Dr. Greg Vigna explores the dangers of polypropylene vaginal mesh mid-urethral slings, devices implanted to treat stress urinary incontinence and pelvic organ prolapse. He explains how these slings can cause catastrophic pain syndromes such as pudendal and obturator neuralgia, leaving women unable to sit, work, or have sexual relations. Dr. Vigna discusses the history of vaginal mesh litigation, the risks of partial versus complete mesh removal, safer alternatives being developed abroad, and the importance of holding manufacturers and implanting physicians accountable.For listeners who are struggling with vaginal mesh pain or complications, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.TRANSCRIPT:Welcome to Justice with Doctor V. I am a doctor and a lawyer. I have a national litigation practice and represent those who have suffered catastrophic injuries. Today's topic is the vaginal mesh litigation lawsuit involving a mid urethral sling used to treat stress urinary incontinence in women. Vaginal mesh litigation really has been going on since the end of 2009. I was still in law school. I was practicing medicine in law school. I woke up one morning and and I looked at the types of devices. I thought, wow, that's pretty interesting where they're putting these devices to support women with pelvic organ prolapse and mid urethral slings, that women were having pain. And I thought that was pretty interesting. So I got online and I wanted to hear what the women were complaining of.And what I was hearing is women were complaining of symptoms of pudendal neuralgia, which is the catastrophic pain syndrome that used to be very rare that most doctors never really heard of. And it presents as intractable pelvic pain where you have pain, where you sit so you can't sit comfortably. It causes you to have in the perineum. The perineum is the area of your body that would be in contact with a horse if you're sitting on a saddle, and it makes that area painful to touch, so that women who had pudendal neuralgia from these devices, they couldn't wear tight pants, they would have intractable pain. That touch would be burning sensation. They would also were complaining online that they were having stabbing pain and growing pains. So I understood that these women had symptoms of neurological injury.They didn't know it and doctors weren't diagnosing them. They were ultimately getting surgery to take out part of the mesh that the doctor thought was causing pain, and they would take out little pieces of mesh, thinking that they were helping it, trying to help them. But the pain is from the arms that are into the legs and going up high up in the pelvis that are getting near nerves.And women were having 7 to 10 surgeries to remove bits and pieces of the mesh and they weren't getting better. And ultimately there was big multidistrict litigation that ended. Thankfully, and ended in 2018. And I was the first lawyer in California to file a pudendal nerve injury case. And I've been suing manufacture for pudendal neuralgia, obturator neuralgia, you know, intractable pain since that time. So women are having up to ten surgeries to get this mesh removed. Why is this mesh still being used? Well, we're going to talk about what mesh does and what mesh is. So vaginal mesh mid urethral slings and they're all made from polypropylene. And polypropylene is basically plastic with a theory that if you put it in it will keep stay in the same place and be able to support structures and the body will grow in that device will be incorporated into the soft tissues and muscles to support things.That's why women with prolapse, that's the falling of the uterus. It could be the bladder, be the rectal. Rectal prolapse. It supports pelvic organ prolapse for women who had babies. So it sounds like a good idea, you know. And then mid urethral slings, they hold up the urethra because if the urethra sags from pelvic, from loosening of the soft tissues around the urethra, the urethra can be supported with the mid urethral sling holding up the tube that goes from the bladder to the external medius. And the urine flows from the bladder through the urethra and then out. What's the biggest issue with using mesh in these surgeries? A mesh is basically polypropylene. It's plastic, and when it's implanted into a woman, it causes chronic inflammation. Inflammation can cause pain. That mesh can cause scarring. You could have muscle pain from the mesh, or you could have mesh impacting nerves that cause neuropathic or neuralgia type pain.Neuralgia is a bad word. If you're a doctor, you know what neuralgia is. It's most severe pain that you can have. That means burning and stabbing pain. These devices can cause pudendal neuralgia and Opteron ader neuralgia to pudendal neuralgia is is known to be a catastrophic pain syndrome. It prevents you from sitting becomes burning, irritated. You can't be touched down there and therefore sexual relations, becomes impossible.Obturator neuralgia, that's pain in the leg and thigh that is burning and stabbing. These are these are catastrophic pain syndromes and destroying women. So when you talk about severity, they get by being on an easy chair like this, tilting back and staying off their bottom. If they start sitting, they get uncomfortable. It becomes very painful and it feels like they're getting stabbing pain. So their best position is is on a reclining chair with pillows underneath their thighs.  Not even being able to sit comfortably is something that affects everyday life. How long do these women have to deal with this pain? Women who have few pudendal neuralgia or obturator neuralgia? Unfortunately, those are life altering pain syndromes that continue the treatments that people can have.You hope that the pain gets 50 to 60% better, and women who get better, 50 to 60% with pudendal and obturator neuralgia, they're very happy with that outcome. These devices, they learned that if a person has one of these catastrophic pain syndromes taking out just a piece of the mesh that might be eroding through the vagina, that won't help the underlying pain.So over the past seven years, there was an article that came out. He proved that for pain, complete mesh removal is superior to partial mesh. What does that mean for an individual patient who has to decide, or individual woman who has to decide between partial mesh and complete mesh removal? Okay, these aren't just small little surgeries. They're they're going into the leg, the vagina going around the urethra.You know, these are big deal revision surgeries. So women need to get to a doctor. They trust that they have confidence and understand his or her decision making with regards to partial mesh removal and complete mesh removal  Pain this severe, how has this not become public knowledge to doctors or patients?So the vaginal mesh litigation, the end result of the vaginal mesh litigation, the big multidistrict litigation where over 100,000 women in a court in West Virginia, the companies made these devices had to admit their warnings to doctors were insufficient to describe the risks of their devices.So they agreed to change their label and they agreed that the device can cause various bad things like chronic inflammation into perpetuity. Scarification, shrinkage of the device, erosion, serious, catastrophic, life altering pain that may not go away with surgical revision. Every complication they were required. These companies put on their warning. If this warning isn't expressed about slings, how long does it take a woman to realize that something's wrong? Pain from caused by a urethral sling can be immediate. It could be within the first few days or any time. And these have been pretty well studied. That polpropylene mid urethral slings 15 to 20% of of the complications are after five years. So these complications can occur ongoing in the time we know that if a woman gets a mid urethral sling, 8% of those women will need to have another vaginal surgery to cut that sling or remove all of it or part of it.For women who have these mid urethral slings, 18% of them will have another surgery of some sort, either a failure of the device to correct incontinence or a complication caused by the device. That's 18% at 15 years  Is there a safer alternative design?Yes, there are safer alternatives in other parts of the world that have not made it to the United States market. DVD that causes less inflammation, less scarring, less pain, and is just as effective as polypropylene. And that's used in Europe and other parts of the world. And now there is a new polymer that's a natural polymer grown from E.coli, which is a bacteria called P4. HB that is completely biodegradable. And you're not going to get chronic complications caused by the device because the device is completely biodegradable. That device isn't on the market. This is huge news for women who've already suffered the pain of this surgery to know there is alternatives. There are other options. Where does the accountability come in? We're suing Colo Plast and the doctors who implant these devices when they cause serious pain, including pudendal and obturator neuralgia, or have significant disabling pain, that women can't have sexual relations or they lose vocational employment because they can't sit and work. We believe that this causes more pain than any other mid urethral sling on the market. We believe that this device causes more dyspareunia and has a defective design, and we are also suing them for failure to warn nowhere. And they're warning do they display the frequency of pain. This device has more pain and more pain that requires medications than other devices on the market.If I had known about all these things and the severity, I would have at least taken the device out quickly. That's a serious harm. When women don't get treated for severe pain after a surgical procedure that may be impacting nerves, there are women who are getting reassured are in a bad spot financially. Socially mobility is impaired. So these are important lawsuits. What else would you want these women to understand on filing the case? Each state has different rules in terms of when a person who is injured and needs to file a claim to preserve their rights. Every state is different. If you're seriously hurt, if you can't sit, if you can't be touched down there, if you have problems with sexual intercourse, mobility, a doctor has told you the meshes is causing your problem.You need to have your rights preserved. You need to call a lawyer pretty much within a few days. From a doctor telling you that the mesh is causing your problem. If mesh removal surgery is planned, we generally preserve the mesh for every client that we, represent, because mesh has will have, pathological evidence of generally chronic inflammation and scarification these things you just can't sit on. 

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