Via America’s Lawyer: Farron Cousins and Attorney Robert Price discuss Hernia Mesh surgeries. With more than one million surgical procedures performed in the U.S. each year, hernia surgery has become one of the most common operations performed in this country. With medical companies rushing to get new hernia repair products on the market, the rigorous testing that should be done is tossed by the wayside, and ultimately, the patients are the one who pay the price. Farron Cousins fills in for Mike Papantonio on this episode of America’s Lawyer.
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Farron Cousins: With more than 1 million surgical procedures performed in the United States each year, hernia repair has become one of the most common operations performed in this country. And anytime a market expands drug companies and medical device manufacturers are always right there to cash in on it. But in their rush to get new hernia repair products on the market, the rigorous testing that should be done gets tossed by the wayside and ultimately the patients are the one who pay the price.
Joining me now to talk about this is Robert Price and attorney who is actually handling hernia mesh product cases. So Robert, we’ve had you on the show in the past, but, but let’s just kind of start with the basics. What exactly is this hernia mesh?
Robert Price: So thanks for having me again, Farron. This hernia mesh is, it’s a, most of it is polypropylene based, which is essentially plastic fishing line. And we’ve seen this used on the market for a couple of decades now. And what’s happening and the reason we’re bringing lawsuits is that over the past 10 or 15 years, manufacturers have really started to balloon out and do some experimental things with their meshes that are causing patients very, very serious complications.
Farron Cousins: And so, you know, what kinds of problems are we seeing with these products?
Robert Price: So, you know, there are a lot of different things going on essentially from the patient’s perspective. They’re seeing their, their hernia repairs fail. They are getting things like bowel perforations, massive infections. Some of these meshes are, meshes are also used in what we call inguinal repairs. So every now and then you will see the nerves and the pelvis be affected. Even things like orchiectomy, men losing their testicles, things that are really serious because of the complications that are happening.
So that’s from the patient’s side, from the device side of things to, to summarize it in a nutshell, first of all, the polypropylene plastic used in the mesh has some problems. It’s subject to breaking down, degradation. Some companies even use stuff that’s imported from different plants that isn’t medical grade. Things like that. And then on top of that, manufacturers in a race to kind of have the newest, coolest, best product or doing things like they have rings in them or they have this gel coating that’s on them. Lots of different things going on that’s not necessarily proven scientifically or medically.
Farron Cousins: So, so this is really interesting because we’re not just talking about this product is causing discomfort. People are losing body parts from this. That is, see, that’s something I, I had not seen in, in my research yet. So that’s, that’s pretty remarkable to know, especially when you consider the fact that we do have so many of these surgeries performed each year and that number is actually growing with every year. So one of the lawsuits has actually been filed, says that these mesh products are “incompatible with human tissue.” Explain that a little because that seems pretty big for something that is meant to be sewn on to human tissue.
Robert Price: Yeah, that’s right. And there’s, there’s a lot of different ways a device can be incompatible. For one, it’s sort of an experiment on the market. So the companies didn’t necessarily do enough, you know, scientific experiments and controlled studies that we see with a lot of other drugs and devices. With hernia mesh especially, they really didn’t study the devices. We’re just learning these things as they go onto the market and hurt people. So incompatibility, few different things. One, we talked about the degradation the nonmedical grade stuff that’s being used.
Another thing is the design of the mesh itself. The, the way it’s woven together, it’s too dense. The pores are too small. The body, when the body heals around it, it forms this big collagen barrier. It causes the mesh to contract and to, you know, it, it grows nerves in it and things like that. And then there’s also other incompatible, compatibility issues like the coatings that are used on the mesh.
It essentially walls off the mesh, which is bad as well. And then, you know, one company just as an example, uses a fish oil on the mesh that is just scientifically unproven. And somebody who just had the idea that, um, well let’s see, fish oil helps with digestion. So maybe we’ll take this mesh and we’ll dunk it in fish oil. Like things like that that are going on in the market, that’s just crazy. So yeah, in a lot of ways a lot of different design aspects are not truly compatible with the human body. To have the human body heal with mesh, it needs to be able to safely grow into the mesh and heal up around it almost perfectly so that the body doesn’t do things like over heal around it. It doesn’t grab nerves.
And when you, when I say things like people have lost testicles or people have bowel perforations, the body in many of these cases grows up into the mesh and it starts to turn the mesh into like a shrunken ball. And it turns into this hardened ball and it will either grab the spermatic cord causing testicle loss or it’ll even puncture through the organs causing bowel perforations and removed intestines and, and pretty intense stuff.
Farron Cousins: So this, these mesh products, they’re actually meant to, to stay in the body. Like once the surgeries performed? Like that’s just a part of you now? That’s, that’s how they are?
Robert Price: Supposed to be, supposed to be. That’s supposed to be, the concept is it’s supposed to be in there. It’s supposed to be what’s called inert. It’s not supposed to degrade. It’s not supposed to migrate or move. It’s, the body’s supposed to grow into it and it’s supposed to heal around it. And that’s theoretically what’s supposed to be happening. But with all of these different designs that are coming onto the market, like I said before, it’s not, it’s not a true controlled study.
It’s more of a, hey, we’ve got this new design doctor, you’ll be able to insert this mesh in and out. It’s real quick, it’s real easy. And then years later we find out from the adverse event reports that people are getting hurt from the mesh. Is, which is really not the way that science or medicine is supposed to work.
Farron Cousins: So why was there not rigorous testing done, you know, prior to these products coming on the market? Because as you’ve mentioned, they’re just kind of coming out with, we’ve dumped ours in fish oil, so here it is. Put this in. Where was the testing?
Robert Price: Well, you know, it’s one of the things that the FDA is slowly coming around to years and years and years. I mean the FDA has been talking about this process for many years now. It’s called the 510k approval process. It’s not, or excuse me, it’s the clearance process. It’s not an approval process. A lot of people think if a drug or medical devices is on the market, it must’ve gone through some kind of safety or testing. But in the medical device world, which is a lot of the law that I’ve been practicing for several years, if a device has come through the market through the clearance process, we call the 510k process, all it has to do is prove it is substantially equivalent to something else. thats on the market.
So in, you know, the FDA, this, this substantial equivalent standard, it was a really loose and relaxed standard. So with the story of mesh, and I’ve been doing, you know, the pelvic mesh cases for about eight years now. What that means is that you can have a mesh product that was put on in the market in the mid 2000’s to actual kind of story timeline here, mid to early 2000’s of mesh products put it on the market and then later on a year or two later, somebody can just say, oh, mine’s just like that except a few device tweaks.
And then another year later, oh, mine’s just like that, except a few more tweaks. And these little tweaks sort of grow along the way and they become a, anomalies or disasters and they all spawned from this mesh device years ago that’s no longer really relevant and you can just have this, it’s almost like a wildfire effect. You could just have these devices just grow off one another and they never really get reviewed for safety or efficacy. They just, they just keep pumping these things out and the FDA just kind of clears them with this 510k clearance process.
Farron Cousins: So, so it’s basically an, an evolution of these products. You know, originally you start with the thing that that I guess did have to be tested. And then well I’m similar to that, well I am similar to that, and then you go along the evolutionary chain here and you end up with something that’s really not even close to what it began with. But along the way, it was close enough and that’s terrifying for consumers.
And we’ve seen that with a lot, you know, not just the mesh products, but pretty much, you know, a whole gamut, whether it’s, you know, a nip, knees, hips, whatever it is, they go through this same process and we’re seeing problems with a lot of these products. So, but mesh, it’s not even necessary to have mesh to repair a hernia. I mean, we were repairing hernias in this country long before these mesh kits came out. So why the change? Why are we now using kits instead of the old fashioned way?
Robert Price: Right, right. So you know, you see a couple of different things. One, like you said, a lot of times it seems to be because these hernia meshes are so marketized their, the sales reps are in there, hey, put these in. Their low, all the representations that are being made to doctors, as a doctor, it kind of sounds like, okay, so easy, minimal risk, no recovery time. Let’s, and this mesh is supposed to be there permanently, let’s just use this mesh. So a lot of times if you have a hernia, especially if it’s a smaller hernia, you don’t necessarily need mesh.
And those are questions, discussions you can have with your doctor. And I’ve had scenarios before where I’ve had a patient or even a family friend say, okay, I’ve got a three centimeter umbilical hernia, which is where my belly button is. Doctor wants to use a mesh. And you know, we have a discussion, well, well can you ask your doctor why he or she needs to use a mesh in the first place? And sometimes that works.
So you realize not every hernia needs a mesh. And then there are different meshes out there. Not every mesh has to be made of plastic based mesh. And what, what type of meshes the doctor uses. There’s so many out there. Some of the newer basic generation meshes are somewhat better, arguably, but a lot of doctors don’t know that. A lot of times it’s just kind of whatever’s on the shelf at the hospital.
So, so yeah, getting to your question, it’s not necessarily meshes is something that has to be used and there are different types of meshes. There are biologically compatible meshes that aren’t synthetic or plastic or they aren’t coded and things like that. So just, so yeah. Yeah, it’s a, it’s a discussion that has to be had with the doctor. First question always is, do you have to use a mesh and can you use my own tissue too? A lot of times the answer to that question is yes. And then on top of that, what kind of meshes being used here, and you can do some research and see are these the type of meshes that are subject to lawsuits.
Farron Cousins: Well great. Robert Price, thank you very much for talking with us today.
Robert Price: Thanks, thanks for having me.