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

Why is it Okay to Use Mesh For SUI, but Too Risky for POP?

AUGSlogoAUGS and the FDA keep saying transvaginal mesh should be reserved for “high risk” patients, and used more as a last resort.  However, mesh for SUI (Stress Urinary Incontinence) is still going full speed ahead.

So, is SUI a “high risk” problem?  
I think not. I’d rather have my original SUI problem any day than what I went through since my SUI mesh implant.

Is the mesh used in “slings” or “tape”  for SUI made out of different material than the mesh used for POP (Pelvic Organ Prolapse)? 
Nope.  It’s the same polypropylene material.  A plastic material that looks nice and soft, but actually hardens in your body, and can erode (cut) through your tissue, muscles, organs, urethra, vaginal wall, etc.


“End of Story?” I think NOT!

Are all the lawsuits and complications I hear about on TV, just for mesh used for POP? 
No.  Mesh manufacturers are also being sued for mesh used for SUI, and there are also tons of reported complications from mesh used for SUIThis includes mesh slings, tapes, TOTs, and the new “mini” slings that so many doctor offices are still aggressively marketing and using today.  Check the FDA MAUDE database yourself for reported complications.  Or check to see which mesh products have lawsuits against them.  Also, check out this article, “Mini-slings can cause complications“, which concludes:

CONCLUSIONS: This series outlines several complications with SIMS (Single-incision mini-slings), similar to what has been reported with other suburethral synthetic tapes. Therefore, caution is required and patient counseling is important.

Then, why is it okay to use mesh for SUI, but too risky for POP?  Why does mesh for SUI continue to be used, and aggressively marketed as, “safe, quick, and easy”?

Largely, it appears to be because the FDA specified mesh used for POP in their July 2011 warning.  This was in spite of the fact that in the very  same FDA warning, they also reported ALMOST as many severe complications for SUI mesh repairs(1,371 complications), as there were for POP mesh repairs(1,503 complications).   Still, they specifically said their warning pertained to POP mesh, and stated they would get back to us on the SUI mesh.

Then, in March 2013, the FDA basically dropped the ball on mesh for SUI, letting the issue slide by putting out some very vague updates regarding SUI mesh, and not requiring the same mandatory studies as they were demanding for POP mesh.

  • The FDA published, Information for Health Care Providers for SUI, indicating doctors should insure patients understand treatment options (including non-mesh surgery), potential complications (including the added risk of erosion for mesh repairs), to convey that a mesh sling is a permanent implant,  and that there is limited information about outcomes after one year.
  • The FDA also published “Information for Patients for SUI“.  I’m not sure how many folks actually wander through the FDA website before they’ve had a problem – but, in this publication, the FDA suggests that patients ask their doctors about treatment options, including non-surgical options, and surgery without mesh.  They warned that mesh had the added risk of mesh erosion which could require additional surgery and cause “penile irritation and/or pain during sexual intercourse” for sexual partners.
  • In the FDA’s page titled, “Considerations about Surgical Mesh for SUI” notice, they said a lot – including that there’s an “approximate 70 to 80 percent success rate of women at one year” (as if 20-30% failure is good?!?), and that the use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion.But these are not the parts of the FDA notice that AUGS like to mention.  Instead, what AUGS, and subsequently most doctors, hone in on is where the FDA mentions,     “The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year”.
    The last statement, is highly debatable.  What exactly do they consider “well established”?.  And “up to one-year” doesn’t help when many women don’t have visible erosion until years later.   Yet, this is the part of the FDA notice that they are focusing on, and it is quoted in AUGS  “Frequently Asked Questions by Patients Mid-urethral Slings for Stress Urinary Incontinence.  In this document, AUGS also states, “The mid-urethral sling is considered safe and effective by the US Food and Drug Administration (FDA).  As with any surgery, complications can occur but they are typically minor and can usually be repaired.”   First of all, they are saying mesh complications are, “minor and can usually be repaired”?  Are they SERIOUS?  Mesh complications are NOT minor.  And, just how/who is “usually” repairing these “minor” complications?  Not the implanting doctors! I had to fly across the country for my very difficult, MAJOR, mesh removal surgery that local doctors told me was impossible.In fact, contrary to the FDA’s recommendation to do so, AUGS makes NO mention in their FAQ document to patients to make them aware of  the added risk of erosion from mesh repairs, OR that mesh is meant to be a “permanent” implant.Also, when answering the question, “What about the advertisements about vaginal mesh and slings?”, they are quick to point out the FDA warning ONLY applied to mesh for POP, and that there must be “some confusion”.    “Some confusion” ?!  I think THEY want everyone to be confused, and believe that all those lawsuits and complications do NOT involved mesh for SUI at all – when, that simply is NOT true!  Thousands of the lawsuits  AND reported complications are for mesh used for SUI.
  • SUI breifing bookIn a separate document,  “FDA’s Role and Activities”,  the FDA  explained that they based their updates on these reports from the  Sept. 9,2011 meeting of the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory CommitteeThat meeting included a “SUI Briefing Book”, provided by most of the same mesh manufacturers that are currently being sued.  Isn’t THAT special?

Look, mesh slings for SUI are made from the SAME polypropylene material as the mesh for POP.  They are being inserted in the same general, very delicate, pelvic areas where you really don’t want to have things eroding (cutting!) through things.  They have thousands of well-known, documented and reported complications (pain, mesh erosion(also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, etc.), just like mesh for POP.   If you search the FDA Maude database, or talk to any lawyer, you will find thousands of complications reported for mesh slings used for SUI, in addition to POP.

Yet, since the FDA warning did not specifically target SUI,  most doctors are claiming mesh for SUI is safe.  They are not legally required to mention any of the FDA warnings to patients suffering from SUI.  They certainly aren’t admitting that many of the current lawsuits and severe complications are from mesh that was used for SUI, or the mesh that they may be using currently.  Matter of fact, they seem to be oblivious to this.  Maybe, because they are listening to AUGs (who isn’t bothering to mention it!), and to the mesh manufacturers.   ?  Regardless, I know the mesh that caused my problems is still being used widely today – and it was for SUI.  The last almost 3 years of my life have been anything BUT “quick and easy”.

Please.  If you have SUI, do NOT get a mesh sling.


Note:   This article is largely drawn, from my last longer post. “AUGS – Addressing mesh complications and helping patients? or just defending mesh?“, which addresses some of this in more detail if interested.


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Categorised in: FDA, Legal News, Mesh Complications, Mesh for SUI vs POP

18 Responses »

  1. I had my sling placed in 2010 and I was never warned of any mesh related risks, my sling was placed for SUI and personally I would rather sneeze or cough and pee my pants any day than go through the hell I am going through. Do not be fooled it is all crap!!! Don’t put in in your body..


  2. Very well written! Take heed ladies, this isn’t the only source out there.


    • Ellen – thank you. And, your right… there’s a ton of information. I try to link to other sources as much as possible too. Feel free to mention any others as well.


  3. I’m in the same boat in a lot of ways as you, Deb. My problems were also all from the SUI mesh sling portion of my bladder repair (the POP was fixed without polypropylene, thank goodness, or I’d be in even worse shape). In 2010 when I had it done (at age 40), there were no warnings out there, no lawsuit commercials. But I still wish I had done more research, because my surgeon failed to mention that there were already FDA warnings back then about severe complications. Still, I doubt I would have worried anyway – after all, the surgeon said I was “the healthiest person he had ever done this surgery on.” I ran/walked 6 miles daily, rollerbladed, biked, and generally was extremely active with my 4 kids and husband. Now, not only can I not do any of that, but I also cannot sit (imagine living life without being able to sit – at all!), cannot work, cannot have sex (4 years now!!!) and have to go to a pain management clinic every month to get the 6 heavy prescription pain medications I need to keep the pelvic pain at tolerable levels. So these “minor” complications that “can be easily fixed?” Um… Not minor. Not fixable at all (I’ve now had 7 surgeries to remove most of the mesh and deal with all the damage it caused). And most certainly mine is NOT a RARE case. There are 100,000+ lawsuits in the USA alone (and counting) at this point. And I”d venture to guess that at least half of those involve a mesh SUI sling rather than a POP repair. I’ve learned that filing a lawsuit is a long, emotionally difficult, slow process – and there’s no pot of gold at the end of the mesh rainbow. Not one woman has seen a penny from a lawsuit yet, and most of us don’t ever expect to. We do it to raise awareness, to try to protect other women from going through this. 100,000 women went to the trouble of filing a lawsuit (again, not an easy process), knowing they would likely get zero, because THAT’S HOW HORRIBLE MESH COMPLICATIONS ARE. And lawsuit filing is one of the few ways we have of speaking out against this terrible product. So please, do not agree to ever let any surgeon implant mesh in your body – not “the new mesh,” not “the better mesh,” not “the gold standard mesh.” Not for POP – and certainly not for SUI. It is not worth going from being “the healthiest person” a doctor has ever operated on – to a disabled, unemployed, sedentary, celibate 44 year old woman who would give anything to go back to the days when my worst health problem was leaking when I coughed.


    • J.B. –
      Thank you for responding here, and sharing a little of your own mesh story. What a nightmare you have also been through. You are so right… about so much.

      People think that because of all the lawyer ads women with mesh complications are getting rich, when I also have not heard of one person actually getting any money. If the few large cases that you hear about (briefly) winning millions – the just go into appeal and dragged out and out. We are fighting huge corporations, like Johnson and Johnson – who can afford to drag things out while women suffer and more and more of their products are sold and implanted.

      Is there any chance you can get to Dr. Raz? or Dr. V? They are the only docs I have heard continuous good things about from women who went to them and got help, when no other docs could/would…



  4. The implanted mesh deliever the purpose of supporting, but the problem is the tissue it support cannot with stand the increasing pressure ( straining for defecation and ageing) and give way to cause complication.
    Evidences show constipation in those who has UI and POP is exclussively related with posterior pelvic floor sagging.
    If the sagging of the posterior part of pelvic floor and constipation are not manage, just matter of time practically all the mesh may complicate.

    Stenting procedure for coronay is much more invasive but it is successfully safe millions of life. It is because the stent patient is supplement with life long anti platelet and anti cholestrol measure.

    If we can provide life long supplementary pelvic floor support during defecation( when pelvic floor support is challage the most) and life long management of constipation, overloading of the surgical site will be avoided and complication prevented.


    • Heng Hai,

      I just responded to your other comment on my blog here:

      Please see that as it also applies to your comment here.

      The only things I’d like to add to that reply here are:

      1) Stenting procedure for coronay is hardly comparable to mesh used POP, or SUI. SUI is hardly a live or die situation… and even if it was, there is NO evidence that using mesh for repairs has any clinical benefit over non-mesh repairs. Also, unless the “stent” is hardening, and “eroding”/cutting through everything around it – I don’t think it has the same characteristics as polypropylene mesh.

      2) Please do not post to my blog again, as I will not waste any more time trying to respond to you, nor will I allow you to advertise your product here.

      Thank you.


  5. At 58 years old in December of 2011, I was in great physical shape. Was very active and worked in a physically challenging field of work. I was implanted with a TVT EXACT Vaginal Sling and from the moment it was implanted my downward spiral of debilitating permanent effects have taken over my body and life. Do not have this procedure for SUI ever.


    • Thanks Janis. I hope more women will research BEFORE they have the mesh put in. So many of us just TRUST our doctors (who then plead ignorance and don’t want to know anything if/when we present with problems). =(


  6. Hi Deb, what about biological mesh, with laproscopic ventral Rectopexy?


  7. Dr Twiss in Tucson Arizonais a good meshremoval doc,he takez the whole mess of mesh out just had mine taken out Aug 2 2016 still Recovering still every painful right now I think
    Its going to take a while Dr Twiss was trained by Dr Raz at UCLA in Calif?



  1. Mini-slings Cause Mesh Complications Too | Mesh Me Not
  2. Mesh: Definitely risky for POP, but for SUI? Eh? It might be ok still, right? | Mesh Me Not
  3. “Considering a Mesh Implant? You have better odds playing Russian roulette” | Mesh Me Not
  4. Doctors ask for the word ‘mesh’ to be removed from new patient forms | Mesh Me Not
  5. Scaremongering or Just Plain Scary? – Mesh Me Not

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