MND Interviews Dr. Veronikis: On Transvaginal Mesh, Injuries and Explants

Jane Akre
December 19, 2013
Dr. D. Veronikis

Mesh Medical Device News Desk, December 19, 2013~ The name of Dr. Dionysios Veronikis St. Louis is one that is increasingly heard among mesh-injured women.  Dr. Veronikis tells Mesh News Desk (MND) he now spends half of his time doing mesh removal surgeries, also known as explants, and although he still uses synthetic mesh on rare occasions, his surgical skills allow him to harvest fascia from one's own body to form a more natural support system to take the place of plastic mesh.

Dr. Veronikis tells MND he has never used mesh kits and does not believe in them.

Educated at the University of Patras Medical School in Patras Greece, Dr. Veronikis runs the Vaginal Surgery and Urogynecology Institute of St. Louis as well as trains residents at Mercy Hospital in St. Louis.  He is board certified in female pelvic medicine and reconstructive surgery and did a surgical fellowship at Mass General, Harvard Medical School in Boston. Here are his credentials. He practices with Dr. Sara C. Wood who also did a fellowship in Vaginal surgery and urogynecology.

dr v and dr wood

Dr. Veronikis was interviewed by Jane Akre, Editor of Mesh News Desk.

Q: I think one of the things we heard frequently was that many doctors trained by mesh manufacturers were not surgeons. Instead they went to a weekend cadaver clinic and were sold on a “minimally invasive” procedure that would be the bread and butter for their practice. Perhaps that was part of the problem. What do you think?

“I think you’re absolutely correct. Anti-incontinence surgery is very tricky. You need to know how to operate, you need to know the anatomy; you have to have some judgment. You have to be able to modify the procedure to fit the needs of the patient. You can’t do the same operation on everyone because their anatomy is different and the pelvic structure is different. The advent of the ‘minimally invasive’ sling was a good idea to those of us who dedicated our lives and careers to fixing women and doing the best we can to get the best outcomes.

“My practice has not changed from before FDA announcements (October 2008 and July 2011) to now. I was always very conservative and always offered multiple options.  So when the companies first brought out the minimally invasive sling, they first introduced it to gynecologic surgeons. The general ob-gyns (obstetricians/ gynecologists), they can be credentialed to do this procedure. So the companies saw the green-eyed monster and went to everyone they possibly could to recruit to do these procedures saying, “it’s 20 minutes; a money maker for your practice; we’ll market your practice.” I blame the companies and I blame the doctors. The doctors have a weekend cadaver course and they are wined and dined. That is not adequate and I blame the hospitals and the credentialing process that someone who didn’t do any anti-incontinence procedures could all of a sudden become an expert at female pelvic surgery.”

Q: Especially since that area of a woman’s anatomy is her core with blood vessels, muscles, nerves and so much that can go wrong.  

“It’s a very intricate part of a person’s anatomy. The human pelvis is very difficult anatomically. The human pelvis is bones, muscles, and organs that have connections among all of them. It’s very difficult to get great outcomes with surgical results."

Q: Does that include somebody like yourself who is experienced?

“No, I’d say someone experienced at doing reconstructive surgery can get uniformly good results whether they are using mesh or don’t use mesh, depending on the patient. A person who is high-risk - who has emphysema, asthma, a BMI of 42 percent - they are probably going to put more stress on the repair.  So it’s up to the individual surgeon to suggest, based on your individual characteristics, here are you options.  At 42 percent you might say here is a list of the risks and the benefits. Those of us who are trained to do reconstructive surgery have better outcomes and not only because we do that procedure much more often. Let’s say a woman says she leaks urine and you can see her cervix half way down her vagina and she has a rectocele. In order to get a good outcome, you have to do more than just putting in a sling you learned in a weekend cadaver course. Even if you have a hysterectomy, you have to fix the vaginal apex, the cystocele, the rectocele and restore the normal vaginal dimensions to make the organ function properly. If you put in a sling and ignore the other defects, you are going to aggravate her prolapse and her sling may not work right because the prolapse is pulling on it."

Q: Tell me about your history using mesh? First of all have you ever been a consultant for any mesh manufacturer?

“I have not. I never agreed with what they are proposing. I thought the original TVT was a dangerous procedure. The white paper instructions for doing a TVT making an incision under the urethra minimally and to try to take a big round trocar and pass it between the urethra and the vaginal wall, between the pelvic side wall and the bladder and then up through the anterior abdominal wall. Then to take a flat piece of mesh and to lay it inside the round channel you created. In second grade we learned you can’t put a square peg in a round hole.

I didn’t like the quality of the mesh when the TVT came out. It frayed it was not a good product."

Perigee and TVT removed, Courtesy of Dr. Veronikis

Image: Perigee and TVT removed, Courtesy of Dr. Veronikis

Q: What sort of mesh were they using?

“It was the same polypropylene mesh. What’s changed is the diameter of the filament and the weave configuration. When TVT first came out by Johnson and Johnson, it was a single filament so when you cut that mesh into a 1 cm strip, it actually frayed.  I did not want to be part of that. I didn’t do that procedure, so I kept doing the sling I was doing. My history started in 1994 at Mass General. We were doing synthetic slings and we had a technique that allowed us to use abdominal fascia, fascia lata or Mersilene mesh, it was not monofilament mesh. We would take our own mesh, fit it to the dimensions we wanted, fit to the properties we wanted it for and had very good success with it. So I was not willing to compromise on my outcomes for my patient’s sake.'

[Mersilene is a polyester fiber mesh made by Ethicon and used for chin implants and introduced for hernia repair in the 1950’s]

"Why did I switch what I was doing? Well after all this mesh literature came out, Mersilene was a type of mesh with a slight higher theoretical, not in my hands, but for other people it didn’t behave well. But the main reason I switched from Mersilene was I used to have to make incisions in the suprapubic area and create channels. If you were harvesting abdominal fascia it was okay because you were there anyway. But for patients who didn’t want an incision, I moved to smaller incisions, it was a more cosmetic, less invasive procedure.

"I‘ve never done any vaginal prolapse mesh kits. Never did a single Prolift, I tried to tell them not to use Prolift. Apogee, Perigee, never did an Avaulta (C.R. Bard), never did a TOT, never did a self anchoring mesh.

"Most surgeons are not trained to find that space between vagina and bladder. The way they were putting it in was too much mesh load for the space and it was rolled up then the arms stuck into the levators.

"I didn’t need to consider it. I had really good outcomes doing conventional suture repairs.  I was told I’ve got to get with the times but I had a fundamental objection to mesh kits. I was very vocal in my community, I went to the CEO of my hospital and said don’t permit this. I told my mesh reps do not approach anyone to do this.  Except if it is a fellowship trained reconstructive surgeon and I still don’t think kits were a good idea."

Q: Was it the size of the kits? The arms? What did you object to?

Prolift explant
Prolift explant
“All of it was too much mesh, especially the Prolift. Even if you were a master surgeon you can’t twist the position of the arms.  A woman’s vagina is as unique as her hands and face. Some of the people putting these mesh kits in are surgeons had limited knowledge of surgery. The only thing they knew was how to put in a mesh kit.  The volume of the mesh was the problem, even if you tried to make it smaller, but it was still too long and the arms going out. And it was a blind passage into the woman’s pelvic floor."

Q: Anything transvaginal is going to be blind passage is it not?

“Absolutely not! I don’t do anything blind.  I don’t do mesh kits. I do use mesh in my technique with my instruments and my procedure which is the same as using a fascial graft, but I open up the spaces I don’t do anything blind. I have designed instruments, I move the bladder and I can see where everything is going in every single procedure that I do, instead of that TVT example where you make a little incision and put the trocar through the patient’s body. If you are a surgeon who understands how to do a fascia sling you’d understand the dangers of using that trocar blindly.  So all the procedures I do fascia lata, abdominal fascia, or synthetic, I try to give women options for biologic materials or for the woman who wants a synthetic, the procedure is exactly the same it is never blind.

"I have been using a simple bladder retractor to gently move the bladder during sling placement.  I have designed my own trocars to pass the patients own fascia through these spaces.  Therefore, the technique is the same and never blind."

Q: And are you able to take it out if necessary?

"Absolutely, and I wouldn’t want it any other way. I want to be the one to take care of my patient. I never put in any anchors; I use the smallest amount of graft possible. If the transobturator sling was a great approach we would be doing that with fascia as well. Instead when we do a fascial sling we place it retropubically as they work the best."

Prolapse, Courtesy Dr. V
Prolapse, Courtesy Dr. V

Q: A woman comes to you and says I have prolapse, what options are you going to offer her?

“Let’s take a woman who has uterine prolapse, incontinence and needs complete reconstruction. She’s in her 50s. I would offer her vaginal hysterectomy, a sacrospinous colpopexy, I would preserve her ovaries, anterior and posterior colporraphies with suture. I would tell her you may need a sling and  options are fascia lata, abdominal fascia, organic grafts and synthetic, I would explain advantages and disadvantages and outcomes. Ultimately I would help guide her on her options depending on how comfortable she is.  The literature says there can be 20-25% erosion rate with synthetic slings.  I would tell her my personal success with continence and any less than perfect outcomes."

Q: Under what circumstances would you offer synthetic sling mesh as a first choice?

“If she came in and had one or more previous anti-incontinence procedures, I don’t offer just one option. Typically they’ll say I had a fascia sling it didn’t work.  I might suggest in the reconstructive ladder a synthetic sling a little higher on their list. The typical question is I’m worried about the mesh. All I can tell you is I’ve been doing slings since 1994 and I don’t have anywhere near the rates that are in the literature."

Q: What type of mesh do you use and what’s your erosion rate?

"My personal erosion rate is less than 1 percent. I use Caldera sling or Boston Scientific sling if using a synthetic.  I use Bard Alyte for sacrocolpopexy if using synthetic or organic. More on Bard Alyte here.

"I don’t use permanent suture because if you suture the integrity of vaginal lumen it will set up a chronic infection that will involve the mesh.  I use absorbable sutures. In 2012 and 2013, I’ve done over 700 surgeries and 600 in 2011. If I had ten percent failure I wouldn’t be as popular in St. Louis. I have been in St. Louis for 17 years. The lawyers refer patients to me because so many women were being referred to me for mesh removals, and once they received the records they found I was able to help these women.

"I have a different surgical philosophy and approach. I was trained as a vaginal surgeon. I design my own instruments for a sling, for sacrospinous, and for sacrocolpopexy."

Q: Blaming doctors for some of the injuries is not a popular concept with lawyers because they blame manufacturers. You seem to be saying some fault does lie with the surgeons?   [*Editor note – problems with usability of a device are also considered a product design defect, therefore a manufacture's defect.]

“We have an obligation to our patient. Our patients are putting their bodies and lives in our hands. We should not be attempting new procedures for the first time on our patients without their express understanding.  In their hearts they didn’t know what they were doing. They did not serve their patients."

Q: Half of your procedures are removals now correct?

“Right. A lot of women come in and ask  ‘if I don’t have a tape what holds my vagina up?’  I ask them jokingly “What is a Vaginal Tape”? Scotch tape or duct tape?  I take the time to educate women in their pelvic anatomy. There is a very simple computer model that I use designed in conjunction with Bard. C.R. Bard did allow me to use their program where I can show a woman during a consultation, I show her the uterus, bladder, rectum and the shape and contour of the vagina. I see in her eyes that a light goes off. Many women don’t understand their own bodies."

Q: Do you think mesh is inert or not inert?

“There is nothing that’s really inert.  Like breast implants, if it was inert the body wouldn’t recognize it. Even with a fascia lata, everyone’s immune system is a little different. I don’t think it’s totally inert. It does incite an inflammatory response so it’s not totally inert. I don’t know if we could fix these women without some type of implant.

"Do you know when they do slings with fascia, the suspending suture is polypropylene (PP)? I use polybuetester not PP sutures. I don’t have patients with pain from the implants. The retropubic sling is the only way to do a fascial sling.  So I don’t see all these problems these poor women across the country and across the planet are having with transobturator slings.

"Even if you harvest fascia, 2,3,4 percent of women have leg pain. You can only harvest abdominal fascia once or the repeated harvest may lead to the patient getting a hernia. One woman had multiple C-sections. For her, fascia was very difficult to work with. We are at a difficult time. If you are doing a sacrocolpopexy and you harvest fascia lata and use fascia lata  for the sacrocolpopexy and since you are opening the belly you can use abdominal fascia for the sling. You get one chance to harvest from the abdomen.  If that fails, the only option you have is the other leg to get a fascia lata sling.

"I envision in 15 or 20 years we will take a biopsy of her fascia lata and will able to make something strong and we’ll be able to manipulate the DNA, make it grow with collagen stronger and grow it thicker and we won’t even need any mesh.

"In the meantime, it’s hard to help without options and I wish more existed."

Q: And you must see a lot they are desperate for help?

“Their lives are mess, they’ve lost the jobs, their husbands, their homes. They are outcasts, their only friends are those on the internet and Facebook because no one can understand what it’s like to be constantly wet, the chronic pain, they can’t get out of the car.  This year alone I did over 350 explants.

"Over the years the need for mesh removal has gotten huge. As a result, for mesh removal I’ve developed instruments. To get the sling out I use an ear, nose and throat nasal speculum. You can actually open the speculum around the sling because an ENT speculum creates a long tunnel. I’m ordering a dozen from Germany to put together a mesh removal instrument set.  I have discovered a machine shop that helps tweak the instruments and I’m putting together a mesh removal pan to remove mesh without traumatizing normal tissue.

"The better you can see and expose the desired tissue and the imbedded mesh, the more precise the removal may be.  I wear a headlight to direct the light exactly where I need it and special instrument that foster the removal of the implanted mesh with minimal damage to the surrounding tissue that has grown in the mesh matrix.  This means removing only the mesh and the scar tissue that has grown into the mesh matrix."

Q: So many women have had the doctors turn their back on them and instead go to pain management as if living on narcotics is a way of life?

“That bothers me. I call these doctors so that they can help their patients and provide an avenue for referral; invariably they don’t return my call. They dismiss these women by saying it only happened to you. It’s okay for a doctor to say I’m sorry this happened, let me call my friend to help you.  A society is judged by the way it cares for its women and children. Many of these doctors put in mesh with no loyalty toward helping their patient when results were not what was expected, no obligation, nothing.” #

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