years I have been wearing a pad due to vaginal or uretha discharge. The have put me on antibiotics and antifungal meds for 2 years. I am in excruciating pain upon exam and even when washing myself.
Comment by Laurie on 2 December 2009:
May 2008 my GYN did a total hysterectomy and a sling for the urethra support, i had a lot of vaginal paid even 8 weeks after! It slowly went away but I felt like something was not right with the sling. By accident I found out that sling has eroded and is in my vagina. I have not had sex in two years but I am sure if I did it would of been painful for the other person. I went to the Urologist for kidney stones but none where found, although it felt like it! After reading all these post I am having an aha moment. I have been to PT for leg pain and we could not figure out from what? OMG! my back hurts and my hips. I toss and turn all night long. I wish I would of done research on this procedure prior to surgery. I am to have it removed completely next week. and I pray the problem will not be worse than before. I did not have the tape sling, my urologist stated, but I am going to find out what kind and do some research. I will kept everyone informed.
Comment by Ramona on 9 December 2009:
3 years ago, I had a Mentor AVIS Bladder work done…It has been a nightmare….I have had infection after infection, parts of the tape coming through my vaginal wall, vaginal erosion, bleeding, foul discharge, lower back pain that virtually shuts my life down at times, and my sex life is gone. I bleed very bad, and sex is painful, and I hurt very bad afterwards.
1 year ago, I had surgery to remove it, but unfortunatly the Doctors was not able to get all of it out. Now, I have more of the mesh protruding through, and another infection, back pain, and all of the above things I mentioned before.
I cannot find any suits dealing with this type of Vaginal Tape, and I know that I’m not the only Woman dealing with this problem with the AVIS tape.
Comment by Nancy on 8 January 2010:
I am planning on have the MiniArc sling procedure next week. Any comments would be greatly appreciated!
Comment by sherry on 12 January 2010:
I would like to get in contact with Peggy from southern az that left coment on 4-2-09.
I also live in a southern az town and have the same problems as you. I would love to talk I thought I was the only one. hope to hear from you.
Comment by dj on 28 January 2010:
Please check out medicalmesh@yahoogroups.com
Also truthinmedicine.us.com
There are hundreds, probably thousands of women just like you. Amazing that our “trusted” FDA allows this c..p on the market and our “trusted” doctors put it in and then haven’t a clue what to do for the severe complications that ruin our lives.
Comment by Cindy on 4 February 2010:
I had my first bladder sling done in 2006, that failed after 4 weeks. I underwent cystocele/ rectocele/ vaginal vault suspension and TOT bladder sling surgery in June 2008. I, like most others, have had constant urinary tract/bladder infections. I have been on antibiotics for six months now. On 1\25\10 I had surgery to remove the grafting material at the top of the vagina due to extreme and constant pain. My doctor did a colposcopy (looked in the bladder) at the time and found that the tape has eroded into the bladder. I face another surgery on 2\23\10. My urologist says he has to make an abdominal incision and slice open the bladder to get to the TOT and remove it. Sounds like the removal is going to worse than the insertion.
Comment by Cindy on 4 February 2010:
Sorry…typo in my previous post. My doctor did a CYSTOSCOPY not colposcopy