You're reading a post...
Risks & Complications

Vaginal mesh for incontinence and/or prolapse: caution required!

In their paper “Vaginal mesh for incontinence and/or prolapse: caution required!” doctors Phillipe Zimmern and Ginger Isom-Batz discuss ‘the dark side of mesh’.  They argue that procedures involving mesh may seem simple and easy to perform but could nevertheless have long-term consequences for patients.

They state that many new products have been allowed onto the market despite limited knowledge regarding their safety and long-term efficacy.  The success of these devices is due to the clever marketing of the mesh kits which require limited training, and the FDA clearance process which allows products to come onto the market with apparent ease.

Polypropylene mesh, known as ‘prolene’, is the most common of the synthetic materials used in pelvic surgery.  It is now used in slings to treat incontinence and also in repairs which use larger amounts of prolene to treat prolapse of the bladder, bowel or vaginal vault. 

The authors note that there is a lack of evidence-based data regarding the safety and efficacy of these meshes.  Some studies have reported vascular and bowel injuries including 8 deaths, which show that serious complications can occur.  Other studies report vaginal erosions, bladder and urethral perforations and erosions, urgency, changes in flow rate and flow pattern and complete obstruction.

The transobturator tape (TOT) was marketed and introduced as safer than the TVT because of the way the side ‘wings’ are introduced through the obturator fossa instead of the retropubic space, supposedly reducing the chances of vascular, bowel or bladder injury.  However, several serious complications have been reported already.  Some studies have described debilitating thigh and groin pain, infections of the tape causing sinus draining or even thigh necrotizing fasciitis.  There have been two reported cases of death after the TOT procedure due to vascular injury.

In prolapse repair, mesh has been used either as a primary repair or in cases of prolapse recurrence.  Reports of vaginal erosions after this procedure have varied from 0 to 18% with short-term follow up.  Painful intercourse has also become a serious concern, with a recent study reporting 38% and calling for surgeons to stop using prolene mesh to repair bladder and bowel prolapse.

The authors note that the removal of these meshes, either partially or completely, via the vagina or abdomen, has proved “a significant challenge”.  There have been reports of vesicovaginal fistulas forming after mesh removal.   They argue that even if the rates of these debilitating complications are quite low, they are “life-changing for the patient, sometimes irreversible and often sources of litigation”.  Many women would have preferred to live with some incontinence or prolapse rather than live with chronic pain, suffer from fistulous tracts and undergo numerous unhelpful treatments and procedures. 

Zimmern and Isom-Batz declare that they are not alone in their concerns regarding the “rampant use of vaginal mesh” in pelvic floor reconstruction.

The authors note that it is still not certain how the aging vaginal tissues will respond to synthetic material just under their surface and this should be a consideration in younger women and in those desiring to remain sexually active.

For the midurethral tape, they have seen some delayed onset of urge and urge incontinence symptoms resulting from a kinking effect in the midurethra with urethral and bladder neck ballooning. Removal of the tape does not always result in an improvement in bladder dysfunction.  Also, midurethral compression from the tape can lead to ischemia resulting in a permanently scarred and narrowed urethral lumen after tape excision. 

In pelvic organ prolapse, meshes to repair cystoceles are placed directly under the bladder trigone. Erosions into the bladder could result in a serious risk of injury if the mesh subsequently needed removing.  There is also the concern that these permanent materials may move over time and become exposed in the urinary tract, causing pain or bladder dysfunction.

The authors note that when a new drug is introduced onto the market and receives FDA approval, several safety and efficacy trials will have already taken place but no such a mechanism exists to test new surgical devices.  They conclude that there is no mid or long-term data on the efficacy and safety of vaginal meshes for prolapse and that doctors must demand higher standards and not agree to use a product based on small, short studies published without peer review.

Read more: http://www.expert-reviews.com/doi/full/10.1586/17434440.4.5.675

Ref: Zimmern & Isom-Batz, Expert Review of Medical Devices, September 2007, Vol. 4, No. 5, Pages 675-679

Advertisements

Discussion

30 thoughts on “Vaginal mesh for incontinence and/or prolapse: caution required!

  1. It is almost unbelievable to note the “declared” number of adverse reaction reported on surgical TVT meshes to the MHRA. The selfhelp websites show a different picture by just the sheer numbers of implant patients who are struggling and who have been brave enough to share their concerns and experience with the general www public, via these brilliant websites and also this blog site – which is up to date and factual and informative. Well done and Thank you. IZH

    Posted by I H | May 30, 2012, 11:55 pm
  2. I hope it is factual because women out there need lots of information and many don’t seem to be getting adequate information from the medical profession.

    Posted by tvtinfo | May 31, 2012, 7:37 pm
  3. I have been suffering with chronic pain following tvto surgery in 2009. I have only recently had a diagnosis confirmed. I have permanent nerve damage in my left groin. I am 38 years old with two children. My youngest, now 4, has only ever known me as a disabled mother. I need to walk aided by a walking stick. I have never been able to pick him up or carry him without it causing me pain, and that is hard on both of us. There is so much of my life lost because of the devastating complications from this surgery. My career, my mobility, my sex life, my ability to care for my family. Knowing that this is permanent and there is nothing that can be done now to repair the damage breaks my heart. I have had to research possible treatments and fight to get to try most of them. Most recently i have had a nerve block injection. Unfortunately that has now worn off and so i have reached the end of the line. So the next thing we have to do is sell our home. We can no longer afford to live here because of the financial losses due to me no longer earning. The fall out and devastation is by no means over. These complications are real and women considering surgery need to be told about them. If I could go back in time with what I know now, I would rather wear pads for life than risk such serious complications.

    Posted by Cat Lee | June 8, 2012, 9:45 pm
  4. Sorry to hear you have had so many problems after your TVTO surgery. Your complications sound terrible and unfortunately all too familiar with this surgery although your complications sound more severe than most. You are so young to deal with these problems and to be told that you have permanent nerve damage must be devastating.

    Have you made enquiries about having the tape removed? There are surgeons in the UK and the US who can remove these tapes. I know quite a few women who have had their tapes removed in the UK with big improvements in their symptoms. If you live in the UK I would recommend you join a support group and ask the other women for advice on surgeons for removal. If you are in the US there are women on the Topix forum who have recommended surgeons to remove tapes – see link: http://www.topix.com/forum/com/jnj/TTE0RAIRMP5EFC052/p159

    I have heard a lot of women remark that they would rather live with a little incontinence than have the symptoms they are now experiencing following the TVT or TOT surgery.

    Hope you can get some support and some help with your problems.

    Posted by tvtinfo | June 9, 2012, 4:45 pm
  5. Thank you for your supportive response, I appreciate it.
    I have already looked in to having the tape removed, but this wasn’t possible due to too much scar tissue.
    I’ve not yet joined a support group – partly because I’ve been trying not to get bogged down with talking about it all, and I want to save my energy for positive things – although perhaps I should start thinking about talking about it as a positive thing…
    Thanks for this really useful blog. It has made negotiating the information on this a whole lot easier!

    Posted by Cat Lee | July 2, 2012, 10:09 pm
  6. Thank you for the encouraging comments about the blog. I hope it’s been of help. I will be posting more articles on various issues and problems of having TVT when I get a bit more time – I have a few drafts in the pipeline….
    Have you had more than one opinion on tape removal and the nerve pain issue? Many women have sought second and third opinions before they find someone who can help. The experts don’t always agree, as we soon find out when researching this topic or speaking to others who have had treatment.
    The thing with mesh surgery is that you can feel alone with your problems which makes the situation worse. The support groups are for sharing information or just having a good rant if you feel like it – others have been through similar things. You don’t have to post straightaway.
    I hope you can get some help somewhere for your medical problems. If you need to contact me you can email tvtinfo@yahoo.co.uk.

    Posted by tvtinfo | July 3, 2012, 8:48 pm
  7. Cat, I’m so sorry to read of your devastating complications. I wonder who you talked to about removal – in which country? There are few surgeons who can safely remove mesh but I am one of the lucky few who have had my TVT safely removed and I know that she has removed some old TVTs as well as more recently inserted.
    If you’d like to know more, email me on lizrharris5@gmail.com – you can read more and hear my interview on Woman’s Hour https://tvtinfo.wordpress.com/2012/03/24/bbc-radio-4-womans-hour/

    You are certainly not alone and I really feel for you.

    Posted by Liz Reece | August 20, 2012, 2:02 pm
  8. i like so many women are wishing they had carried on peeing their pants! I have had 3 operations in the last six years and awaiting another operation as everything appears to have prolapsed now! I have no confidence in the surgery and left to worry about my future! the last consultant stated after the next operation i should never lift, push, pull for the rest of my life..i swim at the moment as this is the only exercise i feel i cant harm myself, i use to love walking now feel the pressure and cycle which isnt good for the bottom area!my working life has suffered ! returning after these operations has left me feeling inadequate and staff not very sympathetic,as they cant see the injury! I am at present on long term sick! therefore my earnings are reduced and i haven’t had the 4th operation yet!

    Posted by ann buck | January 22, 2013, 9:59 am
  9. Hi, I am devastated to read your comments. I have been going through a process with the Dr concerned that did my surgery a year ago. I went for a repair a month ago, where she told me she was making the TVT slack to lessen the tension. The consequences are even worse – I have more pain than before now. I was so worried that it could be permanent nerve damage and now u are just confirming my worst fears. She is going to speak to a Urologist and get back to me but I have had doubts about the outcome since I had it done and now u have just confirmed it for me. I cant go for walks anymore because of the excruciating pain. I am 53 and I cant believe that a simple op like that has done so much damage. She also said on email to me that in 15 yrs that she has been doing this, she has never had a complication and that is why I decided to look on internet if there was anything like I am experiencing

    Posted by claire | May 15, 2013, 7:28 pm
  10. Hi Claire,
    I’ve responded to you personally. I – like so many other women on here – know how you feel. So many were told that they were the ‘only ones’ which is just not true. Are there any other women from South Africa reading this blog who can offer help with surgeons’ names who could safely remove this awful mesh?

    Liz

    Posted by Liz RH | May 15, 2013, 8:58 pm
  11. The pain from scarring and mesh pain are something I never wanted to mention to my doctor. I just assumed that I had scarred more than usual and that I needed to live with it. It got worse. Finally, I talked to my doctor after 8 years. I am guessing many many women say nothing because they do not know what to say. This would be a case in which every complaint could be taken to represent a larger number of women. It is likely that women going into menopause are going to start to suffer when they had been fine with the tape, and therefore likely that more and more often we will hear women speaking up about the pain of the mesh.

    Posted by Joy Lloyd | October 17, 2013, 9:34 am
  12. I have now had 6 surgeries to remove mesh (still lots still in) following mesh erosion into several areas. I am in severe pain on a night and am woken during the night, I am been told its IC but I do not have any urinary incontinence so am confused. Left in pain and sleep deprived I would try anything, the pain is so specific it is so local to the tape location has anyone else suffered the same. Seen 2 consultants in different health trusts and paid for private consultations but am still in the same place. I am now offered pain relief that would be for life and nothing else. Has anyone out here ever become pain free – any feedback welcome. Contacts for Consultants anywhere in the UK who could help would be much appreciated.

    Posted by Amanda B | January 6, 2014, 10:49 pm
  13. Hi Amanda
    Sorry to hear you are still in pain after so many surgeries to remove mesh. What kind of mesh did you have put in?
    How long has it been in? Have you been in pain since insertion?
    Tvtinfo

    Posted by tvtinfo | January 6, 2014, 11:08 pm
  14. Hi Amanda, I know exactly what u are going through. I could not get any pain relief either until a very good urologist said that he would be prepared to remove the mesh. It was almost immediate relief and he got the whole mesh out even though the tissue had grown into it. The doctor inserting the mesh sometimes inserts it too close to some nerve (forgot the name) and that’s why we experience so much pain. If u haven’t been to a good urologist, I suggest u do so. I must just mention that I live in South Africa and we still have some good doctors here. I really hope that u find someone that can help u because that pain is unbearable.
    Claire

    Posted by claire | January 7, 2014, 1:40 pm
  15. I had tot done and it eroded twice 😦 I have had part of the tape removed … The doctor removed it in a way scar tissue helped inncontience … I still have slight pain in my labia . It nagging and there all the time but bearable .. I have been offered to get the rest of the tape removed but am scared I could end up worse rather than better .. Would I be better just bearing with the nagging pain that’s bearable and leaving everything alone !! Scared and don’t know what to do 😦

    Posted by Kelly | November 15, 2014, 10:54 am
  16. That is a difficult one, Kelly, I don’t really know what to say. How long ago did you have the partial removal? If it was recently, then maybe things will heal more over time and the pain will improve. It depends what is causing the pain. Partial removal or the tape left in? Who is offering to remove the rest of the tape and how many of these full removals have they done before?

    Posted by tvtinfo | November 16, 2014, 8:50 pm
  17. It’s an absolute disgrace that this rubbish is still inserted into woman who already have a problem. How come Drs. whose work it is too know that these slings are harmful to patients still let reps sell this stuff. Reps selling this should be asked to leave their offices. Yes, I’m angry!! Because of the “sling” I have developed an autoimmune disease. Thus far it has cost me thousands to try and restore my health. It was only last night that I happened upon a blog where I read that there are thousands of woman with the same problem.

    Before I had my operation in 2011 I spoke to the rep. who sold this sling to the gynecologist and she assured me that it is just the best thing to do! How ruthless!! How are we supposed to ask the correct questions if we do not know what to ask. It was not as if I knew anything about this kind of operation, first time! I assumed that I was doing the right thing when Dr’s office gave me her name and no. She MUST have known about FDA warning!!

    Anyway, I’m on vegetable juice only as it is the only thing that helps with the inflammation that is consuming my body. I’ve become hypothyroid, all joints ache, losing hair, liver is inflamed, as is stomach and part of intestine. Foul urine!!

    I live in South Africa. Claire, would you kindly let me have the name and no. of your Dr. seeing this sling must come out a.s.a.p!! It would seem that you are much improved. What is your health like now?
    Look forward hearing from you.

    Thank you to those who have posted their experiences in order for others to learn. God bless and keep you!

    Posted by lilly | November 22, 2014, 11:23 am
  18. Hi Claire, hope you pick this comment up. My mum lives in SA and is having complications from her mesh op and I was wondering who the urologist was that removed yours? Thanks!

    Posted by Candice | January 15, 2015, 1:06 pm
  19. Hallo Candice,

    I am not Claire but received your email in inbox today.

    Please send your mom my e-mail address. We do have excellent drs in S. Africa. Met very compassionate Dr in December who understands problems related to slings. He removed four of them out of one lady!! Maybe he will be able to help your mom.

    Kind Regards
    Lillyvs

    Posted by lilly | January 15, 2015, 4:21 pm
  20. Claire,

    Please drop me an e-mail if you receive this because I would dearly like to find out which urologist you visited as the Dr. I saw says he will not be able to remove sling without removing my bladder. I’m too young for such drastic measures and believe that there must be Drs in South Africa who have the necessary skill to remove sling.

    Thanking you
    Kind Regards
    Lillyvs

    Posted by lilly | January 15, 2015, 4:41 pm
  21. These slings should be banned, they just create more problems,i had a supris retropubic sling inserted its a nightmare since then

    Posted by suzette | May 21, 2016, 6:38 pm
  22. Hi ladies,
    We are in desperate need of a mesh removal doctor in South Africa. We have a very sick lady in the ICU in a hospital there that needs help promto. Thank you.

    Posted by Marcie | July 13, 2016, 1:52 pm
  23. hi marcie i am also from south africa please mail me your details i had a supris sling marthasteward952@gmail.com

    Posted by martha | July 22, 2016, 9:54 am
  24. is anyone having problems in south africa with a bladder sling

    Posted by brenda | October 10, 2016, 1:02 pm
  25. Yes Brenda, there are ladies in South Africa who are experiencing problems with mesh. Are you aware of Drs. in Africa who remove tvt slings? Information would be appreciated.

    Thanking you
    Lilly

    Posted by Lilly | November 17, 2016, 8:54 pm
  26. Hi lilly do you stay in south africa?

    Posted by brenda | November 18, 2016, 6:05 am
  27. Yes, I live in South Africa.
    Lilly

    Posted by lillyvs1 | November 18, 2016, 6:54 am
  28. does anyone know a urologist in south africa gauteng area who removes these kind of slings

    Posted by martha steward | November 18, 2016, 10:20 am
  29. Hi lilly which dr did you see? And what happened, and where in south africa do you stay, and which type of mesh sling do you have

    Posted by brenda | December 12, 2016, 9:42 am
  30. south africa anyone got tvt mesh bladder sling problems

    Posted by jolly | July 4, 2017, 10:44 am

Please give your comments below. (Leave a name but do not include your full name if you don't want it to appear in full..)

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s