AUGS – Addressing mesh complications and helping patients? or just defending mesh?

By DebCNY • 2014/04/16

Pro-mesh doctors and advocates repeatedly refer to the AUGS (American Urogynecologic Society) website, claiming AUGS is addressing the problems of mesh.   Are they?

In this article, “The American Urogynecologic Society fights back against transvaginal mesh bans” from August 2013, it states:

“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 repeatedly imply that the mesh product is not the problem, but instead it is the skill of the surgeon that needs to be accounted for.

Pro-mesh people want us to believe that it is the DOCTOR, not the product that is at fault for mesh complications.   I’m guessing a lot of doctors who implant mesh might disagree…  but, the manufacturers of mesh? Well, they love this idea because if you can prove it’s the doctor’s fault, 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, doesn’t it?  Recently, the founder of APOPS (Association for Pelvic Organ Prolapse Support) also supported this idea, telling me that, “every woman needs to screen her practitioner for experience and then ask the right questions“.  So, it’s the patients fault for not finding the RIGHT, or better skilled doctor?  That is a bit harsh.   Realistically, how many people even know the right questions to ask?

Besides even when the right questions are asked, the wrong answers are often given. Check out this recent article called, “Top 10 Myths Woman are Told Today about Pelvic Mesh“, where people are still reporting being told things like, “Don’t read the internet”, and “We don’t use the “bad mesh” here”.   They market mesh repairs as “safe, quick, and easy”, to both the public and their doctors.   People are trained to trust their doctors… and apparently doctors are going by what sales reps are telling them.  By the time we learn that we really CAN’T trust everything our doctors tell us, and where to find the right information, it’s usually too late.

A few weeks ago, history was made when Johnson and Johnson TVT-O Mesh was found defective, as mentioned in this article(http://meshmedicaldevicenewsdesk.com/patient-profiles/jj-tvt-o-mesh-found-defective/):

“The trial of Linda Batiste v. Ethicon concluded April 3, 2014, just before 6pm central time with the jury returning a verdict that the TVT-O mesh implanted in Batiste was defectively designed.  That was the central count to this product liability trial.  The jury awarded her $1.2 million.”

NOT the doctor.  The product!   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.   Things that often are NOT being discussed or disclosed.  What if a person has major FBR (foreign body reaction) resulting in inflammation and pain, like myself and countless others had?  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 (not just vaginal walls, which is bad enough and the most common type of erosion)?  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?  Are they being told about non-surgical treatments first?  If/when surgery is warranted, are they being told about NON-mesh repairs?  How many doctors are even doing non-mesh surgical pelvic repairs?  If a doctor only knows how to do mesh repairs themselves, will they mention or refer patients to doctors that have the skill to do non-mesh 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?  Because THAT is exactly what many doctors claim – that they only misinformed patients because they went by what the mesh manufacturer sales reps told them.  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 by all means. 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 even 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 only for high risk patients?  It certainly doesn’t seem so.  Why do I keep hearing of it being used left and right, sometimes the first and/or only option?   Why do so many STILL seem to think it will last longer, or that it is better for younger more active women? Where is the data on this? Why did the FDA state the opposite? (that there IS no clinical evidence mesh repairs are better!).

And, (this is a big one for me) –

Why is it okay to use mesh for SUI, but too risky for POP?

Is SUI “high risk”!?   I think not.  So, 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 POP in their July 2011 warning.  This was in spite of the fact that in the very same 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.  However, the part that AUGS and most doctors honed in on is where they stated,  “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 the part 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.”Minor?  Are they SERIOUS?  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.  Most women who do let local doctors “trim” the exposed mesh wind up with further erosion, more complications, and even more surgeries.  Mesh erosion is the gift that keeps on giving and eroding!

  Contrary to the FDA’s recommendation, 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??   Yes – apparently on THEIR part, maybe.  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. Products STILL on the market and being used today.

• 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 – the “gold standard” even.  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.  I know the mesh that caused my problems is still being used widely today.

AUGs also is concerned about Research, stating:

“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.”
(from: http://www.obgynnews.com/specialty-focus/surgery-hysterectomy/single-article-page/the-american-urogynecologic-society-fights-back-against-transvaginal-mesh-bans.html)

Ahhh…  research!   Now we are getting somewhere. This I believe.
Of course they are worried about halting their precious research.  I can only IMAGINE how many billions are invested in research on mesh?  How many grants?  Clinical trials?  How much FUNDING are doctors and medical centers receiving from the NIH and the government to do their “research”?  And, who pays for all this funding/research?  I’m sure that is a LOT of people’s bread and butter.  I’m sure they do NOT want to stop this gravy train, 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 many human 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?

There are now over 60,000 lawsuits against six different mesh manufacturers for mesh complications from POP & SUI mesh.  SIXTY THOUSAND!  (update!  As of May 2015, there are actually over 100,000 lawsuits now.  ONE HUNDRED THOUSAND!!)  There are thousands MORE of reported mesh complications, and COUNTLESS unreported.  How is getting this crap off the market, “premature?”.  I would say it is LONG OVERDUE.

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” (again, it’s the doctors fault, not the product), 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 mesh repairs, 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 those women, even if it keeps working… even if they are the majority…  does that make it acceptable for all the women that DO have these “not rare” and very severe, life-altering, 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, and is that 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 these same women that sing mesh’s praises, could most likely have been helped without mesh as well – without all the added “not-rare” (also according to the FDA)  and severe risks that mesh introduces.

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 if you do have one of these “not rare” and severe complications?

To me, it seems like AUGS is more interested in defending mesh, the manufacturers, and the HUGE profits involved in the research and marketing of it,  rather than actual patient benefits.

==============Related Blog Posts================

• 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
• Despite multiple FDA warnings since 2008, use of mesh in pelvic organ prolapse surgery continues to grow 
• “Systematic reviews of apical prolapse surgery: are we being misled down a dangerous path?”
• Is it Just Transvaginal Mesh Causing Problems? 
• Searching for Docs Experienced with FULL Mesh Removal, and/or NON-Mesh Repairs
• Finding the Right Doctor for Surgical Mesh Complications
• Are you Sick and Tired of Lawyer Ads about MESH?
• It’s NOT enough. We need help!
• Mesh-Injured People: NOT rare. NOT going away. NOT getting SUPPORT!
• Partial vs. Full Mesh Removal Surgery
• SIMS (Single-incision Mini-slings) Cause Mesh Complications Too
• Top 10 Myths Woman are Told Today about Pelvic Mesh
• Top 10 Things to Know About Mesh BEFORE Having Surgery for POP or SUI

==============Support Groups================

• Women’s POP/SUI TVMesh Complications Support (Closed Group)
• Fighters And Survivors of All Transvaginal Mesh And Hernia Mesh/Plugs (Closed Group)
• Mesh Me Not – Upstate NY (Closed Group)
• Mesh Problems (PUBLIC/OPEN TO ALL, including doctors, etc)
• More resources listed on the footer/main page of this blog!

 

Tagged as: alternatives to using mesh, American Urogynecologic Society, AUGS, FDA warnings, mesh complications, news, no evidence, non-mesh, POP, Stress Urinary Incontinence, SUI, warnings

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

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