, Director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital in Boston and professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School.

Jon I. Einarsson, MD, PhD, MPH

 Deputy Editor Jon I. Einarsson, MD, MPH, PhD, moderated a discussion with Robert K. Zurawin, MD, adjunct associate professor at the Baylor College of Medicine, Department of OB/GYN; and Gaby Moawad, MD, clinical associate professor of ob/gyn at the George Washington University School of Medicine and Health Sciences, and founder of the Center for Endometriosis and Advanced Pelvic Surgery. 

In this article, adapted from the video interview, the surgeons discuss the current state of robotic surgery; the current robotic options available; and how new technology can be factored into clinical practice, the focus of which is the Hominis surgical system. 

The Hominis is a transvaginal robotic-assisted system that has combined the visual advantages of laparoscopy with the transvaginal approach. It is said to enhance and enable transvaginal approaches. Its humanoid design includes two flexible, snake-like arms that mimic the movement and mobility of human arms.

Dr. Zurawin is principal medical advisor for Memic Innovative Surgery Ltd., the company that created the Hominis surgical system. 

Dr. Moawad is on the Speakers Bureau, Intuitive Surgical.

Much of what the surgeons discuss is moving the needle on how hysterectomies are performed, since the vaginal approach remains the preferred method in the specialty, but is performed at a lower rate due to myriad factors. Abdominal hysterectomy is the most widely used approach. The Hominis is not yet for sale in the U.S. and pending FDA approval. Experts will present on it at the American Association of Gynecologic Laparoscopists Virtual Conference, being held Nov. 6-14.

“Technologies are coming through that will facilitate the ability of those with general knowledge of surgery to approach surgery safer and more cost-effectively, and make it more accessible to them to do these kinds of procedures,” Dr. Zurawin says.

The surgeons see the landscape for surgical technology constantly evolving, but that doesn’t replace the need for highly skilled surgeons. Patient outcomes remain the most critical goal. Artificial intelligence and machine learning could help modern medicine create algorithms to better understand triaging patients to different modalities of surgery, whether vaginal or laparoscopic.

“At the end of the day, it is the surgeon’s skill that is the most important factor and we often forget that,” Dr. Einarsson says. “That is the most important ingredient. New devices that are coming out are facilitating the existing surgeon’s skills and help surgeons to develop those skills.

“We do not need to glorify another robot,” he says. “We need to improve the innovative aspect of how the robot or how the computer-assisted surgery can help the surgeon standardizing the outcome of the surgery, rather than relying on a human to make decisions.”

The discussion begins with Dr. Zurawin, who provides background.

: You wanted to address the vaginal approach and this really speaks to the greatest unmet need of gyn surgeries because every single gynecological organization recommends vaginal hysterectomy as the preferred method of hysterectomy. But the needle hasn’t moved past 15 or 16%, forever. 

The reason for that is anatomy, surgical training, and discomfort with surgeons who are coming through training - and even existing surgeons - who perform vaginal surgeries. The key to vaginal hysterectomy rests in safe dissection into the anterior/posterior cul-de-sacs, a feeling of security with securing the vessels, as well as avoiding the bladder and the rectum. 

That is not only unchanged, but it has actually gotten worse, because the world of vaginal surgery now is out of the hand of the generalists and has moved to urogynecologists and some of the oncologists, and of course, specifically trained minimally invasive surgeons (MIGS-fellowship trained surgeons). So how can you possibly have vaginal hysterectomy as the preferred method of hysterectomy? Practically nobody knows how to do it. And one of the challenges is anatomy, but if you remember, back when many of us were in training, cesarean section was only a small percentage of deliveries and now it’s anywhere from 30 to 50 to 70 percent, depending on where you are. 

Once you perform a c-section, you have an increased risk of scarring in the anterior cul-de-sac, so in addition to just getting cleanly into the anterior cul-de-sac, now you have got to dig through that scar tissue. A number of publications have shown the feasibility of vaginal hysterectomy after a cesarean but it still is keeping most people away. The vaginal robot creates an opportunity to combine robotic surgery with a laparoscopic view and a vaginal single-incision approach. One of the advantages of that is that the entry is guided by a small umbilical laparoscopic scope. 

Then it monitors the entry of the trocar through the posterior cul-de-sac. You are not going to hit anything. It is direct visualization and then once the trocar is in, the robot arms are inserted and then retroflex. You can perform the hysterectomy and also adnexal surgery, and then remove the specimen through the colpotomy you made for the insertion of the trocar. The transvaginal robotic approach facilitates all those steps. 

Other robotic platforms have attempted vaginal surgery but they run into problems of entry. There are a lot of excellent surgeons doing vNotes (transvaginal natural orifice transluminal endoscopic surgery), which of course is a very nice modality, but again, you have to get into the anterior and posterior cul-de-sac, before you even get to put in the GelPoint. By that point, 90% of the work is done. After that, you might just as well put a couple of clamps on the uterine vessels and you’re done. I just wanted to give a little background on the vaginal approach. Of course Hominis still is awaiting FDA approval but it is at the final stages.

Dr. Moawad has done a lot of tremendous work not only on the cost but training; Dr. Zurawin turns the discussion over to him.

: These are all really great points that you brought in. We can start seeing why the value of robotic surgery would be beneficial in moving the needle towards vNotes or robotic vNotes. 

In addition to what you said, the important thing is that the robotic platform is enabling the surgeon to be in control of the visualization as well as all the operative arms, minimizing the use of multiple assistants. 

That always was a struggle when we did vaginal hysterectomies, where we have the learners, the surgeon and the assistant, all not being able to visualize clearly the important structures, like the ureters in vaginal hysterectomy, or other anatomical landmarks. 

That was, I believe, one of the drawbacks of vaginal surgery, especially when we get into more complex and difficult cases. The type of pelvis, the body mass index of the patient, and then the more complexity of benign gynecological surgeries (including endometriosis) all lead to increasing the challenges in the vaginal approach. 

The problem with endometriosis is that there are numerous surgeons who are not able to diagnose an obliterated cul-de-sac or having the tools to diagnose that before the surgery. 

Therefore, many rectovaginal endometriosis [cases] with the general ob/gyn are diagnosed by accident intraoperatively. Imagine now with trying to push vNotes or vaginal surgery to a wide variety of less experienced surgeons, thinking that this is the primary approach without appropriate training and triaging of patients, this will lead to multiple safety issues that can compromise the outcomes. 

Here I am going to play the devil’s advocate a little bit and open the discussion a little more, which is knowing that now most of the surgeries are done laparoscopically or robotically, or minimally invasive, let’s say, what could vNotes add to this safe laparoscopic surgery, especially now that we’re moving to less ports, more micro-ports, to minimize the injury or the trauma to the abdominal wall cavity?

: From my perspective, and this is obviously my biased perspective, I like to see what I am doing. I remember in residency when I graduated, I did my residency with Dr. Zurawin, actually, and we did a lot of vaginal hysterectomies at that time. I think I graduated probably with 50 or 60 of them and I felt very comfortable. 

When I got out I felt very strongly that I should be able to do all of these things and offer all of these modalities to my patients but then gradually just realized that there wasn’t any point because, if you think about the patient outcomes, whether you do it laparoscopically or vaginally, the patient outcomes are very similar but you can tackle anything laparoscopically, as opposed to vaginally, you kind of have to select patients a little bit more so I gradually moved to 100 percent laparoscopic. 

Especially if you’re dealing with more challenging pathology, I think you need to be able to see. I think that adds so much to what you are dealing with. You can deal with endometriosis, complicated cysts, adhesions, much better than vaginally. vNotes has been interesting technology because it does combine the vaginal surgery and being able to see. I think that is probably the key to allow more people to use that access port.

: Those points come together this way; first of all, full disclosure, Dr. Einarsson doesn’t do robotic surgery because he can do anything laparoscopically. He doesn’t need anything else because he has a brilliant understanding of anatomy and decades of experience with thousands upon thousands of cases. 

But for the purposes of this article, we are talking about the majority of gynecologists who don’t have those skills. Residents who finish now only have to do 15 vaginal hysterectomies to graduate, and they have a hard time scraping together even that number. They graduate without the skill or the confidence to perform vaginal surgery once they enter practice. 

The difficulty there really comes back to knowledge of anatomy. In terms of visualization, Dr. Moawad brings up a great point about obliterated cul-de-sac. Many people recommend a diagnostic laparotomy before a lot of this is done to know what you’re getting into before you get into it. Now here is the controversy: if you’re doing a vaginal surgery, why are you popping a laparoscope in there? But let’s talk about that. In 1991, Stovall and Ling1 published their very excellent paper on 91 patients who were scheduled for vaginal hysterectomy. 

Only a few of them were thought to be candidates, but when they popped in the umbilical scope, fully 90% of them were able to be done vaginally because the surgeons had the confidence of knowing the anatomy. That is really the elephant in the room here. 

Unless people are properly trained, it doesn’t matter what modality you use, you are not going to be unable to do it. Unlike the other unfortunate circumstances we had with vaginal mesh, and all these other procedures where doctors were trained in weekend warrior sessions where they would claim to teach you how to do it, this is not something that you can just grab onto. 

Another thing is the definition of a high-volume surgeon that is in the literature. A high-volume surgeon is what, 10, 12, major cases a year? You know, one a month? I mean I wouldn’t get on an airplane with a pilot that only flew once a month. I think what we are talking about is funneling these modalities into competent hands and yet facilitating the rest of the gynecologists who want to improve their vaginal surgery skills. I think vNotes is great; I think robotics is great; and I think laparoscopic surgery is great, but it needs to go into the right hands and that is the key. 

Now the next thing about that is the expenses, the cost versus the benefit, and again, I am not nearly as conversant in that as Dr. Moawad is, so maybe he can help us out with that.

: I’m going to talk about a very important aspect of robotic surgery, how it could help spread the robotic vNotes. And then when we look and learn from the experience about what robotic surgery did to open surgery, or laparotomy. 

When we talk about hysterectomy, robotic surgery was able to shift most of the laparotomy into minimally invasive where a laparoscopy was steady and this was shown clearly in a lot of the graphs that we have in one of our studies, which was published in 

 about the movement to outpatient hysterectomy in benign indications (in the United States, 2008-2014).

We can see that laparoscopic surgery rates were mostly stable from 2008 to almost 2016 in terms of percentage. Robotic surgery, where we thought before it could take away from the laparoscopic surgery pool, ended up shifting the more complex procedures done [via] laparotomy to a minimally invasive option. If we extrapolate those graphs, that might be the actual benefit [of] what robotic surgery could do to the vNotes, where it could shift a lot of the laparoscopic, transabdominal, or robotic transabdominal, into a vNote modality but eventually, it is going to take a lot of learning. 

Now in terms of cost, again, as most of the costs in the U.S., where we are talking the direct costs, comes from two things: The direct cost comes from the operative time length; and redundancy of using multiple instruments that have the same function. The third factor, which we never talk about, is the cost of complications, re-admissions, conversions, re-operations. This is what drives the major costs in the U.S. for surgery. 

It might not be true for other countries but this is the main cost factor here. The more efficient surgeon using the appropriate tools with the right training is what will help drive the costs down. 

We need to consider as well the opportunity costs, which is whatever the hospital can do with those resources that were not used if the patient was not admitted to the hospital; rather, what if the patient was discharged the same day with a minimally invasive surgery option? This is the total cost that we need to look at mainly.

Next, Dr. Zurawin elaborates on Dr. Moawad’s points about complications.

: This brings us to my concern about anatomy and patient volume. The issue that needs to be addressed, with any new technology, from endometrial ablation to hysteroscopic sterilization, mesh - anything that we were doing -it’s not the device itself, it’s the surgeon. In terms of post-operative complications with robotics, I think all three of us see medical-legal cases that are related to robotic surgery and most of them that I see are thermal injury. 

They mostly involve burning the bladder, a burning of the bowel, or of the ureter. I think that visualization is important, of course, but unless we properly train our surgeons, unless we change our training programs, we’re really going to see an acceleration of this problem. 

That is why, when we adopt these technologies, we need to put them in the hands of the people who can do it. In terms of Dr. Moawad’s point about robotic vNotes, I think that is an excellent future for the specialty. It takes all the advantages of the vaginal approach, all of the technical and engineering aspects of robotics, as well as cost and recovery. 

Again, I just feel strongly, at least in the beginning, these technologies have to be directed or restricted to people who really, really know what they are doing. 

One of my other fellows introduced vNotes and robotic vNotes into China where it has really caught on very big but it is a different market there and it’s a different group of surgeons. Gynecologists in China do thousands of cases, many thousands of cases. We don’t have that here in the USA.

: If you think about what is most important, obviously that is patient outcomes, and what is the most important thing there, I agree with you, that it probably is the surgeon’s volume. It’s not which robot they’re using or whether they are doing laparoscopic or vaginal surgery. Of course, that should be the main focus. 

My view on that is actually a little bit more optimistic because I think that more and more cases, especially in urban areas, are going to high-volume providers. We’ve been graduating now a few hundred fellows in laparoscopic surgery or minimally invasive gynecologic surgery, and they’re gradually building their practices and taking more cases. 

If you’re an ob/gyn specialist and coming out of school, then your surgical volume is so low and it’s very hard for you to get up to speed on that. It is almost untenable in larger urban areas because high-volume surgeons are doing much more cases, and I think that translates to better outcomes for patients, which obviously is what we want. I think that is happening, at least in urban areas. In smaller communities, it is not as clear cut.

The debate still is ongoing in the specialty that robotics surgery is less expensive, and there are those who will say it is more expensive. What is the surgeons’ take? As Dr. Zurawin asks, “What is the real news about costs of robotic surgery, if you consider all factors, with costs and morbidity, costs to the hospital and to the insurance system?”

: This is always going to be a question of which comes first – the chicken or the egg? Because it’s the same debate and let me tell you why. All the published studies in the literature have a major bias, which is that we don’t compare apples to apples and oranges to oranges. 

The whole issue arises because we don’t have a complexity score for hysterectomy. What we use as a proxy for complexity is the weight of the uterus, which we all know is nonsense. 

The challenge with robotic surgery is that we do not have a way to separate the learning curve of different surgeons. 

But it is not only the learning curve, because many people are lured that they will become expert surgeons if they do 20 robotic cases and this is probably some of the marketing pitfalls to engage people. But the proficiency curve, which is around 100 cases, and 100 cases to be met for surgeons who are even considered high volume doing 15, or 20, or 30 a year, that is going to take them 3 or 4 years to get to that level. 

The major issues we have are defining the complexity of a hysterectomy and assessing the surgeon’s skills and then we can compare groups using the same metrics. 

When it comes to costs, you have papers like Dr. Luciano’s: “The impact of robotics on the mode of benign hysterectomy and clinical outcomes,”

 where he studied the premier database and found the complication rate with robotic surgery, despite obesity, is lower than laparoscopic and open surgery. 

 the sacrocolpopexy randomized trial, again, such studies show that robots are more expensive and require longer time and that is why it will be more costly. But in most of the studies there was no difference between the complications between laparoscopy and robotics. Having a laparoscopic surgeon spending four hours in the OR where the costs of an OR minute in the U.S. is $85, is very different than having a robotic surgeon doing the same surgery in one hour. It is going to be way less expensive. 

Therefore it is surgeon-dependent if you have a laparoscopic surgeon admitting the patient overnight just because this is the practice, where a post-anesthesia-care-unit minute costs $15 versus a robotic surgeon sending a patient home after three hours. 

That is going to be a major difference in cost. So there are practice-dependent cost incurrences; surgeon-skill-dependent cost incurrences, and as you said before, the right tool is the right hand to lead to the best outcomes not only financial-wise but also medical wise.

As BMI increases in the U.S. population, the surgeons also considered how modalities should be considered when working with morbidly obese patients.

: A transvaginal approach has definite advantages in morbidly obese patients. You don’t need the steep Trendelenburg necessarily that you do for robotics. 

I’d be interested to know your experience, Dr. Moawad, and also Dr. Einarsson, you deal with a lot of morbidly obese patients and also in your training program. How do you see the people that you’re training dealing with the epidemic of obesity and its relation to modality – laparoscopic, robotic, and vaginal?

: I want to first echo what Dr. Moawad was saying. I now have done a few randomized trials on robotic versus laparoscopic surgery and we’ve done some retrospective and cohort studies and all. Most of our studies are biased, I will admit that, because I am a much more proficient laparoscopic surgeon than a robotic surgeon. 

I think that is probably true for most surgeons that they have their modality that they’re really, really good at and then the other stuff they’re not quite as good at. It’s hard to do randomized trials from surgical access because the bias always is on the surgeon. 

Population-based studies or having groups that are really good at or in similar environments, and comparing those outcomes, are probably the least subject to bias but it’s never going to be really perfect.

In terms of obesity, I will offer a couple of things. The bigger the patient the more important patient positioning is but what I found helpful with laparoscopy over robotics in obese patients is that I can have complete freedom to move the patient the way I want at any time during surgery so I like to put the patient in a very steep Trendelenburg like 30 degrees, pull the bowel away, and then decrease the Trendelenburg, until the bowel starts to move down but it’s not in my way, and then stay in that position. 

Then you can always put the patient down flat if anesthesia is having a problem then go back. Sometimes you do have to maneuver that around. I know that obviously there are those tables that move with the robot where you can move everything and you have the same freedom but not everybody has access to that. So that is one advantage. 

But I know a lot of people like robotics for obese patients and have different reasons and maybe Dr. Moawad can elaborate on that.

: With obesity, the advantage is that you do not have the fulcrum effect from the thickness of the abdominal wall as you do in laparoscopy. Many times, of course, for more experienced surgeons they can overcome this or overlook that but many times this is a challenge. 

Plus, most of the laparoscopic instruments sometimes for extremely obese patients start becoming a challenge and we do use bariatric [instruments] because the [other instruments] don’t get to where you want to be. 

With obesity, the precise movement with a laparoscope will become an issue when we are dealing with way more complex cases. In laparoscopy, many times, when you have a more complex case, you rely more on your assistant, in the sense that they have to do more, and be more actively engaged in the surgery rather than when doing a simple case. 

You have to rely on the surgeons being ambidextrous for super complex cases, where, if the assistant cannot do the job on their side, the surgeon can move with the same efficiency with both hands. These are challenges mitigated by robotic surgery. 

I think one of the values nobody talks about in robotic surgery is how your assistant becomes less and less relied upon throughout the procedure where you can have three arms and a camera that you fully control rather than, at most, two arms with laparoscopic surgery. 

This is one of the values we go back to, the robotic vNotes, one of the values that robotic (has is that it) could help overcome the challenges of traditional vNotes laparoscopy. With obesity, you have even more limited range of motion with less precision.

Dr. Moawad asks Dr. Zurawin to provide his perspective on managing obese patients with the Hominis platform. Dr. Zurawin has been involved in the trials with the platform in Belgium.

: The largest hysterectomy we’ve done with Hominis is 15-week size, which is good enough, even with some adhesions. We have not done many morbidly obese patients because the trials were done in Europe and Israel where the population is generally thinner. 

We also have not had to put them into steep Trendelenburg. Of course, vaginally, it’s a whole different world because of the way you position the patient, the bowel is normally out of the way, unless there are some adhesions that stick the bowel to the cul-de-sac. 

We haven’t run into those problems but the question back at you is for the robotic vNotes, or any of your vNotes but especially robotic vNotes, don’t you also pop a scope into the umbilicus and look before you do your vNotes? Or are you just going to go in there, hoping that we don’t have a deep infiltrating endometriosis?

 I don’t do vNotes but I think access to the abdominal cavity is going to be the main issue, in addition to the reverse anatomy that the surgeon now needs to be familiar with. When they did vaginal surgery they went by tactile feel; they didn’t go by look and then even for the laparoscopic surgeons, seeing anatomy in reverse is going to be also something that they need to be accustomed to. 

They need to know the different views of the different landmarks. Because now as a laparoscopic surgeon when you look at the abdomen from open incision you start feeling the difference how much you’re more comfortable doing laparoscopy and finding the ureter than when you’re looking above into a laparotomy incision especially for challenging cases. 

Nobody talks about the type of pelvis in pelvic surgery, and I think that is going to be one of the major determinants in the success of vNotes. Because if you have a platypelloid pelvis where the pubis bone is very close to the coccyx, then the range of motion of the straight stick instrument doing vNote is going to impact the difficulty of the cases. be way more challenging to do more complex cases. 

If you have an android pelvis that is going to be a deeper pelvis that requires longer instruments to reach the surgical site, so there is a lot of learning. I think we go back to the same thing where we thought it should be done by expert surgeons before we can find a standardization of triage because triaging patients to vNote is going to be the main issue. 

Using a standardized patient triage guidelines as an initial metric will be helpful to increase the success of that surgery and minimize the complication would be key.

: Just to step up from that point, where do you see vNotes and Hominis robot enter clinical practice? Where are these going to be useful? VNotes is being used for sacrocolpopexies and ovarian cysts, etc. Where do you see this vaginal robotic access fit into clinical practice?

Studies on procedures other than vaginal hysterectomies have been conducted with the Hominis, including a bilateral salpingo oophorectomy.

 Other procedures have included treatment of ovarian cysts, adhesions, fibroids and prolapse.

: But cases like sacrocolpopexies – remember you’ve got a colpotomy – so just by that nature it makes it a little harder to do sacrocolpopexies with that Hominis robot because it goes in and it retroflexes 180 degrees. So that hasn’t really been tried yet. I think where its utility is going to be proven is cost.

It’s a small, portable, inexpensive robot for, at least at this point, cases that don’t need a bigger platform. In future iterations it will be used for other surgical devices, cases besides gynecology – head and neck surgery, and so on. 

But in keeping to the gyn area, I think that it is going to find its niche in people who have had challenges in doing vaginal surgery and helping them enter into the world of vaginal surgery because entry into the peritoneal cavity is easy; dissection is easy; and it allows them to use a vaginal approach but with much better visualization. I think that is going to be where it starts. 

Then when version 2.0 or 3.0 comes out there will be more indications. But I think it will encourage people to go back into that vaginal surgery as the preferred method of gynecologic surgery. 

Summitt RL Jr, Stovall TG, Lipscomb GH, Ling FW. Randomized comparison of laparoscopy-assisted vaginal hysterectomy with standard vaginal hysterectomy in an outpatient setting. 

Moawad G, Liu E, Song C, Fu AZ (2017) Movement to outpatient hysterectomy for benign indications in the United States, 2008–2014. PLoS ONE 12(11): e0188812. https://doi.org/10.1371/journal.pone.0188812

Luciano, A. A., Seshadri-Kreaden, U., Gabbert, J., & Luciano, D. E. (march 2016). The impact of robotics on the mode of benign hysterectomy and clinical outcomes. 

The International Journal of Medical Robotics and Computer Assisted Surgery

, 12(1), 114-124. doi:https://doi.org/10.1002/rcs.1648

Paraiso MF, Jelovsek JE, Frick A, Chen CC, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. 

 2011 Nov;118(5):1005-13. doi: 10.1097/AOG.0b013e318231537c. PMID: 21979458.

Lowenstein, L., Matanes, E., Weiner, Z., & Baekelandt, J. (July 2020). Robotic transvaginal natural orifice transluminal endoscopic surgery for bilateral salpingo oophorectomy. 

European Journal of Obstetrics & Gynecology and Reproductive Biology: X,

, 100113. doi:10.1016/j.eurox.2020.100113

Articles

Three esteemed surgeons discuss technology, weighing the pros and cons of existing and newly developed platforms.

The state of gynecologic robotic surgery

For the cover story in this technology-focused issue of 

most dangerous but sometimes overlooked step of laparoscopic surgery,

It is puzzling how little innovation has taken place for this step, considering that over half of all serious injuries and deaths happen during abdominal entry. The Veres needle was invented by Janos Veres in 1932 and was initially intended for treating pulmonary tuberculosis by causing pneumothorax and collapsing the lung.

Later, Raul Palmer adopted it for use during laparoscopic entry.

Einarsson is Deputy Editor of Contemporary OB/GYN, Director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital in Boston and professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School.

The basic design of the Veres needle is simple and hasn’t changed in almost 90 years; it is an outer sharp hollow needle with an inner blunt spring-loaded tip. The spring-loaded tip is retracted during passage through the abdominal wall and then springs forward upon entry, thereby potentially reducing the risk of visceral injury by the outer sharp needle. 

However, this is still a blind technique and injuries do happen, perhaps more often than we realize. The 2mm diameter of the needle is beneficial since if the needle penetrates through a bowel wall, the small defect may self-seal, while a 5mm defect is too large for that to happen.

A useful rule of thumb is that if a device or method has been unchanged for more than 15-20 years, it is time for an upgrade. This certainly seems to be the case for the Veres needle.

Janos Veres was a Hungarian internist and his needle was not recognized outside of Hungary until he published on it in a German journal in 1938.4 It then became commonly used, but Dr. Veres never collected any royalty on his invention and later gave his patent to Aesculap for a few kilos of coffee!

 This altruistic approach also led William T. Bovie to sell his exclusive patent for an electrosurgical generator for one dollar.

This certainly indicates that physicians and inventors might benefit from a few lessons in business prowess, but it also begs the question, how valuable is an idea? The initial reaction might be that the idea for a new device is the most important component, but I have gradually come to the realization that it isn’t. 

During the development of several devices I have noticed a common thread. After filing the initial patent and doing some development, I often solicit helpful feedback from other clinicians. Invariably, one or more of those experienced surgeons will say “I had thought of that too!” 

Some might even accuse you of “stealing” the idea from them. This is why I always write down the idea as soon as I have it, sketch it out and put my name and date on it and then scan it in digitally so that it is clear when the idea was conceived. 

While this doesn’t help with patent filing, since the patent office goes by “first to file” and not “first to invent,” it can help to convince colleagues that the idea was indeed not taken from anyone else. 

The reality is that we all work in a similar environment, with similar technology and dealing with similar clinical problems. It, therefore, seems inevitable that more than one person is going to come up with a similar idea for a solution to a problem at around the same time. 

The actual pursuit of the idea is what is important, and this pursuit is complex, time-consuming, and expensive.

Let’s get back to how much your idea is worth. 

The answer is, it depends, but you must remember that teamwork is the cornerstone of medical device innovation. 

You will need funding, patent and regulatory attorneys, engineers and people who can navigate through negotiations and business transactions. The idea is just the first step in a long process and even knowing whether the idea is valuable takes effort and resources. This includes evaluating market size, cost of goods, average selling price, etc. 

A benchmark of sorts is that an idea on paper is worth a penny; a working prototype is worth a dime; a marketed product with sales is worth a dollar. 

One important pitfall that I have realized as an inventor during this process is never assume that the people you are working with understand what you mean when you are describing your invention. I have had several in-person meetings or worse, conference calls, where it seemed crystal clear to me what was needed and I thought we were all on the same page, only to realize 2 months later when I see the most up-to-date prototype, that we were not on the same page. 

This can be frustrating, and it uses valuable time and resources. I would therefore encourage inventors to be a little annoying and persistent when working with other members of the team and ask them to describe to you in detail how they understand a particular feature will function or behave. 

At the same time, keep an open mind because one or more members of the team might have a better solution to a problem than you had in the first place.

Janos Veres and William T. Bovie each shaped the practice of surgery more than they could have imagined with their inventions without ever reaping financial rewards for their work. 

Of course, having a positive impact on the lives of patients is most important and should be the guiding principle of any inventor. 

However, it is also important to realize the monetary worth of your idea. For this, inventors need guidance from one or more experts that can help them to become even more successful and thereby develop even more innovative devices.

Dr. Einarsson has ownership in Freyja Healthcare LLC, which is developing a novel abdominal entry device.

Szabo I, Laszio A. Veres needle: in memoriam of the 100th birthday anniversary of Dr Janos Veres, the inventor. 

Almeida OD Jr, Val-Gallas JM. Small trocar perforation of the small bowel: a case report. 

Wayand WU. Jànos Veres: the man behind the needle. 

Carter PL. The life and legacy of William T. Bovie. Am J Surg. 2013 May;205(5):488-91.

The actual pursuit of the idea is what is important, and this pursuit is complex, time consuming and expensive.

How much is my idea worth?

’s Deputy Editor Jon I. Einarsson, MD, MPH, was honored as Distinguished Surgeon by the society for his contributions to the field of gynecologic surgery — clinically and/or through research and innovation.

In his current role, Einarsson serves as the chief of the Division of Minimally Invasive Gynecology at Brigham and Women’s Hospital in Boston. His clinical interests include cervical insufficiency/incompetence, endometriosis, fibroids, laparoscopic surgery, LGBTQ health, and prolapse.

Senior Editor Angie DeRosa and Associate Editor Lindsey Carr sat down with Einarsson to discuss highlights from the scientific meeting. Einarsson gives his take in this video interview, including that surgeries are getting back to a normal schedule as the medical world works through COVID-19.

“All of our patients are getting tested and so on, but we’re back to a fairly normal schedule now,” he reports.

One of the presentations he highlighted was based on a multicenter randomized clinical trial of permanent versus delayed-absorbable monofilament suture for vaginal graft attachment during minimally invasive total hysterectomy and sacrocolpopexy.

According to PubMed, the objective of the study was to compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. 

Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. 

The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. 

Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks, and 1-year post-surgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. 

One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). 

The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event.1

The trial essentially showed that there was no difference in outcomes between the two groups, which Einarsson found interesting because traditionally permanent sutures have been used for this procedure.

“It appears probably that the mesh just gets so incorporated into the tissues that using the permanent suture is not necessary, and that has some advantages because if those sutures get eroded through the vagina you can tell the patient, then, if it’s delayed absorbable, it’s just going to go away on its own, as opposed to a permanent suture you may have to go and remove it,” he explains. 

“In our practice, we converted to delayed absorbable sutures maybe 3 or 4 years ago and we haven’t noticed any difference in our clinical outcomes, so it was reassuring I guess for us to see that there wasn’t a difference in this randomized trial. There had been other studies, but they were cohort studies or retrospective studies, so I thought that was pretty interesting.”

Watch the full video interview to hear all that Einarsson has to say about this topic and other findings presented during this scientific meeting.

Matthews CA, Geller EJ, Henley BR, et al. Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial. 

. 2020;136(2):355-364. doi:10.1097/AOG.000000000000388

Videos

The Society of Gynecologic Surgeons (SGS) held its 46th Annual Scientific Meeting virtually in July, in much the same way that all other associations are holding meetings or conferences these days.

SGS 46th Annual Scientific Meeting highlights

Artificial intelligence (AI) is already all around us in our daily lives. It enables smart phones to sort our pictures based on face recognition algorithms, it helps Google guess what you‘re going to search for the second you start typing and it helps Uber figure out what you are willing to pay for various services. 


	AI is also entering medicine. That is, in part, enabled by the large amount of high-resolution digital data that are collected in electronic medical records and from images, genetic screening, and laboratory tests. The other vital component is the ever-increasing capacity of computers to analyze large amounts of data and create a solution on their own, a process called machine learning. Once implemented, machine learning algorithms can continuously improve their performance by using outcomes to improve the fit of the model. These methods have the potential to help with diagnostic accuracy, outcome prediction, cost-effectiveness assessment, and real-time decision-making in surgery.

Can AI improve accuracy and efficiency of mammography?

Han et al discuss use of AI in ob/gyn ultrasound

 As they point out, AI is especially helpful in image detection and automation. It has the potential to reduce clinician errors and help detect rare anomalies, especially among less skilled providers, thereby reducing clinician variability in terms of performance. AI also has a lot of other potential applications in our field and in all of medicine. A recent systematic review identified nine articles that spanned multiple medical subjects, including retinal diseases, skin cancers, pulmonary nodules, and brain tumors.

All of these articles compared the performance of clinicians and AI and found a consistent theme. Current AI algorithm development has a diagnostic performance comparable to that of medical experts, especially in image recognition-related fields. This is especially impressive, given how fairly recently AI has been applied to medical decision-making. It seems inevitable that this technology will improve rapidly over the next few years, which should improve accuracy significantly. 


	This does not mean that clinicians are not needed anymore. AI is not meant to replace clinicians (at least not yet), but rather, to augment their diagnostic and therapeutic capacity. One of the major concerns for using AI in medicine is the lack of transparency about how decisions are generated and the inherent risk of bias if the training database is skewed. Some recent advances in the field aim to mitigate those risks. For example, some of the newest diagnostic machine learning algorithms are able to create saliency maps, which identify the parts of  the image that contributed the most to the diagnosis. 

These AI-powered modalities will increasingly help physicians in their daily tasks in the clinic and lab and also potentially in the operating room. Because most surgeries are now image-based, i.e., either laparoscopic or robotic, there is ample opportunity to use neural networks and machine learning to identify patterns in how surgeons perform procedures and potentially alert them if they are diverting off course. It seems likely that this technology will be incorporated into surgical suites in the not-so-distant future. The increasing incorporation of AI into medicine has the promise to improve patient care and patient outcomes and it merits careful exploration and study. 

Datkhaeva I, Han CS. Artificial intelligence in ob/gyn ultrasound. Contemp Ob/Gyn. 2019;64(10):XX.

Shen J, Zhang CJP, Jiang B, et al. Artificial intelligence versus clinicians in disease diagnosis: systematic review. JMIR Med Inform. 2019 Aug 16;7(3):e10010.

As artificial intelligence increases its presence in medicine, ob/gyns are welcoming the technology with both excitement and trepidation.

Jon I. Einarsson, MD, PhD, MPH

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