Dr. Veronikis: What is Informed Consent Concerning Transvaginal Mesh Removal?

Dec 17th, 2013 | By | Category: Medical News
Dr. D. Veronikis

Dr. D. Veronikis

Mesh News Desk (MND) interviewed Dr. Dionysios Veronikis of the Vaginal Surgery and Urogynecology Institute of St. Louis.

Dr. Veronikis was brought to our attention by the large number of women referred to his practice for transvaginal mesh removal after suffering the complications of transvaginal mesh implants for both stress urinary incontinence and pelvic organ prolapse. At the present time about half of his practice involves mesh removals (explants) and he tells MND he performs about 350 removals of both slings and mesh kits a year among his 700 surgical procedures.

He is board certified in female pelvic medicine and reconstructive surgery. Dr. Veronikis did his residency at Bay State Medical Center in Massachusetts and a Fellowship at Mass General Harvard Medical School in Boston.  He is board certified and fellowship trained in female pelvic medicine and reconstructive surgery.

He still opts to use synthetic mesh under certain circumstances but prefers to harvest fascia from a woman’s own body. Dr. Veronikis’ profile will follow but here are his suggestions for having a productive conversation with your doctor if you are considering pelvic reconstructive surgery to treat incontinence, prolapse or removal surgery of mesh treatment devices.

A profile of Dr. Veronikis does not imply an endorsement by Mesh News Desk and any woman should consult with a variety of doctors before making a decision about this important procedure. Mesh News Desk or Jane Akre, editor were not compensated in exchange for this content.

Q: What should a woman ask to have true informed consent?

“First of all she shouldn’t go to anyone whose practice is not dedicated to gynecologic reconstructive surgery.  It’s like having a high risk pregnancy and being treated by your family practitioner who did one month of obstetrics 20 years ago.  You should go to someone boarded in female pelvic medicine and someone who has gone to a fellowship, in other words, fellowship trained and boarded.”

Ask the doctor:

  • How much of this do you do?  You want someone whose practice is solely focused on reconstructive surgery.
  • What are your outcomes?
  • What are you complications?  That person should be frank transparent in what he or she does because no one walks on water.
  • The next question should be – So I understand to do reconstructive surgery you need to use to suspend fix to isolate, what are my options?  He will say we can use your own body which is maximally invasive now because I have to make incisions for harvesting and leave a defect at the harvest site.
  • What are my personal outcomes?  We can use an animal – bovine or porcine that makes it less invasive because we’re not cutting on your body to harvest a sling. The third the option is mesh.
  • Ask to delineate outcomes – What the operating room times will be? What are the potential complications? What should the post-operative convalescence be?
  • If it was your mother or sister what would you recommend in my case?  The surgeon should say if you have a sedentary life, you will probably have a good outcome either with your own body or biologic mesh. But if you are prone to blood clots we need to cut down the operating room times as it can take 1.5 hr to harvest fascia only, depending on what we are harvesting. In order to cut down on the time we may want to use cadaveric, porcine or bovine materials.

If you are prone to asthma attacks, if you pick up heavy things for a living, if I use anything but an implant it may fail. That’s okay if we are partners in it. Even the synthetic may fail. In the literature there is a higher rate of erosion but in my hands it’s negligible. What I can’t tell you about are the effects on your immune system.

Finally I tell them I will always take care to you. I will not dismiss your symptoms, if you are having a problem. I am your surgeon.

 Learn More:

Images available from Vaginal Surgery and Urogynecology Institute of St. Louis (Warning many images and videos are graphic!)
http://vaginalsurgeryandurogynecologyinstitute.com/anatomy-diagrams

Vaginal Surgery and Urogynecology Institute of St. Louis http://vaginalsurgeryandurogynecologyinstitute.com/

 

Tags: , , , , , , , , , , , ,

9 Comments to “Dr. Veronikis: What is Informed Consent Concerning Transvaginal Mesh Removal?”

  1. Lisa Myers says:

    Please proof read and correct your story. You have incorrectly used the word incompetence instead of the word incontinence.

  2. Aaron Leigh says:

    Thank you for sharing this info with us Jane! There is a lot of confusion among the mesh injured about which doctor they should choose. Most believe Dr. Raz is the gold standard, but they don’t always have the money to travel so far. This is a good Q & A post. Thank you!

  3. Sharon Sanderson says:

    I haven’t had mine removed because when I went to my doctor he promised me everything was okay. So, I thought all of my pain and discomfort was in my head. Oh, he gave me a prescription for some meds to help the newly arrived incontinence, but it didn’t help either. Then, when my rectum started falling out and I had to have it rebuilt, I heard about the mesh implant lawsuits. “Hello!” This doctor I trusted for years lied to me. So, I haven’t been able to trust anyone to attempt to remove it and my pain worsens daily.

    • Jane Akre says:

      Hi Sharon- You’ve come to the right place. Patient advocates can guide you to the next step in your area or, outside your area. You will need to gather your medical records, they will tell you, as well as let us know where you live and whether or not you have insurance. I’m sorry this has happened. You will need to know what kind of mesh you have and what the procedure was. Often women have no idea as to the answer to that question because they were not adequately consulted. It happens to almost everyone unfortunately. Please get back… janeakre@meshnewsdesk.com Thanks for writing~ jane a.

    • Jaramillo says:

      Sharon,
      Do get copies of all your records from the doctors office and the hospital where your surgery was done. Always keep your originals. If you have to provide copies to other physicians, you have your base set. In the surgical notes you should find the brand of mesh and the number assigned to your personal kit. If you can’t find it, call the surgeons office and inform them you need the note that specifies that. MDND has the information how to report to the FDA. You need your mesh manufacturer and the number for this paperwork. Read through the patient profiles as many women have written about removals and their opinion of who did it, how it was done, and if they support the process used. I read every thing I could. I initially schedule with a clinic in NY but after speaking with one woman in particular, I changed my mind and went to UCLA to see DR. Raz. In 18 months, I have flown out 6 times. I chose to have follow up done after my surgery. It looked good but when I hit the 8 month mark I was symptomatic again. I thought I was as good as I would get. My husband scheduled a 4th trip and forced me to go. Raz was quick and to the point I needed reconstruction. He had informed me it was a possibility depending on how I healed. I went and had reconstruction last week. I had a fear it would be like the initial removal. So far it has not been as painful. We keep each other going. It is similar for many and different for many. I read removal was painful and for me it was. I did not drive for a month, could not return to work for 12 weeks. celebrated 8 months of feeling well at work, improved life quality. Bam, sick again. I was not ready to do it again. (thanks to my good man) it’s over. I am a week post re construction surgery, catheter is out and so far I am peeing normally. My stomach is not swollen. I am resting but beginning to believe maybe I will be better. If I can have 8 more months than it’s worth it. Move quickly. The longer it is in your body, the more time it has to erode into more spaces. In the state I live in I consulted with our trauma center gynecological unit. I did a cystoscopy and uds. They found nothing. 3 months later is when I went to California. I was diagnosed with erosion in the vagina, urethra and was retaining. It is sad to report, the technology used is completely different in Calif. than what I was exposed to in my home state. I don’t know if the doctors here really did not know or if they did not want to aknowledge because they did not know what to do. I have, in writing from this trauma center doctor euro-gynecologist to buy a book on healing my mind and body. If you read the women’s stories, you get educated. I understand it is difficult to trust. First pick a doctor that other women reported they received positive help from. You don’t have a choice but to trust. It has to come out!! I am fortunate, never had a partial removal b/c the doctors in my state never identified it. I could feel it in my vagina, not sure why they couldn’t. You will read that most women and doctors report disaster with any partial removals. Pick a surgeon that is confident he can get it out. I am confident my surgeon got it out. I just know that in a 5 hour removal there was a lot of additional damage, grafting, and so on. I spent 8 months doing pretty well because my symptoms were so much better. Well like many women I needed reconstruction. We can’t bury our heads in the sand. I remember one women telling me sell what ever you have to get it done. WOW I can honestly say she was right. Nothing we own can alleviate the pain. If you need anything or want to talk let Jane know. She can give you my phone number. Please get help. There are doctors that believe, won’t abandon you and will do their best. That was my experience and it sounds like the surgeon in this article has proof from women who continue to recommend him. If you hear it from multiple women on the site , they won’t mislead you. Get to work. am here if you need support, There are always trust worthy people even amongst all this corruption.

  4. Jaramillo says:

    We are now enlightened by the women who experience the symptoms first hand. This is through the ability to communicate via websites. Many of us have been advised not to communicate due to the law suits. My personal experience was I have been saved to this date, by the women that have gone through it. I was not saved by any physician that provided me treatment other than Dr. Raz. How was I directed to Raz? This was by women helping women, not by a single referral or recommendation from a physician. This is the reality many women are still faced with.
    I, like many others was told “this is not mesh related”! Had it not been for the women on these websites I could not with stand the physical pain I experienced and grief I put my family through. My reality continues to be that despite removal, I continued to be ill. I did a second follow up with Raz in June because I continued to have swelling and uti’s. He advised the need for reconstruction , I just completed re-construction last week. I now have a new urethra that we all pray will be successful. I also had bladder repair due to hernia’s in the bladder? Still recovering so I have not researched. I have not heard about other women with. bladder hernia? The reality is no one is aware of what we face. There is a variety of outcomes for all of us! The FDA stepped up and set the requirement for on-going studies and outcomes. What did the mesh companies do ? Removed the product from the market. Does this alleviate their responsibility to do the studies. I don’t know but it sounds like they avoided it. Who will continue to study this? How will on-going symptoms be recorded. What are symptoms after removal looking like. How do we respond after re-construction? Do we pee normal? Are women still experiencing swelling? What causes the un-predictable swelling. Are you able to have normal bowel movements since removal or do you still rely on laxative? The only way we hear this feed back is through other women. Supposedly doctors are giving out informed info these days? Why is this info an issue? I thought it was off the market. Is implanting these devices still being done? If it is, is it safe to say the FDA is mandating the follow-up studies. Who is in charge here? I don’t think anyone knows. It is my opinion,
    NO ONE HAS SAID “NO MORE”, OTHER THAN THE AFFLICTED. It is my opinion the doctors do not know what the long term consequences are or will be. That is yet to be determined. Will it come out in studies? No it will be the afflicted communicating “what is happening with your body?” Women, we need to be realist! No one knows long term, what lies ahead. Doctors will learn as they go with us, the guinea pigs of large corporations. Why don’t we have a way of recording deaths among women with mesh implants? Why don’t we have suicide rates among women with mesh implants? Corporations do not want that information correlated to the product.
    Come on FDA, are the studies mandated regardless of whether the product is on or off the market? Hello, 50,000 afflicted! Do you care what is next for us? We know the damage. Can we continue to learn, through research in order to better treat the afflicted? Could the studies protect future products from hitting the market. After all families are destroyed, careers, marriages, quality of life, the ability to parent, the ability to urinate/defecate, walk, sit , sleep, women write about loss of healthcare, some are homeless. Who is in charge of monitoring this epidemic? Who can advocate? Who will break the secrets? For goodness sake, is there a corporate problem when court orders are put in place and the corporations continue to violate and destroy the evidence. If I don’t pay a parking ticket… a warrant is issued and I can be put in jail until I take responsibility and take care of my mis-doing. I can’t get anyone to accept ” I was not aware, “Oh I have never done a very good job of protecting paperwork, I shredded the parking ticket by accident,” Right now it is the afflicted that help monitor, take care of each other, support our peers, so we don’t give up until treatment is available. How many afflicted have not made it because their physical pain is out of control? How many won’t make it because they can’t get insurance to pay for a surgeon that , one believes you, two is skilled enough to try to help us? Recently I have watched several alerts on TV, produced WARNINGS FROM THE FDA … recall the dog treats because they cause illness and death. A great amount of TV publicity and media coverage! FDA actually re-called the dog treats. Good job, FDA! The treats caused harm. So with all the harm reported to the FDA caused by mesh, why did you not re-call the implants? News flash, FDA is now mandating studies for anti-bacterial soaps. Studies will demonstrate long term outcomes. Good job FDA. I don’t want people harmed from potentially dangerous chemicals. Tell me about the on-going mandated studies to show what mesh does over the long haul? Show me an FDA TV warning about mesh. Perhaps I missed it. Maybe the mesh concerns were on world news like the dog treats/concerns with soap. I continually hear individuals complain about what crooks attorneys are. “Look at their commercials, they just want to make money. True they will make money but perhaps the afflicted will get enough compensation to have removal surgery, secure housing and health care, support their children since they are unable to work. Maybe the commercials will make one more woman aware that their illness could be related to mesh. If something is re-called on my vehicle, I get a notice in the mail, danger, go to your dealership, have this taken care of immediately. I have never received a notice from the implanting surgeon, the device maker or the FDA. The commercials are informative, this is the reality. Do I think I am worth receiving information from the device manufacturer ” Please look for the following symptoms as we have removed your implant from the market. We made this decision so we do not have to study your damage physically or emotionally, not because there is anything wrong with the product. Instead I get to watch family focused commercials …”We are committed to the health and well being of our consumers, we are committed to continued research for the benefit of women. Come on what is the reality? If you were concerned, you would have called me, you would have sent me a letter. I feel the same toward the implanting physician. I deserved a letter of potential consequences, symptoms to watch for, an invitation to the office “.let me do a check up to assure you are not reacting to your implant.” What I got was an actual voice mail “It is not mesh related” after I left a message with the office that I was sick. Really surgeon, “do you think you should take a look between the legs before deciding it’s not mesh related” ? No the women that blog said,” here are the symptoms. Here are some physicians that have positive results. Here are ideas that helped me. Call me don’t give up. Got o the FDA website and file your symptoms. Get to a doctor that is skilled in identifying complications and has experience in treating them.” I am a realist, doctors can’t fully inform because they have limited information. Many have more information than others. I count my blessings that some medical providers are speaking up and writing about the realities they see. There are some people with ethics, compassion, care and concern. The reality is, it is up to the afflicted to guide each other to safety. I feel fortunate for the bravery and courage of the women that have brought us to where we are. I can’t even express the benefit of having MDND to seek information. I am grateful for the warriors, The reality is if a physician would not put it in his wife, daughter, or mother than why would he recommend it to the general public? Why are we continuing to debate this? Is it on the market or off the market? Why is this physician writing as to how he will inform women. If this surgeon is removing and treating women with damage, I want to know are you still implanting it? It’s a time of year to count blessings… Thank you Jane, you are a blessing, my mesh inflicted women who blog… Thank you for you for your unconditional help. Dr. Raz Thank you for you continued work and effort to help us. We are tired, our families get tired, but doc, every time I see you, you are diligent/committed compassionate. I am Thankful that women are identifying other Docs that are helping to heal. I am thankful for the men, in the lives of women, that don’t run away. I ask myself could I be as giving as my husband? I sit here in tears, thinking about how often I want to run, give up, have a different quality of life. Yet the reality is I am unbelievable blessed to have a man that is still here. He encourages, listens, reads, and an endless list of things he gives. For the women that don’t have this, remember you have us. Don’t make decisions without reaching out. We hurt, we are broke, we are sad, but one thing we all have in common is we all believe our reality, there is always someone to reach out to on this site and we love people we have never even met! I hope I have not offended anyone. I hope I don’t get in trouble for contacting. I hope the doctor in this article is not believing he is doing his job because he “informs of potential risks” I hope some day I here a national news warning from the FDA. I hope all my afflicted sisters and their families have a beautiful holiday. We have things today, to be grateful for that we did not have even 2 years ago.

  5. Jaramillo says:

    The second half of the article, dated the 19th was very helpful. It offered more information on how he approaches surgery and his advocacy for all his patients. I would have held back on my first reply if I had the info from the second article. Sorry Dr. V, I over reacted based on having read the first half of the article. The second half presented more information.

    • Jane Akre says:

      Jaramillo- You are a very eloquent speaker and writer and you say it all so well. Thank you for adding your voice which many can do anonymously as well. Thank you for being a vocal advocate…~ja

Leave a Comment