Well, Jeff, thank you very much for the kind introduction. It's a real honor to be asked to give the Ray Lee lecture. And I know that Ray Lee had an enormous impact on many of the people in our organization. And it's really great to see that his legacy lives on in the surgeons that he has trained. So this is sort of a timely topic. You've heard about a little bit this week already, especially because of the last six months what's happened here in the US with the FDA withdrawing the last two transvaginal mesh prolapse meshes, and also what's happening with this mass litigation that's happening in the US. So I want to address where we've been, how we got here, and where we're going. These are my disclosures. I'm actually kind of proud of these disclosures. I know some people look suspiciously on disclosures and our relationship with industry. But I look at it as this is my contribution to making products better and working with industry and coming up with new products, giving them my thoughts on ergonomics and safety and efficacy. So I look at it as a good thing. What is surgical innovation? It's kind of a fuzzy line between what is innovation and what is variation. I mean, we are trained to improvise, to modify, to do variations every day in surgery. No two patients are alike. No two anatomic situations are the same. So that's encouraged in our field, and we should. But most people consider something that's innovative to be significantly different, like a novel procedure that differs significantly from what we previously have done and where the outcomes, at least long-term outcomes, really aren't that well-known. That's innovation. There are at least three different types of surgical innovation. I want to talk about those. The first is called enabling technology. Enabling technology is an innovation that really supports further developments in the field. There are many examples of this in surgery, but the one that I always think of is the introduction of general anesthesia. So this is a painting that hangs in the Countway Library in my town in Boston at Harvard Medical School, and it depicts the first public demonstration of general anesthesia in 1846, more than 150 years ago. And this was a dentist, William Thomas Green Morton, administering ether to a patient with a tumor in his jaw, and the surgeon, John Collins Warren, removed it without any pain to the patient during the procedure. Just think for a minute of what we do on a daily basis and how would we do that if we didn't have general anesthesia. That is the typical enabling technology. The next type of technology, which I think is very exciting, is disruptive technology. And it's technically defined as one that topples industry leaders, where there's a significant decline in the existing technology. The classic one that comes to mind is coronary angioplasty. I mean, it was developed in the 1970s, but later on, it really proved to be disruptive in the field of cardiothoracic surgery. So if you look at the years between 1999 and 2008, there was a significant decline in CABG procedures as an increase in angioplasty. So it really shifted the market from cardiothoracic surgeons to interventional cardiologists. That's a disruptive technology. In our field, the obvious disruptive technology is a TVT, right, introduced by Olmstead in the mid-1990s. It came to the US in 1998. Now, Olmstead did not invent the sling. He didn't invent proline mesh. He didn't invent stainless steel needles. What he did invent was a self-affixing, minimally invasive procedure that totally revolutionized our field. So you could consider it a small change to slings that have been around for over 100 years, but it completely disrupted our field, and it completely changed the way you and I do urogynecology. This is just one study out of England, Warren and Hilton, shortly after the introduction of TVT, it took over the market, and there was a significant decline in the previous gold standard, the Birch-Copal suspension, as well as most other procedures for stress incontinence. This was clearly a disruptive technology. Now, I'll just tell you what you get when you get a good disruptive technology in our field. You get your cartoon on a coffee mug. When I look for a good picture of Olmstead, that's the only one I could find. By the way, it's not just coffee mugs. This is real, but you can also get throw pillows, battery packs, and shower curtains. I'm thinking about getting a whole complete set for my house. The other obvious disruptive technology that we see in our field is robotic surgery. And whether you like the robot, or you think it's a large waste of money, and you can do most of what we can do with straight-cicle laparoscopy, we've had laparoscopic surgery with high-definition monitors and high-flow insufflators and great light sources for 25 years, as long as I've been doing surgery. But it wasn't until the robot came out that we really changed and flipped the minimally invasive approach to hysterectomy and now sacrocopalpexy. If you look at the graph in 2001 and before that, the majority of hysterectomies, just hysterectomy data, were being done by open surgery. No matter how much we promoted laparoscopy, we were about 15% vaginal surgery, maybe 20% around there. But when the robot came out, it's undeniable that many more women got minimally invasive surgery, including, by the way, an increase in laparoscopic surgery. Unfortunately, for some reason, I think because of the love of the robot, there was less vaginal hysterectomy being performed, which is obviously the ultimate in minimally invasive surgery for hysterectomy. So whether you can argue with the robot or not, the fact of the matter is more women are getting minimally invasive surgery, and that's a good thing. The last type of technology is incremental. Incremental technology is when we marginally improve existing technology. It doesn't lead to any significant change in practice of surgery. But let's face it, it's not terribly exciting either. It's not sexy. This is the original TBT that came at least into the States in 1998. And the incremental technology there has been smaller needles, sometimes lighter weight mesh, turn mesh from clear to blue. Those are the types of technologies that we've seen, minor improvements. Why do we need surgical innovation? Our patients pretty much do okay, right? Why rock the boat? And maybe we should just be content on the way we are trained, the way we do things. Well, there are a couple of reasons. One is sometimes there's a frustration with existing treatments. I'm gonna show you a simple example, a simple example. This is a typical posterior repair. I think I must have like three assistants holding Alice clamps everywhere. And then there was this introduction of this simple device, the self-retaining retractor. I love this device. I love this device. I actually went to a meeting. I think it was an AGL meeting. I went over to the booth of the company that makes this. And I said, I just have to meet. I got to meet the guy who invented this. And they said, well, you're not gonna meet him. Number one, he's dead, okay? But second of all, he was a real jerk. He didn't like to work with anyone. I said, that's perfect. That's absolutely perfect. He was like, get out of my operating room. I can do this myself. I love that. Another reason that people innovate is because of repetitive failures. And unfortunately, we've had that in our field. We can't deny that this is something that we have seen repetitive failures with lots of native tissue repairs and high incidence of failure. So what do we do with a case like that? By the way, there are those damn Alice's again. What do we do with an anterior repair? Make an incision, dissect back, placate the tissue, cut off some vagina, close it up. I remember as a resident being in cases where we do an anterior repair. And when we're done, the suture line was sitting right there at the introitus without even separating the labia. And the attending would turn and say, so what do you think? And you'd feel obligated to say, I guess it looks good, right? And then you just leave the operating room. But it didn't look good. It didn't look good. But we tolerated that because that's all we had for years. Then there was the work of John Valancy in the early 1990s that defined site-specific defect repairs and the role of apical support. That made a huge difference. But we still saw recurrences. That was the motivation for us as surgeons to look for other ways to augment our repairs. And that's where transvaginal mesh came about. Not from industry. It came from us. Industry made it better. Industry helped us. But the idea came from us. So, and then actually, that was another disruptive technology. About 10 years ago, over 25% of all prolapse repairs had mesh, pop mesh, whether it was transvaginal or sacral copal pexing. And lastly, the other reason we innovate is if we have unsolved problems. And I can think of several examples we can all. Painful bladder, recurrent UTIs, defecatory dysfunction, things that I still think we're looking for good answers for. Back in 1976, there was an amendment to the FDA that reclassified or classified medical devices into three classifications. Class one devices are very, very low risk. Things like Band-Aids and surgical instruments, stethoscopes. And that represents 47% of the applications to the FDA. Class two devices are considered moderate risk. Wheelchairs, infusion pumps, acupuncture needles. Class three devices are high risk. Things that sustain or support life. Things like pacemakers, defibrillators. And now, as of several years ago, we learn transvaginal mesh. So how do things get through the FDA? Well, they can be approved through the FDA and that's for the class three devices. That requires something called a PMA, a pre-market approval application. It's expensive, it takes time. But the most devices in our field, like transvaginal meshes, have been approved through or actually cleared through the 510K process. And that involves finding a predicate device, something that's similar to it, that's substantially equivalent is the FDA terminology. Now, a couple of years ago, our own Pat Culligan with a fellow gave this family tree in an article and showed that starting at the bottom that all the transvaginal meshes that came out, it's over 60 of them, used a certain sling called the Protogen sling that was approved back in 1996. And these were all approved through the 510K process. It turns out three years later, Protogen was voluntarily removed by the manufacturer, but it still allowed all the other devices to remain on the market. And that's been somewhat controversial in terms of how the FDA approves devices. Well, as you know, there was, and we heard from Jeff earlier this week, that in 2008, there was the public health notification about complications associated with mesh. And then in 2011, we had the safety update. So what happened was after the first notification, there were very few lawsuits, only about 100. But after the 2011 update, which said the complications were not rare, it opened up the floodgate. And now there are over 100,000 mesh cases in litigation. Most of them consolidated in something called an MDL, which is similar to a class action lawsuit, a little bit different, down in West Virginia. It's important, I think, to note that when providers are listed as implanters, 88% of the cases involve non-FPMRS board certified physicians. So in a minority of patients with lawsuits, it involves FPMRS board certified physicians. Of those lawsuits, you may be surprised to learn that the overwhelming majority of them are for slings, mid urethral slings, not for the prolapse mesh. That represents about a quarter. And it's just based on the number of cases. So the plaintiffs are going after the numbers. So, by the way, the least, and within slings, it's equally divided between retropubic and trans-operator. The least number of prolapse meshes involved have been sacrocopalpexy, just a very small sliver. If you've seen Forrest Gump, you'll know the line, stupid is as stupid does. You ever notice that when surgery goes very well, I'm a great surgeon. When surgery that involves a device doesn't go so well, that's a lousy device. You know, I have this engineering friend who said to me, medical devices, who said, you know, we try to design so our instruments are idiot proof, and then they go ahead and build a better idiot. It just happens. And I've talked to, you know, I believe that these devices, whether slings or pop Q mesh, they're very, very simple. I believe that these devices, whether slings or pop Q mesh, they're very well designed. They're well manufactured. That's not the issue. We just have to remember that these devices were brought on and invented by us, by surgeons. And industry simply was there to make, to facilitate the devices, to make them easier for us to use. They responded to the unmet need that we had. So medical device companies use what's called an FMEA, which is a failure mode and effects analysis. What they do is they sit around trying to think of all the ways that surgeons can incorrectly use their devices. I've spoken to medical directors who have told me that it's not that uncommon that people do a TVT and they just cut the mesh with the plastic sleeve in place. Okay, that's a bad idea. And then I talked to one medical director who said that he got a frantic phone call from a surgeon intraoperatively, who placed a beautiful TVT, then reached in with a Kelly clamp and pulled out the mesh, leaving the plastic sleeves in place and wanted to know what should I do now? And he responded, I, you know, you pretty much have to start over, right? You can't feed the mesh like back around, you know? Anyway, so what happened? What happened after all of this? Thank you. As a result of the mesh, thank you, the mesh litigation. Well, unfortunately many manufacturers decided to stop selling mesh. This is one J&J. They stopped selling ProLift and ProLift Plus M and ProSema, TVT Secure. Bard left the field completely, Avalta and Ajust. This company, Endo International was the parent company to AMS, American Medical Systems, which changed its name to Astora. And they just shut down three years ago in April. They were the market leaders in many different products. So Elevate, Miniark, Monarch, gone from the market. And then last year, there were two media events that came out. One was 60 Minutes. 60 Minutes ran a show about claiming from an attorney who claimed that Boston Scientific was importing or smuggling counterfeit mesh from China. This is what we call in the United States fake news, by the way, that's sort of a new term. And then at the same year, Netflix put on a documentary that actually featured and was very critical of the medical device industry, not just transvaginal mesh, but hips, the da Vinci robot and Eshore. So we've had a lot of bad publicity in the last couple of years. You saw this before, this is the hype cycle. And I want to relate the hype cycle to transvaginal mesh. This was developed by Gardner, which is a global research and advisory firm. And it's a graphic representation of the lifecycle stages of new technology. The first stage is the technology trigger. That's when a new technology becomes available. There's a lot of media attention and people jump on board. Then there's this peak of inflated expectations when there are lots of early success stories and widespread adoption of the technology. This is followed by the third, which is the stage which is called the trough of disillusionment. And this is when interest starts to wane because we start to hear about complications and failures. Then there's a slope of enlightenment where there's a more realistic notion of the applications. And then finally, there's a plateau of productivity where there's appropriate indications, which I think where we were prior to April of this year. I'm going to add one more stage. And this is not usually present, but this is the extinction or, and I'm going to say actually near extinction by the FDA. And you'll see why I say near extinction in a little bit. So how does a medical device company evaluate new products or new innovations? Well, there's got to be an unmet need. They need to, you know, does it address some issue by surgeons? Will surgeons and consumers get on board with the new idea? Companies are very sensitive these days, obviously to the risks and benefits of new technology. There's got to be a return on investment. What does it cost? What is it going to cost to evaluate, to develop and to train people? What are the costs of goods? What is the cost to manufacture? What can we sell it for? Is there an existing code that makes it easier? If you have to get a new code, that can be a very lengthy process. Obviously we need to evaluate the legal risk. And finally, as we talked about earlier, what is the regulatory pathway? Is it a simple 510K with a clearance letter or is it going to be a PMA, which is very lengthy and very expensive? There's a huge difference between the two. Sometimes, by the way, a PMA can be beneficial because it can prevent competitors from coming into the field. So I had the opportunity to speak with a number of executives at medical device companies in preparation for this talk. And I wanted to know what their mindset was. And unfortunately, you know, the bottom line was right now, this is a difficult space to innovate because of the need to train, because of different surgeons doing different surgical techniques, and also because of the litigation in women's health. It's not a very attractive place right now. The PMA pathway is long and it's expensive. It may take $15 million typically, and it might take 10 years to get a PMA device through the FDA. And then you're not even guaranteed that it's going to be successful. Whereas a 510K may cost a couple million and you might get the product on the market within six months. So there seems to be now a trend toward less exciting incremental innovation in our field. And I know there's this feeling out there that when the 522 study results come out, everything's going to be peachy keen, everything's going to come back. Talking to industry, that's not going to happen with transvaginal mesh or biologic grafts. Just not going to happen, too much risk. Now we like to think that this is protected, the sling. Well, a lot of people are concerned that the slings are in the crosshairs, the crosshairs of plaintiff attorneys who are determined to get that off the market. And we need to be the advocates for our patients. We need to be louder. We need to work with industry to make sure that doesn't happen. So who are the innovators? The innovators could be the surgeons, they could be the engineers, they could be the scientists. I think the innovators are right here in this room. We are the innovators. We are the ones who are in the trenches. We're doing the surgery. We know the unmet needs. We know the struggles we have. We know what our patients' preferences are. So we need to be more proactive and develop new innovations for our patients. So I don't agree with this. I think we do need to think outside the box. And it's up to us to do that. Now, how do we do that? When was the last time that you walked out of your OR and went into the OR next door to watch a plastic surgeon, or an orthopedic surgeon, or a neurosurgeon, or a cardiothoracic surgeon? It's rare. We're all very busy. But I believe we can take things from those other subspecialties. That's cross-fertilization. We had a lecture by our plastic surgery colleagues. It was fantastic. They know so much about vascular grafts and tissue expanders. There are definitely ways that we can collaborate with them. Just remember, though, that the FDA, they may clear devices, they may approve devices, they may remove devices from the market. At least in the United States, they don't control how we do surgery. If I still feel that a patient is best served by transvaginal mesh and it's supported by the studies and we're going to get the 522 studies, you have a discussion with your patient and you can still do it. It's the same risk as it was before, but you won't have a kit. How many people here use intercede on laparoscopic cases to prevent adhesions? I know people do. That's off-label too. It's only indicated for open laparotomy. We do things all the time. I do a procedure called Topaz for fecal incontinence. There's no product like that. I'm MacGyver in the OR, cutting out pieces of mesh. No problem at all. How about Cytotec? Right, for both OB indications and GYN indications. It's not indicated. It's only indicated for gastric ulcers to manage and prevent gastric ulcers. So we do off-label indications all the time. Not a problem. All right, what about informed consent when you're dealing with an innovative procedure? Well, this is an issue because something comes up called optimism bias. You go to a weekend course, you get excited, and that comes across your patients. We have to prevent ourselves from doing that. For the same reason, we're not car salesmen. We can't sell procedures to patients. So you never want to feel like you're coercing a patient into having a procedure. We may not know what the risks are of a procedure. We may not know what the benefits are, but we have to give our patients the best educated guess. And we have to tell them that it's an educated guess if it's an innovative procedure. And what about the learning curve effect? I think most people here would tell a patient the first time they use a robot to do a sacrocopalpexy. What about the third time? What about the 10th time? If the learning curve is 30 or 50, we need to talk to our patients about that. So this is another curve that was adapted by, well, came out and published in 1962 by Rogers and explains how new ideas spread. It's called the technology adoption curve. And it goes by different groups of consumers. We are the consumers here. The first group of consumers are the innovators. It's a very small group of people. They are risk-oriented. They're on the leading edge. And they're the very first to adopt new technologies. This is followed by early adopters. It's a relatively small group that follows the innovators. This is followed by the early majority. And this is a larger group, a little bit more risk-averse, but they're open to new ideas and they like to have outcome data, which I hope we all do. The late majority are a little bit more skeptical, a little bit more conservative, and they need convincing before adopting. And finally, and I love this term, are the laggards, the laggards. They're the last ones to adopt a new technology. They're very frugal, conservative, and risk-averse. But that explains market saturation. What about the risks of innovation? Clearly, we've talked about the risks to patients. The outcomes may not be known and there may be complications we need to think about. There are risks to us as physicians when we innovate. There's the medical-legal risks. There's a risk to our reputation and potentially disciplinary action. And then there are external forces like the FDA, like industry, that act and react to what's happening in the FDA and with mass litigation. So what about innovation in surgery? Well, I think we should encourage responsible and ethical innovation. It's the only way we're going to make progress in our field. Innovation can be sudden, but more commonly, it evolves over a long period of time. I can tell you that I think the best way to adopt new technology, if you can, is in baby steps. And I'll give an example. When I've converted over from five millimeter to three millimeter trocars for laparoscopic surgery, I just go one trocar at a time. Maybe the next case or two cases later, I'll do two trocars. You get frustrated if you try to do too much in too short a period of time. We found that you don't have to learn in a patient. You can learn a lot in inanimate models, like pelvic trainers. And I really believe we need to collaborate with industry and not throw industry under the bus. They are here to help us. That is essential. Finally, we need to share our successes as well as our failures. If you're innovating and you have some difficulty, we need to describe that to the rest of the world so that they don't make the same mistakes we made. That's an important part of innovation. So I'll tell you, I'm optimistic. I believe the future is bright in innovation. And I think we can do better for our patients. This was Henry Ford who said, if you always do what you've always done, you will always get what you've always got. We should not accept the status quo. We should not accept mediocre results from our surgery. Innovation is central to the future of our specialty. And I think we need to encourage thoughtful and ethical and responsible innovation. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.

surgical innovation

transvaginal mesh

urogynecology

enabling technology

disruptive technology

FDA approval process