Professor of Obstetrics & Gynecology, Dr. Sandra Valaitis, discusses minimally invasive approaches to urogynocology, as well as some recent troubles with Mesh.
[MUSIC] SANDRA VALAITIS, MD: Thank you, Dr. Yamada and Dr. Jaskowiak for inviting me this morning. It's my pleasure to be here. When I was asked to participate they said, well, talk about something new going on in gynecology, and so I thought about it and I thought about it, and I could talk about urogynecology for hours, but I only have about 20 minutes, so I thought I would do a very focused talk about two of the subjects that I spend a lot of talk time talking to patients and other referring physicians about. And that is robotic surgery, primarily sacrocolpopexy robotically for your gynecology patients. And then, secondly, I probably spend a good 10 or 15 minutes with patients when I talk about surgery just trying to briefly explain what mesh is in the vagina and some of the controversies that are ongoing currently about the use of vaginal mesh for pelvic floor repair. So, just out of curiosity, since I'm not familiar with everyone in the room, I wanted to know, how many of you are gynecologists in the room? OK. Great. And how many of you are internal medicine folks? OK. Good. that's very helpful. So I sort of have a perspective now to go from. So what we'll talk about is, I'll show you some of the applications of the robot to gynecologic surgery currently. We'll briefly discuss robotic sacrocolpopexy and kind of how that evolved and some of the pros and cons of doing that particular procedure. And then I'll also briefly discuss some of the controversies of using mesh for different types of prolapse and incontinence repair and kind of compare and contrast several different mesh procedures. I don't have anything to disclose really except for my husband is a scientist, and he's really smart. He works at Eli Lilly, but I will not be discussing any Eli Lilly products today. So this is a list of all the robotic surgeries that are done in gynecology currently. It's not an exhaustive list, but it highlights some of the ones that are most commonly done. Robotic hysterectomy has just accelerated greatly over recent years. How many of you that do GYN surgery do robotic surgery? So almost all of the people who raised their hands as gynecologists do robotic surgery now, and that's not surprising. Five years ago there were probably very few people who did it, or many fewer, and currently now, I think most people they do joint surgery have some experience with using the robot and use it regularly in their practice. It can be used for hysterectomy, for myomectomy, for adnexal surgery. Our colleagues in GYN oncology use the robot all the time, primarily for their endometrial cancer patients but also for some other applications as well. It helps with lymph node dissection, getting into very small, tight spaces, and we use it commonly for sacrocolpopexy and also it's been a wonderful tool to use for patients who have complex vesicovaginal fistula repair. So it's really been a wonderful tool to have available. The benefits of robotic surgery really have to do with the fact that it magnifies your surgical view about 12-fold, so you can zoom in and focus in on your anatomy. It helps with taking care of a little bit more complicated patients, so patients that traditionally you might not have ventured in to do a straight stick laparoscopic surgical repair, you now may more willing to take on a more complicated patient, with more complicated anatomy, using the robot, because of the magnification that comes with it Also on it, it has sort of a tremor dissipator in it, so that the view is more steady. It takes away the surgeon's tremor effect on the camera. And so you have a steady view, it's not shaky, and it gives you 3D vision, so you can sort of see some depth perception when you're operating. It's not just a 2D view, it's a 3D view. And, with time, as you become more familiar with the instrumentation, you learn how to use that depth as you're operating, and so one disadvantage of the robot is it doesn't give you the tactile feel. You can't get your fingers on the tissue and feel where you are, feel the bones, feel the ligaments, feel how thick the tissues are, but as you get more familiar with using the robot, that 3D view helps you kind of see where you're going, and so it develops this haptic sense for you, about how deep you're dissecting and where your needles and instruments are going. And then the 7 degrees of freedom have to do with the joints. So laparoscopic surgery is kind of like Barbie. It has only, like, only so much movement, whereas robotic surgery is more like a Thai dancer, so it gives you a little bit more movement of your instruments, you've got wristed instruments then, that enable you to kind of get in there. And they call it intuitive surgery, because it intuitively follows your emotions as a surgeon as you're sitting at the console. So if you do this with your instrument on the console, you'll see the instrument doing this as well inside the patient, and so it gives you a lot more ease and flexibility in terms of getting into spaces, suturing tying and everything else, whereas with the laparoscopic instrument, it's kind of hard to tie when you're Barbie. The other advantage of using the robot, is that ergonomically it's much more comfortable for the surgeon. So, again, when you're standing over a patient and you're doing laparoscopic surgery, in order to operate over here, your hand has to be over here, and the instrument has to reach across the patient. And so oftentimes you're moving around, you're sort of straining your back, you're leaning over and it can be kind of uncomfortable. So when you do robotic surgery, you're sitting at a console, you're kind of playing a video game, and your head is inside this viewer, and then you can work underneath yourself, so you can seat yourself into a position that's more comfortable, and so it's easier on your back, it's better for you, just from a physician comfort point of view. Now every operation has a learning curve to it. And so many surgeons who actually looked at how robotic surgery compares to the laparoscopic surgeries that they used to do for certain procedures, and there's a study was published a few years ago by this group, who looked at their experience with laparoscopic hysterectomy and then compare it to the first 100 patients that they did robotic hysterectomy on. And they found that with time the learning curve improved and, in fact, they were able to get their robotic surgery times to be shorter than laparoscopic surgery times, especially with the last 25 patients in their series. They found that compared to laparoscopic surgery, blood loss was lower, and that they had lower conversion to open procedures, meaning that they were less likely to need to do a laparotomy on the patient once they started doing robotic surgery. The limitations are that it does take some time, so it's not something that's super simple and quick to learn. I remember the very first robotic sacrocolpopexy I did took me about seven or eight hours, and I thought to myself, what am I doing? But you have to kind of persist through that curve, get some experience under your belt, and then typically by the time you've done a good 20, 25 procedures, you start to feel much, much, much more comfortable. You've kind of seen different views of anatomy through the screen, gotten through the difficulties with learning how to use the equipment, how to get the visualization right, and also how to get your team trained. So a big part of the efficiency of using robotic surgery in the operating room is not just feeling comfortable yourself with how to do it, but also how to get your team on board and have a good strong set of nursing staff available to make sure that you have the instruments that you need when you get started, that they're not expired, that they know how to drive the robot, that the assistance working with you over the patient also understand how to expose things for you, hand you instruments and have everything there for you that you need. So with time, as you get through your learning curve, your operative times will improve. Also the advantage is that if you can do the procedure laparoscopically using a robot, whereas you might not have been able to do that for the patient before, and you needed to open the patient, the patient will have less postoperative, pain, they'll have a shorter hospitalization, they'll be back to doing their normal routine-- activities of daily living-- quicker. The disadvantage of using the robot is that it is costly. So it's a huge capital investment for a hospital to pay for. And along with that comes maintenance costs of keeping machinery up and going. Disposable equipment is very expensive for the robot too, so that adds cost. So when you're thinking about how much you're spending as you're doing robotic surgery, you want to try to minimize the number of instruments that you try to trade out and use during a case. Also see how you might be able to get the patients up and running a little bit quicker so that they have less postoperative pain, and there's techniques you can do perioperatively to try to minimize pain for patients and improve that so that they use less analgesics. So we started doing robotic sacrocolpopexy at the University of Chicago in 2008, and our group happily has the greatest number of robotic surgeries for sacrocolpopexy that's been done in the metropolitan Chicago area. We do a huge number of these procedures yearly, and that's because prolapse is extremely common. About 11% of all women will undergo some sort of surgery in their lifetime for treating pelvic organ prolapse. The traditional repairs that we used to do in the past, and still continue to do for many patients, are vaginal repairs that use native tissue, and so with a native tissue repair we're using patient's own ligaments and connective tissue to support the vagina and reduce the bulge that is seen with prolapse. But the disadvantage of using one's own native tissue is that it's already been stretched out and the connective tissue is somewhat less elastic than used to be, and that's why it's now prolapsing. And so with native tissue repairs, there is this a higher failure rate of the procedure. In some series, the failure rates are about 25% to 30%. And so, keeping that in mind, we try to find new ways to provide better support for patients that will wear the test of time and provide more longevity of the repair. Some treatment options that you can offer patients, not just surgery options, but you can try pessaries, which can be useful for patients to treat prolapse. As I mentioned, you could do vaginal reconstructive procedures. You can do abdominal, and now, laparoscopic or robotic procedures such as the sacrocolpopexy, which I'll show in a second, or you can do an obliterative procedure on a patient if she's no longer interested in sexual activity. So typically we'll reserve those procedures for patients who are a bit older, who are no longer are sexually active, who do not desire sexual function anymore. They've sort of been there, done that, moved on. Maybe their widow. They have no desire for any other partners in the future, and they're very confident that that's not going to be a part of their life anymore and so, only for those patients who are truly confident that they no longer want to maintain sexual function, do we offer obliterative procedures, but those have the highest success rate and a very, very low rate of complication and high satisfaction rate for the patients who end up having them. So what is sacrocolpopexy? So sacrocolpopexy is a procedure where-- I don't know if I can do this. OK. let me see if I can show you. I'm a little audio-visually challenged, so I apologize. So this is just a side view of a pelvis. This is the bladder here, filled with some urine, and there's the urethra. This is the vaginal canal here, and then you can see the sacral promontory here and there's some mesh that's sewn over the back and the front part of the vagina and then attached to the sacral promontory. Typically we use a combination of delayed absorbable and permanent suture to do the attachments, and then we cover the mesh with peritoneal tissue after the mesh is secured in place, just to prevent any irritation to the bowel and intra-abdominal contents. So we're working very closely to a lot of vital structures. We're working close to the ureter, close to the bowel. Sometimes there's previous scar tissue in there, if the patient's had a hysterectomy, so we are trying to get that out the way. So it can be a fairly complicated procedure. In the old days when we first started doing sacrocolpopexies, they were always done through a laparotomy incision, typically kind of a Pfannenstiel incision in the lower abdomen horizontally. We would identify the sacrum, kind of expose the ligament over the sacrum, and then attach mesh over the vagina and then bring that mesh up to the sacrum and attach it there. And so the patient would typically be in the hospital for two or three days and then go home and she would need to recover for good six weeks before she could get back to work. Robotics sacrocolpopexies started to be done in, I'd say the late 1990s, and then they've gained huge popularity in recent years. I'd say probably in the last five to eight years, more and more practitioners around the country have become trained to do robotic sacrocolpopexy, for the reason that it provides a minimally invasive approach to doing the procedure. I'm sorry I was going to show a video of the sacrocolpopexy, but the video that I had made is not compatible on a Mac. I'm a PC girl. So, anyway, so this is just an intra-abdominal view, and what you can see is there's the robotic needle drivers that are in the view at the lower part of the screen, there's a little kind of netting that you can see in the picture that's over an area where there's some tissue that's been exposed, and there's a needle kind of going through the netting. And that's how the needle is placed through the mesh onto the sacral promontory, and so we use that technique then to sew the mesh. It's been already sewn onto the vagina up at the top of the picture, which you can't really see very easily, and now the mesh is being sewn onto the sacrum in this particular picture. And so, once everything's all in all done in place, then we take a look vaginally and we make sure that there's still no additional repair work that needs to be done to provide additional support down below. So once different practitioners started doing robotic sacrocolpopexy, wanted to compare their outcomes with the open technique, which was considered sort of the gold standard for so many years. And they found that-- in this particular series that was published from the group at Duke-- they found that looking at their first 73 cases of robotic sacrocolpopexy, they found that comparing the preoperative stage of the prolapse between the robot cases and the open cases, that the stage that they chose to do robotically was typically a little bit worse. Operative times were greater than open cases for their first 73 patients, but that's not too surprising. Blood loss was significantly less. Hospital stay was shorter and then the complication rates and postoperative findings of patients were equal. So with time, that's also shown to be true as people have done longer follow up with their patients. This particular slide just shows pool data, looking at various publications that have come out, comparing robotic sacrocolpopexy to straight stick laparoscopic sacrocolpopexy, so there are some practitioners who are facile at doing the procedure laparoscopically without using a robot, and we'll get into some of the advantages of that in a minute but, basically, both robotic and laparoscopic sacrocolpopexy do seem to have similar low rates of conversion to open procedures. The blood loss is somewhat less in some series with robotic procedures, compared to straight stick laparoscopic procedures. Operative times tend to be greater overall for many of the studies that were published in this particular group publication. But I think some of that also has to do with the types of procedures that are chosen and the potential complications that practitioners think they may run into. So in some series the robotic procedures were offered to patients where they thought that they may have a little bit more difficulty, the stage of the probate prolapse was a little bit worse. Maybe the patient had had more prior surgeries and so there was a bit of a selection bias in those data sets. That may have had something to do with operative times. The other issues that come into play is that in some of this series that compare open-- I'm sorry, that compare laparoscopic to robotic sacrocolpopexy-- for instance, in The Cleveland Clinic group, their group does a great deal of laparoscopic straight stick surgeries, so they have physicians and assistants who are very skilled at doing laparoscopic surgery, and their preferred route is laparoscopic as opposed to robotic. They have less experience doing robotic surgery for sacrocolpopexy at their institution, and so they found that in their particular series, they preferred the laparoscopic approach. They felt that their operative times were lower and that resulted in lower cost to the patient and the hospital. Whereas other groups of have found that they're more skilled with the robotic approach as opposed to laparoscopic approach and that their operative time became less the more facile they got at using the robot. And so I think some of the data that we read about in the literature has a little bit of selection bias with it, and there just needs to be more study and long-term analysis of the data, looking at these different approaches and what's available, but the trend these days is definitely to offer minimally invasive techniques for sacrocolpopexy for patients and very few places and centers are doing strictly open procedures for their patients anymore, because they want to offer their patients a minimally invasive approach so they can leave the hospital sooner and get back to their daily activities a lot sooner. At our particular institution, we do some laparoscopic sacrocolpopexy. Typically, we'll reserve that for patients who've already had a hysterectomy, so where we're doing strictly a vault prolapse repair, and it we'll usually reserve that for patients where we feel like we'll encounter fewer adhesions. So, again, we're selecting out patients where we think the laparoscopic straight stick approach will be a little bit easier. In other patients, we will do the robotic approach and it's very few patients at our institution that end up having an open procedure. Also there's very low rates of needing to convert from a robotic procedure to an open procedure. If you look at the cost analysis, so a recent study was published earlier this year in January by a group from Loyola. They looked at their laparoscopic cases and compared them to the robotic cases, and they found that with time the results of the procedure, in terms of success and patient satisfaction, were equivalent with the two approaches. The difference really was in the cost. However, if you factor out the maintenance cost of taking care of the equipment at the hospital and strictly looked at the cost of disposables and the length of time that you take in the operating room, once the surgeon gained enough skill and felt like they got through their learning curve and were more facile at doing the procedure, the costs were equivalent. It was just the maintenance cost of the equipment to the hospital that raised the cost the overall cost of the procedure, compared to laparoscopic approaches, so if we can get those costs down somehow, then we may find that robotic surgery is completely equivalent to laparoscopic surgery, and there still needs to be a little bit more work in that area. So how is laparoscopic sacrocolpopexy, which uses mesh, different from some of the other mesh procedures that are available for treating pelvic organ prolapse? And this is where things get very confusing for people, so I wanted to just briefly outline that and kind of explain some of the differences. This is a picture of a pelvis and a mesh repair, as it relates to the pelvis and the anatomy. And what you can see here is there's a very large sea of blue in the picture, and on the blue in the picture depicts the mesh pieces that are placed in order to do the pelvic floor repair. And so, with a vaginal mesh kit, what's done is, instead of a sacrocolpopexy where we're kind of going from inside the patient's abdomen and we're sewing mass over the front and the back wall the vagina, kind of from inside the patient, with a sacrocolpopexy we don't have to make an incision in the vagina to put the mesh on. We're kind of just sewing it over the vagina from the inside. With a vaginal mesh kit, what's done is, there's no entry into the abdominal area all. The mesh is placed through vaginal incision and so you place the speculum in the vagina, you make an incision in the vaginal wall and then you slide this piece of mesh then through the vaginal incision, underneath the bladder, over the vaginal wall, and then you secure it to several different ligaments and connective tissue areas in the pelvis. And so, in this picture, what you see is this blue sheet and then on each of the blue sheets there's a front and back, anterior and posterior pieces that are placed. The anterior pieces have little arms that come off of them that then get secured through the arcus tendineus fascia pelvis along the pelvic sidewall here. So you can see these little spider arms that come out, and they traverse through the obturator membrane as well as through the fascial connective connective tissue attachments on the pelvic sidewall and then, at the apex of the vagina, these extension arms are then placed through sacrospinous ligament to kind of pull up the apical vagina more cephalad. Similarly, this procedure is performed on the back wall of the vagina to correct a rectocele, so there's a plane that's dissected open between the vaginal wall and the rectum, and then this piece of mesh is then slid between those two structures to provide support to the posterior vaginal wall. And so on the piece of mesh that's used is much, much larger and, because an incision is made in the vagina, you have to be very careful about how you tension the mesh, how much vaginal material you trim away as you close your incision, and the technique is very important in order to provide a successful repair and prevent complications from occurring for patients. And that's part of the problem, so it can be very technically challenging procedure to do. The advantage of using mesh is that it replaces that connective tissue that's been stretched out and damaged and no longer supporting things like it should. So the vaginal walls have sagged because the connective supports that were once holding things up have now given way and they've broken. So practitioners started to incorporate mesh into vaginal repairs, kind of thinking, well, it's worked for the hernias and so why don't we use it for vaginal repair as well. And so, in theory, that's a really great idea, because it's replacing the connective tissue that's weakened and it's no longer working. The advantage of using mesh, then, is that it provides a more durable permanent support. The meshes are permanent suture material, so they don't disintegrate with time, they don't dissolve. But the problem is that the mesh stays there and, although long term, if you do an exam on a patient who has had a vaginal mesh repair, they'll have a better outcome long term and better looking vaginal support than someone who maybe has had a vaginal reconstructive procedure just using their own native tissue, ligaments and suture material. But the problem is, that that comes at some cost to the patient. So there's a much higher rate of other subjective complaints, such as dyspareunia, chronic pelvic pain, mesh exposure in the vagina. If things are placed a little bit too tightly and tensioned too much, then that can cause voiding dysfunction, defecatory problems for patients. They can have problems with constipation if the mesh is, kind of, constricting the rectum too much. And if there's a breach of the vital organs, then that can create fistula formation between the rectum and the vagina or the bladder and the vagina, et cetera, and so that can create other problems for the patient too. This is just a picture of what an expose piece of mesh looks like in the vagina, so this glistening, kind of pink, tissue is the vaginal wall, on the anterior vaginal wall of the patient, and then this yellow, sort of rough-looking material, is what mesh looks like once it's exposed in the vagina. And so, if you feel that, it'll feel kind of hard, almost like Velcro, and that can be painful for the patient when it's touched. It can create a discharge, an odor, and also the patient's partner can then feel a scratching sensation because it's like Velcro rubbing on the penis. It doesn't feel too good. And so patients will complain that, not only do they have problems with sexual function, but also their husbands or partners will complain of pain during sexual activity. And so something like this will need to be excised and require an additional surgery to rectify. So we just saw a picture of Prolift repair, a vaginal mesh repair, and we saw how much mesh was used in the repair. In contrast, I thought I'd show this picture, and this is just a picture of what a suburethral sling looks like. And so you can see the difference. The blue is the sling material that's placed. This is a picture of an obturator sling. And so, instead of a big sheet of mesh, we're using a small strap of mesh, so the volume of mesh that's used for a sling procedure is much, much lower. Slings also use mesh that's permanent, and it's one of the reasons why they're so successful at treating stress incontinence long term. Now, this particular table just kind of shows you the difference, in terms of the volume of mesh that's used for different mesh procedures that we use in urogynecology. So TVM is transvaginal match. The sling is a suburethral sling procedure for stress incontinence. And then ASC is abdominal sacrocolpopexy. It's the mesh that we saw, either robotically or through an open incision. The differences really have to do with mostly the volume of the material that's used for the repair. So if you look at the square area of the transvaginal mesh kits, on average, about 150 to 300 square centimeters of mesh are placed in the patient when we do a transvaginal mesh repair. With a sling, it's about 12 square centimeters, and with a sacrocolpopexy, see it's about 36 to 48 square centimeters of mesh. So we're looking at least at a tenfold difference, in terms of the total amount of mesh that's used for prolapse repair, comparing sacrocolpopexy to a vaginal mesh kit, and I think that's really where a lot of those potential problems then with vaginal mesh kits come in. The rate of exposure of mesh in the vagina is higher with the transvaginal mesh kits, significantly greater than what we see with a sling, for sure, and that makes sense, because of the amount of mesh that's used for the each one. Level four severity means that that just has to do with how much involvement is required at rectifying a complaint that the patient has after the procedure. And so level four means there's a greater number of surgeries that's required for the patient to rectify her problem. For instance, she goes back to the operating room several times to take out exposed mesh, or she needs to go you have additional treatment, either in the office or with a pelvic floor therapist or she needs additional medication or some other intervention to help her with her mesh problem. And then dyspareunia rates are significantly higher as well with patients who've had transvaginal mesh. So, because of all these particular issues that have come out regarding the use of mesh in vaginal repair, the FDA has come up with some warnings for practitioners and patients, and there's also been a great deal of litigation that's ensued as a result of this. These FDA warnings have really only to do with the transvaginal mesh kit procedures that have been done. The FDA warnings have excluded sling procedures and sacrocolpopexy procedures because the rates of complications are much, much lower. And so what they've recommended is, if a practitioner is using a transvaginal mesh repair in their practice, which is still considered acceptable, they do need to provide an informed consent process to their patient, provide the patient with a pamphlet about the material that they're using. And then recently this year they addended their recommendation through the FDA and stated that if transvaginal mesh kits were used for the treatment of pelvic organ prolapse, that they would become part of a greater registry to evaluate the safety and efficacy of the procedures and that no new mesh kits would be released to the public until they passed and qualified through specific safety and efficacy studies beforehand. So there's currently a very large registry that's ongoing, looking at these particular procedures for use in gynecological surgery, and I think in the next few years we'll probably have some more significant data looking at long-term outcomes and, sort of, best practice for use of these materials in our patients. In the meantime, when you use vaginal mesh, the FDA has recommended that each individual who's placing the mesh have individualized training on the safe placement of the material, that the practitioner and the patient themselves understand the risks of having the procedure done, that the practitioner be vigilant for adverse events that can occur, watch for complications, inform patients of the potential complications and then provide patients with written information about the procedure that's used, and you can go to the FDA website to have a little bit more specific detail about this. So in conclusion, I know this is a very short, quick summary of the differences between the different mesh kits that are available and mesh treatments that are available for treating pelvic organ prolapse and incontinence in women. We often use robotic applications for sacrocolpopexy Pepsi in our practice and have found that it has had similar long-term benefits for our patients, in terms of treating pelvic organ prolapse. Use of the robot for pelvic surgery has provided a shortened length of stay for patients, quicker recovery, less blood loss compared to open surgery. Limitations for the use of the robot for patients with pelvic organ prolapse include learning curve that the practitioner needs to go through and increased cost compared to other techniques, but hopefully that will change in the future. Efficient utilization kind of depends on the complexity of the patient that you're trying to treat, the volume of surgery that the practitioner does, the skill level of the team that you work with and then, just in terms of mesh in general, use of mesh for sacrocolpopexy is associated with, in general, less adverse events than transvaginal mesh kits but that we continue to be vigilant about potential complications that can occur in our patients. So I'd be happy to take any questions that you may have now. Thank you.