Episode 19: Hernia Repair & the FDA | Hernia Talk Q&A

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Speaker 1 (00:00:00):

So welcome everybody. This is Hernia Talk Live. We are here every Tuesday as our hernia talk Tuesdays to an answer all your pressing questions on hernia stuff today. As you know, my name is Dr. Shirin Towfigh. I work in Beverly Hills at the Beverly Hills Hernia Center. You could follow me on social media, Twitter, and Instagram at hernia doc. Once we are done with our program which is currently SimulCast as a Facebook Live, then you can also watch it on my YouTube channel. And we have a very interesting guest today. Our guest is Dr. David Earle. I’ve known Dr. Earle since I first started in the whole kind of hernia world. He is currently the owner and a practitioner surgeon, hernia specialist at the New England Hernia Center in Massachusetts. You can follow him on Twitter at David Earle 13 and without much more introduction. Welcome Dr. Earle.

Speaker 2 (00:01:07):

Thank you very much Dr. Towfigh. How are you? Pleasure to see you.

Speaker 1 (00:01:11):

Thank you. So you’re in Massachusetts with your beautiful garden background right now?

Speaker 2 (00:01:17):

Yes, I, it’s the end of the day for us. So I fixed some hernias today, saw some patients in the office and now I’m home.

Speaker 1 (00:01:25):

That’s pretty awesome. So you and I have been friends for a while. For those of you that know Dr. Earle, that he is not only a great surgeon but he’s been a leader in hernia surgery at many of our societies. He’s been behind a lot of the consensus statements and books and other projects that have been going on in Sage, which is our laparoscopic our biggest laparoscopic society. And he’s also very fun. I think we always is fun. I feel like you’re not only accomplished, but you’re also very kind of fun. And that’s something unique that I think a lot of surgeons unfortunately are a little bit bland.

Speaker 2 (00:02:09):

And I’m funny you could ask my wife

Speaker 1 (00:02:12):

<laugh>. Very funny. So you have children, right? How many children do you have?

Speaker 2 (00:02:17):

Three teenage girls.

Speaker 1 (00:02:19):

Oh, they’re all girls.

Speaker 2 (00:02:21):

Oh yeah, all teenagers

Speaker 1 (00:02:23):

And all teenagers. Excellent. Are they going back to school during all this COVID stuff?

Speaker 2 (00:02:28):

We’re going to go back to a hybrid model. It’s four days in school, like partial days though. And then one day on Zoom like this.

Speaker 1 (00:02:39):

Okay. I mean yeah, whatever is your, you’re telling like okay,

Speaker 2 (00:02:44):

Our town’s okay. I mean we had a big, at the hospital that I operate at, we had a big influx a surge if you will. We’ve been only hovering around three or four cases now for the last few weeks and it seems to be like it’s going to stay that way for quite a while.

Speaker 1 (00:03:03):

Yeah, we’re still in a, we’re, I think we’re heading down but we’re still at a high rate. So everyone’s really antsy. L A A U S D L A. Yeah.

Speaker 2 (00:03:12):

We’ve got to go through your peak I think.

Speaker 1 (00:03:14):

Yeah, yeah. So we’re being very careful. Well you have a very interesting history in that not only do you have an interest in hernias as a surgeon and mostly do hernia surgery, which involves everything. Laparoscopic, open, robotic Mesh, non Mesh, and then all the different complications that you deal with, including Mesh removal. But you also worked for the FDA for a short while.

Speaker 2 (00:03:43):

Yes, I did

Speaker 1 (00:03:44):

As a medical officer. So I would love to be able to spend almost this a whole hour focusing on that. I know people will have questions about it, about hernias but it’s so uncommon to see a hernia surgeon who also has had a role with the FDA. I want to be able to use all this time to get all the little details from you. So what is it like and how did you even get involved?

Speaker 2 (00:04:11):

Yeah, well I have a general philosophy in my life of trying to amplify my existence, which is <laugh>, you know can do a variety of ways obviously. But everybody, when I was going to medical school, they said, oh, you want to help people? Everybody helps people. And I agree with that. Every job is out there helping someone, whether you’re sweeping the street or cleaning the room, I can’t do and you can’t do an operation if the stuff isn’t there and it’s not so true. It’s more than just being a doctor. So as you’re aware, you’re involved in a lot of things as well developing new techniques, new devices. And over the years with the surgical societies, as you mentioned, I was involved in creating clinical practice guidelines. So if I can create a guideline, I can help lots of surgeons to help lots of patient, each individual surgeon is going to help lots of other patients more than I can touch myself. And as I was moving from an employed job to found the New England Hernia Center and going to private practice, essentially I had some downtime that, I mean as general surgeon, most surgeons downtime doesn’t exist really

Speaker 1 (00:05:25):

<laugh>. So

Speaker 2 (00:05:27):

I met with the director of the surgical devices division at the FDA at a SAGE’S meeting. Oh. And DR to FIG had mentioned, that’s the big laparoscopy society in the country. And we had dinner together at one of the events, but we sat together at the same table and we had this long discussion and well, I want to say maybe three or four months later out of the blue, I got a call from somebody at the FDA and said, we want you to join the FDA. I’m like, oh, I guess that came to fruition. I don’t know. Right.

Speaker 1 (00:05:59):

That’s great.

Speaker 2 (00:06:01):

So I went through that process and that was an interesting process. It was a legitimate, it’s a legitimate government agency. Well obviously it’s a government agency, it’s the United States Food and Drug Administration. But as I was going through the process, I had to, I’m involved in a lot of device development myself. So I had to decide. I said, well, I’m not giving this up. Are you telling me I have to give it up? So I went through the whole ethics committees and all, cause I wanted to be above board on everything and say, listen, I don’t want any special treatment and if I have to give it up, tell me. And I’ll consider either whether I want to continue to work with the FDA or give it up and

Speaker 1 (00:06:42):

All. I see. So you’re working with other companies to develop devices already, so you don’t want there to be a conflict of interest.

Speaker 2 (00:06:50):

Well, the FDA doesn’t, right? Correct. So

Speaker 1 (00:06:54):

Were you, sorry, were also involved in products on your own behalf? Or was this mostly consulting?

Speaker 2 (00:07:04):

Both. Not products that I invented though.

Speaker 1 (00:07:07):

Got it.

Speaker 2 (00:07:08):

Products that I’ve been involved with as, I guess maybe originally a consultant, but super early pre or immediate post prototype stuff.

Speaker 1 (00:07:19):

Got it.

Speaker 2 (00:07:21):

So anyway, so I’m going through this process and I’m not even talking to the person that’s going to hire me or to the team I’m going to be working with. It’s just all these government workers

Speaker 1 (00:07:33):

Who bureaucracy

Speaker 2 (00:07:34):

Are checking all these boxes and I’m kind of jumping through the hoops and I finally make it to, and this goes on for a number of weeks and I finally make it to the I guess you call it the inauguration, I dunno what you call it,

Speaker 1 (00:07:49):

<laugh>. Like

Speaker 2 (00:07:51):

You get indoctrinated to be a government employee.

Speaker 1 (00:07:54):

Yes. You’re a federal employee.

Speaker 2 (00:07:56):

Yeah. Oh yeah. Full on federal employment. It was only a 13 month contract, but it was a legit, you’re now a federal employee. I mean, I raised my hand and I did it over Zoom. I didn’t have to be there, but I raised my hand and I swore to protect the constitution of the United States of America against all enemies

Speaker 1 (00:08:18):

As you show

Speaker 2 (00:08:19):


Speaker 1 (00:08:20):


Speaker 2 (00:08:21):

And the American flag was there. I saved some of those slides, was actually, I felt good about it. I really did feel good about it.

Speaker 1 (00:08:30):

That’s great.

Speaker 2 (00:08:31):


Speaker 1 (00:08:32):

So you passed a background check, surprisingly, and then, so

Speaker 2 (00:08:37):

They must have done some kind of background check, I would imagine.

Speaker 1 (00:08:40):

Yes, yes.

Speaker 2 (00:08:41):

I mean, who know? And then

Speaker 1 (00:08:43):

Did you go an office?

Speaker 2 (00:08:46):

Well, I never even had to go there, which was one of the primary reasons that I did it. I wasn’t going to do it at all if I had to travel down there. So the FDA is located in Silver Spring, Maryland, and I’ve been there actually, I was there for one of their they had a robotic assisted surgical device conference or it’s a recorded transcripted event where they use that for public input and it’s mostly invited public input. And I was invited to go talk at that, but that’s the only time I’ve ever been to the FDA and that preceded my employment there. But one of the really big reasons, going back to this amplify your existence thing, is that I was involved in operating on people and I started fellowship so I could teach people and taught residents and medical students as well. And that’s a good way to amplify your existence.

Speaker 2 (00:09:47):

I already was teaching surgeons overseas with doing a bunch of hernia trips with colleagues that you know, and the one thing in written guidelines and all that. But one thing that was kind of missing was the regulatory aspect. And I had never really even thought about it, but if you can be involved in clearing a surgical device for use, I mean that’s going to be used also by hundreds if not thousands of surgeons to help hundreds of thousands and ultimately millions of patients. And it reminded me of one of my mentors whose name was Félicien M. Steichen and he invented or helped develop, he invented all of many of the surgical stapling techniques and was in on the ground four floor with developing surgical staplers. And I know they have their problems and the FDA just had a big thing about those. But I think about how back when I was interviewing for my fellowship in the nineties and we were talking about a case and I said, well we did a standard side to side stapled anastomosis.

Speaker 2 (00:11:00):

And he just put his finger up and he just said, hold on. And he went and dug through his four drawer file cabinet and there was many of them, all full of his papers and research. And he dug out the paper that showed how he invented that technique. And I thought that was amazing. You know, were involved in the development of something that literally millions of times it’s been used. And I thought that joining the FDA, as in a regulatory fashion would help get devices on the market that would literally help millions of people over the years.

Speaker 1 (00:11:40):

How common is it for?

Speaker 2 (00:11:42):

And that’s kind of how I started.

Speaker 1 (00:11:44):

How common is it for a surgeon to be involved in the FDA?

Speaker 2 (00:11:49):

Well, there are surgeons that work for the FDA, some of them part-time. My job was actually, I had a full-time slot, but I was working part time and I don’t think that was so great for them. I mean, they only have so many slots. They only have I want to say two or three full-time surgeons. I know three, and I’m talking mostly in the general surgery devices. There are other surgeons employed with say orthopedics, obstetrics, gynecology, urology, E N T, et cetera. So in the general surgery space, there was only three, I think full-time surgeons. One was the director of the surgical devices division, Benita Asher. George Elli has been there many, many years and has been a lot involved in hernia devices. And Dorian Cores joined around the same time that I did. And he was a general surgeon in Maryland and he’s now sort of the acting chief of all of the medical officers. So kind of the medical director of the medical officers or something like that. Got it. They’re just reorganized. So it’s a little bit confusing on what everybody’s title is, but they’re really, really good bunch of people. They are not paper pushing bureaucrats and not people with a chip on their shoulder. That was the one thing I learned fairly early on.

Speaker 1 (00:13:24):

So through the American Hernia Society the FDA was interested in the quality cooperative that sprung from our society and they were involved. I met a couple of them really cool people.

Speaker 2 (00:13:40):

Yeah, that was one of ’em was George, I’m sure.

Speaker 1 (00:13:42):

Yes, yes. I remember George. There was a lady, I forgot her name

Speaker 2 (00:13:47):

Maybe Benita Asher

Speaker 1 (00:13:50):

Indian lady, who’s it?

Speaker 2 (00:13:52):

Indian descent. Anyway,

Speaker 1 (00:13:54):

I don’t remember but I got to speak with ’em. They were super eager to be part of the society and interact with the surgeons. They understood how important our feedback and is to everything. And it’s really cool that you got So explain to me, so what do they call you? And they say, we have this product. What do you think? Are you involved in conference calls? Is there paperwork that you’re supposed to handle? How are you able to help move things along?

Speaker 2 (00:14:29):

So the way it works in surgical devices is that a company or an individual can apply for legal marketing for any device, and that includes hernia. Mesh is a surgical device. Correct. So if I had a new device and I said, well, I have this new Mesh I want to market now the FDA is about the legal marketing of devices. They are not in the practice of medicine. And we can get into that philosophy a little bit later. Why? But they don’t, they don’t even approve anything. What they do is they clear it for marketing based on the basic tenants of not, not false advertising. You want to know what you’re getting and you want it to be in the FDA’s words, safe and effective part of the problem with that. So safety is a really, really big part of it. But effective is one of those things that what’s the definition of effective?

Speaker 2 (00:15:40):

And when you’re talking about a hernia Mesh, for example, right? Right. Is effective mean that there’s no recurrences? Does effective mean no infections? Does effective mean that it doesn’t rub on a nerve ever or there is no answer to this by the way. And I always would put myself from the patient perspective because we have to be patient focused? And I don’t mean patient patient-centered care from ACOs and all of that malarkey that’s driven by typically administrators of some type. I mean real pa, what do I want as a patient? And I’m going to regress just a little bit because it does reflect a little bit on the way I handled files with approving devices with the FDA. And that is the only reason we operate on somebody or treat somebody for any reason, but we’re surgeons. So I’m going to stick with operating, is to either fix a problem that exists and with hernias that’s pain or a big bulge or something like that.

Speaker 2 (00:16:53):

And it’s to prevent something, right? Sometimes we operate on people that don’t have any symptoms because we don’t want it to get worse and the patients don’t want it to get worse. So I was always hyper-focused on does this device help the doctor meet those two generic calls of fixing a problem or preventing a problem and does it do it safely? Now with devices, that means that the technique of how the device is used is critically important. So I’m going to use her hernia Mesh as an example. There was a recall of very popular product the market leader in fact, physio Mesh. And that prompted this Rives, this giant, all the lawyer commercials that you see on TV about hernia Mesh, right? Well, because anything that’s recalled, they can capitalize on that financially in terms of gain for themselves and maybe the patient wins in the end as well. The problem with that general concept, and I’m not sticking up for physio Mesh by the way, is that the technique is critically important, critically important. How the product was placed, where it was placed within the abdominal wall, what was the unique clinical scenario that it was placed and used in. And so it’s not just a simple Mesh is good or Mesh is bad.

Speaker 2 (00:18:31):

That is such a gross under oversimplification of that concept that it almost can’t I can’t even fathom that it exists. But anyway, I’ll get back a little bit to what we did when we got a file filed. So if somebody wants to approve, say a new device, a new piece of Mesh, yeah, they will apply. They’ll fill out an application to the FDA and they’ll fill that out. And they’re some fees associated with that, but they’re not anything what you would think. They’re not tens of thousands of dollars, they’re like 1500 bucks very now they’re not in it to make money is my point. So you’ll fill out this form and you’ll choose a pathway and there’s really sort of three main pathways which devices get approved. One is the510(k) Pathway, which has been around since seventies one is the call a PMA or pre-market approval process that is mostly used for drugs.

Speaker 2 (00:19:36):

And the difference between those two pathways is in order to go through all the steps, a PMA is typically something like, I don’t know, tens to hundreds of millions of dollars. And a 510(k) Pathway is tens of thousands to hundreds of thousands. So that is a dramatic difference. Now, not too long ago, and I’m going to say within the last decade, they came out with something called the De Novo pathway. And that pathway is designed to be somewhere in between the 510(k) Pathway and the PMA pathway. And then what would happen is you’d fill out your application and then you would, as part of that, you might have some meetings with the FDA in the beginning. And those are in totality are called Q sub meetings or pre like pre-submission or questions before submission meetings, right? Right. And you can have these informal meetings with the FDA and ask them questions, well how many of these do I need to do?

Speaker 2 (00:20:49):

Do I need to do any clinical data? We’re thinking about doing these kinds of studies in the laboratory are those good and are those acceptable? And they’ll never tell you yes or no answers. And the other thing that you’ll find about the FDA that some find frustrating, but I find it quite refreshing, is that nothing they say, and none of their documents are legally binding. So if they tell you something, oh, you can do this, they don’t have to stick to it. So from an industry perspective, you say, well, why’d you move the goalposts on me? Right. You can’t do that.

Speaker 2 (00:21:26):

But from a safety perspective, from a patient perspective, I don’t want them to get locked into some sort of thing that they said at one time and then a year later the data changes or new information comes in and they’re not allowed to change. That’s wrong too. So I really think that it gives the FDA the flexibility to adjust to those kinds of new data that might come in that say, maybe we shouldn’t approve this or maybe we should approve it. It can go both ways. Now the fear of that is that you get a power hungry government agency that’s now going to say, you will do what I say or you will not. But I can tell you that in the 13 month contract that I worked there, that is so far from the truth everybody there realizes their patients too. And they want these devices on the market, they just want it on safely. So they’re, they’re not the Gestapo by any stretch of the imagination. They really are out there to try and protect the public and also to get new devices to the public.

Speaker 1 (00:22:36):

So as you know, hernia Mesh and before that, pelvic Mesh has been in the news a lot and there’s concern that so many of the current meshes that are coming out in the past couple decades have come out on the box of prior Mesh designs that have been approved. That’s what they refer to as a 510(k) Pathway. So it’s similar to product B is similar to product A, it’s just a little bit, the shape is different or we add an extra layer, but effectively it’s the same and that kind of fast tracks the product at a lower cost than going through the PMA, which is the pre-market approval. So what are your thoughts on that? I mean, that’s a fact. It’s not that right? It’s a fact that happens and it happens a lot and it probably happens a lot more for hernia Mesh than maybe some cardiac device or other surgical devices. What are your thoughts? Is that cool? Is that being abused? Should we modify that?

Speaker 2 (00:23:44):

Well, so I’m cool with it for sure because when the choice was 510(k) Pathway versus PMA we would have no advances in hernia milk. If it costs 50 million to develop it, I mean there would be no advances. All of the products that we have today came through a 510(k) Pathway for hernia. Yes, hernia, Mesh. And now the risk of that, and we saw that with the physio Mesh, is it becomes a little bit like the campfire game. Well that first one was okay, and this one was tweaked a little bit, but we looked at the differences and the difference in the two devices don’t raise new questions of safety or effectiveness. So we’ll go ahead and approve that one. And there’s some data to support that by the way. But 10 iterations down the road in the campfire game when you know whisper something in somebody’s ear and it gets around 10 whole people, you’re right.

Speaker 2 (00:24:43):

Be a way different. So the other thing that I want to say about that, well, let me just finish with this, is that that’s where the De Novo process came from. Okay, so De Novo is a little bit in between. It’s not the guillotine for a device developer that a PMA is like. That’s why drugs, one of the main reasons why drugs are so expensive is because the clearance process and the regulatory process mandates all of these studies that literally cost millions of dollars. Yeah, I know. Yeah. Mean it’s crazy. But we get super safe drugs, we just don’t get very many of ’em. Not that often. So enough come out and the market has kind of sorted that out. And the De Novo process though does not chop you down with a 50 million bar to get over. It’s kind of like a 510(k), but you might need a little bit more robust data.

Speaker 2 (00:25:51):

You might need some clinical data, but not a multimillion dollar prospective randomized trial with 15,000 patients in each arm. Because that’s what it would take. And by the way, any trial with 15,000 patients in each arm with the drug trials has a long list of exclusion criteria. So they try to narrow the patient population down so that they can find out statistical significance between their product and the standard that’s already out there, the legally marketed product, well guess what that doesn’t represent, doesn’t represent who I see in my office and who you see in your office. It doesn’t represent reality. And by the way, that’s all medical literature. So we say this Mesh is got a problem or this Mesh is better for that, or whatever it is, or this pill is better for this or that.

Speaker 2 (00:26:50):

When we’re thinking about what the medical literature says, we don’t apply the exclusion criteria for our patients because maybe there’s 50 studies each with their own unique exclusion criteria. No doctor is, it’s not possible to apply that to your patient in real life. So there’s a disconnect between studies and real life. And that’s one of the things that I think the FDA struggled with the 510(k) Pathway PMA processes only. And I think that’s what the problem with physio Mesh is I, I joined after that got recalled but all of the bench data and the laboratory data looked just fine. And so you can’t say market it for a certain type of hernia or a certain type of technique. So it got marketed by the greatest marketer on the planet, I think Johnson Johnson. But it got marketed for every single hernia. And the problem was what’s the Mesh wasn’t strong enough and I’m okay, there’s a role for a super, a weak Mesh just for a reinforcement. But what did they do as a company, as a big company at that they marketed it for every single hernia repair.

Speaker 1 (00:28:11):

So for those of you, they’re not aware, physio Mesh was a Mesh made distributed by Ethibond, which is a subsidiary of Johnson and Johnson at the time was I think number two in the market in terms of their prowess in the hernia world.

Speaker 2 (00:28:29):

Number one,

Speaker 1 (00:28:30):

Was it number one above Bard?

Speaker 2 (00:28:32):


Speaker 1 (00:28:32):

No kidding. <laugh>.

Speaker 2 (00:28:34):

Okay. I was surprised by that. But

Speaker 1 (00:28:36):

Yeah, number one, okay well CLO, I thought maybe closely number two, but number one, I’ll take that. And they decide there’s so much inflammation from Mesh and there’s so much reaction and heavyweight Mesh is not good. So let’s make a low profile, low weight, sorry, lightweight, a low inflammatory Mesh. And those of us that were involved in the studies beforehand we’re like, this is great. This is exact, we’re moving in the right direction. Less foreign body, less total implant, less adhesions and so on. And we found out based on population studies after it was marketed that people who were putting surgeons who were putting the Mesh in as a bridge, that means a lot of the Mesh was not against muscle just patching a hole. But the hole was there that those patients, it burst in the middle the of the Mesh just gave away. And we don’t see that with heavier weight mes. And we were treating it as if it were like a heavyweight Mesh. And that’s where some of the education and the product marketing failed, and therefore it was pulled from the market. It was a perfectly good Mesh it had some fluid issues, seroma issues because it was so non-inflammatory that it didn’t cause that much scarring. But

Speaker 2 (00:30:02):

Well, and also they made it easy to use. They made it kind of sticky. So for a laparoscopic case. So the surgeons loved it. And I’d say that’s one of the primary ways a surgeon chooses a Mesh Mesh now is ease of use in the operating room. And I think there’s obviously, I mean there’s much more to it than that. Oh yeah. But you’re right about the marketing that failed. It was obvious that you couldn’t use a Mesh that was weak to bridge defects. Large defects for sure. But where was the cutoff? And it was impossible to know that. And I’ll say this in defense of the FDA a little bit, is that it would not have been possible to do a study that showed, well, this is a very weak Mesh. It’s strong enough. We think based on, again, laboratory data and bench data, a lot of what came out of Temple Links lab in Germany.

Speaker 1 (00:30:55):

Correct. And

Speaker 2 (00:30:57):

It met those minimum standards. But in order to do a study where you would do show different size defects to bridge, you know, couldn’t do that in the lab and to do a human study that would probably take, I don’t know, 20 years by which time it would be obsolete and that we’d be doing a different technique anyway. So that’s a little bit, they try to get mark products on the market that are safe. And I’ll say this, the Mesh was safe. It’s not like the Mesh was dangerous, it was the technique of how it was used, the circumstances that it was used that made, that caused the increase in failure rate. And do you knock the surgeon for that? I guess if you’re the patient, you do, but the surgeons were also doing what was cleared by the FDA and what the manufacturer said could be done with the Mesh. So there was a bit of a disconnect there. I would agree with that.

Speaker 1 (00:31:59):

So one of the comments on Facebook live is that the process were more rig, more rigorous, maybe we would not be where we are. And the current process doesn’t seem to protect the patient. It seems to me with the 510(k) Pathway, the intention was to promote innovation. And maybe in some cases such as hernia meshes, there was too much innovation. We were flooded with a hundred different Mesh types with really unproven results. We just kind of like, well, here’s another type of Mesh, this shape or this size or this color. And at the end of the day, in retrospect, patients may have been hurt by certain Mesh designs or it was marketed once it was cleared by the FDA, then the company was marketing it so aggressively that they wanted every single patient to have this Mesh. And maybe a plug is a good for a weak pelvic floor and obese patient, but not good for a ballerina with a small hernia. So that’s where the problem is. I’m hoping that, or is that the hope that the De Novo process, which is, it seems to be partially 510(k) Pathway, but also you have to prove some more data, kind of like a PMA type that will hinder some of these flooding of the market of meshes that we don’t necessarily know if they work.

Speaker 2 (00:33:35):

So that’s a little bit what the thought process behind the NOVA processes. But I’ll say this, that a company that makes a hernia Mesh, for example, they say our Mesh is the best, right? And we see this with surgeons a lot. They’ll do some technique and they’ll do it on a lot of patients and they’ll say, this is the best technique. Yes, you should use this. Right? And if you get a chance sometime, and you maybe you’ve seen this Dr. Towfigh, but Malcolm Gladwell does a great TED talk on spaghetti sauce.

Speaker 1 (00:34:14):


Speaker 2 (00:34:14):

And the bottom line is there is no best spaghetti sauce. There’s only best spaghetti sauces and there’s no best Mesh and there’s no best technique. So a lot of people, and I see there’s a question, Deb Morris saying is it better, what’s the best hernia pair with Mesh or without? And there is no such thing as a best hernia repair. There are only best hernia repairs, and some are with Mesh and some are without Mesh. Now I do think that there are some products that are coming that are on the market in the biologic realm. And I don’t think we want to get into the details of that, but that might be able to bridge the gap between

Speaker 1 (00:35:02):

Talk about it, between

Speaker 2 (00:35:05):

The plastic. Okay. Well, so when we’re looking at this stuff, we went from one product that was a heavyweight that had some complications associated with it. I’m not going to say they were caused by it. They were associated with the use of the product. And again, technique and clinical scenario are critically important in looking at whether or not the Mesh itself. Now can the Mesh itself actually actually cause an excessive inflammatory reaction? Of course. But that is a very small fraction of patients that happens in, and it’s unpredictable. I mean obviously we wouldn’t do it. And one day there’s even people that are working on trying to develop skin testing and things like that to try and predict if somebody’s going to be one of those people that has a bad reaction to the Mesh and then hands down you wouldn’t put it in. So then we went and said, well, maybe we just have too much plastic. So that’s where we went to the ultra lightweight, super weak product. And remember, why do we use hernia Mesh for its strength? We are trying to make the tissue stronger than it is because it failed, right? The tissue itself fails, we need stronger. So we don’t know exactly how much stronger. So out came the biologic Mesh and the problem with the initial onslaught of the biologic Mesh, it was all made from skin pick the species, right? I mean it was human pig, cow, sheep rabbit. Yeah, rabbit, the whole thing. But skin stretches.

Speaker 1 (00:36:51):

Yeah, see, it’s right,

Speaker 2 (00:36:53):

Exactly right. And I mean, someone gets pregnant, guess what? If the skin didn’t stretch, that would be a really small baby. So the skin has to stretch. And the problem with the biologics is that they all stretched. And even when they got remodeled into the patient’s native collagen, I mean if you think the patient’s native collagen and connective tissue is what failed in the first place, so you’re repopulating the area with the same defective collagen with a matrix in a scaffold that’s stretchy, doesn’t pass the smell test for me. So there’s some new ones out that have long-term strength, but they’re fairly new to the mark. They’re made out of pericardium. And then there was a bunch of hybrids as well where it was a biologic with a scaffold of polypropylene of plastic that would maintain that long-term like kind of rebar within cement, except it’s not as strong as cement.

Speaker 2 (00:37:54):

And so the jury’s out on those. The jury’s out with the pericardial product. Cause that doesn’t stretch, but we’re heading in the right direction. And the reason why I am saying it that way is that if the bar was so high that we had to prove beyond, beyond a statistical significance to get new products on the market, we wouldn’t even be developing biologic products that have long term strength right now. We would not be developing hybrid products. And that’s because no one would be able to afford to develop ’em. And so there’s a balance. If you let markets on, if you let on the market with no testing, right? Wild west, right? Let’s go on one extreme right? You’re going to get stuff out there that’s just going to hurt people, it’s going to make ’em sick. Maybe they’re infected maybe they’re going to have a rejection because they don’t wash out the cells and they actually have an allograft transplant reaction.

Speaker 2 (00:38:57):

Right? Now, let’s say you do things like, everything’s like a drug. It’s a super high bar. We’re not going to get any new products. We’re going to be stuck with the same thing we used in 1950 and we’re never going to get better. And it’s all about getting feedback and continuous quality improvement. So where’s the middle ground? Well, I think somewhere between the 510(k) Pathway I think is appropriate for some. And I think that de that De Novo clearance process, and I say clearance, not approval process is going to be that middle ground potentially. But there’s also some common sense that has to be used. The FDA is never going to be able to prove that something is safe and effective, especially when there’s no definition of effective, effective from the patient perspective, the surgeon, the hospital, maybe it’s cheap. So that’s effective for the hospital, right?

Speaker 2 (00:39:54):

It’s very complex. Which brings me to another bit about the FDA, and that is once a Mesh is on the market, there is no post-market surveillance. Yes, that’s correct. It’s like that gate is open and the cows run out. That’s for hernia. Mesh for hernia, Mesh? No, for every device there. I wouldn’t say every device. There may be, there’s some exceptions but those are rare because there’s no mechanism by which we can get that in. There’s voluntary reporting companies are mandated to report any complaints they get from their customers, even if they just hear about it, even if they hears two surgeons talking about it or they hear somebody at a restaurant talking about it, they have to report that to the F today. But I mean really is that the kind of system you want? Right? It’s not the kind of system that I think works so well.

Speaker 2 (00:40:56):

And in fact, if we had a robust system, which would be I’ll use it for the sound bite, but it’s like a single medical record and I talk about this ad nauseum, but I don’t really mean a single piece of software. I mean an integrated record so that we would know that anybody that had a hernia repair with Mesh A, B, or C got re-op operated on, we could mine the database and figure out who those people were that got re-op operated on and why did they get re-op operated on? Was there a problem with the Mesh? And if there was, what was the problem and was there a problem design the technique, whatever it is.

Speaker 1 (00:41:35):

And that kind of system is in certain European countries and that’s how physio Mesh was then tied as potentially a difficult of a failed product because of that type of population. So we don’t have, is that correct?

Speaker 2 (00:41:53):

Yeah. And

Speaker 1 (00:41:54):

So we have a lot of questions for you answer. So is it feasible for the FDA to limit the use of Mesh? This should only be done for open surgery in people with low BMI. This cannot be placed in patients with autoimmune disorders. Is it appropriate for the FDA to then limit the indications based on patient factors, for example?

Speaker 2 (00:42:25):

So that’s a great question. And the short answer is no, they can’t do that. They could do it if they had the data to support it.

Speaker 1 (00:42:34):


Speaker 2 (00:42:34):

Right. But there’s never the data to support it. You can’t put a study in and say, well, we tested this in low BMI patients with hernia defect between this, that and the other thing, and not even BMI, but this fat distribution in this clinical scenario, in this particular location of the abdomen, because you’d never be able to show statistical significance of a difference in all of those different clinical scenarios. So the FDA primarily looks at safety, is it safe and does it do what it’s intended? We don’t want to mis brand it, but what is it intended to do? Well again, that’s effectiveness and that is in the eye of the beholder. So it’s really not feasible at all for them to limit the indications because they’re never going to have enough data to prove one in one scenario is better than another. So they leave that to the doctor. The doctors are the ones with the training and experience. They practice medicine, the FDA doesn’t.

Speaker 1 (00:43:37):

Right. We have some questions that were submitted through Instagram. So these are actually good questions. So how do you know if your particular Mesh was approved or I guess cleared would be a better cleared via the predicate device 510(k) Pathway process loophole.

Speaker 2 (00:43:57):

Well, I don’t think there’s any loophole that I’m aware of, but every hernia Mesh that’s on the market currently was cleared through the 510(k) Pathway process.

Speaker 1 (00:44:08):

I would not call

Speaker 2 (00:44:09):

Five K process a loophole though.

Speaker 1 (00:44:11):

Okay. And then how can you confirm that the Mesh has had sufficient clinical testing done? Is there any way to know what clinical testing has been done on your Mesh?

Speaker 2 (00:44:23):

So no, not most of them don’t require clinical testing to go through the [inaudible] pro process because it’s the same material. And if it’s a slightly different shape we use our judgment. When I was working at the agency, and I don’t speak for the agency, obviously I don’t even work there anymore, but you have to use your judgment. That’s why they have surgeons on the panels. That’s why they have surgeons in these groups to use your judgment and say, okay, well this is sounds feasible. The data all look like it’s safe. It’s not going to cause some sort of a systemic reaction or an immune reaction or whatever. And we know that because we also take into consideration the breadth of clinical data that’s out there for all the existing Mesh products on the market or the preceded whatever’s coming onto the market. So no, they don’t have clinical testing and I don’t think they necessarily need it either. If you were going to wait for clinical testing, again, those trials are extraordinarily expensive and the FDA you understand experience spot.

Speaker 1 (00:45:44):

So what is your response to patients when they say that? Then we’re Jessica Guinea pig because the surgeon is not aware of the limitations of the product. There’s been no clinical testing to support its use in one subset of patients or one type of hernia versus the other. So we’re just randomly placing some new Mesh product in a patient hoping for the best. What do you say that do you to patients about that? I mean, it’s a legitimate concern, especially we have a lot of responses right now on Facebook, but I see it on social media all the time.

Speaker 2 (00:46:22):

So I think that is a legitimate concern. And I can recall being and you said you made a comment about, well, the surgeons don’t know.

Speaker 1 (00:46:33):

I mean, you see these patients, it’s part of your practice. You see how a wide variety of reasons why things go along after cardio care.

Speaker 2 (00:46:42):

So I think that unfortunately the majority of surgeons in the country know very little about the Mesh that they implant.

Speaker 1 (00:46:51):

Yes, I agree.

Speaker 2 (00:46:52):

They know that it’s cleared by the FDA and they know the basics of what it’s made out of. But even if they were given strength data, there’s no context to that strength data. There’s just strong enough and here’s the paper that says it’s strong enough.

Speaker 1 (00:47:10):


Speaker 2 (00:47:12):

And so yeah, that’s on the surgeon. It’s a little bit on the system. There’s too many products mean you and our life is hernia repair and we love it and we look at it and hernia nerds, so we know all the stuff about it and we still don’t know everything. I mean, you can’t know everything. Sure. But I can recall, I think there has to be a little bit of honesty and integrity on the surgeon’s part to not just say, we’re going to put in a Mesh, maybe tell the patient about, maybe show them the Mesh. I have samples in my office that I show ’em me

Speaker 1 (00:47:47):


Speaker 2 (00:47:48):

And I can vividly recall using a Mesh that was cleared by the FDA that had never been put in a person and my own personal, this is just the way I am and the way I practice medicine. I would never put that in somebody without telling it had never been put in someone. And I said, you will be the first. It’s never been, it went through the FDA process, but it’s never been put in somebody. So I can’t tell you with certainty that it’s what’s going to happen. But I can tell you with a very high degree of probability, because it’s the same material, it’s got a different coating on it, it’s got all this stuff. I wouldn’t be doing this if I didn’t think that it was safe enough, but I’m going to be very transparent about that. I have no ax to grind or nothing to hide about that. And I think the majority of surgeons might not do that. And I do think that’s an issue

Speaker 1 (00:48:52):

When you talk to your patients based on your experience because there’s not really good hard data out there, but based on experience that a fraction of patients will have a bad outcome or react to the Mesh or have chronic pain. And you do your best based on your experience to choose the technique. And if you need Mesh to use to choose the Mesh, then maybe it’ll reduce their chronic pain and optimize their outcome.

Speaker 2 (00:49:16):


Speaker 1 (00:49:16):

Do you talk to the patients about potentially reacting to Mesh or Mesh allergies or do you quote them anything? How do you talk about all that?

Speaker 2 (00:49:26):

So what I do is I say that the product’s been cleared through the FDA. I say you might have a bad reaction to the Mesh, not necessarily an allergic reaction if a Mesh is purely plastic. W humans don’t have allergies to plastic, but they can have bad reactions. So from a patient perspective, frankly, it’s the same thing. You have a bad reaction. Who cares if it’s an immune response or a foreign body response? Correct? So it’s not a true allergy, but many pieces of Mesh will have a coating on it. And that coating can be made from an animal and that can have some little protein on it that you could be allergic to. It’s super rare to actually have a true allergy, but bad reactions is a higher percentage. And it’s hard to know if it’s a true bad reaction or if when the Mesh in it got crumpled up and that caused an excessive foreign body response rather than a simple host response, right? Yes. Because that has a lot to do with it. So yes, hernia plug for example, that is going to have a much thicker and more robust foreign body response than a flat piece of Mesh against a muscle. I think everybody could agree with that. And it’s going to be the rare case where somebody has a flat piece of Mesh that’s plastic, no immune response, flat against muscle, and then they have an excessive foreign body response around it that I, I’ve never actually even heard of that. So it’s pretty complex and it’s pretty uncommon.

Speaker 2 (00:51:19):

And people say, well, there’s tons of people out there that’s because there’s a million hernia repairs every year and 90% of them use Mesh. So even a 1% problem rate or a 1% complication rate, that’s a lot of people. And which means we need to be very in tune about treating those complications because they’re going to happen and we have to take care of ’em.

Speaker 1 (00:51:43):

So the American Hernia Society meeting is coming up. We have two papers accepted. One shares our experience with skin allergy testing for patients with Mesh reactions or suspected Mesh reactions. And we report kind of the accuracy of skin testing for that. And then the other paper is our choice of Mesh in patients that have Mesh are at higher, they’re higher than average risk for Mesh reactions and how they respond to different options for Mesh once that’s been established. So

Speaker 2 (00:52:24):

I can’t wait to hear the details. I

Speaker 1 (00:52:25):

Know I can’t tell you until they,

Speaker 2 (00:52:28):

I know <laugh>

Speaker 1 (00:52:29):

They have, but hopefully they’ll get published too so we can share our experience. It’s early experience aren’t hundreds of patients that I see like that, but what I’ve learned is thin young women are at highest risk for chronic pain and people with known allergies or autoimmune disorders or higher risk to kind of react with to certain implants. Do you have a certain Mesh product that you use for chronic pain people or people risk for Mesh related chronic pain?

Speaker 2 (00:53:06):

So if they have chronic pain, say for example from a previous hernia repair, which would be typically what we’re doing, sometimes it’s not. It’s nova the quote sports hernia people, but let’s just say it was from a previous prostatic. The last thing I would do would be to use the same prostatic. That doesn’t make any sense to me at all for inguinal hernias. I’m very, very much gravitating towards a biologic product with its own inherent long-term strength that’s made out of pig pericardium, which is the sack that holds the heart. And it’s actually, that’s strong in itself, but they make it stronger with some chemicals. And then their secret is they wash out all the chemicals so that your own tissue can grow into it, but not to remodel it to be your own tissue. Again, to act as a long-term strong scaffold that has no sharp edges. There’s no plastic. I think that’s going to play a big role and in full. So

Speaker 1 (00:54:17):

It’s technically not a synthetic, but it functions like a permanent synthetic and its

Speaker 2 (00:54:25):


Speaker 1 (00:54:27):

Strength, strength.

Speaker 2 (00:54:28):

So my thought is that it’s going to have the behavior of a synthetic on the strength aspect, but the behavior of a biologic in terms of its biocompatibility aspect,

Speaker 1 (00:54:42):

Which product is that?

Speaker 2 (00:54:44):

It’s called x i s plus from Colorado Therapeutics Company that’s been around making Mesh for only year and a half, two years, something like that. And in full disclosure, I am now on their scientific advisory board

Speaker 1 (00:54:59):

As well,

Speaker 2 (00:55:03):

But I don’t make money off of using their mesh so much. I know everybody thinks that my money, I don’t make any more money. I promise It’s

Speaker 1 (00:55:11):

Exciting to be part of development of new products, but the reality is that we may be wrong. Your product,

Speaker 2 (00:55:21):

Oh, you never know.

Speaker 1 (00:55:21):

Be the best thing and the future of hernia repairs because it’s soft and it’s pliable and it’s low reactive and you won’t get an allergic reaction or autoimmune reaction to it. Or it could be rejected or encapsulated or whatever the situation is if you place it in millions of patients. So I think it’s, what I feel that, and I see it during COVID too, is that as scientists, as physicians, we understand that we don’t have the answer and there’s no solution and perfect answer. Everything is an evolution and we’re okay with that. What I did as a resident, it’s completely different than what I do now as an attending. And I was trained at an excellent top 10 program whereas so somewhere with COVID, like we don’t really know much about COVID. We’re learning. So what was said in February or March, prove not to be wrong many times, and a lot of people think that’s a failure, but I don’t think it’s a failure. It’s just we’ve kind of learned over time and that kind of patience. I always tell my patient, please be patient with me. We’re trying to figure this out and hopefully we’ll get to a solution. But it’s puzzle solving and trial and error sometimes and we can’t expect every single product to be perfect, but we try. One last thing. The most recent in-person hernia meeting that has occurred was a European hernia society meeting in November in Milan in Hamburg.

Speaker 1 (00:57:05):

The European Union by then had already passed a law that transferred all Mesh regardless of where it’s placed from a low risk to a high risk device. And the implication is that all companies need to reapply. All companies, no matter how old the Mesh is, need to reapply to be certified. And if they don’t have robust clinical trials, whether it animals are in humans to prove its safety and efficacy, they will not be granted the application. They will not be approved or cleared, and they must also provide post-marketing surveillance for the lifetime of the implant, which implies the lifetime of the patient usually. And that was mandated that it was a law. No one knew how the hell that’s going to happen. It’s supposed to take effect this year. I don’t have any update as to what happened, but I have a feeling that the FDA will be looking at the European Union very carefully to see if they should be doing the same thing for hernia Mesh. What are your thoughts on that and will end on that.

Speaker 2 (00:58:22):

So I think that it’s going to be too bad for the people of Europe because they will have now limited options for their hernia repair in terms of prosthetics, and that’s who’s going to get hurt. The fact is that, like I said before I know for a fact that the FDA has safety at the forefront. Effectiveness is a little more elusive and is not provable. Surveillance is the answer. The only way. There is no best Mesh and there’s no best technique, but if we get the output from our system, in other words, the outcomes from our hernia, no surgeon knows their recurrence rate in this country or in the world for that matter because we don’t have the data people move around. If we had an integrated record, we could mine that data, get the feedback, and we could change faster and improve. It’s not about the answer, it’s about getting feedback and improving continuously.

Speaker 1 (00:59:29):

I agree. One more question because this is an interesting question and I think people think it, but they don’t ask it often. No matter what, doesn’t Mesh material erode after a few years?

Speaker 2 (00:59:41):

No. Is the short answer to that.

Speaker 1 (00:59:43):

Yeah, I remember that. Yeah. No, it does not. Now, some Mesh are made to be absorbed, but synthetic Mesh is not made to be erode and it does not erode are I think what they’re referring to is some explanted Mesh that have been looked under electromicroscopy and it looks different than the Mesh before it was implanted.

Speaker 2 (01:00:10):

Yeah, that’s different. Yeah.

Speaker 2 (01:00:12):

You can get some of those plastics can oxidize, right? Yes. Because we are an oxygen being, human beings need oxygen to live, so there’s oxygen all over the place and it’s unpredictable. It’s probably of no clinical significance. I almost wonder if the question was about eroding into the intestine or into the bladder or something like that, and it can do that, but it’s certainly primarily the technique. If a Mesh has a buckle or a and is rubbing on it like a piece of sandpaper, then yes, it can erode into another structure. But that’s not all Mesh is long enough. I mean, by any stretch, that’s the vast minority of Mesh. And it’s probably mostly technique related again. Correct.

Speaker 1 (01:01:00):

All right. Our time is up. I want to thank Dr. David Earle, good friend of mine. I’m so happy to be able to link with you. Well, thank you. This is the end of hernia talk. You can follow me on social media where I will post the link to this from my YouTube channel. And thank you to Dr. David can follow him at Dr. D, sorry, at David Earle 13 on Twitter. And thank you for everyone, for always asking really amazing questions. I will see you next week. Have a great evening and I hope you’re all doing well, and thank you again.

Speaker 2 (01:01:35):

Thanks for having me. Bye-Bye.