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Speaker 1 (00:00:10):
Good morning everyone, and good afternoon. It’s Dr. Towfigh. Welcome to Hernia Talk Live. We are starting our new year. It’s our first Tuesday of the year, so as usual, we’re here at Hernia Talk Tuesdays. My name is Dr. Shirin Towfigh. I am your hernia and laparoscopic surgery specialist. Many of you are joining me via Zoom Live, others via Facebook Live. Thank you everyone for following me on Twitter and Instagram at hernia doc. And as usual, at the end of this session, you can follow me and watch this episode as well as all the prior episodes on YouTube at Hernia doc. So today we have a great guest. We have an a little bit earlier Hernia Talk session because our guest is currently in Copenhagen, Denmark. Dr. Hans Friis-Anderson is a good friend of mine. We see each other as much as we can at least once a year at the European Hernia Society meeting. He is a hernia surgery specialist. You can follow him on Twitter at G A S T H F A. And just want to thank you so much, Hans, for joining me. It’s nine o’clock your time pm
Speaker 2 (00:01:18):
It’s stark as pitch black.
Speaker 1 (00:01:22):
So before we went live, we were just talking and Denmark is a beautiful country. It’s a great country, different medical system than the United States. And what’s very unique from a hernia standpoint is you have a very, very robust national database, which we don’t really have in the United States at least not in any way near yours. So I really want to learn from that because you were the head of it and you’ve, you’ve been so involved with the database and all the research that comes out of it and everything. We learn from it and we get a lot of questions about, well, how do you know? And we don’t really know. And when patients are wondering, what’s the percentage of this recurrence? What’s the percentage of that chronic pain? And the fact is we actually do know in certain countries, and then hopefully we’ll review this so quickly, just very briefly, what is your practice in Denmark? And maybe you can tell my audience what the medical care kind of is in Denmark. Denmark’s a socialist medicine. Is that correct?
Speaker 2 (00:02:31):
Yeah. You could call it a socialist medicine system. Nobody pays for going to the hospital or going to their general practitioner. You pay for medicine, the medicines that you need and you’re paid for your dental work. That’s it. Everything else goes through taxes. It’s the same. How higher
Speaker 1 (00:02:51):
Than those taxes?
Speaker 2 (00:02:52):
Oh, don’t talk about it. You’re going to make me cry
Speaker 1 (00:02:57):
More than, yeah. Oh wow. Okay.
Speaker 2 (00:03:01):
I currently pay 52% brutal.
Speaker 1 (00:03:05):
Okay.
Speaker 2 (00:03:06):
Yeah. But apart from that, that’s not what we’re going to talk about is that this, we are very small country and we are the most digitalized country in the world. So every person in Denmark has a unique personal identifier, social security number as you could call it. And then we have at least 70 different databases covering different areas. And we have a hernia database that turned 25 years this year. Wow.
Speaker 1 (00:03:38):
Congratulations. So
Speaker 2 (00:03:39):
We’re going to have a party in next summer, our yearly meeting. And so the system works like this based on diagnosis and treatments and complications. After the ICD coding, we put things into all these different databases and then we can follow people from birth to death. Very interesting. Cause they don’t go from Virginia to Alaska and things like that. Even if they go outside of the country and come back, they will still have the same identifier and we will be able to track them.
Speaker 1 (00:04:20):
So you’re born with an identifier and then most people in Denmark don’t leave Denmark?
Speaker 2 (00:04:28):
No. But then again though, I mean there is probably about 300,000, at least 300,000 Danes living abroad.
Speaker 1 (00:04:37):
And they’re not, so
Speaker 2 (00:04:39):
It’s not that many, but out of 6 million it’s a number.
Speaker 1 (00:04:43):
Yeah.
Speaker 2 (00:04:44):
Anyway, so we put in things into the database, and when we look at hernias, we started out with an inguinal hernia database back in 1998. And in 2007 we added on ventral hernias. So we haven’t been going on for that long with ventral hernias. And then again, when you look at databases and you compare it with the German herniate, German is a country with 80 million people that’s almost 14 times more than there is in Denmark. So the numbers will grow fast in Germany
Speaker 1 (00:05:24):
Because your country is only 6 million. Yeah, that’s like two Los Angeles counties. Two Los Angeleses. Oh my god.
Speaker 2 (00:05:31):
Exactly. Or Houston, greater Houston area. No. Yeah. So when you need to look at databases, and the science you can grab from that is this is not a randomized single small controlled study where everything is the same and where the internal issues are very few. And in database, the external issues are very, very large. So they gave a much more precise picture of what the world looks like.
Speaker 1 (00:06:07):
True. And
Speaker 2 (00:06:08):
So we don’t record recurrences, but we record reoperation for recurrence.
Speaker 1 (00:06:15):
So as a surgeon, you see a patient and you diagnose them. Do you physically put in the information or is there someone that does
Speaker 2 (00:06:24):
For you? I, I put it in myself physically. Currently we are working on a system where the databases will grab the data they need from the patient records, but that’s not in place yet. But that’s probably going to be machine learning or machine reading. But it’s in the beginning.
Speaker 1 (00:06:47):
And then let’s say you do the surgery. Let’s say you do a laparoscopic inguinal hernia repair. Yeah. Do you personally also record that surgery the day, what was up and so on? I
Speaker 2 (00:06:58):
Personally do that, all of it myself.
Speaker 1 (00:07:01):
And then how much detail are you giving like you yes or no, Mesh. And then do you know what kind of Mesh or
Speaker 2 (00:07:08):
We do, what kind of inguinal? Is it the type of inguinal, the size of the inguinal, what type of procedure you do, whether you do open with or without Mesh, whether you do laparoscopic, what type of you do TEP or TAPP? We do all these things. So everything about this of the surgery itself,
Speaker 1 (00:07:32):
Like a
Speaker 2 (00:07:32):
Dream. And we will register the type of Mesh that we use. But then again, looking at differences, if you take 10,000 operations for a hernia and they all get a Mesh and you have 40 different meshes in the market and people use them babababa, and then it’ll take forever to me to have numbers that will show differences in Mesh
Speaker 1 (00:08:01):
Outcomes between the me, the different meshes.
Speaker 2 (00:08:04):
Yeah, exactly. Got
Speaker 1 (00:08:05):
It.
Speaker 2 (00:08:05):
So for instance, we were the ones that showed that the Fisher Mesh was no good,
Speaker 1 (00:08:13):
Which
Speaker 2 (00:08:13):
Mesh Johnson & Johnson’s Fisher Mesh.
Speaker 1 (00:08:16):
Yes, yes.
Speaker 2 (00:08:17):
Correct. That was retracted based on data from the Danish database originally.
Speaker 1 (00:08:22):
Yeah. This is very important because I don’t think our audience, I don’t know that we’ve actually discussed this, we may have, so usually a Mesh is introduced after they’ve gone through phase one, two, and three, maybe studies, and then maybe a phase four study, which is after it’s market, they still follow the outcomes. And that may be hundreds to thousands of patients and they’re followed for maybe one or two years. Yeah, exactly. And in your database, you were able to show based on your own data a certain Mesh, which was brought up by ethicon, which we all thought was a great idea because it was thin and
Speaker 2 (00:09:05):
Fantastic Mesh.
Speaker 1 (00:09:07):
It was like a perfect Mesh. Right, exactly.
Speaker 2 (00:09:12):
Issues all of them altogether.
Speaker 1 (00:09:16):
So
Speaker 2 (00:09:17):
Through cleaning, easy to fix,
Speaker 1 (00:09:21):
Don’t stick to anything, and it’s super lightweight. You don’t have to worry about burden of Mesh and all that. It didn’t have the ring that some of the other meshes had problems with. And we started using it. We’re like, this is great, and the studies look like patients tolerate it very well. And then you showed laparoscopic, I think it was laparoscopic.
Speaker 2 (00:09:40):
Laparoscopic, yeah.
Speaker 1 (00:09:42):
Specifically where it was way too thin. You can be too thin of a Mesh. Right?
Speaker 2 (00:09:47):
Yeah. But it was also causing a lot of adhesions. When we look, had this discussion at the meeting in Copenhagen where you were last year, but the issue is that we don’t have this resources to do constant surveillance of how the Mesh works. You need AI to do that. And we don’t have that. So what we do is that we go down and we make a spot at a certain part of time, and then we’ll do it again. And when we look back into time, we could show that compared when you compared that IPOM meshes all the other IPOMs with Fisher Mesh, after 100 implantations, you could see that there was something wrong. But we dated for years to get the data and to get security for the data was found.
Speaker 1 (00:10:49):
Yeah.
Speaker 2 (00:10:51):
It had to be significant.
Speaker 1 (00:10:53):
And let me ask you this, Ethicon, remove the Mesh after your publication or
Speaker 2 (00:11:00):
After we gave them the data they removed in connection in meeting in 2016.
Speaker 1 (00:11:07):
Yes. Yeah, I remember
Speaker 2 (00:11:09):
That. Yeah.
Speaker 1 (00:11:11):
Yeah. Very unique because this was not a adverse event like the FDA. There’s adverse events that government didn’t get involved. This was purely, look at the data we’re showing it’s a national database, and within hundreds of patients you were able to show that it wasn’t performing the way that we thought it would perform.
Speaker 2 (00:11:29):
And then it was backed up by her in Germany by,
Speaker 1 (00:11:36):
So right now in Europe we have the Swedish, the Danish, and the German hernia registry. And then
Speaker 2 (00:11:43):
Actually the people, United Kingdom in Ireland, they just, they’re going to introduce a complete copy of the Danish, HER database From the beginning of next year? No, no. This year. Year. Sometime during this year, they will start a complete exact copy of the Danish, hernia database in both And the UK.
Speaker 1 (00:12:10):
Does the government pay for maintaining the database?
Speaker 2 (00:12:15):
Yeah, in Denmark it does, but in the UK they have to get resources somewhere.
Speaker 1 (00:12:20):
Yeah, that’s always
Speaker 2 (00:12:22):
Been, and that’s been one of the big issues. But they have the same ability with a unique identifying that they can follow people
Speaker 1 (00:12:29):
For life. This is for the life of the patient. So you’re aware the United States has recently and recent, I think it’s five, I will say six, five or six years started the ACHQC. So the American,
Speaker 2 (00:12:45):
We see data, we see a lot of data from that database. Abdominal
Speaker 1 (00:12:48):
Health. Yeah, the abdominal health, core health quality collateral, ACHQC.
Speaker 2 (00:12:53):
Yeah,
Speaker 1 (00:12:53):
Exactly. Are you familiar with the ACHQC compared to your database?
Speaker 2 (00:12:59):
Yeah.
Speaker 1 (00:13:00):
So one thing that I like about, it’s very granular. How many scissors did you put? How many tax did you put, which tag did you use? Which Mesh, what size? Mesh, where exactly you put the Mesh. There’s a lot of details technically in it that are very, very detailed.
Speaker 2 (00:13:19):
Yeah. I believe that perhaps the number of tacks are, the number of stitches are not that issue, that they’re not an issue. But I believe that charge of Mesh and charge of fixation is an issue.
Speaker 1 (00:13:36):
Yeah.
Speaker 2 (00:13:37):
We’re just going to publish a study we’ve done on emergent, I know on it’s only on TAPPs and Denmark comparing different meshes and different fixation devices. And it looks like that the best way to go is with the Mesh from Medtronic. That fixes itself what’s
Speaker 1 (00:14:01):
Called program.
Speaker 2 (00:14:05):
But we still need to do some data statistics to be quite sure.
Speaker 1 (00:14:11):
Yeah, it’s fascinating. The problem with us one, I belong to it, so I put all my data there. It’s very good. It’ll say tissue repair. What type of tissue repair did you do? Component separation, not a component separation, et cetera. The size of all the defects. But in the United States, I don’t know if it’s like that in Denmark, maybe the culture is different. The majority of people doing hernia repairs are not part of the database majority. We have I think under a thousand, maybe even under 500 surgeons that are using the database. So our volume is high, but law, yeah.
Speaker 2 (00:14:54):
But in Denmark, it’s a law that you have to do this, and our registration rate is above 90%.
Speaker 1 (00:15:02):
Oh, wow. Yeah. We don’t like laws in the United States. The freedom is freedom of practice,
Speaker 2 (00:15:09):
Freedom of speech. I can do whatever I want to.
Speaker 1 (00:15:16):
We can. The other question is, so the ACHQC is dependent on the patient constantly updating. If they have a recurrence, it doesn’t follow the patient necessarily because it’s not national. So they go to another surgeon, it won’t capture it. So this was, it’s dependent on the patient also putting in like, oh, I was just hospitalized. I had a fever, I have pain now. Or I had to have the repair redone.
Speaker 2 (00:15:47):
We don’t have patient data yet. We’re working on trying to get prom into a pre-operative PROM and post-operative PROM combined with the data we put in there. But that’s still in the working
Speaker 1 (00:16:00):
Patient Report Outcome Measures. Yeah, exactly. PROM. Yeah. Yeah. So that’s a problem too, because patients really want the data, but the reality is they don’t fill out these forms, they don’t fill out these emails. The response rates are very low.
Speaker 2 (00:16:16):
So we have, what we are working with is a red camp system that is bombing every two weeks until they,
Speaker 1 (00:16:24):
Yeah, you just start deleting it. The emails, it’s a problem.
Speaker 2 (00:16:31):
But we can only, the whole issue about PROM is that we’ve always said that doctors have always defined what’s a good result and what’s a bad result. But nobody ever asked patients.
Speaker 1 (00:16:44):
So I have something for you. I don’t know if you have Yelp or Google reviews or other kind of online review system of doctors in Denmark. Do you have that? No. So we have that, you know, can go to a restaurant and then you review the restaurant online, say that’s great food or the valley parking is too expensive. They have the same thing for any business, including all doctors. So doctors can be graded and you can say, oh, my doctor was so great. Or you can say their office was dirty or I didn’t like the front desk person. They put me on hold too much. They can say whatever they want. And patients actually find it valuable to go either on Google or on this app called Yelp. And there’s other ones like health grades, vitals.com, these are all different apps that are review apps. They review doctor experience.
Speaker 2 (00:17:36):
That’s not in Denmark,
Speaker 1 (00:17:39):
That doesn’t happen.
Speaker 2 (00:17:42):
Your system is primary based on the fact that the majority of you are in private practice. So you have a business to run.
Speaker 1 (00:17:52):
Yeah,
Speaker 2 (00:17:54):
I’m a hired gun. So when people complain, they rarely complain about the doctor. They’re complaining about the department or the treatment or something else. And we have a system who handle that and they will get remuneration if we think that’s relevant. And it’s not caused on [inaudible]. So you’re not supposed to be guilty of something. It’s only if something happened that generally would be unlikely to happen that they get a remuneration. So we don’t have this personalization of the issue.
Speaker 1 (00:18:30):
Yes,
Speaker 2 (00:18:31):
Of course you can get a complaint about you as a person, but that generally goes not on your skills, but as that they think that you’re an asshole.
Speaker 1 (00:18:41):
Yeah. Okay. Well, of there’s a new program called Outcome Empty that rates doctors based on their outcome, not based on if they have someone who answers the phones on time. So it’s fascinating because as a patient, I would want to go to get my hip replaced by the one who has a best outcome. The
Speaker 2 (00:19:10):
Hip, I don’t care if it’s like
Speaker 1 (00:19:12):
Or not,
Speaker 2 (00:19:13):
Where does the app get the outcomes from
Speaker 1 (00:19:16):
Patient reported
Speaker 2 (00:19:18):
And
Speaker 1 (00:19:18):
Can outcome
Speaker 2 (00:19:20):
And is that realistic?
Speaker 1 (00:19:25):
So for example, there are some validated questionnaires on quality of life and outcomes relate to certain operations and the patients fill out those specific questions. Yeah. Can you walk, do you have pain? Do you need to take pain pills? Are you able to clean yourself? Those kind of things that are validated for each operation. So like the California, the Carolina’s Comfort scale for hernias. Yeah. And then the doctors are rated based on how high they score on average for their patients who have these operations.
Speaker 2 (00:20:04):
But it’s a flaw that you don’t know which percentage of the patients actually do this on each doctor. True. So
Speaker 1 (00:20:15):
Yeah, you have one patient, they get hundred.
Speaker 2 (00:20:19):
Wow. I can give you a funny example of that. That’s true. You have this online and paper, surgical newspaper in the
Speaker 1 (00:20:30):
Surgery News
Speaker 2 (00:20:32):
And Denmark, we have something called Medicine DK. And every year they look at different issues and then they will tell the people that this small hospital that did 22 umbilical hernias last year is the best in Denmark. And one, yeah. That did 600 and had 99.7 instead of 99.8. We were next best. So these things are crazy. Yeah,
Speaker 1 (00:21:13):
True.
Speaker 2 (00:21:14):
The quality of this should be measured in a completely different manner.
Speaker 1 (00:21:20):
Well, okay, so very good. So your database also tracks who the surgeons are. Yeah. Have you been able to show
Speaker 2 (00:21:29):
Yeah, we can show differences.
Speaker 1 (00:21:30):
I know that you show Yeah, the differences,
Speaker 2 (00:21:32):
We show differences and then we look into departments specific operation types of operation. For instance, TAPP, Lichtenstein, whatever it is. And we will go through each department and see whether there are outliers. And if they’re outliers, we will talk to them in the database. Doctors.
Speaker 1 (00:21:57):
Very good.
Speaker 2 (00:21:58):
And we can do that with doctors as well.
Speaker 1 (00:22:02):
And do you consistently show that higher volume surgeons are better or Yeah. Is is it not necessarily volume?
Speaker 2 (00:22:11):
It is a combination of volume and experience.
Speaker 1 (00:22:15):
Okay. Yeah, because we have a lot of people that in the United States that live in areas where they don’t have access to experts. They live far away from the main town and so on, and they’re relying on their local surgeon. And I always tell them, especially now that you have telehealth, get a second opinion surgery, you should always get a second opinion, even small ones, because then you’re going to regret why didn’t I know this or that. But if you talk to an expert, they may give you a different analysis based on their experience. Exactly. Than someone who just has no interest in hernias, but just does a lot of hernias all day. Yeah. Right.
Speaker 2 (00:22:57):
So again, 10,000, 11,000, 12,000 inguinal hernia or groin hernia surgeries in Denmark a year in a few private practitioners and private hospitals and in 22 surgical departments. And we do a thousand in my department. So we do about 15, 1600 hernia surgeries a year.
Speaker 1 (00:23:30):
In your department? Yeah. Yeah. There’s a live question they’re asking about watchful waiting. So does your database capture watchful waiting?
Speaker 2 (00:23:41):
No, but it’s going to do that. But we’re now going from one database system to another one. And context for that, we are going to add on with a number of issues that we need to explore.
Speaker 1 (00:23:58):
But the diagnosis of hernia will be captured at some point. You can track what happens between diagnosis and surgery.
Speaker 2 (00:24:07):
Would you? Could do you do that? Yeah, but the problem with that is that what happens with the general practitioner does not go into the ICD coding system. So they need to be submitted to a hospital for evaluation for you to get the hernia diagnosis.
Speaker 1 (00:24:30):
Oh, okay.
Speaker 2 (00:24:32):
So we are working on that as well.
Speaker 1 (00:24:34):
Interesting.
Speaker 2 (00:24:34):
Because that would give us a a lot of new in information about, for instance, postoperative pain and how often it’s it exists and how long it existence, what type, how it is, stuff like that. Right. Because when we look, for instance at chronic pain after inguinal hernia surgery where the laparoscopic go open, we tell them 10%. But the real numbers probably for severe problems about somewhere between two and five, depending on the time after the time lab after surgery. But if we look at 10% within the first year and we do a thousand of them, that’s right. There should be a hundred patients sitting in my outpatient clinic complaining of pain the year after and then they reduce over time. So I would probably have to have two consultants to look at those that people will pain and we don’t pain problems that much.
Speaker 1 (00:25:38):
I’d like.
Speaker 2 (00:25:39):
And relating to that, the whole issue about Mesh and Mesh complications and Mesh being the mother of Satan.
Speaker 1 (00:25:51):
Yeah.
Speaker 2 (00:25:51):
It doesn’t exist in Delmark because we’ve been registering, we’ve been registering Mesh in hernias for 25 years.
Speaker 1 (00:26:00):
So this is very good information because there’s, they’re always asking me, how do you know? And so on, your database has been capturing 25 years prospectively of Mesh database since the inguinal hernias, right? Yeah, 1998. And what’s the penetration of Mesh use for Inguinal and ventral in your country?
Speaker 2 (00:26:22):
For in Lichtenstein, I mean people, almost all, everybody gets the Mesh.
Speaker 1 (00:26:29):
Okay.
Speaker 2 (00:26:30):
One kind of Mesh
Speaker 1 (00:26:31):
Size. Bassini are not very common.
Speaker 2 (00:26:33):
There are very few Bassini or shouldices, but that’s it. And we don’t do TEP, so we enact, in reality, we have central standardized groin hernia, inguinals into TAPP or Lichtenstein.
Speaker 1 (00:26:54):
So open Lichtenstein with Mesh. Yeah, laparoscopic TAPP with Mesh. Okay. That’s fine. And then for inguinal, now I’m going to just stick with inguinal. What does your database show? You said 10%, any pain within a year?
Speaker 2 (00:27:10):
Well, the data, this is one year data is about 10%. And when we look at it and we look at the pain problems in a group of patients from the database, not all of them, but we pull out a portion of the patients and look at them afterwards, it, it’s obvious that Lichtenstein have more pain in the beginning and taps have less, but at about four and a half, five years they’re the same. And that’s about three 4%,
Speaker 1 (00:27:50):
Three or 4% chronic pain, nine years out,
Speaker 2 (00:27:55):
Five years out. But this is a study where you ask people whether they have problems, any kind of problem. So the severe problems would be much less out of the three or 4%.
Speaker 1 (00:28:07):
That’s really important information because most of the data, what we look at for pain, it’s any pain. And it’s not regular to say, I specifically have testicular pain that’s preventing me from having sex or I can’t sit down. That kind of pain is not 10 or 12% or 20% or large. Exactly.
Speaker 2 (00:28:29):
Exactly. And that this is all any kind of pain including testicular problems for men. But this is the whole group. So the numbers are much smaller than they seem to be in the literature. These data have been published from the database.
Speaker 1 (00:28:51):
Yes. Yes. So it’s fair to say some type of pain likely relate to the hernia repair. We’re assuming we don’t even know that at one year, 10% at four to five years, three to 5%, yeah. Okay. And then open surgery is just as good four or five years out than laparoscopic.
Speaker 2 (00:29:17):
They have the same recurrence rate? No, no. I can’t say the same recurrence rate, but probably the same recurrence rate because we don’t register recurrences. We only register re-operations for and that those are 4%, whether you do tap or leprosy.
Speaker 1 (00:29:35):
Got it. Got it.
Speaker 2 (00:29:36):
And we have looked into a cohort of patients and looked at ’em over time. And when we look at them, then the real recurrence rate should probably in inguinal is about three times higher. So it’s 12%
Speaker 1 (00:29:49):
For open versus
Speaker 2 (00:29:51):
For both
Speaker 1 (00:29:54):
Say that
Speaker 2 (00:29:57):
It’s about 12% for both open and inguinal
Speaker 1 (00:30:02):
Lifetime recurrence. The
Speaker 2 (00:30:03):
Real recurrence rate. Now, within the observation period, the cuing has just published a paper last year or the year before that where they looked at how long should we look at, look for recurrences? Yes. In the groin. And he says 50 years. And in ventral they say 10, 12 years.
Speaker 1 (00:30:28):
See we had this discussion couple, couple weeks ago for breast implants. They say every 10, 15 years you should remove, change them. They last 10 years. For hip replacement or knee replacement, shoulder replacement, it only lasts 15 years. You have to come back for replacement. But for Mesh, we say lifetime, you should be fine for your lifetime. And there’s no life to it. So this whole 50 years situation, what do you think is the right thing we should say about how long a hernia repair should last?
Speaker 2 (00:31:03):
I really don’t know because this is really something that is, I think believed is based on what type of Mesh is. We have seen that some of the meshes, that they get brittle over time and suddenly brittle and suddenly people have recurrences at a later point. Even then though they had a Mesh and for instance, the Johnson and Johnson, the one with the blue lines on it, I can’t remember that.
Speaker 1 (00:31:35):
Ultrapro
Speaker 2 (00:31:36):
Also. Yeah. Yeah. That is too light. And you very light the news data that’s coming out in the new guidelines on the inguinal and Mesh, they’re going back to heavier weight meshes.
Speaker 1 (00:31:51):
Yes.
Speaker 2 (00:31:52):
But still large pull
Speaker 1 (00:31:56):
Because
Speaker 2 (00:31:56):
It requires are too high, but to avoid encapsulation and then shrinkage and due to that, so I’ve done a lot of Mesh studies, but on IPOM in sheep, yes. And I can say that there has been a tendency among surgeons to think that a Mesh is a Mesh is a Mesh. Right. And the fixation device is a fixation device and it doesn’t matter. But we have shown in several sheep studies with the different meshes and different fixation devices that meshes react differently when you put ’em into a sheep.
Speaker 1 (00:32:42):
Yes.
Speaker 2 (00:32:43):
And if you put in a protag or put in some other thing, they will react differently. So a Mesh and tacker is a combination that you need to expand on and investigate. Otherwise you will make serious mistakes. So you can’t just say, this is a Mesh, I have this tacker. This is going to be fine. You can see for instance, ax comp, the Medtronic Mesh for IPOM that now became simpletex because they made,
Speaker 1 (00:33:20):
Yeah,
Speaker 2 (00:33:21):
They made the basic of the Mesh monofil and not rated
Speaker 1 (00:33:27):
Lightweight. Yeah.
Speaker 2 (00:33:28):
Yeah. That shrinks 50% area wise within a year.
Speaker 1 (00:33:37):
Wow.
Speaker 2 (00:33:38):
So if you put in a 10 Mesh in a sheep, it’s going to be seven a year later.
Speaker 1 (00:33:46):
Wow. So do you think the resin makes a difference, like polypropylene versus polyester?
Speaker 2 (00:33:55):
Yeah, I think there’s a difference. And especially when polyester was braided before, when you looked at all the Medtronic meshes for polyester. Yes, yes. They were braided. Now they’re monofilic. And that’s made a huge change for the outcomes of patients with polyester.
Speaker 1 (00:34:13):
So braided versus
Speaker 2 (00:34:15):
Yeah, Braids increased risk of infection.
Speaker 1 (00:34:20):
And Bruce Ramshaw’s original studies showed that it the way each patient reacts differently to the same Mesh as well.
Speaker 2 (00:34:28):
Exactly.
Speaker 1 (00:34:29):
That’s a problem we haven’t been able to overcome.
Speaker 2 (00:34:33):
Then we need to go into tissue types. I mean, that’s not positive, but I think that in Europe that now there’s a new rule of the law concerning implants that they said no implant can be used. It was supposed to be implemented a couple years ago, but all the old meshes are probably going to be chucked out. And they will only work with a few meshes in the future. And then the
Speaker 1 (00:35:12):
Human trials,
Speaker 2 (00:35:14):
And then they will ask for human, if you want a new mess to be implemented used in patients, you will do a trial before you let it go. And they will have to do that too, with people that have a database. Cause otherwise nobody can knows what’s going to happen.
Speaker 1 (00:35:31):
Yeah. It’s a problem because who’s going to pay for the database outside of established ones like yours? Exactly. That was the issue. I remember we discussed this in, I think it was in Hamburg in 2019, exactly. What are we going to do? Who’s going to pay for it? How are we going to follow through? This is the lifetime of the patient. Is industry going to pay for, or a country supposed to pay for it? Does the patient pay for it is mandated. I
Speaker 2 (00:35:53):
Believe that, that the company should pay for it because they have no, and with the current issues about DVR and patient identities and security and stuff like that, the company can’t handle that issue with getting the data and looking at them on a regular basis. So it has to be in a public sense. But since they’re selling this, and I mean if you look at these IPOM meshes very expensive. There’s a little coating on a piece of Mesh, and then suddenly it’s 20 times more expensive than the time with the same Mesh without coding. Yes. I mean, they make a lot of money out this.
Speaker 1 (00:36:37):
They do.
Speaker 2 (00:36:38):
So they should at least be part of the financing.
Speaker 1 (00:36:43):
A lot of companies are pulling out of Europe because it’s not financially feasible for them to go through the human clinical trials to market to Europe.
Speaker 2 (00:36:51):
Yeah. And so what we like about that is that now if Fred Katra, when he was doing his dissertation, he said, ventral hernias a complex issue because we have these 10 or 20 different types of ventral hernias. Then we have these 20 different ways of doing it. And then we have about a hundred types of Mesh true on o Mesh. And then when you start combining it, there’s thousands and thousands of variations and how you ever going to figure out that. But one of the ways of getting rid of that issue is to getting rid of all those meshes
Speaker 1 (00:37:35):
And streamline.
Speaker 2 (00:37:37):
Yeah, exactly.
Speaker 1 (00:37:37):
Now that we know more,
Speaker 2 (00:37:39):
That’s what we are doing right now in Denmark, we have a tender on meshes, and you’re not supposed to use anything but that. That’s when that wins the tender.
Speaker 1 (00:37:53):
You’re not supposed to use how many
Speaker 2 (00:37:55):
You have a tender until you look at the hand price and quality.
Speaker 1 (00:38:05):
You can’t introduce whatever you want.
Speaker 2 (00:38:07):
And then we look at, these are combined in a mathematical model, and then one Mesh will win, and then you generally have two or three meshes. So we have reduced the number of meshes that you can use to a minimum compared to what it was earlier.
Speaker 1 (00:38:24):
Yeah, true. There’s a question about watchful waiting. So what are your thoughts about watchful waiting?
Speaker 2 (00:38:31):
Well,
Speaker 1 (00:38:31):
Specifically showing at five to 10 years, about two-thirds of the pages end up needing surgery anyway.
Speaker 2 (00:38:39):
Yeah. I it’s, you know, what we really know about what we’re waiting is based on, what is the American guy, Patrick Fit Gilet study and the English study, and they both have 10 year follow ups. Yes. And on those, you see that about 60 70% of them end up having surgery anyway.
Speaker 1 (00:39:03):
Correct.
Speaker 2 (00:39:04):
And then actually I think the British one showed that if you were over 65 and had surgery, you had an increased in late surgery, you had an increased risk of dying from it. And the whole issue about what we’re waiting is the doctors are scared of giving people’s pain longer than they need to. So if they don’t have, we have a standard that says no or very few symptoms, you can go from watchful waiting in the groin.
Speaker 1 (00:39:37):
Correct.
Speaker 2 (00:39:37):
We never do that in women, but we do it in men.
Speaker 1 (00:39:44):
So for males of whatever age, no symptoms or minimally symptomatic, watchful waiting is provided, but not for women. We have no data for women.
Speaker 2 (00:39:54):
No. But we know that women are much more prone to have female hernias. And we just looked at hernia surgery, about 30,000 patients in the whole group of 30,000 patients. And out there were 2,700 emergent surgeries over a seven year period in Denmark. And one fourth of them are fems.
Speaker 1 (00:40:19):
Wow. Yeah.
Speaker 2 (00:40:22):
And who are the patients with the femoral hernias?
Speaker 1 (00:40:26):
Yeah, women have the femoral hernias.
Speaker 2 (00:40:29):
So going back to the women have three, four to 6% inguinal compared to many. Much
Speaker 1 (00:40:38):
Lower
Speaker 2 (00:40:40):
Than they actually are. Much larger part of emergent inguinal.
Speaker 1 (00:40:44):
Yeah. Yeah.
Speaker 2 (00:40:46):
So our attitude here is that we do taps on women and we do hydroscopic and we do it laparoscopically, and we do it actually in fast track. So if a woman is submitted with a hernia and inguinals in the groin, we’ll generally see them within two weeks and we will try to operate them within a month after. So
Speaker 1 (00:41:11):
To reduce the risk of emergency surgery in women because that’s a problem. Yeah. Well that’s really good. And question about your, there’s anesthesia question here. The people who get open surgery, do you use general anesthesia or iv?
Speaker 2 (00:41:27):
We do. I and I start to begin to think that we are the only ones that are still doing it, but he keen showed in a studies back in 95 or something like that that you executive 500 patients, all ages above 18 could be performed in local anesthesia, high ligation problem. Yeah, it’s great. But looking at what really happens is that everybody did it for a while. And now there’s a trend that more and more people have primary taps, laparoscopic.
Speaker 1 (00:42:10):
Laparoscopic, which is generally anesthesia
Speaker 2 (00:42:14):
In general anesthesia. And so fewer and fewer have an open hernia surgery primarily. And then the problem here is that the fewer the primary hernia that you get, then it’s going to be a specialist operation to do an open inguinal, which is originally a basic open surgery training operation.
Speaker 1 (00:42:42):
Yeah, I see that.
Speaker 2 (00:42:43):
So there is a political issue here is what’s going on and what’s not going on. But I can see interesting that over the years, within, at least in the last 10 or 15 years, the number of patients operated in local anesthesia, Denmark is gradually going down.
Speaker 1 (00:43:02):
Interesting. And that’s very interesting because we’re having a big debate here about robotic surgery in the United States.
Speaker 2 (00:43:10):
But robotics and inguinal, they’re good for training and they’re good for, if you have a very complex case, if you have had a prior surgery prostate, yeah. Better stuff like that. And there might not be any peritoneum down there, then it’s probably is a very good option. But it’s a standard operation for ins. I think that’s shooting birds with cannons.
Speaker 1 (00:43:39):
Right. I agree with that. See, however, in my hospital was only me and two other surgeons that were doing laparoscopic Anglo hernias. However, with the robot now there’s like 15 people doing mis inguinal hernias. Now I don’t know how good they are because I don’t go in their room to look because I think they’ll get nervous if I walk into their room while they’re operating. But the good news is the robot is encouraging more minimally invasive surgery, but it’s got to the point where not just for inguinal, but for gallbladder surgery and appendix surgery, these are considered low level simple operations. The residents are not really learning how to do open anymore. So when I do open surgery, I do open tissue repair, I have to teach it to them. They’ve never seen it before. Open gallbladders, open appendicitis, they don’t even see it anymore. And it’s almost like you said, the older open surgeries are now being done by experts. And the more kind of technologically advanced operations, everyone’s kind of learned how to do it because technology has made it so much easier to do.
Speaker 2 (00:45:00):
And we are very cost. We worry about cost. And if we look at what we use, how much money we spend on healthcare in Denmark, and by the way, everybody has healthcare. So we use about 7% of p and p.
Speaker 1 (00:45:23):
Oh
Speaker 2 (00:45:24):
Healthcare in Denmark for the whole population, all types of treatment in and out of hospital. So general practitioners in there as well. And then you look at the cost in the US where one third of patients, people don’t have healthcare.
Speaker 1 (00:45:43):
Yeah.
Speaker 2 (00:45:44):
Yeah. That’s 20%. 20% plus.
Speaker 1 (00:45:49):
Yeah. Much higher.
Speaker 2 (00:45:51):
So, and you have all these companies working together, the HMOs and stuff like that, that decide what you can do and what’s costs. And I mean, they’re there for making money. They don’t give a hoot about the patients or you guys.
Speaker 1 (00:46:07):
It’s horrible. Yeah.
Speaker 2 (00:46:08):
So yeah, this is private enterprise.
Speaker 1 (00:46:14):
This
Speaker 2 (00:46:14):
Is true, but it’s only good for the people that are making the money.
Speaker 1 (00:46:17):
Do you have private practitioners in Denmark?
Speaker 2 (00:46:19):
Yeah, we have typically single surgeons working with endoscopies and small surgical operations and stuff like that. And then we have private hospitals that have been growing quite rapidly the last couple of years due to corona issues with nurses and stuff like that. Staffing. It’s a huge problem. Right. Now
Speaker 1 (00:46:45):
There’s another question here about hernia size. If you’re doing watchful wedding, do you recommend regular ultrasounds to watch the growth of the hernia? No. Yeah. No. By symptoms, not by size.
Speaker 2 (00:47:01):
What we say to people is that if they have a small hernia and they have no symptoms or very few symptoms, so we tell them if you suddenly start having symptoms or if it starts growing fast, but both happens then come back. Yeah. Why would you want to do, start doing a lot of sonography on a regular basis to follow the size of the her? That’s crazy.
Speaker 1 (00:47:26):
Doesn’t do anything.
Speaker 2 (00:47:27):
It’s a,
Speaker 1 (00:47:29):
Yeah, it’s the I agree. So going back to your database and the chronic pain or the pain follow follow up, here’s a comment that says under reporting of pain is a fact too many patients are told to be put up with discomfort and that the Mesh is not removable. What are your thoughts on that?
Speaker 2 (00:47:49):
It’s true, but as I said before, if we should follow the data with one 10% in one year and they’re going back to 4% in five years, and then us doing a thousand at grown harness a year, we should have hundreds of people coming complaining about pain. And we don’t,
Speaker 2 (00:48:09):
At any given time, we have perhaps have 10, 15 patients that’s in a process of getting, we are mapping them, trying to give them steroids, trying to give them local anesthesia, they get painkillers. And if not, none of that works. We have centralized the more advanced examinations and operations for this in Copenhagen. So early on, everybody would take out their own Mesh. And that worked resulted in not the patients, but the doctors that operated them. And that resulted in horrible results. So now we centralized that and they tell us that, for instance, what David Chen does doing the laparoscopic nerves translation is that is, it’s a horrible thing because they get really, really lateral buldging.
Speaker 1 (00:49:06):
Yeah.
Speaker 2 (00:49:07):
So if you have to do something, it has to be locally in the groin.
Speaker 1 (00:49:12):
Yes, that’s correct.
Speaker 2 (00:49:14):
Yeah. Otherwise it’s wrong. And they take out Mesh as well. But we don’t only take Mesh out if it’s infected
Speaker 1 (00:49:26):
And what could Yes, infected
Speaker 2 (00:49:29):
Recurrent infections and fistulas. And once in awhile we see a tap patient with an abscess long after they had surgery, but otherwise, so this issue
Speaker 1 (00:49:44):
Uncommon for the,
Speaker 2 (00:49:46):
I agree that it’s underdiagnosed and undertreated, but there is a gray song here that we know nothing about. And that’s one of the issues that we are trying to put into the database by getting prompt, by getting prompts postoperative,
Speaker 1 (00:50:05):
The patient report outcomes. Postoperative. Yeah, exactly. And do you any special testing to weed out who will do best from a Mesh based repair than others? Like inflammatory
Speaker 2 (00:50:22):
Blood tests? No, no, no, no. I’m follow some of your publications and meetings online about this issue. And we don’t have the facilities to do this. It’s very expensive to do these testings.
Speaker 1 (00:50:40):
Most US are not available anyway,
Speaker 2 (00:50:44):
But we are discussing whether we should try to implement that. But if we need to do testing and we from patients that have pain can see that there are certain tissue types that are prone to get pain or certain reaction from the polypro, for instance, then perhaps you could start testing people beforehand. But it’s so rare. And to find the one that gets a lousy result, you need to test everybody.
Speaker 1 (00:51:17):
Correct. So
Speaker 2 (00:51:19):
Enormous costs to the whole process of handling grow areas.
Speaker 1 (00:51:24):
Does your database, can it capture people that are adversely reacting to the Mesh? Not like a mechanically, but like systemically. No, no, it doesn’t. Yeah,
Speaker 2 (00:51:35):
We don’t have that option. And I still think, I mean, taking into consideration that we’ve been registering 25 years, 10,000 patients a year, 250,000 patients, and we don’t have that. We don’t even have a patient group that are complaining about Mesh something that exists in the UK, in the us
Speaker 1 (00:52:08):
Yeah, US, UK, Australia. Yeah, exactly.
Speaker 2 (00:52:11):
But in Denmark, it’s not saying it doesn’t exist. And I’m very open to the idea that some people will be more prone to get reactions to it, but I do believe that trying to figure this out is going to be very lengthy and extremely costly.
Speaker 1 (00:52:32):
Yeah, I agree. I agree. One day we’ll have the funding to be able to maybe do something because we don’t know enough. We don’t. I can’t.
Speaker 2 (00:52:41):
And then again, if you have something, you have something that induces an inflammatory response or a allergic response to something, and then if you take it out, you would expect that to stop.
Speaker 1 (00:52:55):
Yes.
Speaker 2 (00:52:56):
So I don’t know, it’s so little knowledge about this. No, we don’t know it sufficiently to make, yeah.
Speaker 1 (00:53:05):
We’re having some questions here from one of our advocates who’s very involved in this research. And so she’s wondering, maybe we should just look at least maybe a subset of patients. So all the patients with known autoimmune disorder, let’s say, and at least look into them, problem is those tests are all research based. HLA is not research based. You can order those, but it’s very expensive. United States doesn’t pay for,
Speaker 2 (00:53:30):
But there you could say that if you have patients with autoimmune, autoimmune diseases, for instance, yeah. No matter what kind you could say Crohn’s, whatever, then we could combine the databases. And on the social security number, we can identify whether the people there and whether Crohn’s are more common in pain problems. And then you’d have to talk to them afterwards. So there is an issue to look at that. And interest actually gave me a good idea that we’re going to discuss this in the steering committee of the basin.
Speaker 1 (00:54:13):
Yes. Let me know. I’m very interested in this because we published our data just recently. It’s so difficult to get it published because it’s too new. And everyone’s uncomfortable with the idea that there may be one, like a Mesh implant,
Speaker 2 (00:54:33):
Danish database studies that would combine the diff database for different autoimmune diseases and look at whether they also, they exist in the hernia database. And then you could look at them compared to two other hernia patients, whether they have more issues with the Mesh or pain or whatever.
Speaker 1 (00:54:52):
So we showed that we had two sets of patients. We had all the patients where we removed Mesh because they were reacting to it, and everyone got removed. Mesh for other reasons, hernia recurrence, meshoma, Mesh. I think we took Mesh infarction out. So basically like a systemic response versus an actual mechanical or surgical issue. And what we found was in the arm where it was due to me, Mesh reaction, 80% of them had autoimmune disorder, weird allergies to things like food and clothing and environment and all that. However, in the arm where they had no reaction to the match, they just need it removed for another reason. There are plenty of people with autoimmune disorders, so we can’t say autoimmune equals, we just know potentially it’s higher risk. And I don’t even know what that risk is. Is it 2% more? Is it 20% more? Is it 200% more? We don’t know.
Speaker 2 (00:55:56):
No. But we have databases that could probably answer part of that question.
Speaker 1 (00:56:07):
So here’s a question which I think is a nice way to wrap it, wrap up, which the patients are online a lot reading about Mesh problems. And it almost seems like everyone has a Mesh problem if you go online. But the data, your national database data. So can you answer this question, which is posed, which is after all these facts and studies about Mesh and its complications, why do you do this kind of repair?
Speaker 2 (00:56:36):
Well, two reasons. First of all, we’ve shown that they have less recurrences.
Speaker 1 (00:56:43):
Yes.
Speaker 2 (00:56:44):
Significantly fewer recurrences.
Speaker 1 (00:56:46):
Significantly.
Speaker 2 (00:56:49):
And the other is that even though that we look at this issue, people don’t have Mesh removed in that order than they do in the UK and in the us. And we don’t. You actually, we rare have
Speaker 1 (00:57:03):
Many patients.
Speaker 2 (00:57:04):
We don’t have these issues. We have people with chronic pain, but we don’t have these. Sometimes when you see these things, the UK Mesh, anti Mesh group, they’re almost hysterical in their way of putting things and calling doctors Hitler and Stalin and yes, whatever, manually they should all be shot and stuff. And it’s completely crazy. And people, if you ask people in Denmark, do you want to Mesh? They say, yeah, I’ll have a Mesh. And then there are very few that don’t want to Mesh. And obviously right now we have a discussion about whether young guys, I mean even older than 18, should we touch two marcy with them, even with them and two, nothing, no Mesh, and see what happens. Because there is issues about that the young guys that they are more prone to get pain and they have a longer time of living with it.
Speaker 1 (00:58:10):
Yes, correct.
Speaker 2 (00:58:11):
Mesh is causing it. So we are discussing issues about this as well, whether we should do a study and try to compare kids, young men, and then tap for one and then massif for another and see, look at ’em for after a few years and see what happens.
Speaker 1 (00:58:34):
Tissue repair versus laparoscopic. And what do you predict is going to happen?
Speaker 2 (00:58:39):
I think that will probably have this as if you look into the pain problem after open surgery, I don’t believe that the pain in lichtenenstein is caused by the Mesh. I think it’s caused by home surgery.
Speaker 1 (00:59:01):
I think the surgeons are at risk for a lot of these problems.
Speaker 2 (00:59:05):
And so if that’s true, whether there’s a Mesh or not, then it’s got not going to change the, but there are studies out there indicating that might be an issue and that their risk of getting a recurrence is not higher. But that completely against our knowledge about Mesh versus non Mesh in English. Yeah.
Speaker 1 (00:59:29):
I mean, your data shows at one year, 10% has some type of pain and the majority of that is not, almost all of that is not a Mesh reaction issue. And at four, at five years,
Speaker 2 (00:59:43):
Three or four, around 4%, around
Speaker 1 (00:59:46):
4% of chronic pain. And even those are not reacting to the Mesh like a stitch or too tight or a up measure.
Speaker 2 (00:59:57):
And those. And
Speaker 1 (00:59:58):
What do you say to
Speaker 2 (01:00:00):
You have severe reaction? They will be submitted to they centralized unit that we’ll look at them and see what they can do.
Speaker 1 (01:00:08):
And what do you say to the studies that show a tissue repair is just as good as a Mesh based repair in terms of recurrence? Like the Shouldice studies?
Speaker 2 (01:00:15):
Yeah. Well, I believe that if you do something like Shouldice 5,000 times five guys, then you’re going to be pretty good at it.
Speaker 1 (01:00:25):
I think it’s surgeon based,
Speaker 2 (01:00:27):
So there’s no doubt about it that Shouldice, if you wouldn’t want a tissue repair, it would be Shouldice and not Bassini, even though the Italians wouldn’t agree. But still, I used to do Shouldice way back, and I’ve been doing Shouldice once in a little while, but there are so few asking for it now. And they typically go into the private practices.
Speaker 1 (01:00:54):
Well, I’ll tell you, I feel that a lot of it is, I was taking out a lot of Mesh from open surgeries and I’m like, I wish more people would do laparoscopic. But now that more people are doing laparoscopic, now I’m taking all these laparoscopic meshes, they’re folded, they’re a bunch, there’s recurrences. So my personal experience seems most of the reasons we see complications from Mesh is surgeon based. They use the wrong size Mesh, they’ll put it in the wrong area, they use the wrong type of technique, et cetera. And with time, I’ve noticed women tend to have more problems that’s been shown in your studies than others with chronic pain. So I’m less likely to use Mesh in a female, especially in the groin based on my own experience, people with known autoimmune tendencies or disorders or family history or allergy symptoms, I tend not to use Mesh in them because maybe I’m helping them out. And they all understand that the tissue-based repair from a recurrence standpoint and even a chronic pain standpoint in many cases is inferior to the mass repair. But for them, it may not be okay for them to have a 7% recurrence rate, but have a less likely chance of getting sick from the Mesh.
Speaker 2 (01:02:13):
And then again, in some with Shirin, if you have a long reasonable with your patient and they’re fully informed and they make their own choice based on your information, and then that’s it. And then you can wait and see what happens. And sometimes, often enough, many times you’ll be right, but other times you’ll be wrong and they’ll come back and have complaints and that’s it. So I think that the whole issue here is information.
Speaker 1 (01:02:46):
Yeah. And tailoring to the needs
Speaker 2 (01:02:49):
And Yeah, exactly. Needs of course, you don’t put in a huge mission in a small person that don’t need it.
Speaker 1 (01:02:56):
Right.
Speaker 2 (01:02:57):
And the tacks, I mean, we don’t do tacks anymore. And as I told you, it looks like the program might be the answer.
Speaker 1 (01:03:07):
Yeah, it’s a good Mesh. Yeah, I agree. Okay. That was a very intense discussion. We went overtime, hon. Okay,
Speaker 2 (01:03:17):
Thank you for
Speaker 1 (01:03:18):
Now. Well, thank you so much. Thank you so much for your time. Well,
Speaker 2 (01:03:21):
I’ll see you in Barcelona and May
Speaker 1 (01:03:23):
I hope to see you there. Yes. Okay. European Hernia Society, Barcelona 2023. So thank you everyone. Thanks for joining us live on Her Talk. We’ll see you next week. We have more fun guests. Okay. Make sure you follow me on YouTube, Facebook, and Instagram and Twitter. This will be on our site within a day. See you later. Thanks everyone. Thank you again.
Speaker 2 (01:03:45):
Bye. Bye.
