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"I think another good take-home message is the importance of the informed consent process," says Una Lee, MD.
The controversy surrounding mid-urethral sling (MUS) surgery has circulated the world of urology for years. Although many women who suffer from stress urinary incontinence (SUI) experience no postoperative issues from this procedure, others experience the opposite.
In a recent qualitative study conducted by Una Lee, MD, FPMRS, Wai Lee, MD, and co-authors, surgeons were asked for their perspectives on the controversy. Una Lee is a urologist who specializes in Female Pelvic Medicine and Reconstructive Surgery (FPMRS) and is Section Head of the Section of Urology and Renal Transplantation at Virginia Mason Franciscan Health in Seattle, Washington, and Wai Lee is the Director of Female Pelvic Medicine & Reconstructive Surgery at the Smith Institute for Urology, Northwell Health, New Hyde Park, New York.
Una Lee: This study was inspired by patients. My patients. For some patients, and I think a lot of urologists can relate to this, their life is radically improved with a mid-urethral mesh sling. It treats their incontinence, they feel better, and their quality of life is improved. And that's really been the case for the last 20-plus years, since the mid-urethral sling has been in existence.
However, as more and more women received sling surgery, a small percentage also had problems. Those problems can be mild and treatable, moderate, or, in some cases, severe, and patients can have lifelong disability or pain. And so, that percentage of women ended up being a big number of women because of the common nature of stress incontinence and the common use of the sling. We're talking about up to 6% of women [who had sling surgery] having problems.
This problem has unfolded over the years with FDA notifications, litigation, and things in the media. We felt like we needed to really dig a little deeper and understand some of the nuances and some of the complexities of this issue, and we wanted to get the stakeholders involved. One of the key groups of people in this, and one of the key groups that don't always have a voice in this—the patients should have a voice, too—are surgeons. They have a lens into what patients experience and then they have their own perspective. And so, this study is a way to allow surgeons to express their views on this issue, what they’re learning, and delve into these complexities. It was a qualitative study, so not a survey, not a clinical trial, but something where you ask open-ended questions and get their viewpoints. Then we analyzed these transcripts and came up with the themes. So, it's a topic near and dear to our hearts, and hopefully, something to move our field forward.
Wai Lee: One of the study findings that really stood out to me was that so many of the surgeons that we spoke to are such strong advocates for their patients. But at the same time, a lot of them feel almost a little powerless over some of the forces that are existing beyond them, and they don't have a good voice to express how they can best help patients. While they acknowledge that there is this troubled history and this controversy behind mesh sling surgery, they do feel that with the right patient selection, the appropriate technique, and the assurance that patients are equal stakeholders and well counseled, the future is promising and that we can help right the ship.
Wai Lee: Some of the strategies that really stood out to us related to how surgeons just adapt. They find ways to work around these challenges, and they realize that while there's a lot of patient hesitation, there's a lot of misinformation, and there's a lot of controversy, they really strive to do the best they can with counseling. So, some of the surgeons would actually bring the patient back before their surgery day to rediscuss everything and, at that point, do the informed consent. They expect that the patients can develop a lot of questions and a lot of concerns between the time of visit and actual surgery date, and in anticipation, they do this. Other surgeons encouraged their patients to go and Google things, go and find what's out there on the internet, find that controversy, and to come back to the office and get a chance to address those questions. And if they have friends, if they have family that have other questions, bring them together and discuss it together.
Una Lee: I agree. I think that a lot of the best practices that the surgeons had developed and honed were really excellent communication skills, and building a trusting physician-patient relationship, where they truly provided an informed consent of all the risks, all the benefits, and all the alternatives. It's a permanent surgical graft going in an intimate part of someone's body, and there can be unforeseen adverse events or there can be excellent outcomes. But I think patients want to be well-informed, and this particular surgery does need even more attention to that relationship and that care. I think that's what came through in our study—that surgeons really do want to do the right thing for their patients and really want to emphasize that patient understanding and communication so that women can make the right choices for their bodies and their life and their quality of life. So, we were very impressed by the breadth of ways people communicate that, whether it's verbal, whether it's written, whether it's the way they talk to patients, and the comprehensiveness. Ultimately, it comes down to the relationship and making sure that patients are well-informed moving forward.
Wai Lee: Personally, I was part of this study as a fellow. Now that I'm a new attending, I would say I've come away with so many lessons that I employ every time I have discussions with a patient. I think part of it is just really engaging the patient, engaging with anticipated questions, and not taking any shortcuts when it comes to counseling. To really make sure they understand and really make sure that all the family members who are involved in decision-making are brought in to that visit. Sometimes they just have a husband or sibling just lounging out in the waiting area, and you have to remember to bring them into the shared discussion. Sometimes they don't know that there's any controversy with mesh, and it's really easy, especially if you're pressed for time, to skip the discussion. But after this study, I know that it's important to discuss the fact that there is some controversy, discuss the different types of mesh, discuss some of the complications that can occur, and why, in the right hands and with recognition of these complications, we can work together, we won't abandon you, and we'll strive for the best results. I think patients like to know that there are complications, but we can be there if it were to happen.
Una Lee: Based on the study, one of the themes was that patients wanted to be validated, acknowledged, and listened to. Sometimes, they felt blown off by their surgeon and would seek another surgeon, but other surgeons explained that they would stick by their patients through thick and thin. Even if they didn't have the solutions, they would refer them or they would keep with them. I think that's what the patients want. They just want that trusting doctor that they can go to and who believes them, someone they can talk to about it. Sometimes, it might be an unusual symptom, but they want someone to believe them and to work with them until their needs are met. That was a theme that came through, and maybe we, as providers, would take that for granted. But over and over, it's important to develop that relationship and keep that relationship strong with those open lines of communication.
Wai Lee: I would love to share one of the quotes from the study. And that quote is, "We don't aim for problems to happen, but if they do, we're going to take care of you. Because I think at the end of the day, that's the most assuring thing we can tell our patients. That we're honest, and we will continue to take care of them to the best of our ability." That one really struck a nerve with me, and I felt that it was genuine and there's a degree of vulnerability both in the surgeon and the patient, but it is also an acknowledgement.
Una Lee: I think another good take-home message is the importance of the informed consent process. Not just the verbal, but the documentation and what that involves. The mid-urethral sling and everything that's come with it heightens that level of importance. It's a privilege to do surgery on a patient, and a part of that is really making sure they go into the procedure fully informed of the pros, the cons, the possibilities, the potential outcomes. I think we can do better as surgeons. We're doing a good job, but let's continue to do better.
Wai Lee: Una said something very inspiring. She said that we have to continue to listen to patients. Sometimes we lose that. We're caught in the flow of our clinics, we have our surgeries, we have our procedures, but we have to listen to patients, and we have to also listen to other surgeons. They have very unique insights and perspectives and a degree of humility. We need to listen to how we can improve. That's the beauty behind our field.
Una Lee: It's the art of medicine, the art of surgery. We think we're communicating all this, but as opposed to dumping information, it's how to create that form of understanding and how to communicate in a way that the patient really understands what they're getting into. That's a whole other level, and I think that we'll continue to grow, and we'll continue to develop those skills. Every patient is different, right? Everyone has individual needs. But I agree with Wai that we've got to listen to other surgeons and share best practices. We've got to listen to patients and all the stakeholders in this process. Patient-centered care is our goal.
Wai Lee: I was very new to qualitative research before I met Una Lee and started this research project with her. What she taught me and what is important is that sometimes you get caught up with the quantitative, or these definitions of success. Yes, there is sometimes a component of patient satisfaction, but you get caught up in success measures and the type of research that only looks at those hard numbers and statistics.
But then when you switch gears to qualitative research, you generate all of these ideas and concepts that get buried underneath it all, and it really exposes such a gap in how we understand certain areas. In this case, it can be a very controversial area and I think we can learn a lot from this type of research. We broke ground with this in focusing on a different angle with surgeons who were very inspiring. They all had such great stories. I wish we could have kept going and interviewed all the surgeons in the world, but at some point, you have to get the final picture.
Una Lee: I agree. I think the surgeon voice is an important voice to be heard because there's not a lot of avenues for surgeons to be able to be honest and share all the things they've learned and all the things they've experienced with their patients. There's value in qualitative research because it can help us learn what matters to patients, what matters to surgeons, what matters to the important people in this process. Maybe we're missing the mark if we determine the “what's important.” Just by listening, we can learn so much.
1. Lee W, Uberoi P, Lucioni A, et al. The evolving story of mesh mid-urethral slings: the surgeon’s perspective. J Urol. Published online September 21, 2021. doi:10.1097/JU.00000000000002203