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Vaginal Mesh Recall

Harvey Kirk

In recent months, there has been growing momentum for a vaginal mesh recall to be issued, as thousands of women have experienced severe and life-altering complications from surgical mesh or bladder sling products used to treat pelvic organ prolapse and female stress urinary incontinence. Our law firm represents women throughout the United States who are pursuing a vaginal mesh lawsuit for injuries suffered from these dangerous products and we fully support the recent calls for the FDA to recall vaginal mesh.

>>MORE INFORMATION: Vaginal Mesh Complications

In July, the FDA reported that at least 2,874 reports of vaginal mesh complications were received by the agency between January 2008 and December 2010. Although data suggests that the transvaginal placement of surgical mesh provides no benefits over other methods of treating pelvic organ prolapse, an estimated 75,000 women had the vaginal mesh implanted last year.

The FDA has scheduled an advisory panel meeting for next week on September 8 and 9, during which a panel of outside experts will meet to discuss the recent reports of problems with transvaginal mesh and make recommendations to the FDA about what steps should be taken to protect consumers.

The use of vaginal mesh for pelvic organ prolapse and female stress urinary incontinence has been linked to painful and potentially disfiguring problems, such as:

  • Vaginal Mesh Erosion, Protrusion and Extrusion through the Vagina
  • Infection
  • Vaginal Mesh Hardening
  • Urinary Problems
  • Pelvic Pain or Vaginal Pain
  • Injury to Nearby Organs
  • Difficulty or Pain During Sexual Intercourse

During the FDA advisory panel meeting, it is expected that the agency will consider whether vaginal mesh bladder sling products should be reclassified as a Class III medical device. While this would not necessarily result in a recall of vaginal mesh products, it may have the same effect.

If the devices are classified as Class III medical devices, manufacturers will be required to conduct rigorous pre-market testing before obtaining approval to sell the devices to ensure that the benefits outweigh the risks. By contrast, most of the current vaginal mesh slings on the market were approved under the FDA’s controversial 510(k) approval process, which allowed manufacturers to start marketing these pelvic organ prolapse mesh products without any pre-market studies by establishing that they were “substantially equivalent” to other mesh products that had already been approved by the FDA.

The consumer advocacy group Public Citizen filed a petition (PDF) with the FDA on August 25, calling on the FDA to issue a vaginal mesh recall and ban the marketing of all currently available products to protect consumers.

TRANSVAGINAL SURGICAL MESH RECALL LAWYERS

The vaginal mesh lawyers at Saiontz & Kirk, P.A. will be closely following the FDA advisory panel meetings next week, and urge the FDA to take the necessary actions to protect women from these unreasonably dangerous medical products by forcing the recall of vaginal mesh products designed for treatment of pelvic organ prolapse.

Manufacturers introduced these products without ensuring that they were safe, and they provide no benefits over other available treatment options. As a result the medical device manufacturers’ negligent conduct, women who have experienced complications may be entitled to compensation through a transvaginal mesh recall lawsuit.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

34 Comments Add Your Comments

  1. I have so much blocking my vagina that I can’t even get an applicator for a medicine that the doctor gave me to help heal the area, so sex is out of the question and the bladder is now putting pressure on my colon causing hemroids and infection I am very depressed and angry over this. He removed my uterus which another doctor told me was up where it was suppose to be.

  2. I am one of the mesh victims and I hate what Ive been thru for the last 4 years, no one cared what I and thousands of other women were going thru with this. None of the Uriologist that treated me or went to for testing wanted nothing do with helping me and the same goes for 20 lawyers that I contacted about this. The doctor that removed the mesh that was extruding thru my vagina said that the doctor that did the mesh operation had put it in wrong and that from the beginning this doctor should have never performed the surgery that it should have been treated by medication. 2 surgery’s, clipping on me for 45 minutes trying to remove what was extruding thru my vagina, 4 years without sex, and alot of lower pain in front and back. This other doctor told me that he could not remove the mesh that was extruding thru my vagina because it would be a dire operation. That really scared me.
    Thank God for the ones that are wanting to help now…

  3. When I had my sugery done over two and a half years ago all hell broke loose. I hated sex, it hurt so bad and I keep a bladder infection all the time. I have had M.S for 20 yrs now, and have never went through a flare up like I have sence my sugery. My M.S had been in remission for years. After my sugery and my infections my M.S started flaring back up. My Dr. told me infections would flare up my M.S. I was so sick for months with bladder inf. and fevers that I started seeing people who wasnt there and talking to them. i went out of my head saying stuff that i dont remember a very scary time. I woke up five days later in intensive care. Stayed for Three more days intel my infection was under control. It has been a terriable Time Sence my sugery and I was so glad to see the ads about this mesh causing this. I know something wasnt right. I hurt so bad. I still hurt. But maybe I can soon get it right.

  4. when i had my surgery in 2005 i was in a mess thing hanging out did not know what was causing it went to my dr. he told me about the vagina mesh and i had the surgery.i was having so many problems after the surgery yeast infection,unpleasant odor that everyone could smell but me,went back to him 4 or 5 time after surgery because i knew something was not right a part of the mesh was hanging out inside my vigina and boils fill with pus and blood.i had went to another dr in order to find this out.that dr made me an apportment with the one that did the surgery because i could not go back complaining about a yeast infection because that is not what he specialize in. so i went back and he had to revised do the surgery over i still fill like something is wrong i have pain in my leg and my hip and side and its hard to stool and the odor is still there.i have had my share of problems going to dr to dr and all tell me you have a yeast infection.it was and still is the worst time of my life. i dont think i have had sex 2 or 3 time since then and this is 2011 because it hurts so bad. i have not tried since the secound sergery.i have just been by myself for a long time. god bless me and the people who are in pain and nobody to turn to for help or anyone that can understand what life has been like.

  5. Ever since my surgery almost 2 years ago i have had horrible pelvic pain. There are times where i can not even sit down because it makes the pain even worse. It also hurts to try to use tampons now and if i do use them i can only have them in for about an hour and have to take them out because it hurts to bad. If i would have known this was gonna happen i would have dealt with the incontinence. I have 3 kids at home and try explaining to them that mommy can get up and help them because of the pain does not work real well.

  6. I had 4 surgeries for prolapse repair WITHOUT mesh and they all failed, my doctor informed me that 60% of these repairs will fail in 18 months because the reason everything is falling out is poor tissue. trying to pull poor tissue back together without additional support is what caused mine to keep coming back. Lots of pressure and no sex. Finally I had the mesh procedure and I am completely cured… I had a tiny exposure that my doctor trimmed in the office and I am back to life as usual. My small complication was much much better than all of the failed surgeries! perhaps it was a better product or better doctor but I am very grateful for my procedure and all due to mesh. I just wanted to present my side of it. I think that when done right these work really well. What is worse for you? A small complication that they can fix or several failed attempts with no relieve? Unless you have lived with this problem you don’t know how disappointing it is when the other procedures don’t work. I think people are too eager to sue doctors without knowing what they do, they are the experts. I feel fir anyone who is having the symptoms listed above because if mesh, my mesh relieved all of those. I can give the name of a great doctor if needed!!

  7. I got a mesh sling for my bladder prolapse in 2008. I dealt with uinairy issues for years after giving birth… year after year things just kept getting worse. It got to the point I could not have sex without leaking. My regular Gyne would tell me Cagel exercises… OH PLEASE that did not work so 12 years later finally changed my Gyne. On the initial consult I found pamplets in his office about the mesh sling and uterine oblasion I told this Dr. this is what I needed. He agreed and it was done… I thank God for the Dr. that gave me peace of mind and renewed my sex life…lol…It fixed the problems!! Although since then I lost my job (Ecomony Satistic) and my insurance with it. I have not gone back to have things checked… I do have vaginal itching which I associate with a yeast infection but it goes away without any meds… I plan on making an appointment to get things looked at due to all the hype about the sling… but I am gald to have had this sling…It changed my life for the better… or at this point it has. I wouldn’t ever sue the Dr. who made my life better but would sue the manufactrer who did not give a safe product… In my case I have to have things checked to even know if I have any possibility of issues from the sling… but so far nothing I would complain about.

  8. I have a few question if someone can help me. Here they are,1-how many years has this MESH been used as well if there a chance if it was used in other surgery? 2- If so, What Surgery, where the best links/website where I can find the research information on the problem/symptoms it may causes? I have other problems but wonder if I should be talking with my Dr about this. Information in hand to help as I go to a clinic, I do not want to waste time that other need, as well as ruling out possible problems. I had to have ER surgery for a very unhappy and ugly appendices at that time. I have now had pain there where I did not before the surgery as well as pain at the belly button area now that can put me down with ice packs. It very uncomfortable, pain hard to describe after you feel better enough to right it down, just glad it pass without needing to go to ER room, feel to many people abuse it for those who really in need as compared to a ER visit to clinic or Dr office unless they been instructed as more testing may need to be done.. 3- Wonder why I hurt still after all this time in lower pelvic area. My female surgery was done in 1989, so I am not sure how they did all that(too many years ago with little or no major pain that does not pass with time), had some pain, thought it was scar tissue pain. I just want to make use of the time I have with my Dr schedule time allowed, not to misuse other patients valved schedule time.

  9. I just wanted to say I had heard on the news of this recall. I had this surgery done in March of 2009 and am very happy! I am very physically active in sports including riding horses and this is a blessing! I have not experienced any complications and sex is great. Hats off to my doctor who reccomended this and performed the surgery as well. I do feel for those who are experiencing problems, hope and pray for their lives to be back to normal.

  10. I had the bladder mesh implanted in 2009 4mos. after the FDA issued the warnings that my dr didnt tell me about. 6wks later the mesh had already started the erosion process into my vagina and i had to wait 3months until the infection was under control to have it clipped and tissue sewn back together. Then 7 mos and many infections later I found a new Gyno and she schedualed me for another surgery to remove more mesh from my vagina that had eroded thru and a band of scar tissue. That band of scar tissue was the mesh that had rolled at the edges and scar tissue had grown over it and extended out over the 2 main ligaments that run thru the hip. Thats what was causing my charlie horses down my leg and up thru my stomach. After that surgery I felt amazing for about 2mons then the symptoms came back with a vengance with some additional ones like blood in my stool and vomiting so now Im going back on the table next week and praying that this crap hasnt eroded into my intestines. Now I am finally lawyered up cuz my research of the product,which I should have done before I had the surgery but didnt becuz I trusted my Dr that told me about this “amazing” little piece of mesh could do for me after having a hystorectomy and bladder prolapse and leakage,led me to find out that this mesh is made of petroleum waste bi-product that was fast tracked thru the FDA for immediate use without being completely tested…disgusting!!! I am so glad this procedure and product has worked for these ladies posting on here but I also warn u to go to your Dr at the first sign of something wrong because the body typically tries to reject forigen objects and some people are really resistant to the rejection and some arent. I am 33yrs old and cant have sex unless my boyfriend is in the mood to be scraped up on his penis and have to wear pads for bleeding and the occaisional cough.I went to wal-mart for grocery shopping when i had a cold. I had a coughing fit and peed all over myself with my teenager with me. I still cry about that.

  11. wndrwoman254 says:

    I had this crap put in Aug 2010, immediately had almost every symptom listed. Kept going back to my Dr who gave the same answer almost all of our Dr’s give (“I don’t know, you’re imagining this, your body needs time, etc). I knew it was this mesh and immediately reported my case to the FDA, began my search for a qualified OBGYN to remove this (I found one of the best, he spoke at the last FDA meeting) and found a lawyer. I’m 2 months post mesh removal, while not 100% I’m so much better than when I had that human window screen in my lady parts. I feel so bad for everbody that is going through this. FYI, for those that haven’t seen it, Dr. Oz recently aired a show endorsing the use of this… my next mission now is to get the word to him of what this is doing (why doesn’t he know? He’s no Dr, a celebrity now..). Can you imagine how many suckers are going to listen to him and run out to get this done after those episodes aired?? Oh boy!. Please, don’t give up, ask around, stay on our computers and find the right physicians to remove all or as much of this stuff from you as possible. We didn’t deserve this. Good luck and blessings to all.

  12. Marvene says:

    I had this procedure done in June of 2007, it never worked, never. I have 3-4 bowel movements a day and never feel has if that the movement was complete, this never happened before the mesh. I had never in my life had a yeast infection and at age 60 low and behold a pain yeast infection, it felt like something was about to fall out of my vagina. I have now qualiity of life, I wear poise pads every day. I used to run at least 5 days a week, now I don’t even walk, because of the amount of urine that leaks out. I could be just standing and there is the flow. My OBGYN just passes it off, he’s really not interested.
    I’m not from the USA but had the procedure done in Boston MA. I feel like because I’m not from the USA I’m felt out in the cold.

  13. I had surgery in 2004 to help with urinary incontinence. At that time it was bad enough to have surgery done. It seeme to help and about 1-2 months later, it became worse with pain, more leaking and discomfort. My lower back and pain in my legs have progressively gotten worse. Walking and sitting is very hard to do. I’ve had absolutely no life since having this surgery. I returned to my doctor ( a urologist) and he said that my symptons have nothing to do with what’s going on. I haven’t returned to him. Currently, my symptons are unbearable UTI’s with constant burning in my lower pelvis. It seems like my current doctor (a urogynecologist) wants to have nothing to do with this. He has even mentioned that having this surgery warrants more complications, so he must know about this but doesnt come out and say it directly to me. He has tested my bladder – a urodynamic study- and has determined that my bladder does not empty fully. I also have constant leaking, wear and change 4 to 5 pads daily, sleep on a plastic tarp, and am limited to any kind of activity because of pain, embarrasment, and leakage. I want to have this removed but am afraid.

  14. I had my sling done in 2007. I have complained about it since it was done. My HCT dropped, I have constant infections, and during intercourse it always felt as if my boyfriend was hitting something. I also have had blood in my urine and I went to 4 different doctors. No one knew where it was coming from. Finally today, I visited a new urologist and he says the sling is protruding the my vagina. I am going to have to have a surgery for him to cut the eroding part out. Honestly after I got the surgery done in 2007, my friend got the same surgery. I told her it was painful and I didnt recommend her getting it, but she got it anyway. I want to say good luck to everyone and I pray we all get this taken care of. I didnt want anymore surgeries cause I just had a hysterectomy in Sept 2011, thinking that would cure my bleeding/spotting and it did not. So now I’m going get this taken care of and I pray things gets better after 5 years of saying something is wrong.

  15. tabatha says:

    I had a hysterectomocy on Jan.17th 2012 with a mesh sling at the same time after they took the cath.out at the hospital they told me to drink plenty of fluids to make sure i could pee before I left my insurance only allowed 23 hrs.for the hospital stay even though the double surgery ended up being a triple surgery I had to have endometrosis lazered off my overyies to after the nurse made me sit on the toilet for abt 5 hours trying to pee and one of my incisions tried to pull open BC I was so full of pee and the pain was almost unbearable they finally did a scan. And saw I was really about to bust i had to wear a bag home BC I couldn’t pee on my own then I started. Feeling. Like something was trying to fall out of me and severe pain and burning all the time oh and on top of that had to go to er for infection I thought maybe it would stop hurting after my six weeks was up but it hurts way worse when i have sex its horrible still I pray this pain will go away

  16. Marina says:

    Tabitha I had a complete hysterectomy in 2002 I was 32 years old. I have had sex once since then with my husband. I too have had the feeling that since the cathiter came out something wasn’t right it feels as if there is something in my uriter all the time. The one time I have tried to have intercourse it was so painful I can only explain it as trying to have sex with a meidevil weapon called a mace you know the one with the ball full of spikes. In 10 years I have had estrogen cream, estrogen tablets to insert, applicators, vaginal dilators they told me it was psycholgical isues that my vagina slams shut at the thought of penetration, I have been back and forth to doctors forever in the last 10 years. I am so angry now that this has all come out about mesh. My life has become that of an 90 year old woman since my hysterectomy it was supposed to get better not worse. I have chronic pain and receive 16 nerve blocks every month in my lower spine for *&^%$ sake. Is this from that or is it really degenerative disc disease? Who knows but I certainly hope everyone comes out of this. It certainly is dabilitating, physically and mentally and emotionally

  17. My Name is Laurie and I too had a mesh sling surgery done in June of 2009. A year later I had what they called “a trim.” I also have fibromyalgia. I have had it for 21 years. I have suffered with that and opiate addiction. I am finally on track in my life and now i dont sleep. I have severe goin pain, bladder pain, kidney pain, kneck pain. this happens every time my baldder fills up. I am now incontinent again. They keep blaming it on menopause and fibro. I have had fibro for so long and been in a great management progaram. I also can not have intercourse and have bad spasms after. Let these companies take some responsibility. I had 2 doctors lie to my face. I am going for 3rd opinion May 14th. Good Luck everyone.ed for

  18. Stephanie says:

    I had this surgery done about 2004 for incontenience. Definitely cured that problem. My problem now is that it takes forever to pee. That is my only complaint. I figured I could live with that over having to wear Poise pads every day. I was able to return to a normal, active life.

  19. I had a bladder sling in April 2011 and am in alot of pain such as painful intercorse,takes upto 2-3min to pee,low abdominal pain,ripping and tearing of the vulga,hard time having a bowel movement and itch and burn of the vagina. I hope any women who has any problem from this best them all the luck.

  20. I had the mesh sling in 2006. I had a prolapse but only slight intontienece when I sneezed. After surgery I had incontienece, he did another procedure and then it was difficult to pee. A urologist after a really nasty test, filling my bladder and watching it run out, I learned I had a bladder obstruction. I had pain every day, it was hard to pee, sex was too painful, and recurring infections. I took antibiotics every day for 7 months, waiting for surgery. Finally a urologist removed the sling. Now I have to wear Depends and pads day and night. The Urologist is supposed to insert another sling in July. I am scard to have it but the other choice is stay incontiinent.

  21. I had the bladder sling surgery done for urinary incontinence. I’m not really even sure what year it was done. I would have to call dr. And find out when it was done. I have had none of these symptoms, however, should I be worried that they could occur in the future? Is this lawsuit only for women who are experiencing symptoms?

  22. I had surgery in 1999 and have been having trouble for the past 10 years going to the Dr and test after test now the Dr says the mesh they used then is not the same kind that the law suit is about. I feel like I have been on a roller coaster and have no place to turn. I am in so much pain I can not do my normal house hold duties.

  23. My name is Gina and I had a hysterectomy and a cystocele repair in 2005 using the Bard Pelvasoft mesh. I have incontinence worse than before and have had occasional blood in my urine along with urinary tract infections. I have had chronic back pain restless leg syndrome and was diagnosed with Fibromyalgia. I often wondered if my mesh could cause my body to have a slight regection. But I have been told no. I haven’t been the same since. I have been to my OB/Gyn doc that did my surgery and needless to say he is gone d/t mesh related law suits. But his old partner told me people are using the mesh as a scapegoat. So I kinda got the idea that she wasn’t interested in my situation. So I went to see a uro/gyn/pelvic doc and he said my mesh was fine. Never thought my problems were from mesh. Just put me on ditropan. It didn’t help my problems. All I know is I have had to quit working after 20 years. I’m so aggrivated and I have talked to an attorney and they were doing a class action and I didn’t qualify for some reason. Guess since I didn’t need additional surgey maybe the reason. There is no money in this world that can by your health and I just want my health back and live my life. I really want my problems to go away. I hope everyone works through this. It has change my life for the worse. ormation you wish to be published on this page…

  24. I am 52 years old had a bladder sling put in in 2009 while having a complete hysterectomy . This what I am experiencing pain in right side leg pain clear down into my feet abdominal pain and cramping like you would have before and with a period. I ache all the time can not walk any long distances, I have a strange vaginal odor even though I am a very clean person. Every time a I use the bath room I can smell it . I am now starting to have incontinence again and have to get to a bathroom ASAP or will have an accident. I’m fatigued as well. Would like to hear from others if they are experiencing the same thing.

  25. I also had the transvaginal mes implant done Oct 2010. I do have a Lawyer, but my mesh is not on the recall list, but I am having all the issuse that all the othetr women are having. Scared to return to the Dr who put this in, do to the fact at my check up I expressed my problems and was told I would have to retrain my bladder. Well it does not take this long to train anything. I hope no one else recieves this mesh, or any other type.

  26. I have had (4) Bladder Tack Surgeries!!! All from different Urologist, and none of them worked. I called the Attorney’s on TV for the recall. Waiting to hear if mine was recalled… I am so messed up!!!!

  27. I had my surgery in June 2012. In the last couple of weeks of have had constipation and horrible hemmoroids that feel like glass when I pass gas or use the bathroom. Does anyone else have this problem.

  28. I had a pelvic mesh inserted in 2008. I did not know my painful complications were because of it. My doctor told me to use estogen cream 2-3x a week or I would get complications. I felt guilty because I didn’t use the cream as advised after the 2nd year or so. I have most of the symptons, painful intercourse, pain while voiding,recouring utis, I also have a wierd growth on my hip.

  29. I have had the same operation several years ago, have all those symptoms now, the groin and leg pains are severe that I have problems walking, sitting and sleeping.

  30. I started having problems as a teen with heavy menstrual cycles for 2 weeks at a time but was too imbarrassed to say anything. After I had 2 children and graduated nursing school I went to a urologist and gynecologist to find that I had endometriosis on the outside of my uterus that had scar tissue wrapped around my left ureter and I had multiple surgeries to fix this including a hysterectomy, rescetion of left ureter x around 6x bladder reconstruction, mesh sling inplant, too many surgeries to list (28) and still have problems. I have been through 4-5 urologist the last test I have showed blisters inside my bladder for which I went through txs, next I had ecoli last month and still constant uti’s. I am on constant pain meds due to kidney pain and uti asociated pains, I am currently on short term disability to try and resolve my issues and have an appt. with my urologist on friday to dicsuss further txs. I am concerned that the mesh has a major part of my pain and my husband states that is feels like sand paper when we have sex and it is painful for me also, feeling like a foreign object. Not the sex like we used to have.

  31. i’m there with you other women i to had the mesh sling surgury and i have constapation problems and urinary infections, and pain while being intimate with my husband , some pelvic pain but when i went back to my bladder dr he said everything was ok and where it should be. i’m not sure what to do here but i sure am really scared about this whole situation with these slings. mine settled down the leakage problem but i still have the frequent urges.

  32. I HAD THE BLADDER SLING PUT IN 2008 AND 3 WEEKS AFTER THE SURGERY I HAD A BLADDER INFECTION. THE PAST 5 YRS I HAVE HAVE HAD ONE BLADDER INFECTION AFTER ANOTHER. NOW I HAVE BEEN ON AN ANTIBIOTIC (SAME ONE) FOR 4 WEEKS AND EVERY TIME I GO IN THERE IS PUS IN MY URINE. BEFORE THE SURGERY I HAD MAYBE 2 BLADDER INFECTIONS SO I AM THINKING THE SLING IS CAUSING ALL THESE INFECTIONS? I DO NOT WANT TO LIVE ON ANTIBIOTICS AS SOME DAY I MAY REALLY NEED THEM SO MY DOCTOR IS DOING A CYSTOSCOPY TODAY AND DID A CAT SCAN LAST WEEK. THESE INFECTIONS ARE VERY PAINFUL AND I CHECK MY URINE DAILY AND IT IS NEVER NORMAL EITHER A TRACE OR MODERATE AMOUNT OF PUS, THAT IS NOT NORMAL TO ALWAYS HAVE PUS IN YOUR URINE? THIS IS VERY FRUSTRATING AND I AM AT THE POINT THAT I WANT THIS SLING REMOVED FOR GOOD AND SEE WHAT HAPPENS AFTER THAT?

  33. I had this surgery back in 2009, it was the worst mistake of my life. The pain that i have in my but, legs and hips sometimes keeps me from standing or walking. And sex, what is that? I haven\\\\\\\’t been able to have sex since I\\\\\\\’ve had this surgery. I can feel the sling moving around when I have sex. Not to mention the difficulty to have a bowel movement or the frequent yeast infections. I saw my OBGYN and he said I should just live with it, but this sling has taken it\\\\\\\’s total on my marriage. I needhelp finding a solution

  34. In 2010 I had a hysterectomy and bladder sling surgery. About 6 months later I was having excruciating back pain and lower pelvic pain and was given pain pills. Over the last four years I have been to several doctors and have been given different medications for what was thought to be my bladder. The last urologist that I seen is sending me back to the doctor that preformed the sling surgery. I feel hopeless, the pain is so fierce at times that I cant even sit on the stool to use the restroom. I can’t stand for too long or sit for too long with out pain. My life changed dramatically, I can not work the kinds of jobs that I have worked my whole life because of pelvic and back pain. I can’t work out or do daily functions with out pain. I hope and pray when I see the doctor in a couple of weeks she can help me. I feel for those of you experiencing pain like I do.

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