Leading Pelvic Floor Surgeon Concerned by Suspension of Mid-Urethral Mesh Sling Surgeries

Chair of the Urogynaecological Society of Australasia, Dr. Jenny King joins Wayne Bucklar on Health Professional Radio to argue for moderation in the debate about the immediate suspension of mid-urethral mesh sling (MUS) surgeries in the UK. MUS is the most common type of surgery for Stress Urinary Incontinence (SUI), an involuntary urine leakage experienced by women under the age of 60.

MUS was first introduced in Australia in late 1998. It was seen as an excellent operation and the numbers of surgeons and patients recommending it rapidly increased over time. It basically became the major operation done to treat SUI. Vaginal mesh was also later used in surgery to treat vaginal prolapse. However, by the mid-2000s concerns began being raised when some patients were reported to have developed complications including pelvic pain, pain during intercourse and damage to internal organs. As a result, campaigns against the procedure via social media led to government interventions, including a Senate Inquiry in Australia and a total ban on the procedure in the UK.

Dr. Jenny King is a urogynaecologist, chair of Urogynaecological Society of Australasia (UGSA), Program Chair Education Committee of International Urogynaecological Association (IUGA) and director of Pelvic Floor Unit, Westmead Hospital in NSW Australia. UGSA represents pelvic floor surgeons, many of  whom have utilized transvaginal mesh for the treatment of urinary incontinence and prolapse.

– TRANSCRIPT OF INTERVIEW –

Wayne Bucklar: You’re listening to Health Professional Radio. My name is Wayne Bucklar and my guest today is Dr. Jenny King. Jenny is the Chair of the Urogynaecological Society of Australasia. She’s also the director of Pelvic Floor Unit at Westmead Hospital and she’s joining us today to talk about what I think is a very current and very serious issue for many, many people. We’re here to talk about the “mesh issue.” Jenny, welcome to the program.

Dr. Jenny King: Thank you.

W: Now Jenny, for many of our listeners they might not understand the background to this. So can you fill us in on what the background is and then we’ll move on to what’s happening now.

K: Okay. Look, it is a long story so bear with me. For many years, we’ve had operations for women who have urinary incontinence, the typical sort when you leak when you cough and sneeze. Now they’ve never been great operations but they were the best we had and we got a reasonable outcome. In the late 1990s, there was a newer technique developed which involved a little half-inch wide mesh strip that was placed under the urethra. Now these had various names at the time, tension free tape, whatever, but they were made of a polypropylene mesh. This operation revolutionized our treatment for urinary incontinence and it very rapidly replaced all of our other previous operations. So it was first introduced in Australia late 1998. By 2004, it was basically the only operation that was done. Now there were good and bad things about that. It was an excellent operation and was taken up by more and more surgeons and more and more women wanted to have this procedure. However, if you look back over the history, we probably got too excited too soon and started using the slings before we had a whole lot scientific data. In fact, it turned out to be a very good operation, it’s certainly better than anything we did before. We got better long-term outcomes, and in a way, we were very fortunate that it was as good as we wanted it to be. And nowadays, everyone would accept that it is a brilliant operation – it works for most people, it gives them a good result without a whole lot of complications and, it’s been very carefully followed. We’ve got 20 years follow up on those ladies now. It’s probably the most researched operation in medical history. There’s 2,000 peer-reviewed articles looking at this procedure. And I would give it to my sister, I would give it to my best friend; it is a good operation. Now things started to sour in the mid-2000s. Also, the other area we work is in prolapse. Now the trouble with prolapse, it’s like hernias, it’s bits of your insides becoming weak and falling down and we have to try and hold them up against gravity in an aging lady who’s still walking around upright doing lots of things. And quite honestly our prolapse operations were not terribly good and at least a third of those ladies needed further surgery or surgery on other bits we hadn’t reinforced and it was a really frustrating difficult area. So there was real enthusiasm for, perhaps mesh can be our answer for prolapse as it has been for incontinence, and it was very rapidly adopted and it was probably too rapidly adopted, looking back, and it took us a while to see that ‘Look, this may not be the answer for every woman’. Certainly, we’ve learned now that it’s always reasonable or almost always reasonable to do a simple tissue repair first off, and to reserve that mesh for women who’ve had failed previous surgery. But certainly through the period say from 2005 to 2012, the mesh for prolapse was used fairly widely and some women have developed complications and they were complications we didn’t expect, we certainly didn’t anticipate. Very bad pelvic pain and pain in other areas of the body; pain that doesn’t improve when you remove the mesh; pain with intercourse; damage to internal organs. Not a lot of women, but when it happened, it’s been quite devastating. And I think we were slow to pick up on this. Part of the problem is that most pelvic floor surgeons work in big units and it’s all we do. So we actually, not boasting, but we don’t get a lot of complications or if we do, we know how to go about trying to fix them. But when something becomes very popular and you think, ‘Look, this is the best operation I can do for my lady, I may work in Timbuktu, I may only do two of these a year but I’ve heard it’s the best operation’. People will do that and they’ll do it for the right reasons. But in fact, it’s much more complex than we thought and you really do need very careful patient selection, very careful monitoring ofthose ladies. And I really think we were, as I’ve said, slow to pick up on those complications because they were coming in in dribs and drabs, and truly we did not have a very good mechanism for following those ladies and picking up on those complications quickly. We are as a society much better at picking up complications from medications than we are from medical devices, and this is obviously something we’ve had to look at. So through from say 2012 onwards, there were more and more reports of mesh complications, and the regulatory agencies, the Parliament, everyone started to look at this and changes were made but probably not quickly enough for some people. So it became a special media issue, it became a tabloid press issue, it became a senate inquiry issue. Now I think, probably all of those people were well intentioned but what’s happened, we’ve seen a really adverse response to mesh, as though mesh per se is the devil incarnate – always bad – shouldn’t be used – just ridiculous comments saying that it causes cancer – that it migrates. Things we know are incorrect. But it means that people are now frightened of mesh. For example, the senate inquiry, and I find this area really difficult. Once you get legislators, and parliamentarians and bureaucrats involved in medical regulation and medical practice, you get people who are not really answerable to the science. Now I gave evidence at that senate inquiry – we put forward all our data, we put forward our patients’ letters, we put forward really complex information. But for a politician, you are answerable to your constituents or to the people who’ve got you on their side, not because you’re a bad person because that’s the only story you’ve heard and it’s very emotive and it’s very upsetting what has happened to these ladies, but that’s all you see. So the response from the senate inquiry was to say, “Mesh for vaginal prolapse or for stress incontinence should only be used as a last resort”. Now that is nonsense, it is the best operation we have for stress incontinence. I would agree that it should be used far more cautiously in prolapse, but you don’t rule it out altogether. And when you get pressure from parliamentarians and pressure from newspapers and a whole lot of people who have been quite legitimately seriously harmed, people overreact, and they’ll do things like withdraw product. We don’t withdraw airplanes because one will occasionally fall out of the sky. What we do is look at what the devil went wrong? What can we do to prevent that? How can we do things better? And that’s basically happening over mesh. I can understand that that is not a consolation to those ladies who’ve been affected. But I really think we have much better regulations about who uses the mesh, and how we use it, and how we train people, how we monitor those ladies, how we look after them. It’s a much different situation. But now if you mention mesh in public, a whole lot of people won’t have heard about it, but other people will say, ‘Oh my God, that’s terrible. You’re going to get complications’. And they are scared to come for treatment, and that worries me. And I’ve said this in other situations, I am quite honestly doing operations, I know in my heart are going to fail because that lady is too frightened to consider mesh. Now I could probably try to override her, but that’s difficult to do. I find that ethically very difficult and also quite practically, ‘What if she does have a complication and I promised her she’ll be all right?’ You can’t do that in medicine. But I know what’s going to happen, she’s going to come back in a few years – it will have failed. She has to go through another operation and I have to perform another operation that is more difficult, with a high risk of complications and this time use mesh because we didn’t use it due to fear, not due to any good medical reason. And that’s where we are at the moment, and I think that does our ladies some major disservice.

W: Yes. It’s a very awkward situation when you have the media educating patients when it’s a complicated medical issue that needs a level of understanding and a level of expertise that you just don’t get in a 30-second sound bite.

K: No, you don’t. And it’s incredibly powerful, the role of social media. I don’t know how we counteract that and I really don’t know the right ethical answer. So we’ve looked at that mesh situation, I thought, ‘Okay what went wrong? What did we do? Maybe we were too enthusiastic to use new products’. For the right reasons. I know the companies always get blamed but quite honestly, it’s my responsibility as a surgeon to look at the data and decide whether it should be used. So really those companies are doing their job, aren’t they? And that’s what they’re paid to do. We are supposed to get it right so I don’t really think we should keep blaming the companies. But you want a society where patients can be heard, when the little people can speak up people and can pay attention, where problems that we may not have been aware of can be brought to light. That’s really important. Now we don’t want a system where nobody listens to them and everyone squashes them. But equally, I don’t want a system where social media pressures me to practice medicine in a certain way. Ludicrous statements from people.

W: And of course it’s not a profession as a surgeon or being in the medical industry. It’s not a profession where you can hold off doing anything until everything is certain. People die if you don’t intervene at some point. So there is always a risk.

K: Look, there is but there’s the extra risk in doing nothing as well and there’s a risk in doing repeated ineffective operations. I am never going to get it right every time. And it’s been interesting as I’ve looked at all these discussions because as a doctor and you would know this, if you had a tablet or an operation that worked nine out of ten patients, nine and a half out of ten patients, far out we never get anything that good. And to us it’s like, ‘Okay, I’ve now only got a small number of people I’ve still got to work out what to do with’. But we think that’s good and yet, the reaction say from the senate enquiry was, ‘Look, you’ve done this operation on 150,000 women in Australia and a few hundred have had a problem. That’s too many, it’s not worth the risk’. And we’ve had to totally look at that and you question your training. You think ‘Hang on, no that’s actually very good numbers’. But look, maybe we get a bit desensitized because that’s really a very good outcome in medicine or maybe as a community, we’re unrealistic, maybe we think everything should be perfect. As a whole, there’s a lot of stuff isn’t there? I worry about the, “it’s all about me” generations and it has to be perfect, and it has to be instantaneous cure and I don’t want to put any effort into it. There’s a lot of that going on too. That’s something we need to sort out.

W: And what’s been happening globally Dr. King?

K: Look, similar. Similar things globally but until a week or so ago, I would have said Australia had the worst reaction of anywhere, the most stringent restrictions. Certainly, if you talk to the Americans now they feel it coming down the sensible side of all the hype and it’s the place for mesh has been seen as be able to be used without any restrictions. In the United Kingdom, they had a huge review in 2017 and they had everyone, they had their NICE, the National Institute of Clinical Excellence, their college, all their surgeons, their medical regulatory agencies with this huge working group and they work together with patient representatives, patients who’d had mesh problems and they worked out a really good policy. As I said, for training, for how you monitor these ladies, how you make sure it’s working out well. And the things are going along, I thought very well, very sensibly. And then suddenly we find last week that a parliamentary committee says, ‘Stop. Stop all of your operations as of tomorrow because we have spoken with some women who had mesh side effects and we think, it should all stop until we make sure that all the right things are now being done’. Which is extraordinary again it’s that issue of legislators not looking at what’s being done in medical practice. And quite honestly in the United Kingdom at the moment, if you want to have a sling procedure, you have extensive counseling, and you read and sign a 16-page consent form. Now those women have seriously thought about what they want to do. They have taken this all into account and they’ve decided to go ahead. And then a parliamentary committee says, ‘No, stop. You’re not having your operation tomorrow’. There’s been no new evidence, is exactly the same evidence that was presented last year that was looked at last year. So just absolute turmoil in the UK and such a silly decision. I mean if you really wanted to check that every NHS hospital was doing the right thing in terms of counseling and treating patients that you can email, you can check on that through all your administrators within a day. You don’t need to overreact like that. And I find it really offensive. I mean those ladies, they know what’s going on and they’ve made that decision so why do their wishes immediately get ignored?

W: Yes. And I guess on a day to day practical basis, you’re dealing with women here who are at risk of the same sort of outcome, should Australia follow that path.

K: That’s right. I had hoped that the senate inquiry and their recommendations which they’ve essentially passed on. I’m not sure what sort of organization it is, it’s the Australian Commission on Safety and Quality in Healthcare and basically the Senate tasked them with making the regulations, making the guidelines and they have done some really good stuff. And I thought, ‘Okay, look we’ve worked out a good way to use this so women are not going to miss out on the treatment they need.’ But certainly, this occurrence in the UK has made me feel really vulnerable again and so your world has been a bit turned upside down.

W: And is there an outcome that you’re hoping for now?

K: Look, I want people to be able to talk about mesh sensibly. I want the ladies who have had a good outcome to be heard and I think it’s very reasonable that only highly skilled pelvic floor surgeons use this mesh. I think that may have been a mistake we made before, we thought it was a generalist type procedure, it’s not. It’s very complex and you need to sort out those ladies. So I would hope that we can continue to look after our patients now. We’ve got good guidelines in place and I’m happy to abide by them. I have just has been pushing for guidelines and credentialing for years and been ignored. Mesh has a place, it’s really important for some ladies, if we can just do it without everyone else being scared.

W: Yes. And I guess but that’s going to come down to education and professional clinical advice.

K: Look, I hope so. I don’t think the word is getting out there. People don’t want to hear things about mesh. Never let the truth get in the way of a good story. So all the publicity we’ve had is from women have had poor outcomes and I know I can’t turn around and say, ‘Most people had a good outcome’. That doesn’t make it any better for them. But it’s still the reality and it still means that other women shouldn’t be denied that option.

W: Yes, so it’s a nuanced question and a question of balance of probabilities I guess at the end of the day and for informed consent from potential patients.

K: Look, isn’t that a difficult issue? I feel self righteous so I’ve told them ABCDE but truly, can you really imagine what a certain complication would be like unless you’ve gone through it? And I’m not sure any of us can, really. So I’m never sure about the informed consent thing. I don’t know how to completely convey to someone the odds. We work our odds all the time, we cross the road assuming we’re probably not going to get run over. We have an operation assuming we’re probably not going to have a complication but it is still based on odds, the statistics will catch up with you at some stage. So I find it difficult and I know there’s people doing wonderful research into consent and how to be sure that someone really does understand the implications of what you’ve said to them and I think we obviously need more on that. I’ve had times when I thought I’ve explained something really clearly but I’ve obviously been focusing on some other aspect that’s concerning me about that lady’s management, and I’ve missed the blindingly obvious thing that she wanted to know and yet I would consider that I try very hard with my patients to get it right. But I suspect we can never convey, really, the implications of a complication, we can really only convey, ‘this isn’t likely and if it does happen this is what we will do to fix it’. And that’s really the only way we can do it. We just could do our best at it.

W: And I guess sometimes there are complications that are unfixable but that’s not new in medicine.

K: Well that’s not. I suppose the difficulty with pelvic floor surgery is it’s not life-threatening. It can be seriously affecting your quality of life. It’s not like having a damaged knee that you can’t walk in which case you’ll take the risk of a knee replacement. I know for a fact that the complications in terms of chronic pain after knee replacement surgery are in the range of 20%. So the knee is fixed but the pain continues whereas chronic pain after pelvic floor surgery is miniscule, it’s 1 to 2% perhaps at most and that’s with or without mesh. But pelvic floor conditions aren’t life-threatening. So you’ve chosen to go ahead with a procedure to make you more comfortable to stop your bladder being as leaky and you’ve suffered a difficult complication. So it is hard to justify, isn’t it? The balance is difficult.

W: I do wonder if there’s an element in this about the fact that urogynecological issues are a bit taboo. They only affect half the population. They’re not… Pelvic floor things are seen as women’s business or women’s problems and they’re not talked about often in some circles. I wonder if there is an issue of that involved?

K: Definitely. The number of ladies who don’t come because they’ve tried to hide something for years and years – definitely part of it. Now I don’t know if that means they’re more likely perhaps to not deal well with complications, I suspect not. The sort of lady who sits at home and puts up with bad prolapse or puts up with bad incontinence is generally reasonably happy to have an even partial improvement. So the women who would be most nervous about coming to you often the older ladies and the shy ladies, they’re probably not expecting perfect. There is an element in our society now where we do expect perfect and, yeah really, it’s not that simple. I’d kill to have a whole population of ladies have been through the Depression and been through the Second World War and would just be grateful for some improvements. Honestly, they’re a delight to look after. Unfortunately, I’ll be retired before the Y Generation needs my services.

W: Yes, all that generation went through the war and the Baby Boomers are now headed to their retirement. I’m afraid, it’s that generation that understand that outcomes are rarely perfect.

K: You are so right and maybe we need to get that perspective back.

W: Well, we’ll try a little today. Jenny, it’s been a really great conversation to have with you. I do love chatting to experts because they can always make very complex things understandable even by people like me. Thank you for your time today, it’s been a little luxury for us to hear someone speak so passionately and so expertly about their topic.

K: Thank you for your time.

W: If you just missed my chat with Dr. King, we’ve been talking about mesh implants and it’s a chat worth having a listen to because Dr. King is an expert in the matter and articulates her view very clearly. We have on our website a full transcript of our conversation that you can read. Or if you prefer, we also have it as a podcast, it’s on iTunes, YouTube and SoundCloud and you can find the links to all of those on our website at www.hpr.fm. This is Health Professional Radio, my name is Wayne Bucklar.

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