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

By DebCNY • 2015/01/06

AUGS 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 SUI.  This 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.
• In 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 Committee.  That 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.

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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.

 

==============Related Posts================

• Are you a GOOD mesh? Or a BAD mesh?
• Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI
• Is it Just Transvaginal Mesh Causing Problems?
• Mesh-Injured People: NOT rare. NOT going away. NOT getting SUPPORT!
• It’s NOT enough. We need help!
• Were you told that you were the “only one”?
• Are you a GOOD mesh? Or a BAD mesh?
• FDA warns there is NO evidence that mesh provided any greater clinical benefit than non-mesh surgeries
• Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI
  
• Mesh Problems: An OPEN/PUBLIC Facebook Group, where anyone can ask questions and get information on mesh
• Links to many other articles, blogs, support groups, and resources on the bottom of this blog

 

 

Tagged as: American Urogynecologic Society, AUGS, Bladder Prolapse, FDA, FDA warnings, mesh complications, Mini, mini sling, miniarc, polypropelene, POP, quick and easy, Risks, SIMS, Single-incision mini-slings, sling, Stress Urinary Incontinence, SUI, tape, TOT, trans vaginal mesh, TVT, warnings

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

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