Vaginal Mesh Lawsuit Filed Over AMS Sling
A Texas woman has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company, which allegedly caused her to suffer a number of serious injures and complications after pelvic organ prolapse surgery.
The complaint was filed last month in Los Angeles Superior Court by Laura Jones, of El Paso, Texas, against AMS and a number of other unnamed manufacturers.
Jones had an AMS vaginal sling implanted in June 2009 to support her pelvic organs and restore normal vaginal structure. Following the pelvic organ prolapse surgery, Jones subsequently experienced severe pain, urinary problems and had to undergo a number of additional surgeries to have the AMS surgical mesh removed.
According to Jones’ lawsuit, the transvaginal sling eroded, shrunk and part of it extruded into her vagina. The complaint alleges that AMS failed to warn patients about the risk of vaginal mesh side effects, claiming that the manufacturer should be held responsible under theories of strict liability, negligence, breach of implied and express warranty, fraud, misrepresentation and violating California consumer protection laws.
In recent months, several other similar AMS vaginal mesh lawsuits have been filed on behalf of women who experienced problems after receiving pelvic organ prolapse products made by the medical device manufacturer. In March, a complaint was filed by Jeanne Ford of Georgia, and in April, a different lawsuit was filed by Michele and Albert Delorme of North Dakota. Both of those lawsuits were filed in Delaware.
Problems with vaginal mesh have been associated with products made by a number of different manufacturers. The FDA issued a warning about vaginal mesh complications in October 2008, indicating that more than 1,000 people had reported experiencing problems with products made by at least nine different manufacturers. In addition, a study published earlier this year found a high risk of problems with all vaginal mesh implants.
Last year, settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits filed by women who experienced problems after receiving that product, made by a subsidiary of Johnson & Johnson. The complaints alleged that the complication rate associated with Mentor ObTape mesh could be as high as 17% to 18%. The Mentor ObTape was removed from the market in 2006, only three years after it was introduced.
Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.
In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.
18 comments
I had this vaginal mesh surgically put in for incontinence. I had a year or two of relief and am now experiencing the incontinece againetting red. I am also gurring urinary tract infections so I am considering having it remove surcially.
I had a hysterectomy in 2005. The doctor told me that a mesh would help support me and that it was safe. Every since my surgery I have had painful intercourse and some lower stomach pains. I have called to get my medical records so that I may see which mesh was used and find out more info about my surgery. My husband saw the commercial on television about a recall of sorts, so that has me really concerned now.
I had a bladder lift in 2005 using mesh. I am not certain who the manufacturer was. In 2008, after undergoing cancer surgery and chemo, I had to have it removed because I had an infection.
I had a mesh transvaginal sling put in Feb 8th 2011 I have been miserable since about the 3rd wk. I have often severe cramps, burning when I urinate, sitting standing driving bending over has been very hard to do. Sex is a definite no way no how. I get tired easy. I have been diagnosided with “pelivic floor disorder” pain meds. Oh did I mention my hair is breaking from all the meds. Don’t do it ladies for you and your family. I feel so horrible this was supposed to be easy. I am suffering and so is my family!
It all makes since now… I had a bladder lift in 2004 and again in 2008, with the same Doctor in Houston, Texas and the 2nd time with the transvaginal mesh and sling… Since then I have had constant bowl problems, unexplained weight loss (from 170 lbs to 143) which has stabilzed. My groin has occassional pain, lower back, fatigue….as sorts of complications down there… I divorced in October 2008, so I am not sure of any sexual problems but have no idea what to do.. I have had a colonoscopy… nothing…. I feel miserable all the time.. I thought I had cancer.. I am contacting an attorney to see if there is any recoarse to I can attempt to lead a normal life.. I am single for the 1st time in 15 years and have a 12 year old daugher to raise…
I had a hysterectomy and a vaginal mesh and Sling surgically put in for bladder prolapse in 2005 due to childbirth they said. Ever since the surgery I have had NOTHING BUT problems At first intercourse was Very Painful I always feel like I have to go to the bathroom really bad and when I go, barely anything comes out. and once every year since the surgery my bladder will shut down and I wont be able to go at all and it starts to have spasms and end up in the ER in misery and they have to put a cathethor in to relieve my bladder it sucks then this specialist tries to widen my entry way to help me pee better which feels like KNIVES ripping me open it is so painful and Never works. if I knew then what I know now I would have NEVER had the surgery and anyone I hear talking about having it Done I talk them out of it I HATE that I had it done and am so frustrated about it
July of 2008 had surgery . The hospital records indicate the manufacturer to be AMS. My problems are loss of urine during intercourse. I have no control and we have to lay towels down that still do not absorb. I leak 5 or 6 times during intercourse. My bladder hurts often and I seem to have to go alot at night while actually not peeing very much at all then 15 minutes later uncomfortable and have to go again, this happens all the time, 4 to 5 times an hour or so. When Ileak during sex it sometimes is a relief because I know my bladder is managing to get emptied. Not sure if my symptoms fall into the law suits, I have no insurance and live off of alimony payments that are not payed regularly. Any advice?
i have had 2 surgeries for this procedure and still have pain and discomfort daily. now my new stress is finding out exactly which implant was used in my procedure. could this be the reason for all my suffering?
I had the prolapse surgery done last October and have had no problems with the mesh, but… it seems my doctor cut some nerves in my vaginal/clitoral area which now prevents me from having a climax. This is the most distressing thing and the fact that it was never indicated as a possible side effect to me is the worst part. Has anyone else had this situation? If so, is there anything to be done about it?
I had the surgery with the mesh in Dec. 2008. I went to a gyno. she said there was nothing she could do. Surgery is a must. I am awaiting for the doctor who was recommended to contact me for the surgery. I am med.’s for the pain (without any relief) I am basically My insides are falling out.
My aunt under went a surgery in 2000 for the sling and it took till 2005 for her to finally tell a doctor about the pain that was coming from her pelvis. because she is a mentally impaired patient they think she had be making this up so now we are trying to undergo suregeries for her to get it out but we think its to late that it has already attached to other organs and caroted( dont know if i spelled that correctly) does anyone know of a good lawyer? We need as much help as we can get!
My wife had the lift twice, and the third operation was the Mesh. The Mesh did a lot of harm, pain and mental anguish and sever pain when it comes to sex. Lawyers in 2009 said there is no case to be considered. Now I hope justice will be done finally. I know what she goes through and my heart goes to all those women who suffer. Now she need a 4th operation due to a bad hernia caused by the Mesh.
Is that the health system we Bragg about???
I had a bladder sling and a rectal sling put in 1996. A week later I was still unable to urinate.. The Dr. cut the sling. A few weeks later I was smelling like an absess tooth (infection), and had a lot of bleeding.. I was back and forth to Houston to the Dr. They told me nothing, even though my husband saw the sling hanging out while I was being examined. I went to a Dr. out of town, and he said I had to go back to the surgeon, that I had a serious problem.. I went to same place, and they removed the sling, and tried to treat the absesses and infections. It took many prescriptions of antibiotics to clear it up.. After all was well, I had surgery NO. 4. I have had pain, discomfort, and still incontinent since that time in 2007. I have not been back.. I was treated like it was my fault.. I cried all 4 times being put under.. I even contacted an attorney that said that I was lucky to be alive with the infections so bad. (there was no lawsuits pending at that time) I hope that we can all get compensated for our pain and suffering.
Everything I am stating is true and correct. I hope that all women with pelvic organ prolapse –POP–reads this story–my story. I hope that every attorney whether they stand to gain anything monetarily or not will take heed to my words—take them as serious as if their wives, daughters, mothers or girlfriends were me! And, I hope that, given any good opportunity ,that you help compensate women by prosecuting Doctors that do not abide by their oaths to do no harm.
My health was great until I had a bi-lateral oophorectomy in 2001. My life, thereafter, would never be the same–had first cystocele repair in 2004–NO GRAFT BUT GORETEX SUTURES WERE USED. THEY ARE PERMANENT AND CAN CAUSE NERVE DAMAGE. Surgery went great as did the outcome until 2006 when I lifted ceramic pots while gardening and felt intense pain–pelvic and back.
Diagnosed, agian, with severe cystocele in 06. SECOND CYSTOCELE REPAIR WITH PORCINE PELVISOFT GRAFT IN 06. Post-0p urinary retention—severe unrelenting pain which required harsh narcotic pain meds to relieve.
Surgeon in question-in Jax, Fl informed me that the graft was fine–he never had to remove one–only to adjust it. I became bedridden during this time–engaged to be married—and my family had to fly me home to Kentucky due to my illness. My son had to fly to Fl. to fly home with me–I was self cathing during this time.
After seeing mulitiple doctors in Louisville, Ky–Mayo Clinic in Jax, Fl, I was examined in Alpharetta, Ga by an excellent Dr. During A laparascopic procedure to definitively find and remove or repair whatever was wrong with me this Dr. discovered shattered graft materials floating around in my abdominal cavity along with severe bowel adhesive disease.
I was better but pain persisited. I found myself, now sitting in the office of pain management. I was told by numerous doctors that neurons from the rejection of the graft in Fl. would not shut off because of the length of time and severity of the rejection of the graft and, therefore, the pain would persist.
Cystocele symptoms persisted but at least the graft material s were gone as were adhesions or scar tissue. I, now found myself under the care of pain management. I continued to have urinary retention, trips to the ER, foley catheters, and emtional distress due to TRAUMA FROM CONTINUED PAIN.
My life revolved around pelvic organ prolapse and severe pain. I continued to seek help–trying to have a normal life. I consented to see a Dr. in Bardstown, Ky because of the urinary retention and vaginal pain. I researched hours trying to find a cure for POP. Now, I had to rely solely on insurance companies for financial help. I saw the bardstown physican–presenting with symptoms of retention and cystocele. I, now, had a rectocle as well and fecal incontinence.
My story does not end there. I have worked for nearly 30 years in the medical field—part of it at Mayo Clinic in cardiology. I NEVER saw the sinister side of medicine. But, I have, Now. During this surgery, without my consent—I was alsleep–under anesthesia–after the doctor had reviewed—-SUPPOSEDLY–my records and after me telling him that I did not think that his NEWLY DISCOVERED MESH MATERIAL would be a good idea for me–I awakened from surgery with an OMNISURE POLYPROPYLENE SLING MEANT FOR INCONTINENCE!. I awakend from this surgery in a urine-soaked bed, in severe pain and demanding to speak to the Dr.
I felt as if I had been violated in some way from This dr. that took a Hippocratic oath to do no harm—–I told his nurse that I did not consent to have any graft placement. She advised him and he made it seem as if he had no choice but to use the graft and that I did consent. I was and am afraid of him. I was very sedated post-op–very sedated. My speech was impaired—I had swelling in both ankles. He told me that I DID consent to have a graft placed. I, now, have my records from him and the hospital. My diagnosis is urinary incontinence. I have a large shoebox full of medical records that NEVER mention incontinece–quite the opposite.
POSTOPERATIVELY, I PLACED A CALL TO THIS MAN’S OFFICE—ASKING TO BE SEEN—REPORTING SERIOUS ABDOMINAL PAIN. THE NURSE PUT ME ON HOLD AND CAME BACK ON THE PHONE TO TELL ME THAT i HAD JUST BEEN CHECKED TWO DAYS AGO AND DR. DOGE WOULD NOT SEE ME. I PLACED A CALL TO MY BEST FRIEND—SHE TOLD ME TO CALL HIM BACK AND THREATEN TO SUE HIM IF HE DID NOT SEE ME. I CALLED MY PRIMARY CARE DR. HE TOLD ME TO SAY THAT I WAS STILL UNDR HIS CARE AND HE NEEDED TO SEE ME. I CALLED BACK AND SAID ALL OF THE ABOVE.
After that call I was barely acknowledged by the man and his entire practice. I was released at the last post op check up and told that everything was as it should be.
I saw a Dr. that a friend knew here in Louisville, Ky–a urologist. He immediately sent me to Indianapolis, Idiana where I was told that I had a severe post op infection and needed immediate surgery to remove the sling.
By the time I Was feeling well enough to sit stand function without help—statute of limitations was over. (one year in Ky) I became somewhat stable until the end of april. I feel as the prolapse has worsened. I cannot sit, stand, eat,walk—have times when I feel as if I have to void every 15 minutes and times when I have retention. I am bedridden for days at a time. My Son, now, lives with me. I suffer from Trauma—-severe Trauma.
But, I am not a quitter—I hever have been–I am pursuing–through the state of Ky—to have this man and his practice investigated. I have read—recently –medical records that include falsle diagnoses—false accusations and unconscionable statements–attacking my character and credibility.
i had tubligation after my 2nd child a few years later had a tubal pregnancy. i also had endometriosis that had grown my organs together. i miss carried but could not pass the baby because the tube was grown shut. i was admitted in the hospital to have a hysterectomy. i didn’t know anything about a mesh sling implant it was never explained to me. i didn’t even know i had one until discussing all the problems i was having with a friend. she said you probaly have a bad sling. so i researched it and found that all the problems i had been having were due to the sling. i have been to so many doctors over the years and none ever mentioned it, they treated me like i was crazy, and there was nothing wrog with me. i can’t believe a doctor should be able to put something in your body without your knowledge that is dangerous and life altering. it is moraly wrong. i am 38 now and i can’t leave my home without going to the bathroom and going again when i get there. i feel like my life was taken from me.
Hey Karen I have had two c section I have so many problems now I think that’s what happen to me I didn’t know they can put it in you without your consent
I had the vaginal mesh implant in July of 2008, I have been to emergencyroom, my regular MD and Urogynocologists. I have not worken in the last 2 and a half years, in so so much pain and constant infections, I have no insurance, nor do I have thousands of dollars to
pay for a really good doctor. Urogynocoligist that I finally did get to see
was very helpful at first, I was told that he would be performing a urodynamics test and also a cystoscopy. When he found out that I would be self pay, there were no test performed, he told me ” well if you had the vaginal mesh it must have dissolved, he then set me up with pelvic floor therapy telling me that my pelvic floor was too tight and that it was somehow pressing on a nerve causing me pelvic and leg pain. Forgot to mention that he did a pelvic exam and took a urine specimen and found that I had another UTI. He told me that the therapy would solve all my problems and that I would be able to have sexual intercourse again and that all my pain would just go away. After a few degrading statements that he made to me I decided that I would not see him again. Now I have no case and Have a terrible feeling that my lawsuit will dropped. I am so sure that there are several other women that are going through the same thing, I am so depressed over the whole situation and I don’t know who to turn to, I have no friends or family that can lend me this money. If there is anyone out there that is in my situation or you know of someone that is can you please give me some suggestions?
I had a laparoscopic assisted vaginal hysterectomy in 2002 at the age of 25. After having issue with incontinence my doctor recommended a vaginal mesh sling, TVT technique, to support my bladder. I had this procedure done in 2003. The procedure worked for about one year and then I gradually started getting the symptoms again. By 2010 I could not take it any more. I had a second degree cystocele and the doctor recommended me having the sling repositioned using the TOT technique. So now I here it is 10 years later and my sling is failing me yet again and symptoms are far worse than ever before. Having to seek a new doctor to have the sling removed, because original surgeon no longer does surgeries. Perfect!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!