Women face a number of unique health needs, many linked to different stages of life. For example, a younger woman may be more concerned with making the right choice for birth control. After childbirth, the same woman may need to address pelvic health such as incontinence or organ prolapse which can occur after delivering a baby. A more mature woman may face the need for surgeries such as hysterectomies or the removal of uncomfortable growths in the uterus called fibroids.
There are a number of products on the market intended to help women address their healthcare needs. Certain options are safer than others, and through no fault of their own some women end up facing serious health issues caused by a drug or device meant to keep them healthy.
Joining us on the show today is urogynecologist Dr. Chris Walker. Walker is a highly trained surgeon who specializes in many aspects of female reproductive and pelvic health. Women come from all over the country and even from outside the United States to seek his expertise. He touches on a controversial surgical device called a power morcellator, problematic transvaginal mesh implants and possible complications of the Mirena IUD.
The words “power morcellator” alone already sound ominous. One woman remarked to me, “It sounds like a power tool.” Well, essentially that is what the device is. It resembles a power drill with blades at the end. Doctors use it in less invasive surgical techniques to remove fibroids or pieces of tissue. Ideally, these techniques allow patients to health more quickly and have less blood loss.
But recently, the FDA warned doctors and patients that there is a 1 in 350 chance that the devices may spread undiagnosed cancerous cells in the uterus and in the abdomen.
Walker explains what these devices are, how they work and the possible risks associated with them.
As a result of age or after childbirth, women can suffer from incontinence or pelvic organ prolapse, a condition where the pelvic muscles can no longer hold up the organs and they sink into the vagina. Device manufacturers took hernia mesh and marketed it for use in treating these disorders, and it became the “gold standard” of care.
Unfortunately, thousands of women found that the implants ended up causing them hellish pain, nerve damage and the mesh even eroded the walls of the vagina and uterus, damaging other organs.
Walker is probably best known for his work in surgically removing problematic transvaginal mesh implants – a very complicated procedure that encompasses multiple surgeries, including vaginal reconstruction. He treated a number of women for complications from this product and calls it a “horrific plague.” He and his expert team successfully treated a number of women and he offers a message of hope to women “suffering in silence” from these terrible complications.
Bayer markets its Mirena IUD as a convenient, hassle-free method of reversible, hormonal birth control that can last up to 5 years. Doctors implant it into a woman’s uterus and the small piece of T-shaped plastic slowly delivers hormones into the body to prevent pregnancy.
As a laparoscopic surgeon, Walker also had patients referred to him after they used Mirena IUDs and the small, devices ended up migrating in the body. When these devices move in the body, they can damage other organs and require more than one surgery to remove.
Last modified: October 30, 2017
Michelle Llamas: Today on Drugwatch Radio we've got Dr. Chris Walker. He was actually our very first podcast guest on the show so it's very wonderful to have him back on the show today. Welcome back, Dr. Walker.
Dr. Chris Walker: Michelle, thank you so much for having me back.
ML: You are an expert in a lot of things dealing with women's health, since you are a urogynecologist, specifically pelvic health. One of the things that has been in the news lately has been this device called a power morcellator . . .
ML: . . . and I think some women have never heard of this so, could you briefly say what it is and what it's used for?
CW: Sure, so, a power morcellator – this technology really came around in 1993, and what it really is, is a cylindrical blade that’s used to shave off tissue. Usually, uterine tissue, but it can be used in other areas of surgery also, such as the kidney and spleen. But what is done – imagine trying to shave a block of ice, so basically, or you’re peeling an orange. This is very sharp blade that's rotating and as it rotates it's actually extracting a core strip of tissue. And in the field of gynecology, we use it to extract uterine tissue. Specifically the uterus and fibroids, and it's a tool that we use in order to take out large masses through very small openings, thus facilitating minimal invasive surgery.
ML: It was sort of something that would allow patients to heal quicker, maybe less blood loss, things of that nature right, during surgery?
CW: Exactly, because the alternative it to do, uh, an old fashioned approach which is the laparotomy, meaning you make an incision in the abdomen and of course we know that those incisions, if you make those type of incisions, you have the associated increased risk of complications, such as infection, blood clot, just to name a few of those potential complications that can arise from those larger incisions.
ML: So, there were definitely some advantages that doctors saw but recently, the FDA released a warning about these tools because what ended up happening was they were spreading undiagnosed cancerous tissue, right, in the pelvis and in the uterus and in the abdomen. So what is your take on that and since this new warning has come out what is your opinion of these devices?
CW: So, the FDA estimated that the risk of an unsuspected uterine sarcoma would be roughly around 1 in 350 and so they came out after a situation arose in a patient, whereby the instrument was used, and unknowing to the doctor, she had an undiagnosed uterine sarcoma. So, that's why this, you know, these changes took place so rapidly. So essentially uterine sarcoma are very uncommon types of tumors, so because of this situation arose, the FDA issued a warning stating, now doctors, you need to be very careful and when you have these types of cases, make sure to do a thorough pre-op, uhm, assessment. Make sure that the patient that you are going to take to surgery has a minimal risk of a sarcoma before you use this type of technology.
ML: Now, I think the FDA was saying though, about that, that it is so difficult to tell that a bunch of hospitals have just actually stopped using it altogether.
CW: You're correct.
ML: And is that probably a safer way to go about it?
CW: You are correct, so because of the multiple avenues that doctors have to take now to make sure before you perform any morcellation, you don't . . . so to do no harm, a lot of hospital systems have uhm banned or taken the product off the shelf. Those systems that continue to do it, you know the doctors are encouraged to remember the age factor. Any woman who is less than 35 years of age has a lower incidence of a sarcoma.
ML: I gotcha.
CW: That's more commonly seen in women who are more mature in age – usually in women over the age of 65. And if the uterus is a large, rapidly growing mass, or if you had a patient with a hereditary condition, women who have gone through . . . or radiation, then, those are ladies who you would definitely want to be heightened awareness to minimize the risk of taking that type of patient to uhm, surgery and morcellate. That's somebody I wouldn’t be doing that in.
So these are some of the things that the FDA really brought to the table and said listen folks, you really have to think carefully and not use it for every patient to let…but as you correctly said, hospital systems, they don’t even want to take that risk. They have completely taken it off the shelves.
ML: Let me go ahead and take a quick break here and we'll be right back.
ML: Alright, welcome back to the show, we are speaking with Dr. Christopher Walker and he's told us a little bit about some power morcellators. Welcome back to the show again, Dr. Walker.
CW: Thank you so much, Michelle.
ML: A lot of women are still having issues with some of these mesh implants. Can you tell us about any new trends you might have seen? Have you seen an increase in some cases that you've been treating for mesh problems?
CW: I have really been saddened by the volume of cases. It is really a high number of ladies who are unsuspecting of having mesh-related complications. And I will say this, it's to the point where I am having patients flying in from Italy, the United Kingdom, it's all international. By these ladies who are identifying their bodies and finding out during intimacy, this is not comfortable.
One of the hallmark things that I am finding in my evaluations of these patients is that roughly 1 to 2 years after having the mesh implanted they'll start to say that during intimacy, it's just not pleasant, not comfortable. They may have to change positions. The mesh starts to contract and tighten up, and as it tightens up, they start to notice those symptoms. They also start to have situations of incomplete emptying of the bladder. They have to bend forward to empty sometimes, you know. They have to rock on the commode to try and empty the bladder. They find themselves having recurrent bladder infections.
I had a patient yesterday, she flew in from Arkansas, and she had recurrent bladder infections. She was then placed on an antibiotic chronically because the physician had not really put two and two together that the mesh had contracted so much that she couldn’t empty the bladder properly, and the poor lady was having recurrent bladder infections because of it.
ML: Yeah and that's very uncomfortable, so I can imagine . . .
ML: Some stories about women who couldn’t even go to the bathroom at all because their bladder had been so tied up with the mesh that it was blocking, it was blocking the pathway there.
CW: Oh, you are correct. These surgeries are very involved, but it's God's work. This is what we do and uh, we are determined to help to relieve them of their suffering so . . . We are roughly taking about 30 to 40 mesh cases a month.
ML: That's phenomenal.
CW: In fact with the reconstructive surgeries we are doing, we are one of the highest volume that we have. They fly in, and we have a whole team that's dedicated to serving these ladies now because of the volume. Thousands of ladies are suffering, and because of the sheer volume, we've had to dedicate an entire team on my staff to assist ladies with the most simple things. I mean finding a hotel, getting here to the office, simple logistics we are able to assist them. Because the last thing a lady needs to worry about, or her partner, is how the devil to get to the doctor's office. You know the poor lady is so frazzled with pain and suffering that we try to relieve them of these issues by taking away the frustrations of life by trying to help them with this mesh aspect of things.
ML: Wow and you, you hit on something really good there. Uh, that I don’t think a lot of people think about. This condition in particular really puts a lot of stress and worry and pain on the patient, so I'm glad that you have an entire team that can help them with, like you said, the simple things. Let's find a hotel for you, let's find out how you can get to the office. And, I mean, just those small things can help these women so much. So, that's a fantastic service that you have, for sure.
CW: Oh, thank you.
ML: Plus you know, your bedside manner is, is so important.
CW: My philosophy is to treat every patient as if she were my own, a member of my family. Be honest, approach a problem. We always want to get the office notes so we know what was put in. If you know what was put in and you know how it was put in, then you know how to take it out effectively and efficiently. And the, we can start the journey together. Now, and, I'm very upfront with my patients. We really pride ourselves in being honest and transparent and setting up realistic expectations and goals.
Some of these surgeries are so extensive we have to take out the mesh first and after we take out the mesh, then the next phase is the reconstructive phase whereby we are – imagine the vagina is a tube, it has a roof and it has a floor. So in many cases, there are cases where I take out the mesh and there is really nothing left. So what I have to do is put in a new roof, quote unquote roof to the vagina, and I don’t use mesh again. I use a biologic graft, uhm, human tissue. Because they are human beings, I don't use other stuff. And the same applies to the floor of the vagina. I will use human tissues, a graft. And so, that is what I would want with my wife. So that is why I spend a lot of time. And after we do that, you know, once we have rehabilitated the area, then the next thing comes the process of physiotherapy, and all of these aspects of therapy we have here in our office setting. And of course, if the patients are traveling from out of town, we will collaborate with their physicians in other states and other countries.
ML: So that's fantastic. That's another thing that a lot of women don’t understand too. After the surgery there's so much more to do, right? So much more therapy. Just to make sure everything works correctly.
CW: Yes, yes, but I want to share with them that there is so much hope. I will never forget a dear, dear patient of mine. She drives 8 hours to see me, due to of course the HIPAA laws, I won’t mention her name . . .
ML: Of course, of course.
CW: . . . out of respect but she is an amazing, amazing human being. At the end of taking out the mesh, I would say roughly 80 percent of the vagina was gone. There was no vagina 80.
ML: Oh, my goodness.
CW: And then afterwards, I gave her . . . I took it out, I sat down with herself and her husband and we started the journey together. And what we did, I took out the mesh first, and then afterwards, four months after we put in a new roof, quote unquote of the vagina. Then, after that we put in a new floor. And then, came the third surgery where had to lift and support the new roof and floor. And we support it to a ligament known as the sacra spinal ligament. And I am here to tell you and the audience listening that she is amazing, she is doing very, very well and she came by here for Labor Day to visit with me, and I was delighted to see her. And everything functions well and her marriage is better than it has been in years. So I give God thanks for that blessing for her and we can help others also who are suffering in silence because of this horrific plague.
ML: Just what you said there, what a great hopeful story for other patients, you know that – so many of them think that "Oh, my goodness, this is it. I got nothing left and there is no way I can get over this." But when you tell a story like that, it just brings so much hope, like you were saying, so that's fantastic.
CW: Oh yes, oh yes. And she will be a great guide and support for my patients because you know there are many ladies I see every day with this, with these mesh complications. Literally every day. We have about I would say three to five patients a day now with mesh . . .
CW: . . . problems. They are finding us and they read about what we do. What we are doing and how we do it. We try our best to avoid major abdominal surgery and try to approach it vaginally, so we minimize the recovery process in the extraction of the mesh. So many ladies are depressed, and they really have no hope. They feel that this is the end of the road. I have a group of ladies who have travelled the journey with me and they act as patient advocates. And they're there and of course they release their names to allow me to give the new patients their names and phone numbers so that they can walk the journey with them. Because it is easy for me as a surgeon to say, "You know, bear with me, wait for three to four months for the second surgery." I can say that because I'm not the one suffering. When she talks to someone who went through the same journey, "You know what, just bear with him, let him take it out, every week you will see the changes. Positive changes, week by week." They are able to cope with these life changing events easier.
ML: Again, support. Another key tool. And it is so wonderful that your own patients are helping other patients. So, that's fantastic.
CW: Yes, because it is a team approach. I believe in a team approach because you know, there's no "I" in the letter team.
ML: Yes, you are right.
CW: You know in my practice I don’t believe in the "I" concept. I am only a member of the team and we have a team approach here at Urogyn Specialists of Florida and what we try to do is to really focus on each patient on an individual capacity. Based on each patient's complaint, then we create a treatment plan, implement the plan with different members of the team as required. It may require pelvic floor therapists, physical therapists, it may require psychological counseling, it may require just a support group, you know, for us to get the support group involved. You know whatever it requires. We have my dear friends who are urologists, we work extensively with them. Colorectal surgeons also are very close friends of mine and so we have a whole team of experts who will support these ladies who have suffered.
I mean, I tell you Michelle, if you see some of the meshes…I have a case where the mesh had eaten its way into the intestines, into the bladder and into the uterus.
ML: Oh, my goodness.
CW: I mean, this is a case that we are going to write about in a journal. So with three surgeons at the table, one being the colon surgeon, the other being myself and the urologist. Because of God's grace, she is doing amazingly well. She's gotten back her life and she's back at work now.
ML: That's a great success story. Teamwork, like you said. It's not just one person.
CW: Teamwork. No, not one person. And we all know who is the ultimate person who controls the team. You know, and I believe in that very much, so. I appreciate, you know, all the support from above.
ML: Definitely, I am sure other ladies do too, so that's fantastic. Let me go and take a quick break here and we'll be right back.
ML: Welcome back to the show, we're speaking to Dr. Christopher Walker and he's told us about some power morcellators and of course some problems that are still going on with transvaginal mesh. We've got one last question to touch on here, uh, from our listeners. It's about the Mirena IUD, uh, which is a birth control device. And there have been some reports about this device moving in the body and how it has to be surgically removed, sometimes. Uhm, have you come across any of these sort of issues in your practice?
CW: I mean, I'll be very frank with you I've taken out two of these IUDs that had migrated into the abdominal cavity. Not common by any means, but because I'm a laparoscopic surgeon, two cases were referred to me, and they had the complication of the IUD working its way through the uterus. And it had now entered the abdominal cavity, and I had to go in laparoscopically and remove the devices.
ML: When it moves through the uterus, is there damage to the uterus? And could there be damage to other organs because of this device moving around?
CW: Well, yes, it certainly can. So, in the uterus you can have intrauterine adhesions. You can have the endometrial cavity adhesions. If it is in the bowel, you can have it attaching to the bowel and causing any number of complications that can arise. You can have bowel perforation, abdominal pain just to name a few of the potential risks associated with it. Uhm usually, there is a sheet if fat in the abdomen known as the omentum. And it usually gets, the omentum goes and traps it and tries to prevent it from migrating through the body. The omentum is like the policeman of the abdomen.
ML: I see.
CW: So it tried to prevent naughty things from taking place. It tries to wall it off. If not, then you can have the Mirena actually causing bowel problems.
ML: Oh, and I mean, that's something no one things about for sure. You wouldn’t think that and IUD would go and cause you bowel problems.
CW: Exactly. And of course, not to forget, you can have uterine perforation. Because it is a T-shaped device. And uhm you have two different types. You have the Mirena and you have Skyla which is a different type, a smaller version of the Mirena. Same company. It is, I will say it is uncommon, doctors are always going to make sure to be thorough to share with patients in the informed consent process that you can have spontaneous uterine perforations and the migration of the IUD results in perforation of the intestines. You can have intestinal obstruction. You can have abscesses, adhesions, just to name a few of the potential complications.
ML: Surgeons can help, but I guess it's just something patients need to make sure they are aware of. Right?
CW: Right, so what patients should be doing is whenever they have an IUD they should be taught by the provider, the medical provider, with a certain IUD how to check for the IUD string. So, whenever an IUD, whenever I am putting in an IUD after informing my patients of the risks, benefits and the alternatives to the therapy, then when she proceeds to say "I still want the IUD" do an ultrasound after to make sure the positioning is appropriate. And then after, I will teach the patient how to feel for the strings of the IUD. Because if…the trick is if you feel the strings there, if the IUD is perforating through the uterus it is going, excuse the layman's terms but, it's boring a hole in the uterus and entering the abdomen then guess what? The strings are not going to be felt.
You may feel . . . start to have some defined nagging pains, just maybe you cannot blow it off thinking it is gas pain but it's not really gas. If you are checking the IUD strings then all of a sudden one day, now these strings are hard to find. I used to check these strings every week, now, I'm not feeling the string. It’s difficult to find it and all of a sudden, I don't feel it at all. I would encourage patients to go and seek the attention of a physician, and, or a medical provider, and in so doing, what a physician is going to do is immediately order an ultrasound. Because an ultrasound of the uterus is going to pick up any foreign object in the uterus. i.e., the IUD. If the IUS is not present in the uterus, then we know it has migrated out of the uterus and has to go somewhere. So then, you are going to have to do an X-ray of the abdomen to pick it up and decide the location of the device.
ML: I think I read some stories where the doctor gets in to take it out and it's not where they thought it was. So that can even be a . . . that can be . . .
CW: Right, like when you are preparing to go on a fishing trip or you are going to go hunting via surgery, I will always do an image of the . . . just before uhm I go in, you can use what is called a fluoroscopy which is real time X-ray technology. You bring the fluoroscope into the operating room and you will immediately know, you will identify exactly the location of the IUD that way. So you know this isn’t . . . if you think of a patient like your own member of the family you don't want somebody in there going fishing around . . .
ML: Yes, no . . . horrible.
CW: . . . going to find this thing. You need to you know, be professional and know exactly where you are going and to be meticulous. And in so doing with a fluoroscope, a fluoroscopy X-ray technician will identify the exact location of the IUD and then with laparoscopic surgery you are going to reach in, take it out. The case is done, patient is happy and uhm, the issue is resolved. Of course, that's in the best case scenario, you know. You don’t have any issues like abscesses you don’t have uterine . . . you don’t have intestinal perforation, cause if that has happened then the type of surgery will be a lot more invasive. You are going to have to do a more exploratory surgery which is, you know . . . longer recovery time.
ML: Take a quick break here and we'll be right back.
ML: Right, welcome back to the show, we are speaking with Dr. Christopher Walker. With anything else in your practice, uh, are there any other health matters that you'd like to inform women about that maybe they might not know about pelvic health?
CW: One of the things that I believe in is preventative therapy. Believe it or not, I really am an advocate of more holistic natural options versus going on the roads of surgery. If you can avoid a surgical repair, then I am a huge advocate of that. So, with that said, pelvic floor therapy using electrical stimulation called e-stim. Basically, what we are finding is that every woman has some floor of pelvic floor therapy after she has a baby, literature shows us 1 in 3 women, roughly 1 in 3, after having a baby has some form of injury. And it makes sense. If you think about it, you have a very delicate area that at the most can accommodate a small, maybe a golf ball at most. Now, you have a basketball coming through a very delicate area.
ML: Yes, a baby, you know . . .
CW: And another thing, you must have in many cases, damage to nerves and muscle. So, if we were to have that damage done to our legs or arms, we would go and see a therapist, wouldn't we. So, in translating that to what has just happened to a lady after having vaginal birth, it makes sense that 1 in 3 have had an injury. So, to prevent these ladies from seeing me or a colleague with my qualifications, pelvic floor therapy. I highly suggest should be commenced 6 weeks after vaginal birth, ladies. And of course, insurance covers for that, and the results are very good. So, you are implementing preventative therapy. You are preventing and rehabilitating those muscles, you are bringing new nerves to the area. You are strengthening and rehabilitating muscles that were injured in that area called the levator muscles. And so at the end of the day, 5 – 10 years down the road you're not coming to see me because during spin class you are tinkling, you are jumping on the trampoline and you have a little tinkle. No, I mean those are things that women should never have to suffer with. Uhm, that's not fair to them to suffer that indignity because, hey a woman is a gift from God. It's true!
ML: That's nice of you to say, Dr. Walker.
CW: It's true, Michelle! Because a woman can give the ultimate gift of life for a family and we men can't. So, I have the ultimate respect for a woman and so for her to have to tinkle on herself when she's in spin class or trying to jog, but we can fix these things and prevent these things from even developing by implementing pelvic floor therapy. So, to answer your question this is something that we are really trying to emphasize and educate to the populace, to say, hey listen, why suffer in silence? Let's fix this, let’s prevent this.
ML: And then, if this is the case too, if women are interested in doing preventative therapy. This is something too that your office handles as well, right?
CW: We definitely have a whole team of therapists here who do that because, you know, we don't need to be doing surgery for everyone. We really try to embrace alternative forms of therapy. So, as I said before, earlier, we have a team here dedicated to serving patients in every aspect of things.
ML: Oh, fantastic. So if anybody has any questions about any of these things we talked about they can call your office, right?
CW: They certainly can or they can look us up online on the world wide web, www.besturogyn.com, and of course they can feel free to phone the office. The office phone number is 407-648-9400. We'd be honored and delighted to assist in any way that we can.
ML: Dr. Walker, thanks so much for being on the show and giving so much great information. Because you know, so many women have so many questions about a lot of these things that we talked about so it's wonderful to have a uh, expert of your caliber talking to us today. So, thank you so much.
CW: Michelle, you are so kind, and I commend you for what you are doing for women. You are amazing! And what you are doing educating women, helping them, providing resources for them – you deserve to be commended. Thank you so much for having me on your program this morning and I wish you all the very best.
Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.
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