Adding my two cents to the mega mesh mess surrounding transvaginal mesh complications…

“Considering a Mesh Implant? You have better odds playing Russian roulette”

JL-RussianRouletteThat was the title of the poster created by Jaye Lee,  who also suffers from mesh complications (“Considering a Mesh Implant? You have better odds playing Russian roulette”).   She has a way with words (and graphics), eh?  She has shared her story and many of her poignant posters along the way.

When I first saw this particular poster comparing getting a mesh implant to playing Russian roulette, I thought, “wow.  well, that is a bit harsh“.   But, the more I thought about it, the more it hit home for me.   I’m not sure about the “better odds” part.  Which risk has “better odds” is not the point.  The point is that it is a big risk… and to bring up the question if it is a risk worth taking.  Is it?  I happen to agree with Jaye Lee and countless others, that the answer is, “no, it’s not”.

And, I’m not saying all this JUST because I personally am suffering from severe complications from a mesh implant.  I’m sure that plays into any of my current opinions, as do the stories of so many other women I’ve met and heard about who also suffer from mesh complications.   But no, that is not the main reason why I think TVM (transvaginal mesh) is such a big risk.  I wish it were, actually. I wish I did believe that my complications from mesh were just some freak accident and that mesh, in general, was “ok”.  I think I’d be able to accept things, and sleep a lot better at night if that were the case.  It seems that is what a lot of folks marketing and using mesh would like me (and the world) to believe.   But no, I do not believe that.

I believe that mesh,itself, is a faulty product.  And, like the FDA July 2011 warning, I am not limiting my opinion of mesh to just mesh kits or any specific type or brand.  I think mesh is bad (mmmmm, kay?).  I also believe this is generally true regardless of which surgeon is implanting it, or the patient it’s being used in.

I’m the first to admit that I’m not a medical expert, and I don’t claim to have all the answers.  But, I do know how to research things (especially when driven to do so!), and the more I learn about TVM, in general, the more I believe that it is a dangerous product.  I  get into my main beefs about mesh, along with links to resources, in my post, “Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI“.

I know what I believe about mesh, and why….  but, why do so many other people believe mesh is more or less still “a good option”?

I have heard people saying that “mesh has its place“, or “it really is the best option sometimes for high risk patients or in certain circumstances“.
Yet, it seems that doctors are not just recommending mesh to patients “sometimes” or when all else fails.  Based on my own experience, and from what other women have told me, it seems like mesh is still the main, if not only, option often offered for pelvic repairs.  So many are still insisting  that the mesh they use is not “the bad mesh”.  Why is this??  When the FDA makes a point to warn people, and specifically state that severe complications are “not rare”, and that there is not evidence that TVM is more beneficial than non-mesh repairs, why are so many still using it?

When I asked that very question recently in a forum where there are many mixed opinions on mesh, someone pointed me to AUGS (American Urogynecologic Society) website, where they are apparently “fighting back against transvaginal mesh bans. I had seen it before, but I re-read it with new interest.  Did I miss something?

AUGS stated there that;

“officials at the American Urogynecologic Society (AUGS) voiced their strong opposition to restrictions on the use of transvaginal mesh surgery when performed by qualified, credentialed surgeons.”

and Dr. Visco of AUGS stated:

“Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures,” Dr. Visco said.

Just to be clear, there has not actually been any “bans” on transvaginal mesh.  I wish there were, but members of AUGs do not agree with me on that.  They seem to imply that the mesh product is not the problem, but instead it is the skill of the surgeon that needs to be accounted for.  Again, looks like AUGS and I do not see eye to eye.  I’m guessing a lot of doctors who implant mesh might also disagree.  But, the manufacturers of mesh?  …they probably love this idea because if you can prove it’s the doctor – that gets them off the hook, and they (the manufacturers) are the ones being sued most frequently.  Also, it sort of puts the blame back on the patient in a round about kind of way, doesn’t it?  As if they should always know to choose a better doctor.

While I’m sure the surgeon’s skill IS a factor (as it would be in any surgery) there are so many other things to consider about using TVM as well.  What if a person has major FBR (foreign body reaction) resulting in inflammation and pain, like I did?  Or chronic infections? What about the fact that mesh is NOT inert, and that it hardens once in your body  and then it can “erode”/cut through tissues, muscles, organs?  What about the fact that once mesh is implanted, it is next to impossible to remove the mesh in the event that you DO have these problems?  How in the world does all this relate back to the surgeon’s skill who implanted it, rather than point to the product itself?

The AUGS statement goes on to argue that they think we should keep mesh on the market, because the patient deserves to have options:

“In certain cases, the use of transvaginal mesh for pelvic organ prolapse could be the patient’s best surgical option”

Once more, I ask how many options are patients being given?  How many doctors are even doing non-mesh surgical pelvic repairs?  And, do we want to be offered an option that is so risky? A loaded gun, so to speak? Especially if the doctor offering TVM may not even know all the facts themselves?  That is what many doctors claim, that they believed what the mesh manufacturers told them, and that the manufacturers were not upfront on all the facts.  It’s a viscous blame-game circle.

Yes, we want women to come forward and get help for SUI and POP.  They need help. I get that. We need to promote that. But, when they do come forward – vulnerable, embarrassed and in need – HELP them!  Don’t offer them something that has the real potential to cause further and serious harm!

AUGS also seems to reiterate some of the very same things that the July 2011 FDA warning stated which they are opposing.  Things like, being upfront with the patient (there’s an idea) about the risks of mesh and the FDA warnings, and reserving mesh for “higher risk” patients.  AUGS stated:

“In December 2011, AUGS and the American College of Obstetricians and Gynecologists issued their own statement recommending that pelvic organ prolapse vaginal mesh repair be reserved for high-risk cases such as women with recurrent prolapse or who have medical comorbidities that prevent more invasive endoscopic procedures (Obstet. Gynecol. 2011;118:1459-64).”

Again, with the mesh being reserved for high-risk patients?  And, again I ask is it being used sparingly and cautiously?  Why do I keep hearing of it being used left and right, sometimes the first and/or only option?   Why do so many seem to think it will last longer, or that it is better for younger more active women? Where is the data on this?  Why is it okay to use mesh for SUI, but possibly not for POP?  Is SUI “high risk”!?  I think not.

AUGS also states:

“Bans on transvaginal mesh surgeries could also put a stop to critical research on the products, according to AUGS. For instance, the Pelvic Floor Disorders Network, a clinical trials network funded by the National Institutes of Health, is preparing to launch a randomized trial of transvaginal mesh vs. nonmesh, native tissue repair for uterine prolapse.”

Ahhh…  researchNow we are getting somewhere. This I believe.  Of course they are worried about halting their precious research… and, in turn the marketing and manufacturing of more mesh.  We wouldn’t want that, now would we? Well, I would.  Personally, I’m not thrilled about being one of the guinea pigs for their research.  I think they have hurt enough people and ruined enough lives already.

Lastly, AUGS concludes in this website:

“Our concern is that we don’t prematurely make a decision about these procedures before there’s a full assessment out there,” Dr. Visco said.

So, let me get this strait,

they are worried about “banning mesh prematurely” from the market,  but it was alright to market the transvaginal mesh and use it without having research and data showing it was safe in the first place?  How does THAT work?

I also read the  “committee statement” that a group of AUGS members made, mentioned in one of the above quotes.   You can read it (and I suggest you do if you are thinking of getting TVT), but my take away from it was that there is a lot of “insufficient data”, a need for further research and better trained doctors, a request for less mesh kits, and again it mentions reserving using mesh for “high risk” patients:

“Pelvic organ prolapse vaginal mesh repair should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk”.  

What I’m not seeing is anything that really makes me think that mesh is a good choice for most people having POP or SUI.   Did I miss something?  If I did, please point it out to me.

Now, I know that for some women, they get a mesh sling and they do not have any mesh complications.  These women may believe mesh is great and I am happy for them.  I truly am.  I also hope with all my heart they remain happy with the mesh, as I know many women do not have problems until years after the implant.

BUT, does the fact that it works for some women, even if it’s the majority, make it acceptable for all the women that DO have these “not rare” and “severe” complications?  We are not talking about a few freak accidents.  The exact percentage varies depending on who did the study – but we know it’s increasing.  We also know the FDA stated complications were “not rare”.  Are we/they all acceptable casualties?  WHY?  Why is this okay?  I do not understand.

It especially bothers me that this is being allowed when there is not any evidence that pelvic repairs WITH mesh are any more beneficial than non-mesh repairs. It’s not like they can’t help you without using mesh. They did for years and still can. So, when they know that mesh complications are very severe, with no easy remedy, shouldn’t that change the dynamic of things?  Should manufacturers be allowed to continue marketing this stuff to doctors who are putting it in women left and right, when most of those same doctors admittedly know they can not remove the mesh f you do have one of these “not rare” and severe complications?

The way I look at it – if mesh works for you – then great!

You are lucky.  Yippy Skippy for you!  No, seriously, I AM so glad you are ok!  You get to live to see another day.  You can go run, play, sneeze, and jump on a trampoline, all while laughing gleefully, with the best of them. Not that you couldn’t have accomplished this with non-mesh repairs, but hopefully the mesh surgery was less invasive and quicker for you (& your surgeon), and you are pleased. That is awesome. And, hopefully your luck holds out, because there are many women who do not have problems until years later… and there is very little data showing long-term (over one year) success rates for mesh.

If you are one of the “not rare” & unfortunate ones that has severe mesh complications –
then, God help you

– because not many others can or will.  You may not actually die, but your quality of life?  Well, that can change drastically overnight.  At whatever age, you can suddenly find yourself not able to have sex, or empty your bladder or bowel on your own, or in so much pain from infections and/or inflammation that you can barely walk or get around.  And, oh – don’t forget about the financial repercussions this can have.  You can suddenly find yourself jobless, health-insuranceless, and hopeless.   Mesh is the gift that keeps on giving, and people have lost their homes, spouses, even children because they no longer could care for them.  If you are very lucky, like me, you might be able to find a way to travel across the country and get to UCLA to see a specialist and get the mesh removed, and have some hope of resuming your normal life.

I tend to be sarcastic, maybe a little dramatic… and, humor is a way of life for me, always has been… but, this?  This is no joke, folks. 

So, please… IF you are considering a mesh implant – and are lucky enough to have thought to really research this beforehand, not just talk to your doctor, AND you just happened to have stumbled upon this article –  then please, please, please…. before you pull that trigger and get a mesh implant – please learn about and consider all the risks Really get to know not only your  surgeon, but also the product and technique they plan to use… and really consider if there are not better, less risky, alternatives.

I leave you with another one of Jaye Lee’s posters about mesh.  Food for thought:

counting losses

 

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Categorised in: FDA, Mesh Complications, Pelvic Organ Prolapse

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