I just found out Mesh was not FDA approved only "cleared". They stopped the clinical trial because too many woman had severe complications. How did the company get away and sell these to the Drs? My life as I knew it is ruined because of it.
I had the TVT mesh implanted on 8-2009. It's been over 16 months and I've not recovered. I am in extreme pain all the time, even with painkillers. I had complications right after the surgery, including blood transfusion. I should've known then that my body was rejecting the mesh. I had all kinds of test done and they can't find anything wrong with me. I did some research about the Mesh early 2010 and I knew there was a warning but was scared to admit it could be me, since I knew the answer would be removal of the mesh. I just waited and waited to see if my body will just heal but it hasn't and my pelvic/vaginal pain is worse then ever in addition to other issues, frequent UTIs and extreme fatigue. I haven't been able to go back to work since the surgery. I have a husband and three kids, I can't be a wife or mother to my kids. Recently I searched on the internet and noticed many more websites that are suing the mesh makers and more patient complication testimonials. I finally made the decision to go to a GYN (not the uro/gyn who put the mesh in) and he said with all my problems, mesh should come out but that it is a very difficult surgery and he couldn't do it. He referred me to another Dr. Now I am to see the "removal specialist". I am soooo scared. The implantation surgery was so painful...not to go into too many details but had other abdominal surgerys. I also have incisional hernia repair mesh too and that may need to come out as well. If anyone has comments in regard to the Mesh, I'd appreciate it.
What brand of mesh do you have? I am having issues since surgery that really leave me wondering if its the mesh. I'm doing alot of research to get to the bottom of it and try to find as much info on the particular type I have as well. I wonder if its the actual mesh itself or just damage from the actual procedure. I changed from a gyn to a urogyn, but from my visits with my urogyn he hasn't seemed to be willing to look at the mesh as a possible cause. The NP told me that removing it could cause more pain, and that its probally been too long to remove it. I'm not optimistic that he'll look at that as a possible cause anytime soon and like you said the longer its in the more damage it does.
Has a doctor actually confirmed erosion of your mesh or do they just suspect its causing problems internally? I'm in a similar boat as you
I had to go to my GYN not the Uro/gyn who did my surgery to find out what kind of mesh I have in me. Because when I called the Uro/gyn office they "didn't know", which is ridiculous. I guess my GYN was familiar with the surgeons methods. It's TVT made by Ethicon-Johnson & Johnson. Search Mesh complications or Lana Steeton, you will get lots of info on it. Also search Multiple chemical sensitivity and see if you have many of the symptoms, I have almost all the symptoms. The Mesh is made out of chemicals. People with mesh develop autoimmune disease like MCS, I was just DX with MCS probably because of the Mesh.
We should all report our problems to the FDA so they will stop using this mesh, before the mesh was marketed the doctors didn't use anything in the body. From my findings, the mesh is sold to Drs. for lots of profit by the device salesman. They didn't even do the clinical trials that's why it was never approved by FDA, only "cleared" as some marketing scheme. They tried to the trials but it was halted because too many people were having advserse reactions-NY times did a story on it 10-2010. I am soooo upset, there are so many people suffering because of greedy corporations.
You had the Prolift, Mine was the Obtryx made by Boston Scientific. I'm having a hard time finding people that have problems with that specific one. I think alot of women may not even know what exactly was put in them. I only know because I got my chart personally when I changed dr's rather than having them fax it over. I had another surgery on 12/7/10 because the urogyn thought it was all because my muscles were too tense in my pelvic floor. He did botox and PT. I guess its a little easier to have a bm, but the pain is still there and its not necessarily in my vagina its more internal behind my pubic bone and over toward my leg as well as through my SI joint area and down through my butt. The whole right side of my "junk" is swollen and sore and tender. Pain meds don't really help like you said, I'm just in so much constant pain it sucks! When he did my exam initally (when he said it was muscle tension) he told me that he felt "something" when he did my rectal exam, he wasn't sure what it was, possibly mesh. I had a pelvic MRI with rectal contrast pre-op which was supposed to say what that could be but I wasn't able to get definitive results, my dr is a very very very busy man and I saw him for my inital visit then about an hour before my dec surgery. Every other time its been his NP I saw and she wasn't really able to tell me much. I researched him very well and found he was good at what he does so I decided to trust he was making the best choice at that time and there was no scalpel involved. I see him (and it better be HIM) for my 6 week post op on the 20th, and he's supposed to address my groin area pain (the NP said to specifically tell him groin, even though to me it feels pelvic)
As far as FDA approval vs clearance, drugs get approved, devices get cleared, the process for a device (which is what a sling is) is different, they don't have to do trials like with meds as long as the "device" is similar enough to one already on the market. Thats called the 501k clearance. You can go to the FDA website and search the maude reports to see all the adverse reports on the specific brands and types. I did this for mine and found quite a few. But I am not sure which specific one the dr used, there are 2 types of Obtryx slings out there. There is a lady on here sghall82 that had her prolift removed and went through hell and back to do it, she is very very nice and has alot of info. Look for her posts and send her a message. I think it was about a year or so after she had it put in that it was removed and she had to travel from FL to Cali to find a dr that could do it right. I personally can't figure out how I could travel across the country to fix things right now, but I guess it could come to that. I'm definately scared and worried and just want to feel better! This surgery was supposed to give me my life back, it only took more of it away
Is prolift made by Ethicon-Johnson& Johnson? My pain is behind the pubic bone too. Yeah I know about the 501k clearance but I don't think they should allow what is supposed to be permanent device into human body without doing clinical trial.
I faxed a note to my original surgeon about the FDA warning and how come I wasn't advised and told him about all the problems I am having. Well surprisingly he called me this evening, what Drs. call patients call directly now days? I tried to make an appt with him couple of weeks ago and earliest was in Feb and today his staff called me this morning and said to come in today when I called and said I wouldn't, that's when the Dr. called me in person. He told me to go to Pelvic PT and that my pain should go away or at least feel much less pain. He said the removal surgery is not an option and is very complicated and he didn't advise of it. Also he noted the FDA note doesn't is NOT related to my surgery since, he did not use mesh for POP but only used it for TVT Bladder Sling Mesh, which is very small, so he said I shouldn't have all the problems that I am having and that it is not the same "mesh issue". I was thinking to myself, either way it's the same material and I was complaining of pelvic pains not pelvic floor pains. I know how my body feels and it's not been the same since SUI/POP surgery. I wish I never had it done. Not even sure what kind of real diagnosis I have, all I know is the pain I am feeling. I did lots of research before this surgery too and look where I am now. However, I wish I searched under mesh complication or TVT instead I read about SUI and most were good results. Also yeah your mesh is rare brand that I have not heard of. Lastly when you make you appts at your Drs. office always asked for Dr appt not NP., unless you like your NP better.
Prolift is a complete bladder sling and is one of the mesh systems that is very harmful. It has metal clasps or something that is damaging nerves etc for alot of women. The TVT is a suburethral sling which is like you dr said alot smaller and has no "clasps". I had the same TVT done last June, also the one made by Ethicon.
I was doubtful before surgery and was not warned about these risks. After reading stuff on the interrnet I mailed my dr ( a urogyn specialised in urinary incontinence and prolapse) and asked about erosion and the FDA warning. Basically he first told me that people reading on the interenet do not know what they are reading and the warning and other bad stuff out there on the internet was for complete bladder slimgs, not the TVT. So I sent him the link and said that it was definately for suburethral slings such as the TVT. He came back to me and said yes, well, there was a 1 prct. change of erosion issues. He did 400 surgeries and only had 2 cases of erosion.
I was still doubtful going into surgery, but had so much issues with the incontinence that I did go ahead with surgery. Drs here do not do the other procedured such as Burch as they are too invasive...the TVT was my only option. They do not use biological or your won material either.
I had alot of pain from surgery on the left side. Could not pee after surgery for five days and was back in hospital on day three post op for IV antibiotics for an infection.I had a post op check up three weeks later and said thing did not feel right, Peeing was extremely slow and I had urinary retention (I had severre bladder spasms as well). at week three I had a UTI again and also a quite severe vaginal infection.
So I was back on antibiotics and vaginal antibiotics and estrogen for better tissue healing. Four weeks later I had another check up and the dr actually did not know why I came back.....I still had a UTI and was on antibiotics again. Well, the dr said everything looked fine and thing just needed time. So he made an appointment to call me I believe six weeks later. Well, he called, I had a UTI once again and his solution was maybe it was good to start on six months of antibiotics. I told him I did not feel good about the sling and things were still painful on the left side, right above the pubic bone (I cannot lay flat on my stomach, the pressure on my pubic bone hurts).
I actually had other prolapse issues as well which were not resolved either, so decided to go for a second opinion. I found a gyn, not a urogyn, who works closely with a urologist. I had a cystoscopy and my bladder was severely infected, right up to where to opening to your kidneys are. I still had an infection after two different sorts of antibiotics. By then I could hardly pee from the infection. i peed 100cc and had retention of 300 cc. The urologist said that the TVT was probably too tight and needed to be cut on the left side. i had that done on December 10 th together with a hysterectomy for prolapse and fibroids ( which my first dr "forgot " to tell me...). This surgery has helped with the pressure issues I was having on my bladder and rectum, but I still get stabbing pains on the left, the pain above the pubic bone is stil there and yes, I have a quite severe bladder infection again.
The urologist and gyn I have now are quite opposed against the use of synthetic mesh, and my gyn is specialised in the removal of mesh. I don't exactly know what to do at the moment. I am thinking that my bladderr might be so damaged now that that is the reason why I keep getting these infections. I might try the maintenace antibiotics before I do anything else. I am havi g some urinary issues once again, but do not know if it is caused by the infection (once I start to pee I cannot stop for example).
I am frustrated and a little lost with what to do....
Burned Out, your story sounds soooo much like mine! I had the consult on Feb and the surgery on Aug. because I was doing research on the dr and other SUI patients, was even on this sight but I fail to search the mesh, which I regret. Like you, I thought I was doing the right thing to make my life better not WORSE! Even about the Dr telling you not to believe everything on the internet. I don't trust my doctor anymore. Just like you I've had several UTI's and regular antibiotics did not always work and for me it's very scary because I only have one kidney, if that is damaged from too many UTI's I will die. I'm glad you wrote your story, I don't feel so alone. The doctor told my husband right after the surgery that all went well, not so, my blood pressure was so low I could not see, feel my limbs. I had to have blood transfusion, then I developed some kind of infection at the hospital. Went home and I had similar incident as you, it was a horrible experience! The outrage part is I am still suffering the severe pelvic pain, like you behind the pubic bone and feel tugging at times. I have urgency then when I try to go I trickle and my bladder hurts more after I void. It feels raw all the time. I feel I am disabled. I have no life, I'm in bed almost all day long. I feel sorry for my husband and my three kids, they worry for me all the time but feel helpless. I was very active wife and a mother, now I can hardly do anything and that's with being on Oxycontin. If I didn't have painkillers to somewhat decrease the pain, I honestly think I would've killed myslef. I have had to have many abdominal surgeries including kidney removal, and none were painful as the mesh surgery nor the severe pain lasted this long, 16 months and going. How about you, how long ago did you have it. I think our only solution is try to have it removed. I know they can't take all out and have to have multiple surgeries to do it. I think my dr is scarying me about the removal because then it really seems like there was negligence on his part. Also he said he didn't use mesh for POP because of the erosion issue and that small mesh for bladder sling is NOT the issue. As mentioned before I have bladder issues and pelvic pain, not the pelvic floor. I doubt his suggestion of Pelvic PT will help, since it feels raw not like a spasm. He told me he did 1000 surgeries and he never had erosions. Maybe they did but he never diagnosed his paitients with it, like me. I am very skeptical, the more I read it just seems like corporate greed and doctors pocket. My Dr kept saying if I have the mesh in, it will almost be permanent and rarely prolapses again vs. if he didn't use the mesh, I will have reoccurance and asked me if I wanted the surgery every five yrs or one time surgery. So, what right mind patient will want surgery every five yrs.? However that would've been unlikely. I looked at some research data and it turns out the results are the same with or without mesh, but the erosion possibility is only with the Mesh! I FEEL DISTRAUGHT AND AT A LOSS JUST LIKE YOU.
I had mesh erosion with a prolift (posterior), along with pain where it hadn't eroded. This horrible thing was put in in 2005. I had it out in 2006. The doctor that put it in wanted to put in more mesh because the tot she had installed (its like a tvt) had not worked for my stress incontinence. I decided to get another opinion so I went to a urogyne who works in my area. He was very rude and told me to got back to my original surgeon. I decided to order my records from that visit and in the notes he wrote that my vagina was very messed up and he suspected that the mesh was eroding. He went on to say that removing it would be dangerous because it had ended up so close to my rectum!
I found another urogyne in my area and he had participated in the "studies" of the mesh and was very excited about it. He didn't see any erosion and wanted to put a tvt over the tot for my stress incontinence. I didn't go back to him.
Then I decided to try the Mayo Clinic because I live a few hours away. The first urogyne I saw there told me that I was dealing with mesh erosion and that it wasn't a dangerous situation--I could live with it! I wasn't willing to live with no sex for the rest of my life and yucky discharge. the stress incontinence had progressed to the point where I was almost wearing diapers.
I screwed up my courage and decided to see the other urogyne who works at the Mayo. He was great and willing to help me. I had the mesh removed except for the arms and he put in a sling made from my own fascia for stress incontinence. It works great! He also fixed an enterocele that the prolift was supposedly designed to keep from happening after a hysterectomy (I had the hyster at the same time as the nasty prolift was put in, in 2005). I am now pain free, sex is good and no yukky discharge! The surgery wasn't as bad as I thought it would be--except I stopped breathing afterward from the morphine and was given the antidote.
I wonder if we are more sensitive to meds and foreign objects in our bodies than average folks. With my first surgery I had a blood transfusion that I reacted to. I also seem to be more sensitive to antidepressants (can't take them).
Don't give up! There are doctors out there that can help you!
My advice is to find a doctor who has dealt with mesh many times before and get it out! Concentrate on getting the help you need first.
I agree, find someone who will help first. So strange to be told different things by different doctors, some just do not know what they are doing. They only use synthetic mesh for the TVT here. It is either that or the Burch procedure which is also not done everywhere (and very invasive).
I am waiting to see if just releasing the sling will help with my issues. It has cleared up the retention issues so I am hoping the infections will clear up and hope the occassional stabs stay occassional. The sore bump above the pubic bone....I don't know. It mostly stops me from lying on my stomach and sometimes hurts like a bruise when something rubs over it. The left side sometimes throbs a little when I have been on the move alot.
There are hardly any drs here with experience with TVT mesh removal, so that is quite difficult. And my surgeon was 'the' expert so people may find it hard to believe the TVT is put in wrong or something. I am seeing my new urologist next week and my gyno for the post op at the end of january. Hope the infection clears up for now.