Surgical mesh products have been causing problems in patients for years, depending on the brand and the type of mesh that’s used. But now new complaints are emerging about a surgical mesh product that was initially used as a safe alternative because it was made from biological material. Mike Papantonio is joined by attorney Tim O’Brien to tell us what’s happening.
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Transcript:
*This transcript was generated by a third-party transcription software company, so please excuse any typos.
Mike Papantonio: Surgical mesh products have been causing problems in patients for years, depending on the brand and the type of mesh that’s used. But now new complaints are emerging about a surgical mesh product that was initially used as a safe alternative because of the material that was used. It was biologic material. I’ve got Tim O’Brien with me, the premier lawyer, trial lawyer in these cases. Tim you and I did a segment on the artificial implant that was used, the mesh implant. This is a lot more bothersome because this is a biologic that’s contaminated and it’s not artificial. It’s actually bovine material. Right? Tell us about this case and what you intend to do with it.
Tim O’Brien: Right. So this is, I’ve got this case involving the Integra SurgiMend biologic mesh. And a client came to me through Mississippi, had lost her husband, and he went through a horrific death. And the doctors couldn’t figure out what was going on because he had an infection and the infection couldn’t be beat. Antibiotics, intravenous antibiotics.
Mike Papantonio: Was it sepsis? I mean, full-blown sepsis.
Tim O’Brien: He had full-blown sepsis, which of course led to organ failure and respiratory death. And he died. Then a year and a half after he dies, a recall comes out, says, guess what, Integra? Integra says, for the past five years, we are recalling all of those products because of endotoxin contamination.
Mike Papantonio: Okay. Now explain endotoxin because it’s not just a regular toxin. This is where bacteria dies and out of that bacteria comes some awful things. Right?
Tim O’Brien: Right. It is seriously the Trojan horse. So the body attacks the bacteria, it attacks it, the bacteria dies, the cell wall breaks down, and then out of the Trojan horse comes this thing called an endotoxin. And if it’s one of the types of endotoxin like we have here with the Integra products, the problem is by and large, you cannot treat it with antibiotics. And it is designed to kill, it is designed to kill. And the body, if the numbers are high enough in terms of the endotoxin release, can’t fight it. Now, so that’s what I would call the bad roulette wheel because maybe you’ll get lucky and only a small number is released and the body can fight it. Or you can be one of those patients who has a big load of it, and guess what happens? You start with hypotension, your blood pressure goes down, the doctors say, well, he’s got a fever. Maybe he just got the flu. And then they realize this is much more dangerous because the patient’s organs are starting to fail. He’s going into septic shock and he’s diseased. And so then finally the patient because he or she can’t fight it, succumbs. And so short of that, you can also get bacterial meningitis from this.
Mike Papantonio: Okay. Let me ask you a couple questions. First of all, what you’re describing could be a latent effect. In other words, you have the surgery, it may not be next week after the surgery. It may not be next month after the surgery. It’s possible that that bacteria, that endotoxin rises from the bacteria down the road, isn’t it?
Tim O’Brien: Yeah. So think of it this way. So you got the bacteria living in a condo. That condo is put into your body and the bacteria are fine, as long as they aren’t released from that condo, they’re just sitting there in the old bacteria home. And then when the body starts getting into that condo and start attacking that bacteria and it breaking down, the endotoxins get released and they aren’t content to hang out in the condo. They want to take a road trip and that road trip is through the blood. And then when those endotoxins get into the blood, that’s when the bad things happen.
Mike Papantonio: Tell us how horrible death by sepsis is. People don’t, they hear well, they had sepsis. They don’t understand. This is a horrible, horrible death, isn’t it?
Tim O’Brien: It is because it is not like a heart attack or a stroke where it happens immediately. You know something’s wrong. You’re conscious and you know something’s wrong and the doctors can’t figure out what’s wrong. And the pain associated with an infection like this, an endotoxin infection because it’s not just in your finger where you cut yourself and you have a little puss, it’s in your entire body. So everything is starting to hurt. Your body, I’ve heard it described as sounds like a tuning fork, that when you hit that tuning fork and it’s buzzing, but the sound is pain, it’s everywhere. So the body is like a tuning fork. Everything is painful because of the contamination, because of the infestation of the endotoxins. And then you’re slowly watching your organs shut down and you meet your end.
Mike Papantonio: The truth is, there are companies that make this biologic mesh and they do a good job. They not infected with bacteria. They do what they’re supposed to do. This company didn’t do that. What’s the company? Give us a quick history on it.
Tim O’Brien: Alright, so it’s a company called Integra, and they bought another company called TEI Biosciences, which is located up in Boston, which was a biologic mesh manufacturer, now wholly owned. And what you do when you make a biologic mesh is you don’t cut it out of a cow or a pig or a sheep or anything like that. Instead you get essentially progenitor cells, which are kinda like stem cells from either fetal tissue from a cow or neonatal newborn tissues. And you propagate that, you let that grow. But because it is from an animal source, animals like everything carry bacteria, the testing for the bacterial contamination is of critical importance. The most important thing you can do. And so what happened with Integra starting no later than 2018, and in my estimation probably likely before then, they were not assaying the material well enough. In other words, they weren’t testing it to ensure, give a hundred percent confidence that there is no bacterial contamination.
Mike Papantonio: Didn’t they get a warning from the FDA saying, you’re not doing this right. We’ve inspected, you’re blowing this. You got a responsibility, people could die. Didn’t they give them warning letters about it?
Tim O’Brien: They did. And let me tell you, to get the FDA to come to your door and go through an inspection, it really takes, it’s not par for the course. You really have to have done something or the FDA has seen something that they don’t wanna see. So it started back in 2018 and 2019, and the FDA basically gave them a warning to the warning letter called a 483. You do not want to get a Form 483 because it’s very detailed. It says, we found this, we found this, and you company have committed to fix it. And so what happened was they committed to fix it. FDA didn’t follow up. And then lo and behold, five years later, there’s a recall involving much of the same problems that we’re seeing with that 483. That then triggers another FDA inspection. They come issue a 483 and soon after that, a warning letter and a warning letter is problematic because 483 is, you can keep quiet. A warning letter is public for all the world to see.
Mike Papantonio: Okay. Most folks that have been following this litigation for decades understand who you are. They understand that you’ve led the litigation in all types of mesh cases. How did you get involved to where you uncovered step by step, the case that you’re getting ready to go to trial with?
Tim O’Brien: So on the Perfects plug case, I got involved about five years ago. There were attorneys, young attorneys, great firebrands, people who had done transvaginal mesh litigation. And they came to me and to you and said, we think we’ve got the same problem that was in transvaginal mesh, but in hernia mesh. There’s a lot of cross pollination here. So I got involved and started looking into it, and I immediately realized this is number one, an under-regulated industry. And number two, it was using products and systems that were just utterly deficient. And the problem is, it’s so widespread. Hundreds of thousands of people have used the synthetic meshes, and now in the background, the biologic meshes are coming on as an alternative.
Mike Papantonio: You like the alternative, if it’s right, I take it. You like the biologic mesh if it’s done properly, this was not done properly. Is that kind of what your case is about?
Tim O’Brien: That’s right. This is not about the material itself. It’s about what you do with the material. Recognizing it’s coming from a non-human source.
Mike Papantonio: We’re gonna put these companies up, SurgiMend, ReVize, TissueMend, and PriMatrix.
Tim O’Brien: Right. So TissueMend is actually a Stryker product, but it’s made by Integra, by TEI. So that’s what we call private label. They just simply punch it out, put the Stryker label on it. So all the problems go back to Integra’s Boston facility. And those are the biologic products that they make.
Mike Papantonio: Hundreds of cases, thousands of cases. How many are out there?
Tim O’Brien: It remains to be seen. We know that tens of thousands of patients have received these and we, I know from the standpoint of, I just had a client call who lost her husband. My estimation, it’ll be in the low thousands, in the several thousands of cases.
Mike Papantonio: Tim O’Brien, good luck with this. It’s an important case. Again, I’m always amazed corporate America, if money’s involved and they can say, I’m gonna put this product out there and I’m gonna leave it out there as long as I can, this product was not recalled when it should have been recalled. Was it? There was a time gap where they knew way before the recall. They knew way before that they had a problem and they kept it out there anyway, didn’t they?
Tim O’Brien: Yes. They could have recalled it. Stopped manufacturing, got the problem fixed when they first discovered it back in 2018. And instead, tens of thousands of these were implanted into patients.
Mike Papantonio: I can tell you, this company does not want you across the council table. They’re in for a bad day. Thank you for joining me. Okay.
Tim O’Brien: Thank you, Mike.
