TVM Overview: A Conversation with Kila Baldwin, Anapol Weiss

Transvaginal Mesh, or TVM, was once the largest mass tort on the federal docket. Though the MDL closed in November 2022, TVM-related lawsuits are still being filed in state courts. Kila Baldwin, an attorney with Anapol Weiss, has been working on behalf of women injured by TVM for the past several years. We sat down with her to learn about what's happening with TVM cases today. Watch the webinar here or read the transcript of our conversation below. 

Libby Vish: To begin, why don't you talk a little bit about what TVM is used for and the women who are impacted.

Kila Baldwin: Sure, TVM stands for transvaginal mesh. They are plastic mesh devices created to treat pelvic organ prolapse, commonly called POP, which is a herniation of the pelvic organs and women. Your organs generally start to sag as you age, and after you have children. TVM is also used to treat stress urinary incontinence, sometimes called SUI, which is the involuntary leakage of urine when you cough, you sneeze, or do a jumping jack. Again, that happens as women age typically a lot of times after childbirth, or when women hit menopause. 

So obviously, these products were implanted solely in women. But the ages can really vary. Some women develop SUI or POP right after they have children, so very early on. For the majority of women, it takes a little bit of time and going through the aging process. It'll happen in their mid-forties, mid-fifties all the way up into their sixties, seventies and eighties. As they age, naturally the tissues wear out a little bit.

Libby Vish: When you think about these conditions, is TVM the only treatment option?

Kila Baldwin: Absolutely not. If you go back in the history books, for years and years before these products hit the market, doctors could do simple surgeries just using a couple of sutures to treat these things. Using the women's own skin, you can stitch up the ligaments to make things tighter and fix the herniations. If you're in need of a sling or more skin, you can graft skin from elsewhere in the body. So you absolutely do not need a foreign body implant.

Libby Vish: Do you see doctors after the TVM litigation go back to that practice or are they still using these products?

Kila Baldwin:  Honestly, it really varies. You see some doctors who have seen the complications of these products or gotten involved in the mesh removal surgeries, and they have pretty much sworn off mesh altogether. They instead are going back to those traditional surgeries. The big risks with those traditional surgeries is that they don't work. After five to ten years, you might have to get a second surgery. But you're not going to have some of the more serious, permanent, untreatable complications that you would have with pelvic mesh. Now, some doctors who don't treat the women with the complications or haven't seen the women with the complications, are still using mesh even to this day.

Libby Vish: What are some of the injuries associated with TVM?

Kila Baldwin:  So one of the big issues you've got with implanting mesh in your pelvic area is the skin there is meant to contract and expand and be fluid so that you can have intercourse, so that your bladder can expand and contract, so that you can take bowel movements, so that you can birth children. What you're seeing when you get plastic mesh is it makes the skin scarred, hard, tough, and it can't move fluidly, and that creates all kinds of problems. 

The pelvic scarring is a problem because the skin can't move and then you're going to get where the plastic mesh starts to erode into tissue. It can erode through your vagina, bladder, and urethra. You can have pain, and I'm talking very, very severe pain with sex to the point where women are avoiding sex or can't have sex altogether. Women can also have permanent pelvic pain. They are just walking around day to day with constant pelvic pain. The mesh can also erode into other places. I've seen women who have had mesh erode into their spinal column and develop osteomyelitis. You can get pretty severe infections from the mesh, and obviously urinary dysfunction if the mesh goes into your bladder or urethra. But the real issue is that these problems are very, very severe and likely untreatable once they occur.

Libby Vish: What is the treatment if you have erosion or infections?

Kila Baldwin:  Obviously, doctors are going to tell you that you need to get the mesh taken out. If the mesh is rooting through your vagina,  into your bladder, or into another organ, you need a surgical mesh removal. Removal surgeries can get some of the mesh out. But once implanted, it is nearly impossible to remove all of the mesh. So you do have a lifelong risk, and with every pelvic surgery you get, you're going to get more scar tissue, which again, is that tough tissue that's not as fluid as it needs to be in the pelvic area.

Libby Vish: Can the infections be treated? Are you seeing chronic infections?

Kila Baldwin:  The infections can be chronic. Some women suffer with urinary tract infections essentially for the rest of their lives, and as their body builds up the tolerance to antibiotics, they can't be treated. So women just have to simply deal with them, which is horrible. And then, as I said, some women have the mesh erode into other organs, and it creates much more serious infections like osteomyelitis or things along those lines. I've seen one case where it was so severe that the infection spread to a woman's leg. She ended up getting gangrene and lost her leg as a result of pelvic mesh.

Libby Vish: When you and I had this discussion first, we were talking about the TVM litigation, and you mentioned there is a new product category called Y mesh. Help us understand what that is and how it’s different from TVM.

Kila Baldwin:  So earlier, I talked about pelvic organ prolapse, which, again, is when your organs herniate or sag down. Very early on, there were kits sold for the treatment of pelvic organ prolapse. An example is the Prolift, and many of these kits were voluntarily taken off the market by the manufacturers. 

When the FDA asked the manufacturers to do more studies about their safety and efficacy and after taking them off the market, the manufacturers came out with new products and new kits known as Y mesh, called that because they are shaped like a giant Y. These are not technically transvaginal meshes, because they are not implanted through a vaginal surgery. They are implanted through an abdominal route, but they are then placed under the pelvic organs the same way the transvaginal mesh kits were for the treatment of pelvic organ prolapse. So it's treating the same condition, but it's not technically a transvaginal mesh. However, we're seeing the very same injuries because the mesh again, is plastic. It creates this hard, scarred tissue, and it can erode into the organs the same way the other kits did.

Libby Vish: One thing I remember from the TVM litigation is there were conferences or weekend getaways to teach doctors how to use these products. Is that something you're seeing with the introduction of the Y mesh?

Kila Baldwin:  Absolutely. The big pharmaceutical medical device manufacturer companies spend a lot of money on marketing these products. One of the ways they market them is by hiring key opinion leaders or preceptors to teach these products to their colleagues. They sponsor dinners, they sponsor weekend trips, they sponsor trips for people and doctors to come and see surgeries so that they can spread the use of them and obviously make more profits.

Libby Vish: What is the market size for Y mesh?

Kila Baldwin:  Honestly, the Y mesh litigation is somewhat new, so I can't say there's been very few cases actually litigated all the way to a trial to date, and there hasn't been a lot of discovery or information learned about it as of yet, because it was not part of the MDL for the transvaginal meshes.

Libby Vish: There used to be an MDL in West Virginia, but that’s been effectively closed, right?

Kila Baldwin: Yes, essentially all the firms with large inventories have settled them. There were some cases that weren't settled that were remanded out for trial. They're few and far between now, and they are not accepting new cases into the MDL. So if you do get cases, we're seeing in Bergen County, New Jersey there's an MCL, a multi-county litigation, open for Ethicon and Bard, who are headquartered in New Jersey. There are Boston Scientific cases being filed where Boston Scientific is headquartered in Massachusetts, and Coloplast cases being filed in Minnesota, where Coloplast is headquartered.

Libby Vish: Are these the only options for where you can bring these cases, or are there other jurisdictions that are possibilities?

Kila Baldwin:  There are always other possibilities. It really depends. In some cases, it's appropriate to sue the implanter, either for not implanting the mesh appropriately or properly, or for failing to warn the women about the true dangers that they were aware of with the mesh. In those cases, you can typically file in the state court where the mesh was implanted. So it really varies based on where it was implanted. It really is a case by case analysis here, and I think that's what's important. It is no longer truly a mass tort, so each case needs the analysis of looking at the woman's medical records about what happened to her, about what warning she was given, and when she had symptoms, and what those symptoms were.

Libby Vish: So let's talk about some of these verdicts. There is a decent amount of information out there about these products, and when you balance that with how horrific the injuries are, these verdicts are less of a surprise. 

Kila Baldwin:  It's absolutely horrible when you hear these women and their individual stories about the ways they've suffered, and the fact that they can never have a sex life again, they walk around with constant pain, or they deal with chronic infections. I'm glad that the juries really listened to the evidence and listened to the damages. And not only did they give significant compensatory awards, but significant punitive awards as well. 

Libby Vish: Do women typically know what type of mesh is in them?

Kila Baldwin:  It really varies. It's important as part of the client screening process to talk to the women about it. Most women know they got a mesh, and it really depends on what the doctor tells them. Some women know very specifically the brand and type of mesh they got. Some women can only say “I had a sling for the treatment of SUI.” So it really varies, and you have to talk to them. But it is somewhat irrelevant what type they had in the initial screening process, so long as they know they had mesh. You can then go and get their hospital records and look at the implant stickers to see what it is they had.

Libby Vish: Let's talk about how firms can get involved as they’re seeing these cases. 

Kila Baldwin:  There are firms  who are still advertising for the cases, and you'll see ads pop up for them even though the MDL has resolved. Firms who do a lot of mass torts are also going to get phone calls from women who've had these implants. What's important to do is just talk to the women. Ask them if they got mesh and other things along those lines. Because there is no longer an MDL , what you're going to want to do is refer the cases to a firm that has a team and are prepared to litigate them as one off single injury cases. You have to be prepared in order to get full value for the clients, and work each one up individually.

Libby Vish: As you and I have talked about this, a great point you made is that women may still be calling the firm in their local market. And maybe they're not litigating TVM cases anymore. But just because they're not litigating these cases anymore doesn't mean that they can’t train their staff to ask the right questions and still help that client find someone like you who's very involved in the litigation, really  understands, and has had great results.

Kila Baldwin:  We see a lot of women who have called smaller firms and been turned down because they were told there is no way to file a suit now the MDL is over. And then they do a little research and find us. But I think you certainly can train your staff to ask the women if they've had a transvaginal mesh or a mesh for SUI or POP, and take it from there. There are definitely still litigation options for women, so they're not just out of luck.

Libby Vish: What can you tell us about the criteria for these cases?

Kila Baldwin: There are the prolapse products which were for the treatment of pelvic organ prolapse. This includes the Johnson & Johnson subsidiary, Ethicon’s, Prolift and Prosima. Boston Scientific had the Upsylon, Xenform, and Uphold. Coloplast had the Restorelle. And Bard had the Avaulta.

For the treatment of stress urinary incontinence, J&J had TVT and its variations including TVT-O, TVT-S, TVT-E, and Abbrevo. Boston Scientific has the Advantage, Solyx, and Obtryx. Coloplast has the Altis and Supris. And Bard has the Align. Some women will just say, “I know I had what's called a sling” because that's what it is. It's a sling that supports the urethra. So again, it can vary. 

And then for the Y mesh that we talked about, we're seeing the Alyte, Restorelle, and Upsylon.

Libby Vish: Tell us about the latency on some of these products.

Kila Baldwin:  In some women when the products are implanted, they're effective and they don't notice any symptoms. They don't have any problems for long periods of time. I've seen women who can go five, six, even eight years with no problems at all. And then one day, the mesh erodes through their bladder or through their vagina or they get a chronic infection, so there can be a latency of injuries. And it's important to remember, too, that  even though the MDL resolved, the sling products for SUI are still being implanted to this day. So you can have women who got later implants after the MDL essentially shut its doors down. And Y meshes are still being implanted to this day.

Libby Vish: So the sling products are still on the market. How did the warning labels change, or or did they change?

Kila Baldwin:  The labels have changed over time and gradually become more specific to include the full host of all of the injuries such as pelvic pain, scarring, pain with sex, infection, erosion, and extrusion. The big issue with the labels is they aren't specific enough about the severity of the problems and the chronicity of the problems. The fact that in many women, they will not be treatable whatsoever, even if they get their mesh removed. And they also don't mention the true frequency rates. And that's really important, because if you've got an injury that's so severe that it's likely not treatable, and it happens frequently, that is an important part of the warning process.

Libby Vish: You read “infection” on a label and think “Infection? Ok, I’ll get an antibiotic.” I'm imagining a minor post-op infection or maybe one urinary tract infection a year – not a big deal. 

Kila Baldwin:  Right, and the issue here is that they become reoccurring. They become untreatable because your body becomes resistant to the antibiotics that treat them. And the infections can spread and trigger much more serious problems.

Libby Vish: What are the important dates to look at for considering statutes of limitations?

Kila Baldwin:  It will be relevant when a woman got her mesh implanted. Some women get their mesh implanted, and from that first day, it's a problem, they are aware it's a problem, and the statute of limitations is triggered. In some women, there can be that latency period where they don't have any symptoms, and the statute of limitations does not get triggered until they A) have symptoms  but B) are aware that the symptoms are being caused by the mesh. So what that means is, if you get your mesh implanted and then six months later you have some bleeding, that doesn't necessarily trigger your statute of limitations unless you knew that bleeding was caused by the mesh. We see a lot of women who come and tell us when they first had symptoms, they asked if it was the mesh, and their doctor told them no. They investigated further and were repeatedly told it wasn’t the mesh. So it wasn't until a year or two  years down the road that someone finally told them, “It's your mesh, and you need to get it removed.”  So these are all important dates that you have to look at, and sometimes the women can be a little fuzzy on the dates, and you have to get the medical records to really analyze it.