We are now going to shift gears and weíre going to talk about avoidance and management
of mesh related complications. And ladies and gentlemen please donít go because
this is very, very important as you will soon see.
Well the fact is that the goal, I canít see this so well, the goal of pelvic floor
surgery is of course to put together good anatomical and functional outcomes. And
the bottom line is we have to do so with very, very low risk to the patient. Secondarily,
of course, we always are looking, striving to improve quality of life. Pelvic prolapse
affects up to half of all women, especially those women beyond 50 years. The prevalence,
of course, increases with age as well as with repair.
Interestingly enough now and this is going to be a very, very, very important number
for you all to remember. If you look at pelvic floor repair data from 2005 to 2007
there were nearly 900,000 pelvic floor reconstruction procedures during this period
of time at which over 350,000 were using synthetic mesh. So a good percentage of
these are mesh procedures, over 33%. If you look at our urinary incontinence data,
the stress urinary incontinence data, during that same period of time, nearly 660,000
SUI procedures and there were a total of 631,000 synthetic mesh procedures. So you
can see a great number of procedures being done, nearly one to one ratio in terms
of stress urinary incontinence. In this period of time then the total number of
mesh procedures nearly one million procedures in the United States in three years.
Now, traditionally prolapse repair has an estimated failure rate of 30% to 50%.
We know that pretty well, which is served as the impetus. Why? People have started
to do the mesh with care. Complications are not isolated to vaginal mesh repairs.
And with these there was a 36% recurrence with porcine dermal graphs in the study
and Linda Brubaker from my hometown, Chicago, Linda Brubaker the diva of Chicago
pelvic floor reconstruction has reported a 5.5% mesh erosion rate but a 7.7% suture
erosion rate following abdominal sacrocolpopexy. So very interesting.
Now, why this is all important to us, why this is all important to us is that just
very recently, how many of you have heard about this FDA pelvic, the notification.
So a majority of you do, very, very interesting. There has been but for those of
you who donít, there is an alert regarding complications of transvaginal placement
of surgical mesh both for prolapse as well as for stress urinary incontinence. Over
the past three years, the past three years, 2005 to 2007, FDA has received 1000
reports of serious mesh related complications. Now the first thing youíre going
to say is when I say to you thatís a 1% complication rate. Call it what you will,
thatís a 1% complication rate. Now, we can all say but of course we underreport.
We underreport every single complication. We underreport on hissence at time of
hysterectomy. We underreport public inflammatory disease. So, please, yes, this
is one more complication that has been underreported. But if you put it to the total,
this is a 1% complication rate. Most frequent complications that you would expect
are erosion, infection, pain, urinary problems and recurrence. Remember, we talked
about recurrence in series of over 30%. Additional complications, however, can be
more severe. Those related to bowel, bladder, blood vessel, injuries. So they are
not to be taken lightly. Iím not being cavalier by any means for qualifying percent.
Well, in this notification physicians were basically told what they should be doing
already. And itís never wrong for this emphasis to be given. Firsts of all physicians
must be trained properly. That is always something weíve spent the whole half of
this talking about. We must be vigilant about the potential adverse events. We must
watch for those complications. We have to give our patients proper informed consent,
both from a standpoint that these meshes are permanent and that these meshes can
be related to serious complications. And finally, we have to provide patients with
a written copy of patient labeling from the surgical mesh manufacturer. Something
that quite honestly I have not done but sure as shooting I will be doing after this
So with that in mind, I have the opportunity to have on my panel two of truly the
world leaders in urogynecology, both from a standpoint of the clinical treatment
as well as teaching. Ladies and gentlemen, weíre hanging out with two superstars.
The first is Marie Fidel Paraiso. She is Chief of the Division of Urogynecology
at Cleveland Clinic. Marie Fidel has told me recently that she is about to become
an Associate Professor at the Medical School with Cleveland Clinic and we are certainly
proud of her. And the second is, when I was a fellow at the University of Pennsylvania
my former resident and he did well. Bob Rogers is in private practice in Northwest
Montana. And thatís not good enough. He has a passion for the study of and teaching
of gynecologic surgical anatomy. I think most of us learned our anatomy training
originally with Bob. The fact is, is that Bob was the one who was behind the very,
very first cadaver course that was performed in 1996. And here we are now where,
Bob, I think there are three different cadaver courses here at the AAGL this year
alone. And something that Bob continues to be really one of the gurus in. So with
that in mind, setting the stage with such excellent physicians, Iím going to start
with you, Dr. Rogers. What do you think physicians should keep in mind when they
select patients relating to avoiding mesh complications? Tell us about patient selection.
First of all, I donít use mesh as a primary procedure. If a patient has not had
reparative vaginal surgery, if a patient has not had prior vaginal surgery, Iím
not going to use mesh. Iím going to assume that their visceral connective tissue
is going to be strong enough with the use of permanent suture using proper anatomic
landmarks to do that repair. And if you look at the literature, for instance doing
a bilateral uterosacral ligament colpopexy for enterocele repair and support of
the vaginal apex, thatís going to take care of your high cystocele your high rectocele
your vaginal wall prolapse, your enterocele and the literature shows for a two year
followup in 80 to 85% of the patients that will remain successful. I will only use
mesh in patients that have a massive reoccurrence or a multiple reoccurrence situation,
particularly if the anterior vaginal wall is smooth and the estrogenized vagina
that is smooth without good rugations. If you have good transverse rugations anteriorly
or posteriorly that means that patient has good useful visceral connective tissue
that you can use for your repair. You donít want to use mesh in people that have
had pelvic radiation. Never use mesh in that situation. And if people are on steroids,
particularly high dose steroids, you donít want to use mesh in those situations
cause that will erode, that will erode and that will be exposed. But mainly you
want to use these procedures for multi recurrences in an older woman who wants to
maintain the vagina for vaginal intercourse I will tell you that these mesh procedures
work when theyíre properly performed and theyíre a godsend for our patients.
I want to ask you about that. You said you never use that as a primary procedure
even for stress urinary incontinence?
You asked me about a prolapse.
Okay. In terms of just selecting patients from a standpoint of mesh complications.
But I just want to understand that mesh complications, of course, weíre looking
at both, both pelvic floor as well as SUI. I just wanted to get on record that with
I agree with that and with your urethral slings and of course I use either the TVTO
or the TVT secure. That is now, in my opinion, the gold standard for hyper mobile
urethras and urinary incontinence. Again, you donít put mesh in a radiated pelvis
or a patient who is on high dose steroids.
Well, can I just make one statement. I think the FDA lumps urinary incontinence
and pelvic organ prolapse procedures together, which really probably was not the
right thing to do because there are no better data in the literature regarding urinary
incontinence procedures than actually the retropubic TVT which has 10.7 year data,
which is excellent in prospective cohort studies. So, the TVTO and the TVT secure
are also great procedures and theyíre a lot of other alternatives but they should
have really just focused on complications associated with the pelvic organ prolapse
kits and that is, I think a lot of this ascends from certain patient populations
that were complaining on blog sites and I think that also too raising awareness
in the media. And thatís why women started asking about complications of mesh and
then the lawyers started looking for people that had complications of mesh.
And in that FDA statement I will tell you many of those meshes were not the loosely
woven polypropylene mesh that we use. A lot of that were the more solid meshes,
which do have higher rates of erosion. So you have to differentiate what kind of
mesh youíre talking about in that FDA statement.
I think thereís a question or comment.
I think thatís a very, very good point. That is something that Iíll bring back to
our board. Thatís a very good point. You know itís interesting that we have always
been somewhat feeling like weíre still not ACOG but at this point we are the physicians
involved in minimally invasive gynecologic surgery and we should have a position
on this. What can you do surgically in terms of your dissection techniques, etc.,
to decrease that potential risk?
Thereís a lot that you can do. You need to understand your pelvic anatomy. You need
to understand vaginal support and vaginal suspensory anatomy. And you need to realize
that you need to leave the visceral connective tissue where the fibromuscular coat
around the vagina, you need to leave it on the vaginal epithelium and you need to
be dissecting in the true vesical vaginal space anteriorly and you need to be in
the true rectovaginal space posteriorly. And you know youíre in the true spaces
when you dissect with your finger, those spaces are avascular. And if youíre in
the right space it will be avascular. You need to put the mesh between the capsule
around the bladder and the full thickness of the vagina. You need to make your incisions
as small as possible. My anterior colpotomy incision is only about 3 centimeters
in length and I only do my dissection in the vesicovaginal space in the upper third
of the vagina. I stay away from the lower third and thatís where the urethra is.
I stay away from the middle third of the vagina where the trion is. Okay, these
are very important points. And when you put the mesh in, you put it in very, very
loosely. And when youíre at the end of the procedure, to show you how loose that
mesh is, I like to push that mesh up to behind the pubic bone and before I close
that vaginal epithelium, I want to be sure that mesh is well away from the pelvic
sidewall. And when youíre through with the procedure you look in there and say my
goodness the patient still has a first, a second degree anterior vaginal wall prolapse
down towards the foraminal ring you must pack them for 24 hours at least 24 hours
but when they come back to the office they have a slight anterior vaginal wall prolapse
but itís asymptomatic. They have mobility in that area but they can urinate, they
can hold their urine and they donít have that irritability of the bladder if you
stay away from that middle third of the vagina.
Let me ask you? What are your trends?
Well I think you definitely need to keep the operative site clean. I canít stress
enough the important of hydrodissection. I use 1% lidocaine and one hundred thousand
epinephrine, 30 ccís and 30 ccís of injectable normal saline, I inject it. And you
donít want to see blanching because then youíre in the wrong space. If you see the
anterior vaginal wall balloon up the that means that youíre in the apex. The true
vesicovaginal space, it should be avascular but there are a lot of women who have
had previous anterior repairs. Your dissections need to be clean. I irrigate with
Bacitracin. I cover the rectum. If you perforate the rectum I would definitely not
place a synthetic mesh. I think we also too, I recommend prepping the vagina with
estrogen unless the patient has contraindications to estrogen. Also those chronic
tobacco users, thatís another contraindication, as well as poorly controlled diabetics.
I think those patients arenít going to be infected. So the operative site needs
to be clean. The repair needs to be under no tension. And you canít send them home
on the same day. You really do have to keep them packed so that you have adequate
If you want to get an erosion in mesh, get a hematoma. You have to have a meticulous,
meticulous hemostasis at the end of the case. No question about it.
And avoid the T-side incisions so a lot of people donít recommend concomitant hysterectomy
but if you do concomitant hysterectomy you could either do laparoscopic supracervical
or you could do a double layered closure of a vaginal hysterectomy and then place
your mesh into another incision. But you never want to have a T-incision.
And I do not bring the mesh over the apex when Iíve done a hysterectomy because
you will get an erosion of about 20% to 25% of the cases. So Iíll take that mesh
up to the vaginal cuff anteriorly up to the vaginal cuff posteriorly but I donít
sew across the apex but I will do a uterosacral ligament suspension procedure. Thatís
worked well on my patients.
And the anterior inferior and the anterior superior arms of the anterior mesh have
to be at least 4 to 5 centimeters apart so that the mesh is does not bunch. And
you donít have to use all that mesh in the kit. You should trim it according to
the patients size and what she needs in her repair.
I do want to talk about a choice of instrumentation, Bob. You utilize the ProLift
system. What do you see that as an advantage? Why do you like that system? Why does
it work well for you?
Because it is easy to place. It works. It is much less trouble than during traditional
reparative vaginal surgery. And it helps me avoid a too extensive of a paravaginal
dissection. And itís anatomic because youíre putting those arms, the first arm goes
to the junction the infrapubic ramous where the by the pubic bone. The second arm
goes right back towards lumbar spine. And what youíre doing is recreating that horizontal
supporter, Delancey level two that goes from parcus tendineus fasciae pelvis to
arcus. Itís just easy placed and it works. My failure rates are very, very low.
Is there a comment?
First of all, if I have patient Iím doing a vaginal hysterectomy or a patient that
has prolapse in the estrogenized vagina, if she has good transverse rugations anteriorly
and posteriorly, if you want to repair her cystocele, her prolapse, her enterocele,
her high rectocele, I do a bilateral uterosacral ligament colpopexy. Okay. And that
works. The literature shows that that works. And in my experience that works about
80% to 85% of the cases. I no longer do a vaginal, paravaginal defect repair. The
apex is the key to reparative vaginal surgery and be sure to reconstruct that perineal
body. You reconstruct the apex, you reconstruct that perineal body cause with a
patient with a weakened levator plate and it doesnít act as a back stop for the
upper third of the vagina, if you recreate that perineal body that will assist as
a back stop to help prevent prolapse. So thatís what I do with a patient thatís
not had surgery before. Now my consent, hereís what I tell all my patients, okay.
During any surgery there could be high expected injury to the bladder, ureters,
bowel, rectum, intestines or blood vessels that may require further intervention
or a blood transfusion or further surgery.
And I say after surgery weíre concerned about blood clots in the legs, blood clots
in the lungs that can be life threatening. Weíre concerned about hematoma or blood
collection around the surgical site. Weíre concerned about abscess formation around
the surgical site or infection somewhere in their body. Weíre concerned about stress
on the heart, lungs or kidneys, which can cause organ damage such as a heart attack
and weíre very concerned about a lot of our patients who have lower back pain or
leg pain on the table or the use of retractors. Occasionally, a problem or complication
or unexpected outcome can and does occur from time to time. Are you willing to work
with me so hopefully we can diagnose and resolve whatever has occurred. Yes doctor.
All that is documented, signed, sealed, delivered.
You know, I want to add because you asked about adding cadaver fascia. I donít think
there are any data to support using biologic measures at all in the literature.
Definitely not on primary repair or even recurrent repair. And actually there are
only two prospective randomized trial using biologic tissue. One of them is Tutoplast
versus polypropylene mesh for sacrocolpopexy and Tutoplast which was solvent in
dehydrated cadaveric fascia lata and sacrocolpopexy was associated with a 68% cure
rate versus a 91% cure rate for the vaginal apex. And then I published the only
rectocele trial and actually biologic mesh was shown to be disadvantageous. It wasnít
as good as traditional posterior repair or site specific area.
By the way, the more you do these dissections and the more you use these meshes,
the first year I was doing these mesh procedures my erosion rate was 4.1% and after
that itís dropped to less than 1%. It depends on the patient, the situation, I have
one patient who has a 1 cm erosion in the anterior vaginal wall near the apex. She
has very little discharge, it doesnít bother her. She and her husband are able to
have very satisfying comfortable vaginal intercourse. Iíve offered to take her to
the operating room as an outpatient to excise that area and she will not do it.
Sheís comfortable. Her surgery is holding up well. Her bladder is working well.
She wonít have it done. But Iíve been fortunate in that Iíve just had a couple of
patients take back to the operating room, excised the exposed mesh, freed up the
edges and I didnít even close the area. I just let it epithelialize in with the
vaginal estrogen. And they did fine. Iíve had limited experience with exposure
Letís divide it first of all. I want you to look at three classifications. One the
conservative approach. Number two, the mesh is less than 1 cm. erosion and mesh
is greater than 1 cm. erosion. Why donít you give me all three.
You asked about vaginal estrogen. I think 2 grams every night, her vagina, vaginal
estrogen cream, 14 days and 3 times weekly, I think you should get a good response
by four to six weeks so you should see them after that. I think that most people
will respond to vaginal estrogen. I had an erosion on one of my anterior prolapse
at the apex and I was surprised when she came back she was refusing to take estrogen
and I just treated her and I saw her four weeks later and I had an erosion that
was greater than a centimeter and it covered that. I think if a patient doesnít
want to go to the operating room, you could excise it in the office, although I
had given her local anesthesia in order to do that and make sure you have good adequate
lighting. Most of the erosions or extrusions are going to occur at the incision
site of the anterior vaginal wall and so unless they were particularly bothered
about it and did not want to take estrogen, then Iíd give them a trial of estrogen.
If itís less than a centimeter you might want to try to treat it in the office and
maybe over sew it. And then if not, then I take them for an outpatient surgery and
then I like to actually, unless they have vaginal constriction, I like to lift the
flaps up about 1 cm. and then excise not the entire mesh, and that would be only
a pain issue or a stricture issue, but excise the part that seems to be either folded,
most of them are either folded over on themselves and then you can excise that portion
of extrusion and then close it over. And I would use a monofilament mesh. Iím sorry,
monofilament suture like Monocryl for that. And then let them use some vaginal estrogen.
Unless they were infected I wouldnít take out the entire mesh. Iíve seen some complications
especially with the mesh that has a porcine barrier and so to make sure that Iím
not biased towards or against anything Iím not going to mention any groups but that
type of mesh sometimes seems very infected and most recently Iíve seen a lot of
erosions, big bands in the vagina and in some cases where it was through into the
rectum. So I would tend not to use that particular kit.
Have you ever had to take out the entire mesh?
Oh, yes, in a lot of patients. We have a large series that weíre following and mostly
these are for patients with severe pain. The meshes have been placed under too much
tension and they have a lot of erosion and folding over. And these patients then
also to have levator spasm and I send them to physical therapy. And sometimes just
even removing the mesh or the infected portion, some of these procedures take about
four hours to remove the entire mesh. And itís very hard to take the straps that
go through the ischial rectal fossa and the actuator fossa out.
Is this a loosely woven polypropylene mesh that gets infected?
Yes that too sometimes gets infected. But more than likely the barrierÖ
Yes, I was going to say with the loosely woven polypropylene mesh, like I use a
ProLift kit. Now that Iíve said that, it will happen. But Iíve done hundreds and
hundreds and I have not yet seen an infection of that loosely woven polypropylene
Neither have I. Itís mostly extrusion of those particular meshes.
What do you do in the case where you put in mesh and as you saw one of the alerts
from the FDA was the concern about dyspareunia and that patient comes back and says
I have dyspareunia and everything you do it looks perfect. It feels perfect. So
everything youíve done and you say to the patient this looks great, it feels great.
What do you do in that kind of case?
Well youíre going to find certain sites in the vagina and you should try to reproduce
it in the office. But a lot of times it might be that particular arm thatís been
pulled too tight and I might inject them with Marcaine and steroid at that site,
sort of a trigger point injection. And if they donít respond, send them to physical
therapy and I might use Botox for levator spasm. Botox isn't covered all the time
for muscle spasm but I use about 10 units in 1 cc of injectable saline. It comes
in 100 unit vials and that can resolve levator spasm but itís only temporary. But
sometimes that will be enough to break up that nerve loop. Most of the time patients
have pain, particular pain laterally where the mesh has been put under too much
tension. You need to go in there and release that off paravaginally. And that will
I will tell you in any reparative vaginal surgery, even when you donít use mesh,
you will form neuromas or trigger points from time to time and that patient will
have dyspareunia. The problem with dyspareunia with mesh is not unique to the use
of mesh. It can happen in any type of reparative vaginal surgery. And the way to
treat it is to inject the trigger points with your .025% Marcaine, sometimes you
use a little bit of a steroid. Sometimes even after Iíve numbed up the area Iíll
inject the area with a little hypertonic saline solution, 5% sodium chloride to
help deaden the nerves in that localized area and thatís worked also. But injections
are the mainstay that should begin with. Okay. And Iíll tell you the vast majority
of patients will come back two weeks later and their pain is still there but itís
half as bad as it was before you inject. And then you do another series of injections
and half to 6% of my patients will have significant relief of their neuroma. Sometimes
youíve got to take them back to the operating room and cut that scar tissue out.
And you can also place them on medication such as Neurontin or Lyrica that will
decrease their ability to sense pain there but, again, a lot of patients donít want
to take medication for pain issues.
But it starts when, make small incisions. Be sure you have hemostasis, youíre dissecting
the correct plane and I cannot emphasize enough that mesh has to be loose. Itís
got to be spread out, it canít be bunched up but it has to be put in there loose
so at the end of surgery you look in there and say oh my goodness I havenít repaired
anything. But because the mesh as it is incorporated into the fibroblastic collagen
thatís put down, the scar tissue, it will shrink about 25% and Iím telling you the
Prolift in my practice has been a godsend for my patients.
It can also shrink up to 40% in some animal studies.
Thatís the purpose of making sure you have hemostasis and I pack the vagina for
a minimum of 24 hours. Some doctors will actually pack for 3 days. You never ever
show the mesh to the vaginal epithelium. The purpose of the packing is number one
to be sure you continue to have good hemostasis because with a hematoma thatís where
youíre going to get an erosion. And number two, just because you dissected in those
area youíre going to get a coagulant and with that pressure pack it will allow that
coagulant to actually place the vaginal epithelium the entire thickness of the wall
against that mesh to hold it up and then that process of that shrinkage or whatever
you want to call it, occurs and it works very nice. Vince Lucenta yesterday brought
up a good point that if we donít exercise that area, you know that mesh can become
stiff. So he has the idea of using dilators several days after surgery start using
dilators to keep that scar tissues, that mesh pliable to hopefully decrease the
risk of dyspareunia. And I think heís going to do a study on that.
We just have just a few more minutes and you have two experts up here.
You know what, I also wanted to add one thing. Sometimes the vagina might get constricted
to the point where you might not have enough vagina to bring back over the mesh
and Bob says heís leave it open in those cases and they might epithelialize. Some
people use biologic, and again I have no ties with them, but Sugisis, itís a porcine
small intestine submucosa graft that is actually processed in such a way that has
itís growth factors intact and Iíve made neovaginas with that graft and there is
some series out of Mayo and, in some cases, the Cleveland Clinic where weíve actually
put those grafts over the areas where weíve excised mesh and the vagina has been
repaired very sufficiently and re-epithelized.
This material, and I donít have any connection with them either, but you have an
in-growth of visceral connective tissue, in-growth of vaginal epithelium, and most
importantly in-growth of vasculature.
Itís a beautiful thing.
Iím going to take that one. I love laparoscopic sacrocolpopexy and I think itís
having a resurgence because of the robot. And I think specifically, you know Iím
worried that we might be placing vaginal mesh into a contaminated field. Iím not
going to say that thatís the case because certainly in Bobís hands or in Vinceís
hands itís very good. Laparoscopic sacrocolpopexy is great surgery. Iíve probably
done over 500 to 600 laparoscopic pelvic organ prolapse procedures and I donít have
to take very many of them back to the operating room, if ever, because itís practically
a hundred percent cure for the vaginal apex. And thatís whatís going to bring you
home free. So, thereís still a role for that but I think there are some laparoscopic
surgeons and some vaginal surgeons and you should really do whatís best for your
And I can tell you there is a resurgence. Last year we had a laparoscopic sacrocolpopexy,
it was robotics sacrocolpopexy at the telesurgery. I think theyíre doing side by
side this year, if Iím not mistaken at this meeting. So youíll see both the laparoscopic
approach as well as the robotic approach. Tony Viscoe just wrote an article for
me in OB/GYN News, the Masters Class, on robotics and Marie has done it on a laparoscopic
approach. So itís a very popular area.
Itís all the same. It is laparoscopy, because the robot is a tool. And I think that
for people who have that as their go to gold standard procedure than it can be done
laparoscopically and itís a great surgery.
Well Iíd like to thank all of you. Itís just been a wonderful evening. I hope youíve
enjoyed this as much as I have. The fact is that we all owe it to the Ethicons,
the twin towers, Ethicon Endosurgery and Ethicon Womenís Health and Urology for
bringing us together. Look forward to seeing you all down the road. Enjoy the rest
of the AAGL. Thanks a lot everyone for sticking around.