Below are some of our videos explaining the potential dangers of Hernia Mesh devices, and especially the connection to infections, bowel obstruction, scar tissue and chronic pain. To learn more about the types of injuries that have been linked to these products, and the legal claims that have been filed, click Hernia Mesh.
Hernia Mesh Hype: Manufacturers Now Face Over 54,000 Lawsuits
Mike Papantonio: Hernia mesh implants have become a widely popular procedure for patients suffering from any kind of hernia but with more than 54,000 lawsuits filed against the manufacturer of these implants, many now are wondering if what they were sold was really pure hype rather than a solution to their problems. Joining me to talk about this is attorney, Robert Price.
Robert, hasn’t hernia mesh been around forever? I mean, what’s going on with this?
Robert Price: Hernia mesh repair, you know, hernia, the use of mesh to repair hernias has been out there for decades, even since the 1950s. But what we’ve seen with the big manufacturers is that there’s this evolution or a de-evolution, if you will, of taking these meshes and putting them into experimental designs and experimental kits and, as you mentioned a moment ago, the idea here is that it’s a market. Get as much of this stuff out there on the market as possible. And the premise behind a lot of these kits is that they’re easy to use, they’re easy to put in and they have this special coating on them that’s going to make them easy, theoretically you can put them closer to the bowel, you can do a lot of things with them that, sort of, empowers surgeons to use them but, really, what we’re learning is that their designs are very defective.
Mike Papantonio: Well isn’t part of the problem … it used to be not everybody performed hernia surgery. You had to have some training, you had to understand what you were doing but these manufacturers, what they did is came out with this package where they tell doctors, oh, you know, this is easy to do, just mix and shake and you got a hernia mesh solution. Isn’t that kind of what happened and who are these manufacturers? Who’s responsible for this? I mean, it is really a healthcare catastrophe when you start looking at the numbers of cases where this had gone bad causing real serious injuries and even death. Who are these manufacturers?
Robert Price: It’s the same manufacturers we’ve seen in a lot of the mesh litigations. The biggest manufacturers are Johnson and Johnson, C.R. Bard, and a company called Atrium, that’s from New Hampshire. Those manufacturers are … The idea, what you started off saying is exactly correct. The idea is that there are some hernia repair clinics around the country that specialize in hernia mesh repairs and a lot of hernias out there don’t need mesh to repair them but surgeons have used mesh to … when mesh is needed but the concept of when mesh is needed has just exploded over the past decade or so as more and more surgeons are being told, hey, you can use this kit, you can use this type of mesh.
Manufacturers are saying you can take this mesh and you can place it right up against the bowel, it’s got this special coating on it, it’s got a chemical coating that’s going to help protect the bowel, which is not backed by studies. It’s not backed by adequate science so a lot of this mesh is being placed in patients that’s experimental in design and it’s the same manufacturers, many of the same manufacturers, that did the women’s pelvic mesh years ago that we’ve seen lawsuits over that. So, some of the same actors here, same meshes, same problems.
Mike Papantonio: That ended up killing a good number of women. These women were told here’s this vaginal mesh, it’s going to solve incontinence problems, no need to worry and once it was put in their body, they couldn’t get it out of their body. It had migrated to all different parts of the body. The mesh would break, it would migrate to their brain, their heart, all over their body and the manufacturers knew then … matter of fact, I took a deposition on that case and I remember that one of the descriptions of what it looked like inside the body was it looked like concrete and rebar, trying to remove it from the body was like trying to remove concrete from rebar.
So, this is really no different. What are they doing with the meshes that make the design so bad, Robert? Why is this such a big problem for people? Why should people say hell no, I’m not going to have this in my body if I have an alternative?
Robert Price: I’ll give you a couple of examples. There’s a lot of different designs out there with a lot of different problems but I’ll give you a couple of the worst designs and here’s what they are. There’s a laparoscopic technique where, essentially, if you have a ventral or a hernia in the stomach region, there’s a technique where instead of opening up through an incision, you can get a laparoscope and come through laparoscopically and some manufacturers, including Johnson and Johnson, they allow the mesh to be placed right up against the bowel on the inside of the skin, on the inside of what’s called the perineum, that layer right there, and be placed right up against the bowel. And allegedly the special coating is supposed to stop the mesh from integrating in the bowel. Well, what we found out is it actually does the reverse. The coating on the mesh actually stops the mesh from integrating into the tissue, which is what you want, and it does something called a reverse integrates and eats into the bowel. That’s one example.
Another example of this experimental coating is the Atrium Corporation, for example, coats its meshes in fish oil. Now, there’s no studies, there’s no studies out there that prove that it’s safe to coat a mesh in fish oil and put it in humans. It is unstudied design, there are a couple of studies in rats that showed it actually caused massive adhesions in rats. But literally, they’re taking fish oil from barrels, pouring it over mesh, coating it and then sticking that in a human body. You see massive infections, bowel removals, bowel recessions, some patients have to live with a colostomy bag after some of the stuff that they’ve been through.
Mike Papantonio: Too often they go in a doctor’s office, the doctor says this is how it is. The patient doesn’t do research to find out what the doctor’s just told them, it’s a huge mistake. The second problem is that we believe that the FDA actually is there to help us. The FDA has become as dysfunctional as the EPA and the FCC and every other regulatory agency in this country, maybe even worse because it’s our health that the FDA’s supposed to be looking out when it comes to things like mesh and pharmaceuticals and they have totally, totally become an extension of corporate America. They’re absolutely useless as a regulatory agency.
Thanks for joining me, Robert.
Surgical Mesh: Patients Have Become Guinea Pigs
The story about surgical mesh, this product that's being implanted in the bodies of thousands of people every day, it isn't a story that corporate media would ever tell you. In fact, they can't tell you because their corporate advertisers, the people who make these products, well they won't allow them to do investigative exposes about how dangerous surgical mesh really is. The advertising dollars are just too big.
Surgical mesh reinforcement use has become routine for hernia repair and a handful of other surgical procedures that are performed every day all over America. What most patients don't realize is that the mesh is made up of polypropylene, and has the ability to oxidize and degrade directly into human tissue and throughout the entire body.
The first signs of this manifestation begins with things like chronic fatigue syndrome or extreme consistent rashes, and the diffused joint pain throughout the entire body. In addition to those issues with polypropylene that we've seen so often, the added problem is the use of experimental coatings that have been used mostly as a sales gimmick by manufacturers to sell doctors a product that has potential to degrade and migrate throughout every organ in the body.
The pitch that the companies use is that the mesh is quick and it's fast, and anybody can do it, even without special doctor training. The sales gimmick coatings have been associated with increased infections, bowel perforations, fluid buildup within the wound, and overall failure of the device which necessitates a second, third, and sometimes a fourth surgery to correct the problem.
The most interesting part of this story though, is that mesh isn't even necessary to do the type of tissue repair that takes place with a procedure like hernia repair. For decades doctors who are specifically trained for natural tissue repair have successfully made hernia repairs and other human body tissue repairs with natural body tissue, with no use of anything called mesh. The obvious advantage of that is that there's no introduction of a foreign body into the procedure that has the ability to degrade and migrate throughout the body, triggering autoimmune reactions, which is what we see with the coated mesh gimmick that's being sold to any and every doctor who wants to perform a procedure without any kind of special training.
Here's the real stinger, though. None of these procedures have been studied before they received approval by the FDA. In fact, the only reason that these products are on the market is because of a fast-track 510K procedure that the FDA permits for these types of surgical devices. Unlike what most people believe, there is no FDA testing with in-house on these experimental meshes before they're placed on the market, but everybody believes that's the case, that the FDA is looking over the manufacturer's shoulder. That just is not how it works.
As we've seen so many times again and again, it's always about quick profits and big risks where it comes to so many medical devices and pharmaceuticals that have been placed on the market where patients actually become guinea pigs. In this particular story, guinea pigs are not doing well at all.
Papantonio: Medical Hernia Mesh - A Health Disaster
Electing to have surgery is not a decision that most people take lightly because they understand how risky any procedure can be. Medical errors are one of the leading causes of preventable deaths in the United States. Most of those occur on the surgical side. On top of that, there are complications that can arise from anesthesia, the possibility of infection, and even the amount of pain that patients have to suffer when they go through a surgical procedure, but in some cases, surgery is the only option and that's the case with most hernias. Each year, hundreds of thousands of hernia surgeries are performed in the United States.
There are numerous types of hernias, but the two most common hernias are the ventral hernias and inguinal hernias. The ventral hernia is a bulge that occurs at the abdominal wall muscle and an inguinal hernia is a hernia near the groin. Many years ago, a product came out on the market. It was called the Kugel Mesh Patch. That hernia patch was a horrific product that was made of a plastic chemical polymer, and it had a ring around the patch that was supposed to break, and it ended up dislodging in the patient's skin, their abdomen, or their intestines. People suffered debilitating injuries. They even died from this product. Turns out that was only the tip of the iceberg.
Since the Kugel Mesh days, medical device companies have continued to produce devices that supposedly have this innovative technology that are nothing more than marketing ploys that involve little to no science and a whole lot of experimental medicine and marketing. Thanks to the FDA's Medical Device Clearance Process, which is totally inadequate, these devices don't have to be independently verified as to their safety. For example, a company called Atrium releases a product called C-QUR Mesh. The C-QUR Mesh was a mesh patch that was coated with omega-3 acids. Basically, fish oil goo is the best way to describe it. This goo causes severe reactions inside the human body, and it leads to infections, adhesions, and can even cause a person's death. On top of that, not only does the product employ a bogus design, but the company itself has been in trouble with the FDA for contamination issues surrounding the way it handles these products.
Then Ethicon, a subsidiary of Johnson & Johnson, is always in the news for defective products these days. They make a product called Physiomesh. It's used as a chemical coating on top of its mesh. This chemical coating as touted to doctors as something that was going to help wounds heal. Turns out that it did just the opposite. It caused healing problems and increased infections. The problems got so bad that they issued an Urgent Field Safety Notice voluntary recall in May of 2016. The reason that the company issued this recall is because their mesh products were causing an array of problems, which included the mesh beginning to bind with internal organs or the mesh falling apart, causing the hernia to reopen, and the patient being forced to have corrective surgery. In fact, these negative side effects became so severe that a clinical study on the product was actually terminated early because they found out it was so dangerous.
We cover stories like this every week on America's Lawyer where we tell you stories that corporate media can't tell you because their advertisers won't allow them to do that. Follow me on America's Lawyer.
Mike Papantonio: The Latest Medical Product Disaster - Surgical Hernia Mesh
Mike Papantonio: Electing to have surgery isn’t a decision that most people take lightly because they understand how risky any procedure can be. Medical errors are one of the leading causes of preventable deaths in the United States, and most of those occur on the surgical side. On top of that, there are complications that can arise from anesthesia, the possibility of infections, and the amount of pain that patients understand is going to come with any surgical procedure.
But in some cases surgery is the only option, and that’s the case with hernia surgery. Each year hundreds of thousands of hernia surgeries are performed in the United States. There are numerous types of hernias, but the two most common are hernias, the ventral hernia and the inguinal hernia. The ventral hernia is a bulge that occurs in the abdominal wall muscle and the inguinal hernia is a hernia near the groin.
Many years ago though a product came out to market called the Kugel mesh patch. That hernia patch was a horrific product that was made of a plastic chemical polymer and had a ring around the patch that would break and it would just lodge in the patient’s skin, their abdomen, their intestines. People suffered debilitating injuries and even died from this product. It turns out that it was only the tip of the iceberg. Since the Kugel mesh days, medical device companies have continued to produce devices that supposedly have innovative technologies that are nothing more than marketing ploys, that involve little to no science, and a whole lot of experimental medicine.
Thanks to the FDA’s medical device clearance process, which is totally dysfunctional, these devices don’t have to be independently verified about safety. For example, a company called Atrium released a product called Secure Mesh. The Secure Mesh was a mesh product that was coated with something called Omega 3 acids, basically fish oil goo. That’s the best way to describe it. This goo caused severe reactions inside the human body and leads to infections, adhesions, and can even cause a person to die. On top of that, not only does the product employ a bogus design, but the company itself has been in trouble with the FDA for contamination issues surrounding the way it handles these products.
Then Ethicon, a subsidiary of Johnson and Johnson, who are always in the news for defective products these days, they make a product called Physiomesh, which is used to … It’s a chemical coating on top of its mesh. This chemical coating was touted to doctors as something that would help surgical wounds heal better. It turns out that it did just the opposite. It caused healing problems instead. The problems got so bad that they issued an urgent field safety notice voluntary recall in May of 2016.
The reason that the company issued this recall is because their mesh products were causing an array of problems. They included the mesh beginning to bind with other internal organs or the mesh was falling apart, causing the hernia to reopen and the patient being forced to have corrective surgery. In fact, these negative side effects became so severe that a clinical study on the product was actually terminated early because the product was so dangerous.
Joining me now to talk about the dangers of these mesh products is attorney Robert Price. Robert, tell us the purpose of these hernia mesh products. We think of hernia surgery as kind of a minor process, but these cases are anything but minor. What’s happening? What is the need for this mesh design to begin with.
Robert Price: Yeah, Mike, thanks for having me on the show. To answer your question, what we’re seeing here is we’re seeing these generations of these new innovative basically marketing ploys by these hernia mesh companies. Now when a patient has a hernia and they go in, most hernias require a surgical repair. They have sheet meshes or just uretal mesh that’s been used in the surgeon community since the 1950s, but since mesh is such a big profit driver for so many companies, there’s a huge amount of competition among companies to gain a competitive edge over one another, and that’s what we’re seeing here. We’re seeing these companies just take these-
Mike Papantonio: Robert, let me make a point. The reason it’s such a competitive product is because what it enables is doctors to use … Doctors who may not ordinarily be able to do a particular kind of surgery, now they have this mesh product that allows them to do that. Did I get that right, or … There’s another reason for mesh being on the market, isn’t there?
Robert Price: Right. Right. There’s two reasons. One reason is just as you said. They want to present it to doctors as something that’s easier than what it is to do. There’s sheet mesh that’s been on the market forever, and more advanced surgeons know how to use these basic mesh products, but then it’s a marketing technique. You can convince any doctor that it’s a quick, easy, low risk, easy recovery type surgery with these special innovative procedures.
The second reason is the mark-up on meshes … I mean think about it. It’s basically a plastic sheet of mesh. It costs the company a couple of bucks to make and then they can sell it in a package for $1,000, $2,000. They can bill insurance … I mean the margins on these meshes are just … They’re insane, so they’re a huge profit machine for the company. So you got big profit machine plus trying to gain a competitive advantage equals big disaster.
Mike Papantonio: Okay. Because it’s a medical product it goes from a cost of $2 to $1,000 basically answers that question. But look, Ethicon’s Physiomesh was pulled off the market in 2016, so it was only on the market for about six years. It was approved by the FDA in I think 2010 through a process known as fast tracking, which is an absurd process that the FDA has embraced. Explain this fast tracking phenomenon that’s causing so much harm across … With so many products across the United States.
Robert Price: Yes. So the FDA … Many people don’t know this, even sometimes doctors we talk to don’t know this, but the FDA … If you have a medical device and it’s not what we call a life-sustaining device, like a pacemaker or something like that … You can have a medical device. You can present it to the FDA and instead of studying the device for safety and efficacy, all you have to do is say, “Okay, FDA, I’ve got this mesh and it is what we call substantially similar to another mesh that’s on the market. I’m just like these other guys. Approve me.”
What you see … That’s called fast tracking through the 510(k) process. In that process, on top of that we see what’s called piggybacking, so you see a device over here six years ago that started out as one type of device and then one piggybacks across another, across another, across another. Then you have 10 different devices that have just hit the market in the matter of a year, none of which have been studied for safety, efficacy. The FDA has not questioned hey, what is this goo? What is this coating you’re putting on your mesh? Has this been studied? Has it been tested in humans before you start implanting it in thousands of people? None of that. It’s just … It’s what’s called a clearance process, and sterilely it’s just that easy.
Mike Papantonio: Yeah. So Robert, most people think gee whiz, it’s being sold as a medical device, surely the FDA has tested it? The weird answer is no, they haven’t. With this device, this goo that they put on there, no, it wasn’t tested in humans. The product itself wasn’t tested in humans. It was simply that a product similar to that had been put on the market, so they said gee whiz, we’re going to put our product on the market. We’re going to put this fish oil goo on it and everything is going to be okay. Unfortunately, that’s the way things really work.
Look, Ethicon isn’t the only company facing litigation for their mesh products. What other hernia mesh companies are being looked at for this outrageous thing that’s happening in these surgeries? The results of these surgeries sometimes go really, really bad.
Robert Price: There’s other companies that are being investigated for similar type of coatings on their product. Probably about 80 to 90% of the market share is held by three companies, C. R. Bard, Ethicon, which is the Johnson and Johnson company, and the Atrium company. They’ve got about 80% of the market, and many, many, many of these meshes that have been put out and used by doctors in the past let’s say eight or nine years have been this composite, plastic covering, goo type mesh coating. There’s a lot of them out there, and these three companies hold the largest market share.
Mike Papantonio: So Robert, so we have a surgery that should be fairly minor, a hernia surgery, that all of a sudden has turned into a little bit of a nightmare for a lot of people across the country, but we’ve seen this before. Years ago, there was a litigation called vaginal mesh, where the mesh industry employed bad products in an experimental design used in women. I mean it literally was … They were experimenting on women. Are we seeing the same types of corporate behavior in this case?
Robert Price: Absolutely. Same type of behavior, same type of concept, same type of taking advantage of the FDA’s fast tracking clearance process. We saw a lot of cases with a lot of similar design problems. In fact, there was a case that we had worked on where a lot of these vaginal meshes in women had this coating that they put on the mesh that would make infections and everything else skyrocket through the roof, so same kind of companies, same kind of behavior, same kind of experimental design, and the same kind of situation where, unfortunately, you have doctors and patients being taken advantage of. You’ve got these companies that don’t do the proper research. They don’t study. They don’t do clinical trials. They just put this stuff out on the market, and unfortunately it harms thousands and thousands of people.
Mike Papantonio: If you asked 10 people is that how it works, nine of the 10 people say no, this product is only out there because surely somebody tested this goo that they put on the product. You’ve got to believe that somebody tested this in humans before it was put out there, and unfortunately that is not how this works.
Robert, real quick, we’ve got about 30 seconds, is this a risk benefit analysis where the company says we can make a lot of money doing this, we only have to pay out a little money so we come out ahead? When all the numbers add up we make more money. Do you see that same thing happening with this product?
Robert Price: Absolutely. Absolutely. Let’s put this product out there, and if it doesn’t work out, let’s try to blame the patients and let’s try to blame the doctors, and that’s not right Mike.
Mike Papantonio: So the quick on this is the company looks at the numbers, they say we can harm this many people, we’re making this many billions of dollars. At the end of the game, we may have to pay out one billion, but we’ve made 10 billion, so it is a good profit margin. Unfortunately, we’re seeing more and more companies do that. Robert, thank you for joining me.