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

Oct 10th, 2012 | By | Category: Op-Ed

Deb Contestabile

by Deb Contestabile, October 2012

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 POPThe 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

BUT…..,

….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??

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

  1. Betty says:

    I right there with you!

  2. DebC says:

    Jane, thanks for letting me vent here. I know that compared to so many others dealing with mesh complications, my story is not nearly as horrific. That is part of what is so sad. This has completely ripped apart my life – but, when I read other women’s stories of their mesh complications (http://meshmedicaldevicenewsdesk.com/category/patient-profiles/) I almost feel like my story isn’t even worth complaining about in comparison. Then again, I think maybe we all need to start complaining a lot more. I just don’t understand how doctors and the FDA are allowing this to continue.

    Deb

    • Liz Reece says:

      What you write is spot on. I have had similar ‘if only’ conversations with myself and many others – but only those who have felt the blackness of mesh pain can really understand. A good analogy for the pain -like barbed wire twisting inside.
      Take care
      Liz

      • DebC says:

        Hi Liz,

        Thanks… and yes.. that is a good analogy for the pain – l”-like barbed wire twisting inside”. I have also told my people it feels like a steak knife jabbing me inside on certain steps… the dull ache never goes away now… not even when resting.. but, it’s definitely worse when trying to walk or even move. Even sleeping is hard, because it hurts to move and I can’t lay on my left side at all or it really feels like something is jabbing me….

        Fun Fun! (NOT!)
        Deb

  3. Nonie says:

    We need to remember and understand that the trauma of an adverse event is not measured by the event itself but the impact it has on the victim. A strong person who has learned and practiced coping skills can survive a terrible event while an unsuspecting vulnerable person can fall apart and have their world destroyed by an event that another would just dust themselves off after and move on. Synthetic mesh has and is causing life altering complications…no matter your story, it is worth sharing, it is meaningful, and we are not making comparisons of the extent of injuries….we are sharing that we have been harmed by those we trusted, which makes the wounds seem harder to accept, and deeper because of the breach of trust. Thank you for sharing Deb.

    • Jane Akre says:

      Beautifully put Nonie!!! You are so right! Thanks Deb, others have listened.

    • DebC says:

      Thank you Nonie. I appreciate your saying that. I can be the queen of guilt.. and lately, it is even easier to feel that way…. but, I know you are right. I am so glad I found this site, and women like yourself. It’s scary to think where I would be right not if I never went “online”…
      Deb

  4. Marcella says:

    Thank you for your website and the nice summary of pros and cons above .I’ve delayed TVT for SUI after initially researching it ( have to say the dr. did say 10 % risk of not being effective or side effects and it made me pause I work in Medical device regulation and know what corporations are like- lots of “group think” and focus on sales anad profits). I had a friend who had “successful” outcome and the up side is such a nice picture and the FDA failure to act on SUI meant I was waiting for their final word – or MHRAs.. So had provisionally rebooked it but still held many of the worries nicely captured in the humourous and honest take portayed here. This really echos my mental assessment based on months of reading. Seeing it laid out is the final confirmation. I won’t be going ahead with TVT, now or ever. Thank you

  5. DebC says:

    Marcella –
    I can’t tell you how thrilled I am to read your comment. =) As great as it is to have support and understanding from women who are also dealing with mesh complications (and it is VERY very cool)… it is even better to know that I might be helping some women who have NOT been injured by mesh STAY that way. When you wrote, ” I won’t be going ahead with TVT, now or ever.” – that just completely validated to me why I’m sharing my story. I wanted to scream at you “YES!” =) So thank YOU for commenting.

    That is the main reason I’m sharing so publicly my story. Not to gain sympathy and support for myself, but to warn others who might be considering the surgery. Yes, there are people who have the surgery and do NOT have complications… As I told Jane when she interviewed me (http://meshmedicaldevicenewsdesk.com/patient-profiles/deb-c-suffering-stress-incontinence-mesh-injuring-women-too/), I also have a friend who had the same exact procedure done as I did and so far, my friend is doing great. Of course I know there are many it DID help… and I pray all of their success and luck holds out. I do worry about my friend, though, after all the horror stories I have read where some women don’t have complications until years later. There is just so much unknown about the long-term effects of mesh still.. and, what IS known about mesh is really NOT very good other than the fact that it is “quick and easy” to put in.

    Yes, every surgery has risks… but in my opinion using mesh is NEVER a good option or worth the risk – especially for SUI. It also is NOT the only option, although it’s often the only one mentioned. I never even knew they could fix it using your own tissue, or the “old fashioned way”.. but, of course they can. They did for years before mesh came along… and, IF my SUI returns and/or becomes so bad that I do want it fixed again in the future, I will go back to Dr. Raz or a doctor experienced enough to make a sling using my own tissue. Dr. Raz already said that is what he would do, IF I want him to down the road…IF I need it. Truthfully, after evreything I’ve been through – I would have to be having some pretty damn bad SUI before I would even consider having any other procedures after I get this mesh out.

    If you (or anyone) is interested in procedures (SUI, POP, etc.) WITHOUT using mesh, my friend Linda made a post on her wonderful blog about that: http://teapapers.com/bladdersling/2012/07/non-mesh-bladder-repair-surgery/

    Thanks again and take care.

  6. Kristina says:

    I was just doing some research and you caught my eye in google! Hi, my name is Kristina and I feel and know the pain, frustration, and every other problem you and every other woman on here is feeling. This mesh (mess) has been causing problems for years! I found a letter that the FDA sent to the health providers in October of 2008, warning them of complications and reports of over 1000 reported cases. I had my surgery done in December of 2010, and wasn’t even aware of these warnings, my Doctor was just making me feel like it was a piece of cake, and everything would be fixed like new. I had 3 devices inserted in me, and wasn’t even aware that I had mesh, she never even mentioned it to me. I started having complications right away, couldn’t urinate the day they sent me home, bladder was gonna burst!! Trip to the ER, and they sent me home with a cathedar, infections, pain, the feeling of something being inside and not knowing what the hell it was!! I have had a total of 3 surgeries, and still feeling like I will never be the same again, we know our bodies..and no we are not nutso and imagining it! Our quality of like has gone from some to none!! The FDA needs to be more aware and careful of what devices they clear!! Clearance isn’t the same as approved!! These devices were just cleared. Which is wrong for the FDA to do, they are partially responsible for this mess!! Sending letters out to medical providers about warnings and complications regarding these devices, how many doctors actually read these letters? I know mine didn’t, if she would have explained the procedure and the risks and complications to me, I would have run out of there too!! I would have just lived and dealt with my old body wigging out on me, I’d be happier and content with my life. Now I feel I don’t have a life, can’t have sex,have bladder spasms, pain, nerve damage, and I could go on. Shame shame on you FDA and these medical doctors, and especially the makers of these devices!!

    • Jane Akre says:

      Kristina-

      I’m so sorry for what you are going through. Unfortunately, your experience is all too typical. If people had just know, if they truly had informed consent. You have to wonder if doctors read the FDA warning and take it seriously or take the pitch from the sales rep more seriously. Are you having removal surgery or have you had it?

      Your words are powerful- I hope you can get help…

  7. DebC says:

    Hi Kristina,

    I know. It’s infuriating, isn’t it? The fact that they are still putting these in left and right, and saying how safe and helpful they are is so disturbing. Just the other day I was on hold with my OB office (NOT the office/doc who put in my sling), and while I’m on hold they are piping into my ear an advertisement for mesh slings… about how fast, and effective and easy of a fix it is for SUI – and, to let your doctor know if you have any embarrassing leakage and they will fix you right up. UGH!! I wanted to scream “what is WRONG with YOU people!!??”…. but, I’m not even sure who to scream it to, and even if I did, I’m sure I would be labeled as the crazy one and not heard at all. =( When will they realize just how many lives they are destroying… not just the women who have the complications, but their families as well?

    I am fortunate that I will have mesh removal surgery soon with Dr. Raz – and all I can do is hope and pray that I will regain my mobility and quality of life after that… First, I have to get through this month…. This is like the worst year and holiday season ever for me and my family… but, at least I have hope for 2013.

    Deb

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