Transvaginal Mesh Implants May Lead to Serious, Life-Threatening Injuries



Kendall Dunson: Welcome to the Beasley Allen Report. I'm Kendall Dunson, and Gibson has a night off. Every year many people use a variety of medical devices. Consumers trust that these devices will be safe and will make their lives better. But sometimes they don't work out the way they were designed and can result in serious injury. Tonight my guest is Beasley Allen attorney, Leigh O'Dell. Leigh joins me to discuss the most common medical devices known to be defective. Thank you for joining me, Leigh.



Atty. Leigh O'Dell: Good to be here. Thank you!

Kendall Dunson: Leigh, let's start by telling the viewers a little bit about yourself.

Atty. Leigh O'Dell: Well, I'm originally from this area. I grew up in Prattville and went to Auburn and Alabama to Law School. And then I've been practicing, and now, it's about 20 years. It's hard to believe. It's going that fast.

Kendall Dunson: Time flies when you're having fun. Leigh, everyone knows about our topic tonight is going to be defective medical devices.

Atty. Leigh O'Dell: Alright.

Kendall Dunson: Give us a general or background overview of what medical devices are, and when we talk about being defective, what that means?

Atty. Leigh O'Dell: Sure. The Medical Device Safety Act governs medical devices, and we think of knee replacements and maybe even a heart monitor. That can be a medical device. The ones we're going to talk about tonight are called transvaginal mesh devices, and they're used to repair specific conditions that women experience, post-menopause.

Kendall Dunson: Okay. Now, we know we're talking about transvaginal mesh. What is a transvaginal mesh?

Atty. Leigh O'Dell: Well, a transvaginal mesh is a mesh product used to repair pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse, I never heard of until a few months ago, and it's when organs in the female pelvis move at a position as a woman grows older. And that often causes discomfort in other conditions, and so that needs to be repaired, and that's been happening for hundreds of years in the lives of women. But in the past ten years instead of using traditional procedures, they've been using mesh to try to repair those problems, and that's caused a lot of difficulties in the lives of women.

Kendall Dunson: Now, tell us a little bit about, we know that it's just for women, so in terms of do we have any information about the number of women who might have to use transvaginal mesh?

Atty. Leigh O'Dell: Right. Well, in a year, there are probably 500,000 procedures that are done. Whether it's for pelvic organ prolapse repair or stress urinary incontinence and stress urinary incontinence procedures are probably the most common. And for many women, stress urinary incontinence is something that's not discussed. It's sort of embarrassing, but it occurs when maybe coughing, or sneezing, or with exercise. And so that's a condition that can be very embarrassing and so that procedure to repair those problems is done in hundreds of thousands of women each year. And until the last ten years, those procedures were done using traditional sutures or native tissue repair. But when other medical devices were introduced to address those conditions, some of these challenging problems started to occur.

Kendall Dunson: Now, may I ask a difficult question, Leigh, you may not know the answer, but you talked about traditional means of dealing with these issues versus transvaginal mesh, are most of those half-million ladies who have these procedures are they now transvaginal mesh. However, some doctors do use those traditional procedures?

Atty. Leigh O'Dell: For the vast majority of women, they are implanted with mesh. And when we say transvaginal mesh, what we're talking about is polypropylene mesh that is used to move the organs back into place. What is polypropylene? Well, a fishing wire is actually made out of polypropylene. A lot of things are made out of polypropylene and that material can cause some significant problems when it's placed into the female pelvis and so for a lot of women they are, I say, let me back up and say the grand majority of procedures now for stress urinary incontinence use polypropylene or transvaginal mesh. For pelvic organ prolapse until recently, the vast majority of those procedures also were done using pelvic mesh or transvaginal mesh. But recently, the FDA put out a bulletin that has caused a lot of doctors to rethink what they were using for pelvic organ prolapse.

Kendall Dunson: Okay, well, you mentioned some FDA. When we come back from our break, we'll talk about the FDA.

Atty. Leigh O'Dell: That sounds good.

Kendall Dunson: You're watching Beasley Allen Report. We've got more after this short break.

Kendall Dunson: Welcome back to the Beasley Allen Report. I'm Kendall Dunson, Gibson has a night off. My guest tonight is Beasley Allen attorney Leigh O'Dell. Now Leigh, before we left for the break, we were talking about the FDA. Now, are these transvaginal mesh products are they approved by the FDA?

Atty. Leigh O'Dell: Well, they're actually what's called cleared by the FDA through the 510(k) process these products are placed on the market often without testing in humans which is a surprise really to patients who receive them in physician to place these products, and so there is no testing for safety by the FDA. There's no review of studies in humans for the FDA to make a decision about safety. These products are really placed on the market with minimal testing in what they called a lab bench testing. And we feel like that's one of the huge problems that are associated with these products.

Kendall Dunson: Well, I know you just said the FDA didn't do any testing. What about the manufacturers? Do they test this product before they start, you know, and using more women across our country?

Atty. Leigh O'Dell: The only testing that they did on these products before placing them in hundreds and thousands of women is they placed them in cadavers. And cadavers would be, you know, bodies of people that have died that have been used for experiments, and that is unreal, unrealistic way to try to learn if these products are safe for the female pelvis, which is a very dynamic part of our body.

Kendall Dunson: Okay, that led into what's the real concern here? What are some of the injuries, or what type of injuries are caused by this transvaginal mesh?

Atty. Leigh O'Dell: Well, and that's really some of the saddest parts of this story, the problems are everything from erosion of the mesh through the vaginal wall, which is very painful. There can be nerve pain that causes chronic pelvic pain. This often is a 24-hour, you know, 24/7 type of pain that women experience, chronic infection. They also can have permanent incontinence, both urinary incontinence and fecal incontinence, and painful intercourse. These injuries caused a tremendous quality of life problems for the women who experienced them.

Kendall Dunson: Yeah, that sounds serious now. What is it about the transvaginal mesh that causes this to cause these issues?
 
Atty. Leigh O'Dell: Right, well, there are a number of things that can cause these type problems in women. I think one of the huge things is the way that these products are implanted in women can cause tremendous nerve pain. They're implanted through incisions into the vaginal wall and then through trocars that really cut through very nerve-rich areas that can cause a lot of difficulty for women. The other thing is the mesh which manufacturers represented to the FDA would not change once it was placed in the body. It, in fact, does change and it begins to degrade, and when it degrades there are particles that are slough off essentially into the cavity of the woman, and then that can cause inflammatory responses that lead to a lot of the chronic pain as well, so scarring chronic pain results from that type of inflammatory response that is caused by the mesh breaking down within the body. And so they're just a myriad of causes of the problems that the women are experiencing. And for many of these women, the treatment options are very limited.

Kendall Dunson: Okay, now you just mentioned something that struck me. You said that the manufacturers somewhat gave the FDA wrong or misleading information. Were there any consequences to them telling the FDA that mesh would not change?

Atty. Leigh O'Dell: Well, we're proving that now that in fact what the manufacturers told the FDA was not the whole story, was not the true story essentially. And so what you're seeing proven through the course of litigation is facts being established showing that in fact when the mesh is placed within the body, it does break down and so we're seeing the manufacturers now be held accountable for those statements to the FDA. Today the FDA has not taken any action on some of those statements.
 
Kendall Dunson: Okay. Now we heard earlier that the estimate was half a million of these procedures per year to have this transvaginal mesh installed. What's the failure rate? I mean, what percentage of women who have this install and then have subsequent issues or problems.

Atty. Leigh O'Dell: The failure rate is 10-25% depending on the product that is used in the type of procedure that's done. And for pelvic organ prolapse patients, up to 25% of the patients who have received certain products will experience difficulties over their lifetime. And you have to remember that these products are placed, and they're intended to stay in the woman's body for a lifetime, and so whereas some women don't experience problems immediately but oftentimes 3, 4, 5 years down the road they can begin to experience problems as that inflammatory process continues to escalate.

Kendall Dunson: Explain to our viewers how it came to light that these products were causing these types of issues.

Atty. Leigh O'Dell: In 2008, the FDA issued what they call a public health notice to give the first sort of warning signal that there might be problems, but it wasn't until July of 2011 when the FDA issued another bulletin. But this time very strongly worded basically establishing that for pelvic organ prolapse repair that the use of mesh was not appropriate unless it was some extraordinary circumstance where the traditional procedure was not an option. And so that was really the first time I think for physicians and for a lot of patients, they begin to understand this is a serious problem that is something that needs to be addressed. And for physicians, in particular, I think their habits in terms of what they were recommending to their patients really changed at that point.

Kendall Dunson: Let me ask you a question about the doctors, and I oftentimes know when it comes to the litigation people assume that the doctors are complicit with the manufacturers. It sounds to me like in this particular case, doctors were not complicit with the manufacturers. They were just like the consumers were.

Atty. Leigh O'Dell: I think that's largely the case that women, excuse me, physicians who were implanting mesh into their patients had no idea it'd never been tested in patients prior to being placed on the market. They had no understanding of the true failure rate for these products. That the studies that they were reading in the scientific literature they had no idea that for the large majority of those they were sponsored and controlled and sometimes manipulated by the manufacturers of the products and really used essentially as marketing pieces rather than true scientific studies. And so for a lot of physicians, I think that they look back now and realized that they weren't told the truth and they weren't given all the information they needed in order to make an informed decision about the risks and the benefits of these products.

Kendall Dunson: And then by the same token, if the doctor is fully informed, they can't fully inform their patients.

Atty. Leigh O'Dell: Correct. Absolutely, and so for many many women, they went into these procedures, thinking that there were low risk and a large benefit. And had they known, and I think this is particularly true for those women who had stress urinary incontinence procedures. They had no idea that what they thought was going to be a very simple outpatient procedure could result in them having chronic pain for the rest of their life and into an experience all the other difficulties that they're having.

Kendall Dunson: Okay. Now, who are these manufacturers that were talking about?

Atty. Leigh O'Dell: Well, there are a number of manufacturers, but the primary manufacturers are Bard, Boston Scientific, Johnson & Johnson, and American Medical Systems, and you see that they had a large percentage of the market share for these particular products.

Kendall Dunson: Okay, I think it is a good opportunity for us to take now to talk to some of our viewers. We invite viewers to ask questions by emailing the show, so let's pause and take a few of those questions right now.

[Q&A Intro]

The Beasley Allen Report Q&A with Gibson Vance. You ask, we answer.

[End of Q&A Intro]

Kendall Dunson: Tonight, our email question comes from Shay S, "I've heard it's very difficult if not impossible to remove that mesh device. Is this true?"

Atty. Leigh O'Dell: It is true that oftentimes that once the mesh has been in the body for more this as a small amount of time is 30 days, it can be very difficult to remove the mesh. And so for example, many of the women that I represent have had multiple procedures trying to remove the mesh. And that's one of the most challenging aspects of this public health problem is that once the mesh is implanted, it can be difficult to impossible to remove the mesh.

Kendall Dunson: Tracy emailed this question, "How can I find out what company manufactured the mesh product my mother had implanted?"

Atty. Leigh O'Dell: A number of ways you can do that. First, you can call the physician who implanted the device and ask what device was used, that's one way. You can get a copy of the operative report or what we call the sticker page, which indicates the product that was used in the medical records, and through either of those two ways, you can find out what device was implanted.

Kendall Dunson: Thank you, Leigh, for answering those questions we'll be right back after this short break.

Kendall Dunson: Welcome back to the Beasley Allen Report. I'm Kendall Dunson with the Beasley Allen Law Firm, and my guest tonight is Beasley Allen attorney Leigh O'Dell. Leigh, we left off and answered some viewer's questions, but we talked a little bit about that bulletin that the FDA put out in 2011. What else has the FDA done to make people aware of this health issue?

Atty. Leigh O'Dell: Well, after the bulletin was issued in July of 2011, the FDA actually required the manufacturers to perform studies in actual patients, and you would think that would have been done long before these products were placed on the market but it hadn't been done. And so the FDA required manufacturers to do what they call Section 522 Studies. And in order to keep the products on the market, the manufacturers and these were primarily for pelvic organ prolapse products had to perform studies in patients. And for the majority of the products once they were required to do studies in patients because of the fear that the studies would be negative and they would show that the risk was much greater than the benefit to these patients then most of the pelvic organ prolapse products were taken off the market. And there still remain products for stress urinary incontinence but a large portion of the pelvic organ prolapse products now have been removed. And this is primarily because not only what the FDA did and requiring those studies but also because of the accountability that's being brought to bear through the litigation process very frankly.

Kendall Dunson: Okay. Let me ask you this. Let's say we would have a litigation process. Do you think those manufacturers would do the testing that they should have done before they put this stuff on the market?

Atty. Leigh O'Dell: You know, had the FDA not issued the bulletin and had pressure not been placed on manufacturers through the litigation process those products would still be on the market. In fact, the health problems and the safety concerns would have never been brought to light. I don't think there's any doubt about that. For 10 years manufacturers of these products did all that they could to suppress information about the risk associated with the products. And that was true not only for our physicians but true for patients as well so that they could not make informed choices about the risks and the benefits, and that's really what we want, isn't it? When we make a medical decision after consulting with our physician we want to know that we have accurate information. And I know physicians want to know that as well unless the manufacturers are held accountable for these situations where they have not provided the true rate of risks, the true rate of complications then that can't happen. And we feel like that that is something that a manufacturer should be held accountable for.

Kendall Dunson: Now, we've talked about this new process but they have to go back and do their testing, and some of the mesh material is being pulled from the market, or doctors now going back to the traditional methods either they have to come up with something else to take the place of these removed mesh product.

Atty. Leigh O'Dell: Right. Well, they're going back to what's called native tissue repair which is using the tissue of the woman who is the patient to do these repairs or suture base procedures and these were the traditional procedures. And just because something is traditional it does not mean it's not effective and it can't be the right approach. And so for a lot of physicians now they've gone back to the procedures that they had used in years past and for many women, this results in a good outcome. In other words that their condition is repaired and without any of the risks that are associated with polypropylene mesh.

Kendall Dunson: Now, if we have someone out there who's watching our show tonight and they have a mesh implant and they were having slight symptoms or even serious symptoms. Is there anything they can do where they can go seek treatment for that problem or that condition?

Atty. Leigh O'Dell: If you're having pain, chronic pelvic pain, incontinence, painful intercourse, maybe you feel the erosion of the mesh and many women experience that, and because it's such a sensitive subject many are hesitant to talk to somebody about it. But I would encourage you to talk to your doctor about what you're experiencing and have a test to see in fact if the mesh is something that's causing those difficulties that you're experiencing, so go to your doctor. And I think for many who maybe have been to their doctor and still have unanswered questions then I would encourage them to seek consultation from what's called a urogynecologist which is a specialist that is trained to treat these types of conditions in women, this pelvic organ prolapse and stress urinary incontinence conditions. And so I would seek those medical opinions to get more information to see if there's something that they can be done to help your problems that you may be experiencing. For those of you, maybe you're not experiencing problems, yet I think it's something just to be aware of, and to seek follow-up in fact if you do experience problems in the future.

Kendall Dunson: Okay. I feel a good place for us to conclude this discussion is for you to give us an update on the current state of litigation around the country involving these mesh materials.

Atty. Leigh O'Dell: Well, for the last 18 months, litigation has been ongoing, and against the primary manufacturers we talked about. And a lot of that litigation is denuded in West Virginia, and there was a recent trial that took place. In fact, the jury returned a verdict on Friday for a woman who had a pelvic organ prolapse procedure and had two surgeries trying to remove the mesh. It's still not completely removed and has had tremendous problems, and the jury returned a verdict in favor of this plaintiff for the problems that she'd experienced. And really for the punishment of Bard was the manufacturer on that particular case, and it was a verdict for $2 million. And for that particular woman, that was a very good outcome and light up all that she's experienced in life-altering problems. So trials are ongoing in fact, another trial started today, and I think there will be trials of many cases over the next year, not only in West Virginia but New Jersey and other courts around the country. And we're pleased about that because it's in a courtroom that these facts come to light, and regular people like you and me can hear this information and learn more and really realize what's been done in these cases, and so we're very pleased about what's coming.

Kendall Dunson: Well, thank you, Leigh, for being my guest tonight, that's all the time we have. You can catch the Beasley Allen Report on Sunday nights after the ten o'clock news and on Monday nights at the news at nine on WSFA12.2 channel Bounce TV. Thank you for joining us.

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