“Mesh: Definitely risky for POP, but for SUI? Eh? It might be ok still, right?”

Jane Akre
October 10, 2012

by Ms. Anonymous, October 2012

Ms. Anonymous is represented in pelvic mesh litigation and does not wish to be identified. Here is her story:

I was reading the FDA alert from July 2011, (yeah, I have strange hobbies lately) and this part gets me. It says:

"from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP(Pelvic Organ Prolapse) and SUI(Stress Urinary Incontinence), with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs."....

Yet, in spite of those numbers, it goes on to say,

"The Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP. The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date".

First of all, isn't it a "later date" yet? Where's this "further communication" about using surgical mesh to repair SUI? Don't they already have enough guinea pigs, I mean women, like me, with reported proof of complications from SUI surgeries using mesh?? How can so many doctors still be telling patients that mesh for SUI is ok... and it's the "other, "bad" mesh" for POP - that is the problem?? Is it because the FDA warnings sort of allow this by not specifically addressing mesh used for SUI?

Secondly, it's all so absurd. Mesh is mesh. It's going into the same general area. If it's not safe for POP, why in the world would it be safe for SUI??? If there's no evidence that it "provides any added benefit compared to traditional surgery without mesh" for POP, then WHY would it be better for SUI?? I don't get that. Maybe I'm not a genius, and I know I'm not a doctor - but, this just doesn't make any sense to me. And, actually, for SUI, often it's even more of an "elective surgery"... So, wouldn't those risks of complications from mesh outweigh the benefits even more for SUI than for POP??

In my case, and I'm sure many other women like me, it wasn't like I HAD to have surgery for SUI. I chose to. I kick myself in the ass for that now, but yeah, I chose to. No, I did NOT really research it before hand. I didn't think I needed to. I just heard it was quick and easy, that it would alleviate the kind of problems most women my age with kids have (SUI). I had a friend who had it done, and I thought - "cool. sounds easy enough. I'm going to do that". I assumed a doctor wouldn't put something in me, or perform a surgery that might really harm me, especially for SUI. I thought it was suppose to be "minor surgery" to fix a minor, somewhat embarrassing, and mostly just inconvenient problem. To "improve your quality of life". It never dawned on me that "they" (you know... "them"... "those guys"... whoever "they" are) would allow a product with such devastatingly high risk complications to be used for a surgery like this? Especially, without trying all other options first, AND without fully explaining the risks?

Can you imagine if they DID warn people about all the risks? What it they just really laid it all out for you? What if they just told the truth about POP AND SUI surgery using mesh and the high risks involved... and just what those complications entail?

I mean, what if a doctor had said to me,

"well, ya know, if this works... Great! You won't pee when you sneeze, or when you laugh! And you will be able to jump up and down on a trampoline and never have to worry about wearing a pad again!! =) YAY! right?? Right!! =) .... And, we really DO think it will work.

BUT, well, just so ya know... if it DOESN'T work... ummmm......

I should probably warn you that you might never walk normally again, if at all, aaaaaand you could be in constant severe pain... you also just might get really sick with chronic infections... but, really, it's actually MUCH more likely that it will just erode through your vaginal wall and you won't be able to have sex... but before you realize that, your husband or significant other might just have to find that out the hard way.

Did I mention the soft mesh turns into more like a wire screen, with sharp jagged edges, once it hardens in your body? Yeah, it's true.. looks like a piece of screen from your window, and, well, it could possibly work it's way through your vaginal wall.. or into your colon, bladder or other soft tissues...... *shudder*

Of course, we certainly HOPE this doesn't happen to you...


....you probably should know that the FDA put out a warning in July 2011 that said complications are NOT rare. So, yeah... "not rare"...? What exactly does that mean? We don't really know. "Not rare". ? I know, right? Vague, but still doesn't sound good, huh?

And, get this... if you DO have any of these problems? Well, you might just have to deal with it because we don't really know a lot about this, and there's a lot of mixed messages out there. There's not really very many doctors that have a lot of experience removing it once it's in there... because, you know, it's not really SUPPOSE to be removed. Personally? I wouldn't dream of removing it... so, don't look at me if there's a problem! You see, it literally "meshes" with your tissues and errr... stuff... so, it's very tricky to remove it once it does that, let me tell you!

Most women who do need it removed because of complications wind up needing to have multiple surgeries to remove it... often resulting in more complications, and often permanent damage. Terrible, I know... What's worse is there are some docs that might even just tell you that you're crazy and wash their hands of you when they don't know what to do to "fix" the mesh of a mess you're in, rather than refer you to an expert who maybe CAN remove it all. Not me. I wouldn't do that, but I hear it happens... but, hey... that "expert"? well, they are probably no where near where you live anyway... probably "out of your network"... and also booked solid for months and months... so, good luck getting to see them! And besides, by then, you may or may not still have a job or health insurance anyway. So, yeah.. that sucks even more I guess right?... Yeah.. well.... Sorry to have to tell you all that... but... well?...

WHEW!! Do I feel better getting all THAT out in the open!!

Now, back to if it DOES work...

Did I mention you can actually jump up and down on a trampoline again without a wearing a pad! And SNEEZE or LAUGH without peeing!! Won't THAT be cool?! =) You BET it will be! So!?! Are ya ready to do this? Let's do this!!"

Can you imagine? Yes, I wrote this tongue in cheek... I have to amuse myself with sarcasm and humor. I can only WISH my doctor was cool enough to have said this to me. If he had, I sure as hell would NOT have had the surgery. Call me chicken... but, I'm pretty sure I would have ran like hell. Which reminds me, I really MISS being able to run like hell! Anyway, unfortunately no... no one mentioned all these serious "not rare", terrible risky, complications to me beforehand! Granted, no one mentioned the trampoline either... but, I thought it.. and, well, you get the gist.

Now, maybe, "they" didn't need to "warn" me, because the FDA specifically talks about POP and not SUI mesh surgeries? Maybe, they didn't even know about the FDA warnings? I don't know. All I do know is that the more I learn about MESH and hear first hand from women suffering such terrible complications - not to mention the longer I deal with my own pain and problems walking (which really isn't THAT long compared to a lot of women), the more frustrating it all is.

To me, using mesh for SUI is sort of like someone with yellow teeth wanting whiter teeth, but using a product that has a "not rare" risk of making all your teeth fall out, and maybe your face melt off too. But, hey... ya might have a great smile IF it works. ?! Besides, it won't kill ya.. so, it's not life-threatening... you can LIVE with NO teeth, can't ya ?!?

Ok, maybe that's not the best analogy, but again... you get the gist, right??


Full FDA alert: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Short FDA notice: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079028.htm6

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