Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study
Sports Betting Addiction Lawsuit Sports betting addiction lawsuits are being investigated for college students and young adults who developed gambling problems after using apps like FanDuel and DraftKings, alleging that the platforms failed to warn about the addictive nature of their features and marketing practices.
Nitrous Oxide Lawsuit Individuals who suffered harm, or families who lost a loved one after using nitrous oxide products may be eligible for financial compensation through a nitrous oxide lawsuit.
Hair Relaxer Lawsuit Regular exposure to chemicals in hair relaxer may cause uterine cancer, ovarian cancer and other injuries. Women diagnosed with cancer may be eligible for settlement benefits.
Depo-Provera Lawsuit Depo-Provera lawsuits are being investigated for women who developed meningioma brain tumors after receiving Depo-Provera birth control shots, claiming that Pfizer failed to adequately disclose side effects.
Ozempic Lawsuit Lawyers are pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits over gastroparesis or stomach paralysis, which can leave users with long-term gastrointestinal side effects
Suboxone Tooth Decay Lawsuit Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.
Change Healthcare Lawsuit Lawyers are reviewing Change Healthcare class action lawsuits for individuals who had their personal information stolen due to the data breach.
Bard PowerPort Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
AngioDynamics Port Catheter Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Processed Food Lawsuit Lawsuits are being pursued against the food industry over their manufacturing and advertising of ultra-processed foods, which have caused a generation of children to face an increased risk of developing childhood diabetes and other chronic illnesses.
FDA Warns About Complications of Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence October 22, 2008 AboutLawsuits Add Your Comments The FDA issued a public health notification yesterday to warn about a number of serious problems that have been associated with transvaginal placement of surgical mesh that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to reports received by the FDA from nine different manufacturers, over 1,000 people have suffered severe complications from the surgical mesh, including reports of infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. Women have also reported recurrences of the prolapse or incontinence, and the need for additional surgeries to remove mesh that had eroded into the vagina. 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. The surgical mesh is used to support the muscle. Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Female stress urinary incontinence is a condition where urine is involuntarily released during moments of physical stress due to weakened of the muscles that support the bladder and urethra. In repair procedures, the surgical mesh is designed to act like a hammock to reinforce the muscle. The FDA recommended that physicians obtain specialized training for various placement techniques and that they closely monitor patients for problems with the surgical mesh. They have also indicated that patients should be informed of the surgical mesh risks, so that they understand that complications could seriously impact their quality of life. No specific groups of patients were identified as being at an increased risk of thee surgical mesh complications. In addition, the notification does not single out any particular manufacturers or types of mesh. In 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 large number of women experienced severe problems. The Mentor ObTape surgical mesh differed from most other mesh devices, since it contained a “non-woven” design. This blocked oxygen and nutrients, substantially increasing the risk of surgical mesh problems, and some estimates suggested that the complication rate could be as high as 17% to 18%. There are currently 22 ObTape surgical mesh lawsuits pending throughout the United States, which have been filed by women who suffered severe infections, extrusions and urinary tract erosions. Tags: ObTape, Surgical Mesh, Vaginal Sling More Vaginal Mesh Lawsuit Stories Study Finds Some Transvaginal Mesh Degrades Within 2 Months After It Is Implanted October 29, 2024 Supreme Court Rejects J&J Bid to Overturn $302M Vaginal Mesh Lawsuit Award February 23, 2023 Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study January 16, 2023 203 Comments Yvonne October 24, 2009 Hello to all . I am back to update you regarding the Mesh issue. I have had the opportunity to see my new surgeon and have surgical plans set for three weeks from now while I arrange my own patient schedule. The plan is to remove as much of the two Mesh slings as possible by peeling them from my urethra, bladder and other surrounding tissue. The urodynamics and cystoscopy tests I endured were extremely painful when normally they are not due to the nerve damage found that I now have from the mesh erosion and original surgery. Oh, did I mention from my records review received from my previous Urologist, I was told by my new surgeon that I never needed to have the urethral sling based upon the fact that I never had incontinence and I never needed to have the bladder mesh because I never had anything more than a 2 plus prolapse bladder but told I had a 4 under anesthesia, therefore; was documented as such and told I needed to have it fixed. I discovered my previous Urologist embellished the records so that he would get authorization to do the procedure by my insurance co. That was when I had insurance. Now I have none. I was laid off and now work part time, so I now have to pay cash out of my home equity to have the extensive repair for a surgery I never even needed which has left me injured and with permanent nerve pain. I am so very sorry to hear that there are other women who have been injured by these products and by the medical providers who see fit to continue to use the products despite the complications. There must be a pay-off somewhere! God Bless you all! Mary October 17, 2009 Dear Sisters, I feel like I know you all and I could have written most of these articles. I had a rectal and bladder sling surgery for what I thought was bladder infections. The operation was a failure and I couldn’t hold my urine at all. The dr. said she’d have to redo the surgery. Before the surgery she said you’re going to be so happy with the surgery. So after two surgeries now I have mesh protruding through my vagina at two places. I have terrible back pain and a different dr. said I’d need surgery to repair the tears. I am bleeding, spotting and have a bladder infection. I’m still working and it’s so hard. My bowels are terrible and I’m always straining and constipated. I’D GIVE ANYTHING IF i’D NEVER WOULD HAVE HAD THIS OPERATION DONE. I was much better before. Now I’m facing more surgery and this awful back pain. I cry lots with pain and I want this mesh OUT. Is there any help???? How can so many have been treated so badly. So sorry. Love you all. Wish I could help. We must band together so noone else will suffer. sterre October 13, 2009 Dear women, I’m living in Europe and also a victim of Gynecare mesh. In decmber 2006 I’ve had a total Prolift. Since that time lots of pain. In a few weeks I will visit another surgeon to ask for removal. I don’t know if that is possible. Now I’m feeling sad and it is impossible to do my work. Cindy October 5, 2009 Just found out over the weekend that Gynecare mesh was used in my surgery Aug ’08. Have another appointment with a surgeon but not feeling like he is the one to do the removal and fix the prolapse that never was fixed by the mesh. Would love some input on where to go if living in Maryland. martha October 3, 2009 HELP! I’ve undergone TWO surgeries this year for vaginal prolapse and more and problem just keep getting worse while doctors say they can no longer help. HOW CAN I GET THE MESH REMOVED and a doctor who cares! lynda September 28, 2009 I had a monarc sling in 2005, terrible pain in leg, swelling still now in 2009, didn’t help the leaking,, also i was on pain pills which may have caused the leaky but they never said that , just wanted to do the sling, sorry I ever did still haveing pain and swlling in the upper inner part of my thigh, also had blood transfusion, doc said there was a point I should have stopped, sorry, ha, I tried to sue but attorneys said I still have both legs, and then destroyed all my paper work and took it to the out to the statue of limitations Cindy September 22, 2009 Comment by Susan H on 18 August 2009: It is Susan from above. I have been wondering, if anybody had been diagnoised with fibromyalgia before this surgery , or any type of arthriitis. Since having this mesh placed, I believe that it has worsened by symptoms of these disease. I ache and hurt all over, and it seems that my bones and muscles hurt much worse, and the pain seems to be progressing. Susan, now that you mention it, I have had all over aches and pains and have wondered if I have fibromyalgia. I do have arthritis in my lower back anyway, but the pain in the back has been lower since my surgery a little over a year ago. I had uterine prolapse, rectocele, and cystocele surgery resulting in my uterus and cervix (found out was precancerous) removed and mesh being used to repair the rectocele and cystocele. Now a year later and a urogyn says the mesh needs to come out and the prolapse (both rectocele and cystocele again) would have to be addressed in another surgery. Although he could help the leaking issue in the first one. rebecca c September 22, 2009 IN RESPONSE to SUSAN H…. I too was diagnosed with Fibromyalgia prior to my pelvic surgeies.I had my surgeries done 6 days ago and feel so uneducated on what the recovery REALLY is like. I have given myself two enemas due to the constipation (due to surgery and narcotics). My back pain is almost unbearble. I take Tramadol for my Fibromyalgia and now since surgery the Tramadol dont even ease the pain for a moment. I am helpless and in major pain. I am a tough cookie, 2 kids, work full time, and with this Fibromyalgia and NOW constant low back pain, I am becoming depressed. I felt rushed out of the hospital after 3 days. I was not given an antibiotic after I left hospital and fear infection, due to constant pain in pelvic area and fever. Dr says all is fine and when I asked “could I be infected”, he laughed and said :no, silly”..HELP Lana September 20, 2009 These doctors who deny the complications are mesh are pathetic. They are so interested in covering their fannies, they tell any lie necessary. I am so sorry everyonei is suffering so. I have taken action and contnue to fight for all of you. Truth in Medicine is leading the charge to get this stuff off the market. Our website is www. truthinmedicine. us. com Our first conference is this coming weekend. We have a good group of medical professionals who will be speaking and who we are bringing together to help women like the ones on this site who have been abandoned. Hope you find the solutions you are looking for. Marion September 18, 2009 I wrote a comment several weeks ago. My surgery was on May 9, 2008. Since my last report, I have had 2 ct scans, several ultra-sounds, blood tests and put on depression medicines to calm my nerves. Before the surgery, I was in great health but since, I have fallen apart. I had severe heart palpitations and put on another blood pressure medicine. I am taking 3 different b/p medicines. I am also on warfarin which is a blood thinner. I was sent to a heart specialist and now am going to a pulmonary heart doctor. My stomach is still so bloated as I stated in my last blog. I look like I am pregnant and due any minute. It still bothers me to walk without holding my stomach so it won’t giggle due to the pain. I am seeing my woman specialist again for a consultation as to what is causing all this problem. If she finds all of these problems are caused from the mesh, she is going to have surgery done to hopefully correct what was done to me. My back hasn’t stopped aching since my surgery over 16 months ago. She suspects my body is rejecting the mesh. My primary doctor says all of these tests and specialist visits are to cover all the avenues. (in other words, cover their a_ s) before a law suit is maybe done? My heart goes out to all these women that have reported their problems as I am in the same boat without a paddle. If and when I have the surgery I will keep everyone posted on my results. I pray that I will return to normal once again like I was before the prolapse surgery. I regret not doing research on the prolift mesh before I had the procedue done. Never in my wildest dreams did I imagine what I have gone thru. By the way, the collagen helped the incontinence for about 7 months but it has slowly worn off. My woman specialist said when it didn’t help anymore, she would inject a new type of medicine into my uretha which would help the incontinence.for a longer period of time. I NEVER had incontinence before the prolapse surgery. She also has me using Estrace Cream to help with the bleeding. I appreciate reading the coments as I know this is not all in my head. Kelly September 18, 2009 I lost my relationship and my job because I was so sick post, prolift placement. I was to have an A and P repair. The DVD that I received to view as a learning tool made it look like I was going on a holiday.They kept saying how much better the sex would be. (I never ever had any problems with it.) 7 weeks post surgically everything fell out. My uterus was literally sitting in my panties. The pain was terrible and I was driven into a terrible depression which I still haven’t overcome. I have never been treated for dpression. A month after the failed procedure I had to have a laproscopic hyster and was out 5 hours to have the mesh removed. I still have a piece in my rectum. 3 weeks after that I developed a hematoma inside my anterior wall as the porcine mesh the Dr. placed to support the wall was decaying and it had to be removed that afternoon. I am in pain every day. I can’t have a whole relationship with a man and may never be able to again without pain. I have only just now been able to wash there without feeling like a freak. The hospital wishes to offer me a settlement. They had better make it good because I have reached the point that I would sooner see it tried in court and not win a penny than have any other woman have to endure this. I wouldn’t have done this to my dog. My heart is broken. This product need to be removed from the market. Guess what the Dr. used to support my bladder after the mesh came out. MY OWN LIGAMENTS! DUH! Thanks for offering me that in the first place. I can’t say the Dr’s name but she sure took my money. I hope she rots in —-. I have to have pelvic floor physio and have been referred to a sexual therapist. I’m just so devastated. I tried to have relations and ended up in the bathroom with the door locked sobbing. Yvonne September 7, 2009 Hello again. I thought I would update you to the latest regarding the erosion of the mesh with extrusion given my initial report that my Urologist/surgeon denied the second repair failed. I recently was seen by my Primary care MD who is female and does OBGYN care as well. She examined me thoroughly and found the erosion and the extrusion with the fistula. She also found that there were two similar small areas of erosions as rough in the most upper portion of the vaginal area on each side where the “arms” of the sling are attached, a part I did not were a problem as the Urologist never said anything to me. My Primary care MD confirmed this needed to be addressed as I had been distressed and tried to convey to the Specialist who basically ignored two weeks earlier. I lost trust in him. I told her I would not return to see him and wanted a referral to a Urogyncologist who could handle such complicated cases. Her response to me was compassionate and firmly stated: “You gave him an opportunity to address this now, twice. When there was a continued problem and he did not acknowledge this, I agree it is time to move on.” I can only surmise from the sample of cases I am reading and the cases that will continue to be posted that women will find they too are not alone when they investigate what has happened to them with placement of the transvaginal meshes and the post operative complications. There are likely thousands of other women who will eventually find their way to this very site just as we have. I hope they too will report what has happened to them in the same manner. It is my belief that there is significant under reporting by the Physicians. The reason I say this is because I believe the patients are reporting the symptoms and having repairs done, but not all and in fact few of the repairs are being reported or the FDA would be taking more notice than they have and would look into this more seriously than it would appear they are doing at this time, or at the very least insist on forcing the various manufacturers of the “Meshes” to re-call their products due to lack of safety until further investigation can be performed. Today, I filled out a survey sent to me by the hospital and the surgery center where my surgeries have been performed and I questioned them in the comments section if my surgeon has properly reported to the FDA the complications related to the meshes as required are to be reported. I placed them on notice that I am aware of the proper reporting procedures. Geralyn September 2, 2009 Amy I am not a doc. BUT it sounds like you need to find another doc. But before you even do that. GO to an emergency rooom and complain abuot the pain so somebody will take an x ray. Amy September 2, 2009 I was scheduled to have a partial hysterectomy, laprascopic, in July of 2009. I was told I would be off work one week. That didnt happen. I woke up in recovery with a catherter and severe pain. While performing the hysterectomy, my surgeon said I had quite alot of scar tissue that he began to remove. Doing so, he accidently knicked my bladdar and had to then had to open me up and repair my bladder. He also mentioned that he placed “mesh” inside me so the scar tissue wouldnt grow back again. I also was required to have a catherter for 2 weeks which alone with the pain from the incision was too unbearable. About two weeks into my recovery I noticed a horrible odor. I called the doctor and was diagnosed was a bacterial vaginal infection. I returned to work on the 24th of August thinking I finally had a clean bill of health. I was wrong. I began having these horrible sharp pains near my pelvic bone on my right side of my body. The kind of pain that would bend me over trying to catch my breath. The pain would gradully go away and suddenly and unexpectantly happen again. It feels like someone in stabbing me over and over again. I cannot hold my urine anymore either and sex with my boyfirend is horrendous. It is so painful! I went back to my surgeon and he told me is all a part of recovery and maybe I returned back to work too soon. Prescribed me some toradol and excused me from work another two weeks. I have read some of these blogs and I am wondering if anyone has any knowledge of what is happening to me and if I am going to continue to have these problems. I am a single mom working two jobs, raising two teenagers and need some answers. Laura August 24, 2009 Susan, I had a hysterectomy with A&P repair in 2006. Immediately following the procedure had terrible pain in my spine. It was so bad I couldn’t turn over in bed and had to carefully work my way out of the bed. I found that I had arthritis by having an MRI, but these symptoms were not present to my knowledge as such prior to surgery. I had an accute attack of arthritis, and I spent the last two and a half years seeking and getting help for arthritis symptoms after the hysterectomy with A&P repair.. Further, The gynecological surgeon essentially blamed my bodies autoimmune (ARTHRITIS!!!!), problem for causing me to have 11 months of bleeding vaginally after the hysterectomy and needing to be burned and coterized several times removing granuloma tissue before he pulled out a long suture vaginally. WA LA!, it seemed as if that problem was gone, but it layed beneath the surface until this year. My husband left me during the continual bleeding thing. I had no sex for nearly three years, and therefore did not have erosion vaginally that I could detect, nor did I have any symptoms other than severe back pain that went thru to my hip. Diagnosis, Osteoarthritis.. I have been standing up and falling to the floor, feeling as if my hip is giving out, this started a year after the surgery. Scans were done and no doctor was able to give any explanation for my hip failing me!!, reading this blog has been eye opening. Then it finally happened, The bio arc sling got ugly enough to portrude vaginally and I found it over 2 1/2 years later!, The surgeon who did the surgery, said that I would probably have a tiny knot of string needing removal. A second surgeon went in and found a huge mess!!!, an infected ball of granuloma tissue, the sling had broke and rolled up like a taco in two places, one going vaginally and one toward my pelvic bone. I cannot sit for more than an hour and three colonal rectal doctors say I can do nothing. I am currently trying to get help for pain that has continued possibly due to the posterior portion but still could be remaining mesh. After the sling removal I tried to work until I couldn’t bear the pain any longer. The mesh is supposed to dissolve right, no worries!!!,..The posterior part is not operable?!, I am now unemployed and paying for Cobra health insurance. What is it going to take for the FDA to stop allowing doctors to have women be put at risk and for doctors to be quietly sitting aside not telling women the truth after the slings and mesh implants have been put in as to the problems that might occur. I suppose its ridiculous to consider a recall of the slings? Or is it. Were IUD’s recalled at some point? I think all women who have ever had a mesh implant ought to be contacted by the FDA as to the warnings of complcations that could arise assuming the medical community is too scared to do it. Also, we need to be given avenues to get immediate help! from doctors who are knowledgeable if seroius implications of damage arise. Why are we left out here to suffer,?!, The last three years of my life have been spent with suffering and maybe, the erosion wouldn’t have caused so much damage if I could have been INFORMED and TREATED sooner. I went thru HECK of a process and was given warnings forward backwards and sideways in order to begin taking the drug accutane!, WOMEN there ought to be fair warning given to us regarding complications, especially after having ANY SUSPICIOUS SYMPTOMS after an implant has been done!!!, Can the FDA somehow help the doctors so they can become a women’s best advocate and start treating women quickly who could possibly be having mesh complications? I need a surgeron, can anyone help me?, Penny August 24, 2009 At 52 I had a prolapsed bladder and a uteris full of fibroids. With my gyn we made the decision to do a complete hystorectomy and she recommend the use of “this great new mesh” that would make the bladder stay in place longer. I had the first surgery in Sep 07. I did not have many issues at that time but within months my husband could feel the mesh and then I began to feel it. I went back to my gyn and he cut some of it away and told me if it continued to be an issue I would need to have surgery so they could cut it closer to the tissue. I thank God that when it did continue I decided to find a new doctor. I had gone to the office of a Womens Pelvice Surgeon for tests before the first surgery so I decided to go back to him. Based upon what I know now that was probally one of the best decisions I have ever made. He explained that my body was rejecting the mesh and that my bladder was already falling again. He also explained that the mesh was created so that more doctors could do this surgery. He also told me that he was seeing a lot of women with mesh problems and removing it for most of them. I was set to retire in January 09 so I wanted to go ahead and get this fixed before I changed insurance. Another great decision as when he performed the surgery he found that the mesh had mostly balled up inside me and had created a “Steril Absess”. I have no doubt that had I not acted as quickly as I did I would have suffered as many of you have. My recommendation is to find a good “Womens Pelvic Surgeon” and get a consult. Also to tell every women we know to never allow anyone to use the mesh on her. Yvonne August 23, 2009 This is Yvonne from above. I read my lengthy paragraph and found spelling errors and omissions. I wanted to clarify a couple of things. My Urologist never agreed that the second and more serious erosion and extrusion has occurred. I am now in the process of seeking another MD for yet another repair due to the pain of the material that is falling out and rough. The other omission is that my life has been completely change by this and certainly not for the better. My husband and I have not been able to be sexually active due to this since November 2008. Before this we had a fulfilling intimate life which has been destroyed. Prior to the sligs, I never had back, hip or buttock pain the radiated to my posterior thighs. I have trouble sitting and even lying down due to throbbing and shooting pain. I had this pain gradually come on and it has grown in intensity over the past 9 months. The pain is in the entire pelvic girdle and is deep bone pain it is like nothing I have ever experienced before and I have had a c-spine fusion multiple levels anterior and posterior of which I take no pain medications. I had a fused ankle. This pain is far greater in intensity. Yvonne August 23, 2009 On November 5th 2008, I had the Monarc and Perigee slings placed without complications. For two weeks I could barely walk due to bilateral hip and groin pain, but otherwise things seemed to run the usual course. The one problematic thing I did notice was a constant greenish vaginal discharge that never went away even after my two month check-up. I saw the Urologist at two weeks post -op and he said he did not want to see me back for four months. I was subsequently laid off and lost my insurance. During that time, my husband and I remained abstinent due to the severe discharge and the fact I felt the anterior mesh. I continued the cream daily as the Urologist had instructed, but by the end of May 2009 when this did not close and pieces were hanging out of the opening ass well as the hip pain and buttock pain continuing and increasing, I went back to the Urologist paid him cash and said FIX this! I then had the excision of the eroded and extruded mesh and take down of the necrotic tissue around the area of the opening where the mesh was eroding out from. Then at 5 by six weeks the mesh had eroded out again, so I went back to the Urologist to show him. He looked in there and said to me, “I only see two small areas at the very top where the arms are that are not healed that I can feel” . ” I The suture line is intact and there is no mesh exposed.” I told him back up to the anterior repair that you did because there is again a piece dangling on the left and the entire line again exposed my husband can feel this and I can feel this it is even larger than before and more rough. The piece hanging is larger. He had his MA glance over his shoulder and quickly concur and that was that. I am a medical professional who performs pelvic exams on women, so I know what to look for, how to examine them and he did not perform due diligence. I was appalled. He would not listen to me and wanted no part of another problem, it was very clear. I was never given any literature about the meshes and the possible failures nor was I counseled about the fact that i likely was not a good candidate for the meshes given that I have extremely thin vaginal tissue due to having had hysterectomy at the age of thirty two and being fifty now with estrogen levels having been depleted long ago. I would have never had the mesh placed having known this. I only learned about all of these things by researching this the day of my appointment to evaluate my second erosion and extrusion. I have been told like many of these other women to go home and use the Premarin Vaginal cream. Well, I can attest to using this faithfully and compliantly for a daily regimen for many months without any success. It is my belief that the surgeons resort to telling the patients to use this as a back-up so they have something to hang their hats on in court when it comes to patient compliance when they have nothing else to place blame on and have to come back to the patient when something fails. Susan H August 18, 2009 It is Susan from above. I have been wondering, if anybody had been diagnoised with fibromyalgia before this surgery , or any type of arthriitis. Since having this mesh placed, I believe that it has worsened by symptoms of these disease. I ache and hurt all over, and it seems that my bones and muscles hurt much worse, and the pain seems to be progressing. D'Anna August 16, 2009 I had bladder and rectal repair due to the tissue being thin in both areas. I had some incontinence and was told by my doctor that the surgery would not be a walk in the park. What she didn’t tell me was it would be a long walk through hell! The gynecare was used placed in my body on Oct 22,2008. I wnt home with a catherater and one week later the cath was removed. I could not urinate on my own. For 3 months I self cathed and had repeated infections. On January 15,2009 the same doctor went back in and cut the mesh away from my urethra so that I could urinate on my own. On May 28, 2009 I had my vagina pulled back up because it had “fallen”. This surgery was done by one of the best in Ohio. I am now experiancing buring, vaginal yeast infections and lower stomach cramping. Sex is very painful and I am trying to continue to keep my job. If you have a doctor that is telling you to have thias surgery, do your reseach and have a secondary game plan. I am 50 years old and wish I could turn back time to Sept 2008 when I thought it would help me to have this reapir surgery. Vendla August 16, 2009 I’ve now had 3 surgeries related to Apogee & Parigee systems. I’m appalled when I read everything on this site! It is like all of us were in the same place with this. Not a fun way to try and have a problem addressed and have it fail due to a product! The last surgery was a abdominal, not vaginal thanks to all the problems created by this. Susan H August 16, 2009 I had anteroir/posterior lift in May 2007, several months after I had several heavy periods and then stopped having them. I also starteded feeling stuff that was sticking me, and sometimes very painful intercourse. I went back Dec 2008 for heavy bleeding, and had a DC, and a sling revision,I was not told by my physican that there were these complications with the Prolift Sling. Feb 09, I had a ruptured ovary on my left side, with a cyst on the lright ovary, this resulted in a total abdominal hysterectomy. For nine weeks I kept telling my OB that I felt something sticking me, sex was painful, my lower abdomin hurt, and up in the left side at my kidneys. I was put on Premarin Cream 1Mg every night for two weeks, at my follow up visit I informed him that it felt as if something was comming out, I was told my vagina was swollen and irritated from the cream, and to cut back. Every office visit I have told him about the pain, my husband penis was actually cut from the mesh, I informed my OB, who told me he did no’t see any more mesh protruding, but my husband looked with a flashlight and found a piece sticking out that looked like a candle wick, why my doctor could not see this I do not know. It has caused a lot of misery in my life, and has affected my mental state. As I sit and write this I still feel as if something is sticking me. I want this fixed and to be my self again, sex is getting non-exsitence due to the factt, my husband, and I can feel the rough edges of this. I want compenstated for this pain and misery. This has caused a great distress in my life laura s. August 11, 2009 I am another victim of the surgical mesh. I suffered for almost a year before I had the straps of the mesh patch surgically released. The surgeon that did the original surgery told me twice that the mesh was not the problem, which delayed my diagnosis by many months filled with pain, embaressment, and depression. I am asking anyone who has experienced this horrible result from the mesh to please, please, report this to the FDA and don’t give up on finding a urologist or specialist surgeon to help you with your condition. Don’t let the pharmacuetical companies ruin your life by giving up on this fight to bring an awareness of their dangerous products into the publlic eye. Also, don’t be too trusting of some of the misleading surgeons that don’t explain the complete side effects of the unnatural substances that they are putting in your body for their own profit. Be a voice for yourself as well as our future generation! Marion July 1, 2009 This is Marion again ( see the above). It is now July 1st and am still just as miserable. The bloating is getting worse, my back is killing me, I still have leg pain. The collegen helped at first but my incontinece is coming back. I wear pads day and night. Oh how I wish I could turn back the clock. I would rather have the prolapse than what I have gone thru since May 9th, 2008. By evening, my stomach feels like it is going to burst, my back feels like it is going to break, and I have pain in my left kidney area. My female doctor has removed peices of mesh and I am now having her save the peices of mesh she has removed. I am waiting for the results from my primary doctor to see what is going on. Please, please tell others of the problems that can result from this surgery. I have gained weight due to not being able to be active like I was before the surgery. Reading over the other comments, it all sounds so familiar! I have been contacted by attorneys but am waiting for the results of all the test that I have had in the last 2 months. I will then decide what steps I should take. Marion May 24, 2009 I had surgery on May 9, 2008 for uterine prolapse. What a mistake!!!! I had no incontinence befoere the surgery. It was just my bladder coming out of my vagina. I was referred to a gynacologist which recommended surgery. My mom and sister had it done over 40 some years ago and never had a problem after thar. My gynacologist did the surgery after taking lessons from a docter in Las Vegas. He used a prolift mesh which he said was a new procedure. I had the surgery May 9th, 2008. The hospital neglected to do an ultrasound which was recommended by the doctor after the surgery. It was not done! I was in such pain during the nights following the surgery I actually asked the nurse to give me something to let me die. They said they could not do that. They gave me morphine and also a morphine pump to help with the pain. I was trying to vomit all night with nothing to come up. They gave me something to help the vomiting but still nothing helped. My stomach hurt so bad from the dry heaves, I could hardly move. When the doctor came in, which was Mothers Day 2008, a nurse was with him to check how I was feeling. I told him my suffering and wanted to die. He asked if I had had an ultrasound. I told him I had not had one. No catheter was put in after the surgery. He and the nurse inserted a catheter and their comment was “no wonder you were in such pain, your badder was full and over flowing”. They catherized me. I filled the bag and it over flowed. They drained 700 to 800 cc. I told the doctor I couldn’t go home as I was in such pain. He recommended I stayed an extra day and was released May 12 around 6:30 P.M. From that time, I have had NO control of my bladder. I have had pain in my left hip/leg, back pain and severe stomach aching. I went for therapy for my incontinence and back/leg pain with 2 sessions a week for 10 weeks. Nothing has helped. I have had bloating which feels like I am going to burst. I have had 2 CT-Scans, sent to a urologist specialist, and finally to a female specialist 100 miles away in Orange County. I was “home bound” because I could not control my bladder. I was put on antibiotics for UTI’s one after another. My female specialist has done many many procedures, removed mesh several times. She finally injected collegan for my incontinence on March 10th, 2009.. That has helped the incontinence but not the bloating, leg, back pain and the severe pressure on my stomach. The past year has been a night mare. I just had a series of blood tests, am going for a series of ultra-sounds and a heart doctor for more tests. I get light headed and feel like my heart is skipping. I think the stress is getting to me. I felt like I was a healthy 80 year young person before this surgery and now feel like I am a 180 year OLD person. If any person has had all these problems, please let me know. If anyone has any ideas what else can be done, please let me know. I am at a loss. My female specialisrt in Orange County said when the collegen wears off, she will put me in the hospital and do some type of mesh procedure. Sue May 19, 2009 In Nov. 08 I had a full hysterectomy due to bladder prolapse and the mesh. I have had 2 surgeries since to correct and remove alot of the mesh but my bladder is falling out again! I still have pain in sitting, sex of course and the more active I am the more my bladder hangs. My doctor told me about a devise I can insert for activities, has anyone tried it? I also am looking at these lawsuits against the Mentor Corp. or whoever; this needs to stop or be corrected. I’ll never be the same again. I still see my doctor every couple of weeks; keep going till they fix you. Sally May 15, 2009 I had surgery in Ocotber 2008 to repair a grade 3 bladder prolapse and prolapse of the lower bowel. I have had rectal, pelvic and lower back pain since the surgery. I am having a colonoscopy on Tuesday to find out if the issue is my colon or if the sling is causing the problem. Readiing all of the emails with similar complaints really frightens me. My prolapse was really bad but the pain now is even worse. I hope that this can be corrected without complications. I can literally feel two hard nubs that feel like platic at the back of my vagina. This cannot be normal and scares me. Kimberly May 14, 2009 I had a total hysterectomy in May of 2006. I also had surgery for pelvic organ prolaspe using the surgical mesh. My incontinence has not improved and I have pain during intercourse. I was not advised of the FDA alert until last week. I had not been back to my doctor because I thought it was just me and there was nothing to do to fix my problems. I went for a three year check up (doctor recmmended a three year wait for pap test) and complained that I still had urinary problems and pain with sex. The doctor who performed my operation had moved out of state and I saw a new doctor. He told me that the pain was due to the fact that I wasn’t taking hormones and if used hormones that would help. It didn’t. I have a schedule appointment next month to review my “urine diary” to see what can be done. The letter from my doctor’s office with the FDA alert was not sent to me until after I went in for my check up and had complaints about the same problems that were discussed in the FDA alert. Karen May 14, 2009 I had a partial hysterectomy back in 1998 also a bladder repair the surgeon used some kind of mesh back then. Everything was fine I had no problems. Then in 2006, I had to have a rectal repair and also a vaginal repair. I also had a benign cyst on my left ovary that was then removed. The second surgery was done by a different Dr. He had to do another bikini cut like I had the first time. There was alot of bleeding and he said he had a hard time with all of the mesh that was put there from the first surgery. I have had nothing but pain alot of pain. Intercourse with my husband is unbearable. I had been using the premarin vaginal cream, but it does nothing. I just have not been myself since this surgery, also a bloated abdomen, It is like he stitched my abdomen up so tight. Also, my vagina was stitched up very tight. I kept going back and back to this Dr. He informed me every time he does not know why months after I was still feeling that way. He thought it was all in my head, so frustrating. I did not go back to him. Since then my new family Dr. cannot figure out why it is so painful. My lower abdomen is painful also. I’m a mess and I just need some answers, I feel like I’m falling apart mentally and physically. I’m only 48 yrs old and did enjoy an active sex life with my husband. Now we very rarely have intercourse, too painful. Is there anything that can be done. My rectal repair is falling apart and my bladder repair needs a lift again. Sorry if I’m going all over the place with this but I was just searching through the info and I think I finally found my answer. Maybe the mesh. Rhonda May 12, 2009 I had the TVT sling surgery in July 07. I am 35 years old. My gynecologist told me how great it was….and acted like it was an easy fix….and no big deal. Oh how I wish I would have done more research on my own! I started having pain about 6 months after the surgery…a pinching feeling when sitting and walking….and sex was very painful. In July 08 I had my first revision….by this time, the mesh was nearly coming through my vaginal wall….my dr trimmed a piece of the mesh on the right side of the sling. I got through this…..maybe feeling a little better at first. Within a few months, the pinching pain was back. Sitting comfortably was not possible. Sex-painful again. I have had sooo many UTI’s since having the initial surgery. This Feb. (2009), I had my 2nd revision. This time I saw a urologist, not my gynecologist like with the first two surgeries. She removed all the mesh she could from the right side (which has always been my problem area). She said the band was so tight that she understood why I was in pain. After this surgery…I was a new woman! I felt better than I had felt in almost 2 yrs. I felt like I had lost my life before…and now I had it ALL back. I’m talking answered prayers from this nightmare. Don’t know how many nights I cried over all of this. Unfortunately, about a week and a half ago, I started experiencing pain on the right side and frequent urination. I went to see my urologist today. The sling seems to be in place, but she thinks I have inflammation of my pelvic bone (and I had another UTI). Sitting is painful and when I bend over….I feel the pinching and pulling in my vaginal area. I go tomorrow for pelvic xrays and possibly a bone scan. Has anyone else had this problem? It’s like people can’t really understand how this has affected our lives…….I just want my life back…..I don’t care if I pee on myself!!!! Just give me my life back! rosemary May 11, 2009 I had surgery on 11/10/06. I had an A&P repair with the Gynecare Prolift Mesh. I had terrible pain in my left hip and leg upon awakening in the recovery room. I stayed all night in the center, and had awful pain all night. I was told it was probably my back from the position I was in during surgery. The pain lasted for 15 months. I had multiple procedures for mesh erosion, Epidural Steroid Injections for back and hip pain that did not help because it was not my back causing the problem. I experienced terrible pain with intercourse every time we tried. I was told to wait a few weeks and try again, but the pain was too severe. I eventually had to have part of the mesh removed. I still was no better for a few months. I now have some pain in my hip, but things are some better. I put my trust in my Doctor and a product that he believed in and it ruined my life. PLEASE TELL ALL THE WOMEN YOU KNOW THAT IT IS NOT WORTH IT. MY RECORDS ARE NOW AT A ATTORNEYS OFFICE. Lana Keeton May 10, 2009 SAVE THE DATE!! MORE DETAILS COMING SOON!! TRUTH IN MEDICINE FIRST ANNUAL CONFERENCE FRIDAY AND SATURDAY, SEPTEMBER 25-26, 2009 FT. LAUDERDALE, FL USA OUR FABULOUS SPEAKERS: DR. DIANA ZUCKERMAN, PRESIDENT NATIONAL RESEARCH CENTER FOR WOMEN & FAMILIES NANCY MULLER, EXECUTIVE DIRECTOR NATIONAL ASSOCIATION FOR CONTINENCE DR. G. WILLY DAVILA, CHAIRMAN OF THE DEPT OF GYNECOLOGY, HEAD OF UROGYNECOLOGY & RECONSTRUCTIVE PELVIC SURGERY CLEVELAND CLINIC WESTON, WESTON, FL DR. RICHARD MILLER, PROFESSOR OF SURGERY, MEDICAL DIRECTOR, TRAUMA INTENSIVE CARE UNIT, DIV OF TRAUMA AND SURGICAL CRITICAL CARE VANDERBILT UNIVESITY MEDCIAL CENTER NASHVILLE, TENNESSEE Unofficial Events for the Conference: A MEET AND GREET COCKTAIL PARTY on Thursday, September 24, 2009 WORSHIP SERVICE followed by BRUNCH ON SUNDAY, September 27, 2009! HOPE YOU WILL BE ABLE TO ATTEND ALL THE EVENTS!!! I REALLY LOOK FORWARD TO MEETING ALL MY WONDERFUL MESHIE FRIENDS!!:):) GOD BLESS, LANA LANA KEETON FOUNDER and PRESIDENT TRUTH IN MEDICINE INCORPORATED 1521 ALTON ROAD,#198 MIAMI BEACH, FL 33139 Lana May 10, 2009 Jennifer, It is better to be incontinent than to suffer life-long complications and pain from the implantation of sythetic surgical mesh. If a doctor is going to implant a “sling” in you, what is it made of? Most slings nowadays are synthetic….be sure to ask the question… blessings, Lana lou April 28, 2009 I work for a urology group…I know that we rarely use mesh for the sling procedure. I also know that there are manufacturers out there who have done lots of clinical studies to ensure the safety of their product. I think it is a safe procedure, but I would make sure the doctor doing it has done enough that you would feel comfortable about it….. If you are having problems I would go to a doctor..if the one who performed your procedure won’t see you then go somewhere else There is always a good doc around to help you…don’t give up if you are in pain..go out of state if you have to just get some help and some advice Jennifer April 9, 2009 I actually have a question and for some advice.I saw a urologist for the 1st time yesterday,and he advised after examaning me to get this surgery done,due to my bladder being dropped,and causing me problems,leaking when sneezing and various othe things.He said in someone my age(34) I would be crazy not to do this surgery.He does not advise using the mesh,only the sling,unless the sling did not hold,he said he usually does not put the mesh in if you are younger. Maria April 7, 2009 I had the Bard/transvaginal mesh surgery for bladder prolapse in July 07,six monthslater started having pain in my pelvis,sex became painful,I tried toignore thepain as I have 3 kids under 6 and an autistic son, as time went on the ,esh worked its way down in pieces,in Feb of 09 when my husband could feel thehard mesh he forced me to goto my ob,found out the mesh had eroded,was in pices adhered to different organs,emergency surgery 2 days later,5 day hospital stay,went home with a cath bag for a week,bagis out and I’m voiding allll the time,this defective mesh has ruined thelastyearof my life,I have not been able to go back to work,have not had sex in manymany many months and my husband isvery agitated although he knows its not my fault,it has caused marital strife.my ability to be a patient kind mother has deteriorated tothe point family members have been helping out daily with my kids,my nerves are that shot.I have contacted a lawyer and the company directly who made the mesh,been told theyare settling out of court,not sur ewhat road I’ll tak ebut I amdetermined to be compensated,not enough trials were done or theywould have seen the mesh erodes,anyone who has this problem needs to be compensated,call a lawyer,or find out from your Dr. the comapny who madethemesh andn the specific mesh used and contact them and see if they are willing to settle out,there IS a class action suit as we speak but it could drag on for years and I want compensated NOW!I’ll let everyone know my out come,please dont passive,it’s your body you trusted professionalsl to repair,if you’vehad the mesh erosion,you qualify for compensation…………… ksc April 3, 2009 Is it possible that we can unite?I don’t know where to turn for answers?If the FDA comes out with a warning like this,it is obvious we have something to worry about.I worry every day about LONG TERM.I’m in my fiftys,what about when I’m seventy?This material will be old.Will it fall apart?Will it get moldy?Will it cause infection? Can anyone help? I had a miniarc sling placed in 2007.The dr. told me they were very safe.He stated they didn’t have any problems with slings at all. I Sharon March 29, 2009 I had obturator transvaginal tape procedure in 05. I started having pain in 07 and it escalated, also bladder infections. Had a cystoscopy by urologoist who said the tape had not pentrated my bladder and was very defensive about the TVT procedure and did not give me any explanation for my symptoms. I am going to another doctor. Bottom Line: I was pressured into this procedure by my gynologist when I had to have a hysterectomy and I regret ever having this done and am very angry and upset. lisa March 19, 2009 I meant I had to have a colonoscopy and the colon rectal surgeon said that the only treatment if the mesh erodes through the bowel is a colonostomy. Sorry I made a mistake in the last posting. Lisa March 19, 2009 I had an Apogee and a Perigee graft placed in July of 2006 for bladder prolapse , rectocele and entrocele repair. I have had to have 5 surgeries since to remove as much of the mesh that my doctor can I also had to have a hysterectomy due to the mesh problems now my Dr. thinks the mesh is erroding through my rectum. I have had chronic pain, painful intercourse not only for me but also for my husband the mesh cut him during intercourse, painful bowel movements pain in my buttocks at the site where they pull the arms of the graft, and also pain in my hips. I am on pain killers that are no longer helping that much had to go see a colon- rectal specialist had an MRI and have to have a colonostomy all due to this mesh I will NEVER have any other mesh put in my body or wish this on even my worst enemy. I have not been able to find an attorney to help me I have called several but they say there is no class action suit and the manufactors of these products are hard to get anything from because they are so protected and they all want to go after the DR. my new doctor say that the Dr. may be at 10% fault but probably 90% the mesh company. Shirley E. March 6, 2009 In response to Judy from December 19, 2008, I had this surgery about 5 years ago. The hip pain I had from the time I woke up after 5 hrs on the surgery table. They said it was my sciatia from laying on my back so long on a hard table in an awkward position. That pain was so terrible I could hardly move. It lasted day and night for about 6 weeks. and every once in awhile returns but not like that bout. Stiff upper lip, you will make it through. Dianne February 24, 2009 I had a rectocele surgery 2 years ago –after the first one I thought i had strained and did some damage while having constipation issues –went to the dr and had another surgery to repair the mess that I had –went to get the stitches out and found out that i have what feels like a mest wire that has been cut with sharp edges inside my vagina –I am sick about this mess –has anyone else out ther experienced this ?? ksc February 17, 2009 Someone please tell me what to do.I had a sling put in in August 2007.I’m so scared thinking about what is going on with this thing inside me.I had a miniarc sling.I’ve called two lawyers …both said they are involved in different sling lawsuits. With this warning from the FDA I want some help.My urologist has never seen me since this was placed. I don’t know where to turn. jackie February 9, 2009 women, get a good attorney right now!! I am crippled now and the metal in the mesh has given me lupus!! I have been to the ER’s at least monthly since the awful thing was put in May 2007. the worst part, my doctor at loma linda just let the damage keep going and going and only removing the last half of that sling 5 months ago. DO NOT let your doctor take this lightly….my life is destroyed and live on pain killers plus with the lupus now I am fighting for my life. I never imagined the destruction something like this could do to your body. Listen to your body and if you feel something isn’t right, find a doctor who will take care of you. God Speed to you in pain. Cristine January 28, 2009 I had the surgery 21 days ago,and after experiencing cramping,discharge and pain in my lower back and hip,I was able to get in to see a soctor.(Mine was on vacation) I was told the mesh had eroded thru the wall of my vagina.Doctor suggested I use the estrogen cream for a few weeks before we talk about surgery.But my thought is obviously my body is rejecting the material, so I would just as soon have it removed.I am just totally disgusted and freaked out about the whole thing! sha sha January 17, 2009 I just ran across this blog and with a shock realized that I was reading my mother’s blog. All my life she has been the picture of health and vitality and to see this totally unnecessary problem arise from this surgery is heartbreaking. To all family members who care about their mothers, please read this and take note. Sometimes we don’t do enough or care enough until it is too late. If I had really understood the severity of my mom’s problem, I would have reacted much sooner to become educated on this and what I can do to help. I would have been much more supportive. It’s critical that we help as much as we can by taking an active role in managing our parent’s healthcare. elizabeth January 8, 2009 I had an Op for Posterior Prolaps Feb 2008, also Mesh for Vaginal Vault. (To cut a long story short) I had a fall in June and have been in terrible pain and disscomfort since, surgeon was addament nothing would have moved,!! Eventually in August she agreed to loosen tape, another surgeon told me to be fair to me it was too tight !! It has given me no reliel anyway and after goung backwards and forwards for months to the hospital I still cannot SIT comfortably, and am in pain and disscomfort all the time. I’m still trying to get help, not giving up. I want my life back as I have had none for SEVEN months. Be very careful with this procedure , it speaks for itself !! If I could have my Prolaps back tomorrow i would. I,m 69 years and I too was very active, it is heartbreaking. Ruth January 8, 2009 I had a Gynecare Prolift implant for prolapsed bladder performed in April of 2008. Following this surgery I was unable to void, so I was on catheter for 2 weeks. I began getting Urinary Tract Infections and have subsequently had 9 UTI’s. I was put on self cath for many months. I started taking xanax for anxiety as I am extremely active and have never suffered this type of problem. I went to a urologist who performed a surgery and I am now off the self cath, but I am up 4 to 6 times per night to void and continue to get UTI’s. The urologist told me I need a surgery to release the sling which may be too tight, and that this may cause incontinence. Then I would need a further surgery. This sling has caused me untold grief, and I would have lived comfortably with my prolapsed bladder if I had been told of the side effects. Mommy2Boys January 8, 2009 At 32 years old, I had a total hysterectomy (for utuers prolapse) w/ AP Repairs (for rectocele & cytocele), TVT & bladder sling in Feb 08. Since then, I’ve had several bladder infections, painful sex, sometimes unable to have sex due to the pain, and the past month or so I’ve felt the old prolapses back. Also, I’ve had weird stabbing pains in my hipbone/pelvic area. They don’t last long and but they hurt and they are getting more frequent. Until today, I had no idea that these recalls/warnings had been put out. I am now terrified that this is what is causing my problems…will be calling my doc tomorrow. Does anybody have these symptoms and know for sure that it is due to this mesh??? Judy December 19, 2008 I had this surgery on September 2, 2008, and things were going along beautifully and was giving a clean bill of health. Doctor said I could resume normal sexual activity. Well the first time, my boyfriend and I tried it was like trying to put 10 pounds of potatoes in a 5 lb bag and the pain was awful. I called the doctor and they said that it happens and to keep trying. We did and it was not any better. I went back to the doctor on October 24th and he said Oh NO. He said my bladder was prolasping again, he had to cut out some of the mesh that we were feeling and he said I was his first failure. He said he wanted to keep an eye on it so I went back on November 24th and it had gotten a little worse. I returned today and he said it was still failing but was still attached and to keep using the Premarin Cream as it looked better this time. I have to return on January 22nd. After I started back to work at both my jobs, I noticed a terrible pain in my hip which I never had before the surgery. It had gradually gotten worse and it almost drops me to the floor when the stabbing pain hits. I asked him about it and he said it could have been from the fact that I was in surgery for 6 1/2 hours total as he had to remove scar tissue from my hysterectomy I had in 1990. This is the worst pain I remember by far in my life. Childbirth was not this bad. I am seeing an orthopedic doctor on Dec 23rd to see if he can figure out what is going on. Was just wondering if anyone else has experienced this complication? This has ruined my quality of life as I am a very active person. Newer Comments 1 2 3 4 5 Older Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. 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