Dr. Miller

We are now going to shift gears and we’re going to talk about avoidance and management of mesh related complications. And ladies and gentlemen please don’t go because this is very, very important as you will soon see.

Well the fact is that the goal, I can’t 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 don’t, 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 you’re going to say is when I say to you that’s a 1% complication rate. Call it what you will, that’s 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. I’m not being cavalier by any means for qualifying percent.

Well, in this notification physicians were basically told what they should be doing already. And it’s never wrong for this emphasis to be given. Firsts of all physicians must be trained properly. That is always something we’ve 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 notification.

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, we’re 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 that’s 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, I’m 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.

Dr. Rogers

First of all, I don’t use mesh as a primary procedure. If a patient has not had reparative vaginal surgery, if a patient has not had prior vaginal surgery, I’m not going to use mesh. I’m 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, that’s 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 don’t 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 don’t 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 they’re properly performed and they’re a godsend for our patients.

Dr. Miller

I want to ask you about that. You said you never use that as a primary procedure even for stress urinary incontinence?

Dr. Rogers

You asked me about a prolapse.

Dr. Miller

Okay. In terms of just selecting patients from a standpoint of mesh complications. But I just want to understand that mesh complications, of course, we’re looking at both, both pelvic floor as well as SUI. I just wanted to get on record that with SUI…

Dr. Rogers

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 don’t put mesh in a radiated pelvis or a patient who is on high dose steroids.

Dr. Paraiso

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 they’re 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 that’s why women started asking about complications of mesh and then the lawyers started looking for people that had complications of mesh.

Dr. Rogers

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 you’re talking about in that FDA statement.

Dr. Miller

I think there’s a question or comment.

Dr. Miller

I think that’s a very, very good point. That is something that I’ll bring back to our board. That’s a very good point. You know it’s interesting that we have always been somewhat feeling like we’re 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?

Dr. Rogers

There’s 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 you’re in the true spaces when you dissect with your finger, those spaces are avascular. And if you’re 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 that’s 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 you’re 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 you’re 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 it’s asymptomatic. They have mobility in that area but they can urinate, they can hold their urine and they don’t have that irritability of the bladder if you stay away from that middle third of the vagina.

Dr. Miller

Let me ask you? What are your trends?

Dr. Paraiso

Well I think you definitely need to keep the operative site clean. I can’t stress enough the important of hydrodissection. I use 1% lidocaine and one hundred thousand epinephrine, 30 cc’s and 30 cc’s of injectable normal saline, I inject it. And you don’t want to see blanching because then you’re in the wrong space. If you see the anterior vaginal wall balloon up the that means that you’re 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, that’s another contraindication, as well as poorly controlled diabetics. I think those patients aren’t going to be infected. So the operative site needs to be clean. The repair needs to be under no tension. And you can’t send them home on the same day. You really do have to keep them packed so that you have adequate hemostasis.

Dr. Rogers

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.

Dr. Paraiso

And avoid the T-side incisions so a lot of people don’t 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.

Dr. Rogers

And I do not bring the mesh over the apex when I’ve done a hysterectomy because you will get an erosion of about 20% to 25% of the cases. So I’ll take that mesh up to the vaginal cuff anteriorly up to the vaginal cuff posteriorly but I don’t sew across the apex but I will do a uterosacral ligament suspension procedure. That’s worked well on my patients.

Dr. Paraiso

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 don’t 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.

Dr. Rogers

That’s correct.

Dr. Miller

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?

Dr. Rogers

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 it’s anatomic because you’re 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 you’re doing is recreating that horizontal supporter, Delancey level two that goes from parcus tendineus fasciae pelvis to arcus. It’s just easy placed and it works. My failure rates are very, very low.

Dr. Miller

Is there a comment?

Can’t understand.

Dr. Rogers

First of all, if I have patient I’m 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 doesn’t 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 that’s what I do with a patient that’s not had surgery before. Now my consent, here’s 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.

Dr. Rogers

And I say after surgery we’re concerned about blood clots in the legs, blood clots in the lungs that can be life threatening. We’re concerned about hematoma or blood collection around the surgical site. We’re concerned about abscess formation around the surgical site or infection somewhere in their body. We’re concerned about stress on the heart, lungs or kidneys, which can cause organ damage such as a heart attack and we’re 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.

Dr. Paraiso

You know, I want to add because you asked about adding cadaver fascia. I don’t 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 wasn’t as good as traditional posterior repair or site specific area.

Dr. Rogers

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 it’s 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 doesn’t bother her. She and her husband are able to have very satisfying comfortable vaginal intercourse. I’ve offered to take her to the operating room as an outpatient to excise that area and she will not do it. She’s comfortable. Her surgery is holding up well. Her bladder is working well. She won’t have it done. But I’ve been fortunate in that I’ve just had a couple of patients take back to the operating room, excised the exposed mesh, freed up the edges and I didn’t even close the area. I just let it epithelialize in with the vaginal estrogen. And they did fine. I’ve had limited experience with exposure

Dr. Miller

Let’s 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 don’t you give me all three.

Dr. Paraiso

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 doesn’t 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 I’d give them a trial of estrogen. If it’s 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. I’m sorry, monofilament suture like Monocryl for that. And then let them use some vaginal estrogen.

Dr. Miller

Very interesting.

Dr. Paraiso

Unless they were infected I wouldn’t take out the entire mesh. I’ve seen some complications especially with the mesh that has a porcine barrier and so to make sure that I’m not biased towards or against anything I’m not going to mention any groups but that type of mesh sometimes seems very infected and most recently I’ve 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.

Dr. Miller

Have you ever had to take out the entire mesh?

Dr. Paraiso

Oh, yes, in a lot of patients. We have a large series that we’re 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 it’s very hard to take the straps that go through the ischial rectal fossa and the actuator fossa out.

Dr. Rogers

Is this a loosely woven polypropylene mesh that gets infected?

Dr. Paraiso

Yes that too sometimes gets infected. But more than likely the barrier…

Dr. Rogers

Yes, I was going to say with the loosely woven polypropylene mesh, like I use a ProLift kit. Now that I’ve said that, it will happen. But I’ve done hundreds and hundreds and I have not yet seen an infection of that loosely woven polypropylene mesh.

Dr. Paraiso

Neither have I. It’s mostly extrusion of those particular meshes.

Dr. Miller

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 you’ve done and you say to the patient this looks great, it feels great. What do you do in that kind of case?

Dr. Paraiso

Well you’re 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 that’s 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 don’t 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 it’s 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 usually work.

Dr. Rogers

I will tell you in any reparative vaginal surgery, even when you don’t 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 I’ve numbed up the area I’ll inject the area with a little hypertonic saline solution, 5% sodium chloride to help deaden the nerves in that localized area and that’s worked also. But injections are the mainstay that should begin with. Okay. And I’ll tell you the vast majority of patients will come back two weeks later and their pain is still there but it’s 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 you’ve got to take them back to the operating room and cut that scar tissue out. Not often.

Dr. Paraiso

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 don’t want to take medication for pain issues.

Dr. Rogers

But it starts when, make small incisions. Be sure you have hemostasis, you’re dissecting the correct plane and I cannot emphasize enough that mesh has to be loose. It’s got to be spread out, it can’t 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 haven’t repaired anything. But because the mesh as it is incorporated into the fibroblastic collagen that’s put down, the scar tissue, it will shrink about 25% and I’m telling you the Prolift in my practice has been a godsend for my patients.

Dr. Paraiso

It can also shrink up to 40% in some animal studies.

Dr. Rogers

That’s 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 that’s where you’re going to get an erosion. And number two, just because you dissected in those area you’re 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 don’t 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 he’s going to do a study on that.

Dr. Miller

We just have just a few more minutes and you have two experts up here.

Dr. Paraiso

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 he’s leave it open in those cases and they might epithelialize. Some people use biologic, and again I have no ties with them, but Sugisis, it’s a porcine small intestine submucosa graft that is actually processed in such a way that has it’s growth factors intact and I’ve made neovaginas with that graft and there is some series out of Mayo and, in some cases, the Cleveland Clinic where we’ve actually put those grafts over the areas where we’ve excised mesh and the vagina has been repaired very sufficiently and re-epithelized.

Dr. Rogers

This material, and I don’t 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.

Dr. Paraiso

It’s a beautiful thing.

Dr. Miller

One question.

Dr. Paraiso

I’m going to take that one. I love laparoscopic sacrocolpopexy and I think it’s having a resurgence because of the robot. And I think specifically, you know I’m worried that we might be placing vaginal mesh into a contaminated field. I’m not going to say that that’s the case because certainly in Bob’s hands or in Vince’s hands it’s very good. Laparoscopic sacrocolpopexy is great surgery. I’ve probably done over 500 to 600 laparoscopic pelvic organ prolapse procedures and I don’t have to take very many of them back to the operating room, if ever, because it’s practically a hundred percent cure for the vaginal apex. And that’s what’s going to bring you home free. So, there’s still a role for that but I think there are some laparoscopic surgeons and some vaginal surgeons and you should really do what’s best for your hands.

Dr. Miller

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 they’re doing side by side this year, if I’m not mistaken at this meeting. So you’ll 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 it’s a very popular area.

Dr. Paraiso

It’s 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 it’s a great surgery.

Dr. Miller

Well I’d like to thank all of you. It’s just been a wonderful evening. I hope you’ve 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 Women’s 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.