As part of a series, Mesh News Desk interviews doctors who are dealing with mesh complications. This month it is Miklos & Moore and their http://www.meshsurgeons.com/, International Urogynecology Associates, based in Atlanta, Georgia. A large part of their practice is now dealing with complications from polypropylene transvaginal mesh implants. These are the voices who make up the Doctor Directory, a valuable resource for those looking for mesh solutions to their transvaginal mesh complications. Editor, Jane Akre interviewed Drs. Miklos and Moore and spent a day at their surgical suites.
*Editors Note* ~ One cannot underestimate the stamina it takes to be able to perform these surgeries. They are physically grueling and very intense. More than once I thought I’m glad that is not me a the end of a laparoscopic camera where it is necessary often to cut through tissue, fat and ligaments to find the offending mesh. A rich knowledge of anatomy is absolutely necessary. Your editor walked away with a renewed appreciation of the years of accumulated skill these delicate procedures require.
Q: A woman experiences pain sometime after her mesh implant. Should that be ignored and should she just do what her doctor says, such as go to pain management and give it some time?
John Miklos – “Of course after surgery everyone will have some pain, but it’s the experienced surgeon who asks if the pain is out of the ordinary; is it more than what one normally sees. Now if you are three, four, five months after surgery and there’s a lot of pain, there is obviously a problem. If you do an exam and you palpate the mesh and can reproduce the pain, I believe, and it doesn’t mean we are correct, that with pain that severe, you are better off removing the mesh as soon as possible. Many of our colleagues and conventional wisdom suggest one should postpone surgery and use anti-inflammatories and massage therapy as first line therapy. We disagree because once scar tissue actually matures, usually after five up to seven weeks, the mesh is usually anchored in place very strongly and it won’t dislodge as readily. I suggest removing it as soon as possible as the mesh is more readily removed completely intact and has less of a chance of creating muscle contortion and secondary nerve entrapment.”
Robert Moore – “I agree with John. There is a balance of postoperative normal pain and healing but there is also severe pain postoperatively that could be a problem and should not be ignored if it is not improving. For example, a woman gets a TOT (transobturator) sling and she can’t walk the next day or she can’t pick up one of her legs, that’s a severe problem. At this point the surgeon needs to make a decision – do I act right away, or maybe give it a few days. But if the pain doesn’t improve, one has to consider early intervention of removal or revision. The same is true for transvaginal meshes that may go through the sacrospinous ligament and the patient has so much severe pain immediately postoperatively that is not improving. Again, early intervention needs to be considered which may mean immediate removal as the mesh may be in the wrong position or irritating a nerve. We’ve had surgeons call us with those scenarios and we’ve told them you need to go back and take it out. They ask “Really, take it out?” Yes, take it right out now. They’ve done so and the patient is 100 percent fine.
Unfortunately, if the sling or mesh is removed that soon after surgery, the patient isn’t treated for her incontinence that she had surgery for in the first place. She can always come back at a later date with a different kind of procedure and at least she’s not stuck with chronic lifelong pain. If it wasn’t addressed as early as it was, a chronic pain scenario could have been set up. So I, 100 percent agree with John that if these things occur, i.e. early complications of severe pain, there are conservative measures that can be taken but if they don’t work rather quickly some other sort of intervention needs to be considered and typically that’s a mesh revision or removal even at an early postoperative time frame.”
Q: How has your practice changed from mesh implants to mesh removals in terms of trends you’ve noticed? What percentage of your practice is now directed to mesh removals?
Miklos – “Since 2010 we have removed over 500 pieces of mesh. Though we have been removing mesh since 1995, including sacrocolpopexy and sling mesh, it was a much less robust number. The reason for the increased mesh revision surgeries, I believe, are obvious: 1) Dr. Moore and I and doctors who remove mesh have a learning curve – over time we have learned that mesh can cause complications other than mesh extrusion through the vaginal epithelium. Recently, in a deposition, an attorney asked me, ‘Dr. Miklos in 2004 (during another deposition) you said you never had a patient with a sling with pelvic pain?’ Back then I don’t remember anybody presenting with such an issue. But as you go through medicine you learn from listening to your patients. I have learned if a patient says she has pain, it actually could be the sling. We never knew this before. Most mesh implanting surgeons do not realize that people implanted with mesh can have pain from implantation surgery. It’s not common conventional wisdom among implanting mesh surgeons either. So we had to learn on our own and now when a patient says she has pain we are more attuned to it.
“Now at that point in our careers we do a site specific exam that identifies where the pain is coming from (i.e. the mesh), hopefully, so yes, we have become more attuned to it. One of the reasons we remove more mesh now, which I would say constitutes 15 percent of our practice, is because patients who have had mesh implants are complaining of chronic pain after implantation. Whether the pain is due to the mesh or the surgeon putting it in, about ten to fifteen percent of patients who receive mesh say the mesh causes pain. Usually if a patient comes to see us and they complain of pain after mesh implantation, we can identify the mesh as the point of origin of pain in approximately 85-90% of these patients. One problem is if we can’t elicit the pain, we can’t do a surgical procedure to remove the mesh because we’re not sure it’s the mesh causing the pain and also we’re not sure performing a surgery for mesh removal is going to help them.”
Moore – “Now we have removed mesh for other reasons. It may not be just pain. It may be an autoimmune response and the patient is 100 percent convinced that her health may be compromised, and even though there is scant medical evidence that may or may not be occurring, we are open to that interpretation and it’s her body. If she wants it out, or her physician has recommended it, then we definitely will consider that and make a plan with the patient.
“I think definitely the mesh removal has slowed down a little bit but this may have been driven by lawyers telling women to hold off on getting surgery until more court cases are heard. I’m not sure this is true but if so, I don’t understand the strategy behind that. I think there are thousands of women who still need help out there.
“I would agree our current practice is 15-20% mesh removal with women coming forward with problems. We still believe in the use of mesh in certain situations. We agree with the American Urogynecologic position statement that in certain situations mesh is certainly indicated. Mesh slings are still indicated for incontinence and sacrocolpopexy mesh as well. Our mesh implantation has also decreased substantially because women are coming in more educated and we give them options. We tell them the benefits and risks of every procedure and they ultimately make an informed decision of what exact procedure they will have.
“Sometimes a patient doesn’t want mesh even though we believe she may need it, for example, if she has a stage 4 prolapse where her uterus is hanging inside out by 10 cm. I truly believe her ligaments and her own tissue will not hold; that surgery will fail, and this is supported by medical literature. So we have to tell her what we believe will be the most effective procedure, however, we also inform her of the risks that we know of all approaches. Working with the patient in that way many women are electing not to have mesh, and they need to know there are alternatives to using mesh and we certainly do a great deal of those surgeries, including laparoscopic and other minimally invasive approaches that don’t use mesh.”
Q: You are still using polypropylene (PP) mesh to treat women with extreme prolapse and multiple situations and it’s not working. What percentage still require a PP mesh implant?
Miklos – “You know, require versus not require really depends on the diagnosis. If you have a mild uterine prolapse, if your uterus isn’t coming half way down the vagina, a lot of times we will use the patient’s own uterine ligaments (i.e. 4-5 sutures using her uterosacral ligaments without mesh). If the uterus descends beyond that, a more devastating or larger uterine prolapse, the less likely 4-6 sutures without any distribution of surface area (that’s what mesh really does, it distributes surface area), the less successful it will be. Occasionally patients will ask about pigskin. We will use pigskin but we will ask you (the patient) up front, do you know the literature on the use of pig skin 3 years, 5 years, 7 years out? Nobody does – as there are not good studies on longevity cure rates of vaginal vault prolapse and the use of cadaveric and animal grafts. Sure there are a few studies that say a year out the prolapse cure rate is 80, 82, and 85 percent successful. But there are a lot a studies on sacrocolpopexy mesh that says a year to five years out it’s between 95-99 percent successful. So are you robbing Peter to pay Paul? As we can use pigskin at the patients request but the patient is not really sure what the long term success rates are going to be nor do we know the long-term complications like graft abscess, infections, autoimmune disease and graft rejection. What we do in our practice is to let the patient make the decision. If they don’t want it (i.e. mesh) we don’t put it in, but you have to be aware of the success rates and lack of literature of the other types of graphs (i.e. non mesh).”
Moore – “Since we’ve been educated and now been exposed to seeing patients from all over the U.S. present to us with various mesh complications, (we were not aware of the numbers of women that really have been suffering in silence as they went to their physicians and were just told nothing was wrong and to just live with it), we have become much more conservative and much more open to offering patients options both for incontinence and prolapse. We’ve done more laparoscopic Burch Procedures (non-mesh traditional surgery for SUI) in the last two-three years than in the last eight years combined. One of the big problems now is that it’s gotten to the point that nobody knows how to do a laparoscopic Burch, sometimes even open, because we’ve lost a generation, 15 years of young, educated surgeons who do not know how to do a Burch Procedure. This is because they are not taught this procedure anymore in training, nor have they been taught many of the traditional surgeries to treat prolapse without mesh. The last generation of residents have been primarily taught mesh slings and even mesh kits to treat prolapse which is a major issue.”
Moore – “Currently about 50% of patients are opting for a laparoscopic Burch and 50% for mesh tape slings. These numbers are significantly different than 2-3 years ago when it was about 95% mesh tape slings in our practice and most other practices as well. Pubovaginal slings, i.e. slings using cadaveric tissue or dermal grafts or even harvesting the patient’s own fascia to make the sling, are making a slight comeback as well, however one must remember that traditional pubovaginal slings are a complex, invasive operation that still requires needle passage, harvesting a graft in many situations, graft rejections, urinary obstruction, and attachment to the pubic bone by bone anchors by many surgeons as well. We have seen many complications even from traditional pubovaginal slings that don’t use mesh as the graft, so I don’t believe that to go backwards to these very invasive procedures is the best choice for women. We believe that in straight forward female SUI, most women can benefit from a Laparoscopic Burch procedure, which can be completed in an outpatient setting, with excellent cure rates and when done by experienced laparoscopic surgeons is a very safe operation.”
“Yes, there are still mesh kits available for prolapse. One has to remember that both the AUGS and SUFU consider the mesh tape slings still to be a gold standard for SUI and that they also feel that in certain situations vaginal mesh use for prolapse is still indicated. The mesh kits that are available on the market today are considered second generation mesh kits, i.e. the mesh is softer and lighter and there are no external needle passes or trocar passes with mesh arms going through and through the levator muscles. We now know the mesh arms created many of the problems that women suffered from. These second generation kits are considered to be much safer than the first and with less risks of complications, however even with these improvements the overall use of vaginal mesh kits is significantly down, i.e. a huge amount, throughout the U.S. and the world, which we certainly agree with. We feel they should only be used in very limited situations by extremely experienced surgeons.”
Q: Is TVT the gold standard?
Miklos – “I think there are two gold standards – the TVT sling, i.e. retropubic mesh sling that comes out in the lower abdominal wall or the pubic region, and the Burch procedure which is strictly performed using sutures. Those I believe are the gold standard. The TVT sling is often touted as having cure rates of 90 percent at 1 year, 85 percent at 5 years, and 80 percent at year ten. The Burch has similar cure rates of 90 percent at 1 year, 85 percent at 5 years and 70 to 80 percent cure at year ten. The problem is very few people feel comfortable doing Burch procedures, either through large abdominal incision or laparoscopically. As well, the Burch is a much more invasive and potentially dangerous surgery. The Burch will probably result in greater postoperative pain, longer hospital stays, greater number of bladder neck obstructions with the patient having greater difficulty urinating postoperatively. There will also be a greater number of intraoperative complications including: obturator nerve injury, intraoperative blood transfusions, bowel, bladder and ureter injuries. So statistically the cure rates are about the same but the patient is giving up a less painful and less invasive operations (i.e. TVT mesh sling) for a more invasive and painful operation with potentially greater and more devastating complications by having a Burch. Again one can consider pigskin or cadaveric slings however we have revised number of these types of slings too due to severe pain, incomplete bladder emptying and painful intercourse. There is just not enough research done on these types of procedure either.”
Moore – “I would agree with that. Certainly there is so much data on the TVT, those are the two procedures with the most data, the most years of experience and research and the Burch and retropubic sling are typically the gold standard.”
Miklos – “I have been performing laparoscopic Burch procedures since 1993 and Rob’s been doing them since ‘97 or ‘98. So people will say ‘See there’s an alternative; do a laparoscopic burch or do an open burch’. Yes, we agree there are alternatives, however, as stated above the intraoperative and postoperative complications can be worse than with the mesh sling procedures. The Burch is not synonymous with having no problems. People think just because it’s not mesh, there are no complications associated with it. It’s just not that simple. I wish it were. And please note that it’s easier to teach most doctors to do a sling then a Burch. The Burch procedure is a much more complicated and potentially devastating procedure if not performed correctly. Now you start opening the doors and everyone starts doing laparoscopic Burches, which I don’t think they will because they don’t know how to do them, you are going to have major problems on your hand. I wish it was simpler than this, but it’s not.”
Q: We still have no idea which women will be high reactors and how many are not, nobody has identified that factor and there seems to be no way to review that in advance of mesh surgery. Does that concern you? Should we have that answer before we proceed and call this the ‘gold standard’?
Miklos – “I think the problem is you won’t be able to determine, who will react and who will not react because this isn’t always about reactivity like an immune response, this is also about aggressive scar tissue which I believe is the potentially the number one cause of the pain and not an immune response. How do we fix the problem? The option is to totally do away with the TVT, and it is certainly an option. Or fix one of the biggest problems which is a surgeon’s lack of knowledge or education. You must understand it is when a patient has a problem most doctors are ignoring it, pigeonholing it because they don’t understand it and they don’t want to admit the mesh can cause problems. Over 90 percent of our patients who see us for mesh complications have been told there is nothing wrong with them. Over 70 percent have seen more than one doctor prior to seeing Dr. Moore and myself.”
“So of course we don’t want to have patients with complications but the next step is if you are going to use it maybe the companies have a responsibility to teach these doctors about the risk of the procedure including the long-term risk and including educating the doctors on how to diagnose and take care of the risk. Also, if you as a surgeon don’t know what you are doing surgically to help the patient is remove the mesh, then refer the patient it to somebody who knows what they are doing so they can address the risk. The surgeons shouldn’t just tell a patient, it’s in your head, there’s nothing wrong with you. You don’t know what you’re talking about.” The surgeons implanting the mesh should be taught the potential complications, how to potentially diagnose the complications and either treat the complications by removing the mesh or refer her to someone who has the knowledge, education, experience and expertise to help the suffering individual.”
Miklos – “But that’s the difference between the Prolift and the TVT. The TVT can be completely removed. You are right, the Prolift and the arms, they’re not getting removed. You and others, as well as myself, may not agree with placement of mesh kits with arms, and this awareness has pushed our current situation to the point that basically there are very few doing mesh procedures especially transvaginal mesh kits with arms. Previously at my hospital in Atlanta GA, surgeons were putting transvaginal mesh kits in routinely (3-4 times per week) and many of the surgeons doing the placement were not the most talented or the best trained pelvic floor surgeons. Now most of these surgeons have stopped doing TVM (transvaginal mesh) at least in our hospital. I rarely see transvaginal mesh kits being utilized. They were doing it every week, now it is once every 6- 8 months.”
Moore – “But now we have a huge amount of women who aren’t getting treatment so we’ve swung the pendulum the other way with that. Certainly there is balance and we have to get the word out there are other options beside mesh if they don’t wish to have that.”
Miklos – “We recently heard that most doctors are treating prolapse by doing nothing. They give them a pessary and tell them nothing can be done. Now we are getting a situation where doctors are not referring them out. My opinion is that’s a disservice to the patient.”
Moore – “We need more information, we need more data and more studies done. One of the problems with medicine is it’s not an exact science. There is no one procedure that may not have risk, whether it’s an implant or not an implant. John and I have treated patients with traditional surgeries who have had lifelong issues secondary to pain, nerve damage, bladder damage, fistulas, and vaginal pain. Not one piece of mesh was used and not one implant was used. So unfortunately, nothing is risk-free. I agree with you we need to minimize our risks as much as we can and find out as much information about everything and hopefully that’s the next step. Should everything be removed from the market until we get that? I don’t have the answer. I think, for now, you give the patient as much information as we can and help them make an educated choice.”
Q: A woman says she recently had her medical records reviewed by your office but she cannot afford your cost. Miklos and Moore do not have a contract with her insurance. She wants me to ask why you’re not in contract with Blue Cross Blue Shield, for example, otherwise it is too costly a surgery for her.
Miklos – “One of the problems is the insurance companies. I have said this to the attorneys, you know; who should be held accountable for this – the insurance companies. For the patients who now have a complication, it was the insurance company who told this patient to go to a certain doctor who was on a list. Now they have a complication. So the insurance companies now should be held accountable for the removal of the surgery. That being said, insurance companies want to pay $600 to $800 to remove a piece of mesh. There are very few skilled surgeons who can remove mesh and the risk of that surgery far outweighs the reimbursement, and that’s the scary part.”
“There are surgeons who will cut the mesh and not remove the mesh. This is not how to treat mesh pain. Look at the patient who I just took into the operating room yesterday who had nine surgeries at one major university. She was told the mesh could NOT be removed. We took her to surgery and removed the vaginal portion of the TOT type sling, the body (not the arms) of the both the anterior and posterior TVM mesh kit. We took her back to surgery yesterday to perform a Burch for her urine leakage and I found another piece of mesh which was the arm of her anterior vaginal wall mesh kit and I removed what I could and completed her Burch for incontinence. She suffered from 8 surgeries and they didn’t remove but a mere 1 cm of mesh in all eight surgeries. So the problem is most of the doctors, even at this major university she came from, are just cutting the mesh, cutting the arm and you need to remove it! It’s not a risk-free operation. And from our point of view, we haven’t participated with insurance companies for 15 years because we don’t believe the reimbursement is appropriate for such a skilled surgical technique. We wish we could help everybody but, on the other side of the coin, there is a lot of risk involved in these surgeries and the fact that if you’re only getting $600 to $800, it’s not economically feasible as a business. For Dr. Moore and I to be in an operating room for 2-3 hours removing mesh, incurring the risk of medical legal liability for $600, not only doesn’t make sense, it doesn’t even begin to cover our office overhead (i.e. expenses), which we have calculated to cost between $5,000 to $6,000 per business day (without compensation to the doctors). It is really simple arithmetic – if we both did four cases a day at $700 and our total reimbursement for the day would be $5,600 for both of us in the operating room, it doesn’t even cover the expenses of running our office for the day. A root canal costs $1,200 and this is, in my opinion, just as important as a dental procedure.”
Moore – “It’s crazy what the insurance companies want to pay, compared to what they are making and what they are charging patients for their policies. I mean $600 for a very advanced technical surgery with a lot of risk and a lot of time. That’s the problem. We are always willing to look at an individual case to be able to help a patient. They may be able to go to one office versus another, i.e. our office in Los Angeles versus Atlanta and in different states their coverage may be better in one versus the other. We want to help every woman we possibly can, that is our overall goal, not just making money. However, we have to be able to run a business in a way that can keep our doors open to be able to continue helping as many women as possible. The cost of business, overhead, staff, medical malpractice insurance, it’s not a doable business model. We want patients to understand this and understand that we don’t mean that we’re “not making enough” just for the sake of the dollar. We do review every case on an individual basis and we do our best to be able to help each and every woman the best we can and in many cases we fight the insurance company to get that patient better coverage as there is no one else that is as qualified in their network to be able to do their surgery We have been very successful with this type of strategy and will continue to try to do this for patients. Please Call Mindy (our office manager) directly and we can look at everybody’s individual case and see what we can do, as again, our overall goal is to help as many women as we can take care of any complication they may be having because we know they have been suffering and have not been able to find the help they need.”
Q: The last question is about your article, In Timing of Mesh-Related Complications. Mesh Removal following sling/mesh placement: A Multicenter Study: [Miklos, Moore, International Urogynecology Associates of Atlanta along with Emory University and the Cleveland Clinic]. This was a retrospective look at complication rates from three centers in the U.S. that deal with mesh complications including from 2011 to 2013, all patients who underwent surgical removal of slings, TVM and sacrocolpopexy following complications. Of 445 patients 40 percent had TVM for POP, 83.8 percent had a sling and 8.5 percent had sacrocolpopexy.
Q: You concluded the average timing of a mesh complication was 3.67 years approximately ….and there wasn’t much difference whether it was a POP or a sling. Did I get that right?
Miklos – “Our time to diagnosis was the longer than any other scientific paper reported time to diagnosis to this point. The reason is the patients are being pigeonholed, avoided, told they are crazy, there is no problem. So we don’t really know if it’s the mesh having delayed problems and manifesting much later after implantation or if it’s the doctors who keep telling the patient there is nothing wrong with them and they are just being diagnosed so much later than they should be. Only until recently through websites like yours, patients have become aware that they might have pain due to mesh implantation and they might have developed pain with intercourse five years later due to a previous mesh implantation. Patients are saying only now, maybe I had my surgery in 2010, I didn’t have a problem before, maybe I have a problem now and this is a delayed manifestation of the mesh complication. So there’s been a delay in diagnosis.”
“Basically you ask any surgeon before 2010, what’s the number one post-surgical complication with mesh and they would tell you, mesh erosion, but mesh erosion or extrusion in the vaginal skin is an objective finding. A lot of doctors hear complaints of pain and discomfort and they look in the vagina and say, ‘There’s no mesh coming through your skin, you’re fine.’ They don’t understand it can be underneath the skin and still cause pain. Even I’m probably guilty of this scenario and overtime I have learned the clinical manifestation of mesh complications. We never were taught this in training because there has never been a time is surgical history where this much mesh has been used to fix vaginal vault prolapse and urinary incontinence. It has taken surgeons years to learn and understand mesh underneath the skin can create pain. Mesh extrusion can usually be readily treated, but when it has accompanying severe pain, not isolated to the point of mesh extrusion, it can be a real problem. So I think it’s a delayed diagnosis by the physician, a lack of our knowledge, meaning not only myself, but most doctors didn’t know you could have these other problems until you’ve been exposed to them. Only then do you start looking for them.”
Q: And the TOT incident of pain was five time higher than retropubic group. What does this say about TOT mesh? Should it be on the market?
Moore – “It’s the same exact mesh. The TOT and retropublic is the same exact mesh. Both John and I believe currently that TOT slings should not be done even though it’s one of the number one procedures done around the world for incontinence in women. The risks of groin pain, leg pain, and nerve injury may be small but we think it’s too high and there are other alternatives for surgeons. We don’t believe that mesh should be brought through the groin, or through the buttock cheeks, because if you have a problem with that it’s very difficult to treat and if you have problems, mesh arms in these areas can be impossible to remove and impossible to treat. So for those reasons, again it’s the same material. But to pull it through the groin and through the levator and obturator muscles and in certain situations the adductor muscles, we don’t think that’s a procedure that should be completed.”
Miklos – “The problem is the method of doing it. In terms of mesh contracture, it’s not occurring in the body of the mesh like the TVT, but it’s where the mesh inserts. If you think about the TOT placement from the vagina to the groin there are multiple layers of tissue it goes through including the urogenital membrane, endopelvic fascia, vaginal skin, obturator internus muscle, obturator membrane, obturator external muscle, scarpus fascia, subcutaneous fat and skin. Each layer of tissue has its own ability to create scar and fibrosis. In some women that’s 2 to 3 inches thick. Each layer can actually create scar.”
“Now with a TVT sling there is a scar underneath the urethra, but the real scar occurs between the vaginal ceiling and the internal superior vaginal wall. There is really nothing in that space between these two layers of tissue but a potential air space. Now it does scar to the wall but it’s the tissue between the wall and the vagina that tightens. So there is less ability to have one continuous scar plate formation. The more multiple layers of muscle and tissues these arms go through in a transobturator implant (like the Prolift, Avaulta, TVT-O and TOT type slings), and considering muscles have more nerves than fat, the greater the potential for pain. If it goes through muscle you have a greater risk of contracture, scar plate formation, and the more contracture there is or tightening of the muscles around the mesh, then you notice secondary nerve entrapment.”
“When you think about sacrocolpopexy, it doesn’t go through any muscles. Don’t get me wrong it can contract and cause pain too but not to the degree you are seeing in these meshes with arms. These are big arms going through the pelvic floor, levator ani and obturator internus and obturator externus muscles.”
“I personally believe, at this point in my career, that the transobturator (TOT) tape sling should not be on the market because it transverses too many layers of tissue which, on occasion, can cause nerve entrapment and it’s extremely difficult to remove these slings from the groin. Whereas a single incision sling, you can usually remove 95-99 percent of the mesh. But the TOT type slings, I personally believe even though the risk of permanent groin pain is low, there are other alternatives where you aren’t going to get permanent groin pain. So I personally think it should be removed from the market.” #