Justice With Dr. V.

Coloplast Sling Complications Explained | Ben Martin & Greg Vigna

Episode Summary

Millions of women have received vaginal mesh and sling implants, but many are now suffering devastating complications. In this episode, Physician-Attorney Greg Vigna sits down with attorney Ben Martin, one of the nation’s top trial lawyers, to discuss the truth about Coloplast Altis slings and other vaginal mesh devices. They explain: Common complications (chronic pelvic pain, leg/hip/thigh pain, erosion, nerve damage) What recent medical studies (including FDA 522 data) show Why women are still filing lawsuits What legal options may be available if you or a loved one is suffering

Episode Notes

Dr. Greg Vigna and attorney Ben Martin examine the dangers of the Altis mid-urethral sling, a device used to treat stress urinary incontinence in women. They explain how it was rushed through the FDA’s clearance process, its use of polypropylene mesh, and the severe complications it can cause—including chronic pain, nerve damage, and pudendal neuralgia. With evidence from studies and patient cases, they highlight how manufacturers downplayed risks and why this device is considered the most dangerous sling on the market today.

For listeners who are struggling with vaginal mesh pain or complications, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.

TRANSCRIPT:

I'm Ben C!  I'm doctor V.   The medical legal guys. 

V: I'm doctor Vigna. I am a doctor, lawyer and medical expert on injury medicine. And I have a national litigation practice in California, in Washington, D.C., as well as Connecticut. 

B: I'm Ben Martin. I'm a lawyer. I live in Dallas, Texas, and that's where my law firm is. But we practice law all over the country. 

V: Today we're going to be talking about the Altis Mid Urethral Sling and the litigation my law firm and Ben Martin's law firm is pursuing across the country on behalf of women who have been injured by what we believe is the worst device on the market.

B: So a altis sling is a single incision sling, slightly different. And in a lot of ways, a lot different than the standard issue full length mid urethral sling. And I'm going to let Doctor Vigna explain that 

V: Mid-Urethral slings, have been used since 1997 for the treatment of stress urinary incontinence, in women. And it basically supports the urethra, the tube that goes from the bladder to the exit of the body, called the urethral meatus, and it holds up the urethra to help reduce the involuntary loss of urine, which is in convex. The Altice mid urethral sling was, brought to the FDA. With hopes that it would be approved in 2009. And the FDA had some concerns with this new device. Since, like the other devices, it was made of plastic. It was made basically of similar materials, but it had a different anchoring mechanism and, a suture mechanism that allowed that sling to be tensioned. And the FDA had concerns that this was a substantial change in the device, and they wanted this device to be tested before it would come to the market. 

B: Well, let me ask you something, doctor Vigna, a couple of things you said in there. I want you to explain it a little bit more. When you say stress urinary incontinence, let me give it a try. And you correct. So stress urinary incontinence. Everybody knows what incontinence is, right? Your bladder is out of control. Peeing your pants up your pants. Okay. And, you can have mild, you can have moderate, you can have severe, it's not a life threatening condition at all. I never killed anybody. But it can be. I would say uncomfortable can be embarrassing. Inconvenient. So back in the 90s, these companies put out slings and urethral slings. I call them, right in the middle of the urethra to help prevent stress urinary incontinence. And they put these devices in this Altis device. They cause problems. 

V: So in 2009, Coloplast asked the FDA through a submission, the 510 process, to get this device onto the market and just described the 510 process for us. 

B: Well, is 510 okay. And the 510 K process allows a company to point at another product on the market, medical device and say, hey, our device is pretty closely similar to that other device. And hey, FDA, don't make us go through testing of our device and presentation of anything except the fact that, hey, we're similar to another device. Let us put our product in the market as opposed to a premarket approval, where these companies go through all kinds of studies for the FDA to then approve the device and actual approval of device. The 510 K product is not a product that has been approved for sale. It's just been cleared. 

V: The two other devices that it said it was substantially similar, the mini arc from American Medical Systems and the adjust length from Bard. They're no longer on the market.

B: Wonder why? Let's just talk about mid urethral slings themselves. And I don't know if we've explained that well enough what a mid-urethral sling is. Greg, can you explain what a mid urethral sling is? 

V: So you have full length slings. This is the full length slings generally get placed through the vagina, where there is an incision on the ventral aspect of the vagina, and they place the sling right underneath the urethra. And generally it has arms that leave the body either out the side wall through your groin or by the bikini line. But these device, these are all made out of plastic. And that plastic is called polypropylene. They're used for stress urinary incontinence. 

B: Well, and some of the problems with putting plastic in the body. And polypropylene studies have shown that it creates a foreign body reaction. First of all, where your body is trying to fluff it off and get rid of it. When you have a, a foreign object in the body, the body's natural immune system tries to get rid of that foreign body. And so when you're putting plastic in a person's body, not everyone has this problem. But a lot of people try to reject that foreign body. And that's called a foreign body reaction. And FBR and that's bad. 

V: The foreign body reaction happens with any type of foreign material that's implanted in the body. There are some materials that don't really react with the body at all, such as platinum. Okay. And and then there are materials that the body can tolerate better than others. Polypropylene has has been used since the 1950s. It's been known to cause significant foreign body reaction in a significant number of of people who receive polypropylene. And that causes inflammation, scarring, pain, scar tissue, causes contracture, and it can cause significant pain and then in itself called mesh related pain. Or it can cause nerve and muscle related pain because it inflames and scars adjacent tissues, organs and, and nerves. 

B: So if you've got this sling and it's put in the body, there have been studies that show some of these slings contract over 50%. In other words, they shrink. So if you've got a piece of plastic that's attached to some tissue in a body and then it begins to contract, what's going to happen? It's going to pull what it's attached to, and it's not good for the body. And to this day, the manufacturers have not come up with an excuse to explain, oh, it's okay, no problem, no problem. Shrinks. But we put a piece of plastic in, but it shrinks. That's okay. Don't worry about it. 

V: There are other, materials that are currently on the market out of this country. So far, companies that have plenty of money have not, gone ahead to go through the process of bringing safer materials to the United States market. So, in other words, women in the United States are getting 1950 mesh 1990 mesh 2004 mesh, while they're safe for materials that are available at this time. And then the nice organization out of England, they don't allow this device, the single incision slings, they don't allow this device to be implanted in England unless it's part of a study. So what does that tell you? Tell us about the nice organization. 

B: Let me tell you what you now see is it's the National Institute for Health and Care Excellence. A British organization there recommend recommendations, help practitioners and commissioners get the best care to people fast while ensuring value for the taxpayers. That's the NRC. And they actually watch out for the patients in Great Britain. And they speak about patients receiving these devices all over the world. 

V: And their opinion is this device should be studied more before they implant this device. In the United States, this device is being placed in women all the time. The coloplast In 2009, submitted a 510 K to the FDA and and the FDA asked for another study that they wanted this device to be tested to ensure that it is at least as safe and efficacious that it works as well as the other slings that are on the market. And Coloplast, they wanted this device on the market. So they went through what is called an investigational drug exemption. Ben. So tell us about what a IDE study is.

B: An investigational device exemption. And that's it. And all that means is that if a company wants to put a product in the market under the 510 K process, in other words, they want their product cleared just like product A was cleared and B was cleared and C was cleared, not approved. They want to put a product on the market and do the shortcut. They use that 510 K. And they can ask the government or the FDA can tell them, well, why don't you do an IDE study before you put this product in the market so they can do that? They did do that. 

V: So, this investigational drug exemption study provided by Colaplast device and the FDA accepted it and the device got on the market. The one year data had an interesting finding. And I'm going to read it. What they found, they found the most common device and or procedure related adverse event was non pelvic pain occurring in 8% of the subjects. Non pelvic pain consisted of groin, hip or thigh pain. In all cases non pelvic pain was defined as procedural related the woman's up in stirrups during surgery and then subsequently has groin or inner leg, thigh or hip pain. And they said that complaint of pain was from the positioning in surgery and not from the device. Again, they reported in this article, 8% of of women had inner leg, thigh or hip pain from the procedure. It wasn't from the device, it was from positioning. Okay. And they submitted this data to the FDA. 

B: Let me stop you there. So what they were saying, they being coloplast that research that it's their study, yet what they're doing is they're pointing that finger to the doctors. They're going to say, oh, there's nothing wrong with our device. There's nothing wrong with this plastic that shrinks and, erodes. It's the doctors that are putting them in wrong. 

V: Essentially, yes, but they didn't exactly point at the doctor on this. They said, oh, we happened to be because of positioning during surgery. 

B: Who puts the who puts the patient in the position during surgery. Gets the what. Right. Okay. So what's the company doing? The company is saying, hey, not me, not me, doctor. It's the positioning, the patient. It's not the device. That's what they're saying. 

V: They attributed this pain to positioning, not related to the device. And this device gets on the market with what we consider a safety signal. And what is the safety signal? 

B: Way back when there was, a drug called thalidomide. It's back in the 60s, I think, and a lot of women who were pregnant were given thalidomide. And as I recall, I think it was for nausea, during pregnancy and then there were folks who mothers took this thalidomide, and they were born with birth defects, a particular type of birth, in fact. And that was kind of a safety signal. Nobody had put two and two together until studies were done to show that thalidomide caused these, these very serious birth defects. And since then the thalidomide was taken off the market. That safety signal was when those first few babies seem to have had these birth defect. The the company has a duty to do post-market surveillance. They've got to follow along the people who have these products. And there's pre-market analysis for these two different times that safety signals can be seen. But many times these products get on the market just like this one did with problems. And then post-market surveillance goes out the window and you end up with the product on the market for years and years, and it may stay on the market. This product still on the market. Altis is still on the market.  

V: So here in this case, these devices, these polypropylene vaginal mesh devices were having problems. And the FDA said, hey guys, we need to do what is called the 522 study to show that this device is safe and effective. And they asked for another study, a three year study that's called the 522 study. So guess what? After three years is this FDA 522 study showed that safety signal. This device in this 522 study had significant leg, thigh and hip pain, which was not seen in the other devices. And, if you look at table four, in this three year study, you could see cases of leg pain. And in the comparator group, the full length sling group, there was no such leg pain. What was their conclusion? The authors conclusion 522 study they said that it was related to positioning. Same excuse as the ID study. Hey guys. The women in the full length sling group, they're positioned in the same way. They're in the same position. No complaints of leg pain in the full length group. The single incision group 12 cases. When the three year study comes out. They blame it on positioning, and it's statistically not possible if you're in the same exact position during surgery, same amount of time. There is a problem with this device. 

B: I want you to let me do something. Yeah. Talk about this is my machine. Okay, so while Greg was talking, I pulled up an ICE All right. And then. An ICE it's the United Kingdom's National Institute for Health and Care Excellence. Okay. What the NRC says is that with a limited long term follow up and with the potential for complications such as mesh erosion, pain, difficulty urinating, which necessitates proper patient counseling regarding the risks and potential benefits and the doctors and the patients were not given back. Coloplast. The ability to understand what all of the problems are with these slings, right? And so that that's what we're dealing with. 

V: The Altis group caused more pain at all time periods than all the other devices had more dyspareunia than all the other devices at all periods of time, and required analgesics, pain medicine, pain interventions than all other devices at all time.

B: Wow and thats Coloplast. What's the worst sling on the market today? 

V: There's no doubt it's the altis device. And and women who are choosing to have their incontinence treated with the mid urethral sling, they are not being warned that they're being implanted with a device that causes two and a half times the risk of, dyspareunia compared to full length slings. Women are not getting warned that there is inner leg, thigh and hip pain more so than any other device on the market.  

B: I wanted to talk about something that's really important to me. It's important to these cases. You know, we represent women who have this altis device, right? These women all over the country. And you can't believe how badly hurt and hurting some of these women are. We've talked about pain. Pain is a relative thing. Tell us what you have experienced in looking at these cases and the particular problem that they have that leads to these really, really devastating, painful injuries. 

V: Yeah. So I became an expert on nerve related pain and neuralgia. Pain. These devices cause burning and stabbing pain. This Altis device causes neuralgia pain in the Prudential distribution, which has the branch to the clitoris, the perineum, which is the area of your private area and it prevents touching. It causes intractable vaginal pain. It causes intractable bladder pain. It causes anal, rectal pain. And these women are pretty much done okay. Their sexual function is over, they often can't work anymore, and many of them become very immobile because they have to spend time laying down, and because they can't sit there. Catastrophic injuries. 

B: Doctor Resnick there's a study published in the New England Journal of Medicine, 2012. I believe it was. And it was determined in that study, published in the most respected journal in the world, found that only one out of every 200 complications were reported. So let's get away from the study for a minute. Let's just look at underreporting. Think about that. One out of every 200 actual complications is ever reported. Do we even really know, number one, what those people were feeling? Five years? Whole group of people who got it. Not just talking about the 8%. I'm talking about all of them. Why don't we know what happened to those people five years down the road? Because I'll just tell you, because it wasn't study, it wasn't followed up on. Coloplast didn't follow up on it. And why would they? 

V: So get this, Okay. So you have a woman who has intractable vaginal pain, thigh pain, and they need to have this mesh device removed. And obviously they've been hurt bad and they want complete mesh removal even in the best of hands. Sometimes when doctors are trying to get this mesh device out, the anchors break off and they remain in the body, and that foreign body remains in the muscle that is irritated and primarily responsible for the nerve pain it stays in forever. We know this device is the worst on the market. The IDE showed a safety signal. The 522 study showed inner leg, thigh and hip pain. This huge study out of England shows it has more pain at all time periods. Tell us about these. The warnings that these these companies provide. They list every type of complaint known to mankind. Is that a real warning? Doesn't frequency of complications mean anything anymore in medicine?

B: So when physicians are talking to their patients about whether or not a particular device is to be placed into the body, there's a conversation that should take place in a conversation that normally does take place, kind of a risk benefit analysis of the risks. These are the benefits. You're going to be able to improve your stress urinary incontinence by putting in one of these devices. But in making that decision, do the risks outweigh the benefits or do the benefits outweigh the risks? The important risks, the risks that cause problems need to be discussed. If something happens one out of a thousand times as much different than if something happened, 50 out of a thousand times, or 150 out of 1000 times. Right? So that's the frequency of the risk. And then the physician and the patient need to know about the severity of the risk. If there's a risk of pain, how often is it going to happen if there is a risk of another side effect, how often is that going to happen and how serious is the pain? Well, Doc V just explained that particular pedendul neuralgia very severe lifelong problem. And it's harmful. You know, I think what doctor V is getting at is that this company did not tell doctors who were putting this in the body, didn't tell the patients of frequency or the severity of something like pudendal neualgia 

V: Or obturator neuralgia. And in fact, they don't mention prudential neuralgia and obturator neuralgia on their warning 

B: Dr. V has talked about prudential neuralgia. I hope that everyone now can understand and know that's a serious painful sometimes called the suicide disorder prudential neuralgia because it's so painful and it affects these women's lives so much. I hate to say it, but it brings women to that point. Sometimes that's written about. 

V: So doctors have a responsibility here that this data is available in the literature. But I'm Doctor Vigna and I read all the literature okay. And doctors really need to be warned this by the manufacturer of the significant frequency. When women have these acute complications, they are just reassuring women instead of removing these devices early before the body grows in and make these things very difficult to remove. You know, I have to believe that if doctors knew this data by way of warning, they would not implant this device.

B: So if a woman is presented with a choice, you can have a device that does cause problems, specific problems, pain in the groin, pain in the thigh. Would you rather have the device that causes those problems? Would you rather have the device that doesn't cause the problems? The issue is, and the problem is that doctors and patients weren't told about this situation.