FDA warning about surgical mesh dated July 13, 2011
FDA warning about surgical mesh dated July 13, 2011
Athlete until pain started in 2001. Diagnosed with PN in Nov. 2010. Probable cause: 3 difficult labors, 5 pelvic surgeries for endometriosis, and undiagnosed hip injuries. 60% better after 3 rounds of shockwave therapy in Cornwall, Ontario (Dec - Feb/12). 99% better after bilateral hip scopes for FAI and labral tears (April and July/12). Pelvic pain life coach Lorraine Faendrich helped me overcome the mind/body connection to chronic pain: http://www.radiantlifedesign.com
Re: FDA warning about surgical mesh dated July 13, 2011
Thankyou Lernica, I don't know how you find these articles but they are very useful reading.
This article is scary stuff, and it is all true. I am glad the FDA is looking at it and making these recommendations.
I've got, I believe, ten separate pieces of mesh holding my insides back where they are supposed to be, and I can tick the boxes for every single complication mentioned there, except organ perforation , and with the addition of nerve damage that has caused PN. I've had mesh extrusion fixed twice already, and I've got it back again for a third time.
However I think it is important to note very clearly that there are some cases where there is no other option but to use mesh, this is mentioned in the report. One such instance may be where there have been repeated previous repair surgeries that have failed, so there is a lot of internal scarring - in my case, there had been four such surgeries. This surgery was my only chance, and although I have had complications - which include PN - I would not choose to go back and have the surgery undone even if that were possible, it is much better have my insides actually inside and in the right place. I was informed of the risks before the surgery.
It is a good idea to consider all the options, as it says in the report.
This article is scary stuff, and it is all true. I am glad the FDA is looking at it and making these recommendations.
I've got, I believe, ten separate pieces of mesh holding my insides back where they are supposed to be, and I can tick the boxes for every single complication mentioned there, except organ perforation , and with the addition of nerve damage that has caused PN. I've had mesh extrusion fixed twice already, and I've got it back again for a third time.
However I think it is important to note very clearly that there are some cases where there is no other option but to use mesh, this is mentioned in the report. One such instance may be where there have been repeated previous repair surgeries that have failed, so there is a lot of internal scarring - in my case, there had been four such surgeries. This surgery was my only chance, and although I have had complications - which include PN - I would not choose to go back and have the surgery undone even if that were possible, it is much better have my insides actually inside and in the right place. I was informed of the risks before the surgery.
It is a good idea to consider all the options, as it says in the report.
Re: FDA warning about surgical mesh dated July 13, 2011
Somehow I am on a mailing list for ob/gyns! The post containing the FDA warning also had a very graphic, very disturbing surgical video of a gyno surgeon removing mesh from a 71-year old woman's vulva with a scalpel. OMG the pain the poor woman must have been in, both before and after surgery. Made me feel lucky in comparison.calluna wrote:Thankyou Lernica, I don't know how you find these articles but they are very useful reading.
Athlete until pain started in 2001. Diagnosed with PN in Nov. 2010. Probable cause: 3 difficult labors, 5 pelvic surgeries for endometriosis, and undiagnosed hip injuries. 60% better after 3 rounds of shockwave therapy in Cornwall, Ontario (Dec - Feb/12). 99% better after bilateral hip scopes for FAI and labral tears (April and July/12). Pelvic pain life coach Lorraine Faendrich helped me overcome the mind/body connection to chronic pain: http://www.radiantlifedesign.com
Re: FDA warning about surgical mesh dated July 13, 2011
Ah well then, all is explained!
I have seen a video of a vaginal mesh extrusion being removed (not from the vulva) and if memory serves, it was from a woman past 70. So it may well be the same video. An extrusion like that is exactly what I've got right now, except of course that I have two at the moment. It is a bit painful whilst the mesh is working through, yes - and of course it continues to spread, and that is a bit nasty too.
How I came to see it - after the mesh extrusion came back yet again, I went looking. I wanted to investigate the standard surgical technique for dealing with mesh extrusions, and so I found that video.
What really surprised me was that after they had dissected away the mesh from the tissue behind to which it was adhering, they did nothing to reconnect the edges of the mesh. They simply pulled the vaginal skin layers together over the gap. That leaves all those edges of mesh free - and believe me the cut edges are sharp. I have had two mesh extrusions removed now - both in the exact same place. And right now I've got mesh extruding yet again in the same place. The first time it was an area of mesh, the second and third times it has been edges coming through and sticking out. It is my belief that those sharp edges just cut straight back through, my experience certainly supports this.
In my opinion a better surgical technique is needed, where the edges of mesh are reconnected or at least dealt with in some way to prevent their re-emergence.
I have seen a video of a vaginal mesh extrusion being removed (not from the vulva) and if memory serves, it was from a woman past 70. So it may well be the same video. An extrusion like that is exactly what I've got right now, except of course that I have two at the moment. It is a bit painful whilst the mesh is working through, yes - and of course it continues to spread, and that is a bit nasty too.
How I came to see it - after the mesh extrusion came back yet again, I went looking. I wanted to investigate the standard surgical technique for dealing with mesh extrusions, and so I found that video.
What really surprised me was that after they had dissected away the mesh from the tissue behind to which it was adhering, they did nothing to reconnect the edges of the mesh. They simply pulled the vaginal skin layers together over the gap. That leaves all those edges of mesh free - and believe me the cut edges are sharp. I have had two mesh extrusions removed now - both in the exact same place. And right now I've got mesh extruding yet again in the same place. The first time it was an area of mesh, the second and third times it has been edges coming through and sticking out. It is my belief that those sharp edges just cut straight back through, my experience certainly supports this.
In my opinion a better surgical technique is needed, where the edges of mesh are reconnected or at least dealt with in some way to prevent their re-emergence.
Re: FDA warning about surgical mesh dated July 13, 2011
Oooh, Calluna, you poor thing! It must be so painful! Did you have intra-vaginal or intra-abdominal surgery? My understanding is that the former presents more problems than the latter.
Athlete until pain started in 2001. Diagnosed with PN in Nov. 2010. Probable cause: 3 difficult labors, 5 pelvic surgeries for endometriosis, and undiagnosed hip injuries. 60% better after 3 rounds of shockwave therapy in Cornwall, Ontario (Dec - Feb/12). 99% better after bilateral hip scopes for FAI and labral tears (April and July/12). Pelvic pain life coach Lorraine Faendrich helped me overcome the mind/body connection to chronic pain: http://www.radiantlifedesign.com
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Re: FDA warning about surgical mesh dated July 13, 2011
Lernica, Calluna,
I wasn't until I read your thread that I realized that I almost had a urologist do that surgery on me. I was having leakage problems and the doctor said I'll just go in a put a little tape in the vagina and hold up the bladder. When I read about the FDA warning, I looked up surgical mesh and surgical tape. They are the same thing!!! Thank goodness something told me that the doctor was wrong. The problem was caused by the pudendal nerve.
Kate
I wasn't until I read your thread that I realized that I almost had a urologist do that surgery on me. I was having leakage problems and the doctor said I'll just go in a put a little tape in the vagina and hold up the bladder. When I read about the FDA warning, I looked up surgical mesh and surgical tape. They are the same thing!!! Thank goodness something told me that the doctor was wrong. The problem was caused by the pudendal nerve.
Kate
Surgery with Dr. Micheal Hibner March 14, 2011
Am 85% better in only 5 months and so grateful to Dr. Hibner
THIS FORUM ANSWERED ALL MY QUESTIONS!!!
My thanks to all of you.
Am 85% better in only 5 months and so grateful to Dr. Hibner
THIS FORUM ANSWERED ALL MY QUESTIONS!!!
My thanks to all of you.
Re: FDA warning about surgical mesh dated July 13, 2011
Kate - yes, the tape is made of mesh. That was a bladder sling that your doctor was talking about. I had colposuspension about 17 years ago, the tape surgery had not been thought of at that time.
Colposuspension holds the bladder up by taking some long stitches from the back of the pubic bone to the outer wall of the vagina, each side of the bladder neck. The stitches dissolve over time, but scar tissue has formed around them before they disappear, and everything stays in the same place. It is done via an incision along the bikini line. I had a lot of problems with stress incontinence before, the surgery was very successful and stopped it completely.
Lernica - the mesh was placed through the back of the vagina.
I had a series of prolapses and repairs following the colposuspension, then a hyst after which everything was fine for about 10 years. Then I had a very severe prolapse and was told that nothing could be done about it, there had been too many previous surgeries and there was too much scar tissue, no more surgery was possible.
My consultant arranged for me to see an Australian surgeon who was able to help me, the surgery that I had is described here and here - total vaginal reconstruction, but modified, mine was a 'custom job'. I have no anterior mesh and no anterior retropubic sling, due to the previous colposuspension which has been left in place. I have a sheet of mesh at the top along the lines of the 'Honda repair' to replace the pubocervical fascia, with attachment to the sacrum. There are lateral transobturator slings for stability, and the distal edge of the mesh provides additional stability for the bladder. I also have posterior mesh and a posterior translevator sling - these are what is causing a problem at the moment - and perineal body reconstruction. This was all done vaginally.
Just about the only mesh I don't have, is the bladder sling that Kate was offered!
It is painful when the mesh extrusion moves, and of course I do have PN now - but other than that it has been a complete success. Everything is back in the right place and appears to be staying there - 2 years now - and everything functions. Except that the mesh extrusion means that sex is impossible, the mesh hurts both of us. Hopefully that will be fixed soon, and who knows maybe the PN will get fixed too.
Colposuspension holds the bladder up by taking some long stitches from the back of the pubic bone to the outer wall of the vagina, each side of the bladder neck. The stitches dissolve over time, but scar tissue has formed around them before they disappear, and everything stays in the same place. It is done via an incision along the bikini line. I had a lot of problems with stress incontinence before, the surgery was very successful and stopped it completely.
Lernica - the mesh was placed through the back of the vagina.
I had a series of prolapses and repairs following the colposuspension, then a hyst after which everything was fine for about 10 years. Then I had a very severe prolapse and was told that nothing could be done about it, there had been too many previous surgeries and there was too much scar tissue, no more surgery was possible.
My consultant arranged for me to see an Australian surgeon who was able to help me, the surgery that I had is described here and here - total vaginal reconstruction, but modified, mine was a 'custom job'. I have no anterior mesh and no anterior retropubic sling, due to the previous colposuspension which has been left in place. I have a sheet of mesh at the top along the lines of the 'Honda repair' to replace the pubocervical fascia, with attachment to the sacrum. There are lateral transobturator slings for stability, and the distal edge of the mesh provides additional stability for the bladder. I also have posterior mesh and a posterior translevator sling - these are what is causing a problem at the moment - and perineal body reconstruction. This was all done vaginally.
Just about the only mesh I don't have, is the bladder sling that Kate was offered!
It is painful when the mesh extrusion moves, and of course I do have PN now - but other than that it has been a complete success. Everything is back in the right place and appears to be staying there - 2 years now - and everything functions. Except that the mesh extrusion means that sex is impossible, the mesh hurts both of us. Hopefully that will be fixed soon, and who knows maybe the PN will get fixed too.