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Dr. Twiss Part II: On the Basics of Medicine and Biocompatible Materials for Transvaginal Mesh

Dr. C. Twiss, Urologist, U of Az.

Dr. C. Twiss, Urologist, U of Az.

Christian Twiss, MD  is a surgeon at the University of Arizona’s Department of Surgery, division of urology. He is a Board Certified urologist by training with a subspecialty and certification in female pelvic medicine and reconstructive surgery (FPMRS). Dr. Twiss studied with Dr. Shlomo Raz at the University of California Los Angeles (UCLA) between 2006-2008.

I miss him, I’d do it all over again in a heartbeat,” he says. “He’s given me helpful tips and tricks. It’s easy to put in mesh but it can be quite a difficult and complicated procedure to take out mesh depending on what type of mesh is put in.

Dr. Twiss says half of his practice these days is in the removal of transvaginal mesh.

He talked with Mesh News Desk Editor, Jane Akre in this Part Two.  Interview Part One is here where Dr. Twiss talks about the difficulty of mesh removals, his policy of informed consent and the option of autologous slings harvested from your own body!

Q: Do you think the doctors were not properly counseled on mesh by the sales reps?

Dr. Shlomo Raz, UCLA Urology

Dr. Shlomo Raz, UCLA Urologist

A:  “I’m not sure where the problem lies, whether we didn’t have enough experience with it, after all, mesh came out on the market for prolapse relatively quickly. The question was did we realize these problems were occurring? Did we distribute that information relatively rapidly and say hey there are some issues with this stuff we need to discuss as pelvic surgeons. I don’t know I’m not willing to assign blame. I can say as a physician if you’re having a problem with mesh and you are not quite sure what to do with it, you’re still obligated to the patient to say look this is a complication I’m not quite familiar with and I need to find you somebody who can fix you and not dismiss the patient and say you’re fine, there’s nothing wrong with you or say I’m sorry I can’t help you because that is  going to generate a very dissatisfied and upset patient.”

Dr. Shlomo Raz, UCLA Urology

Q: Why do you think that happens so often, I hear that all the time, their doctor says go to pain management as your next step.

A: “I really don’t know. I don’t have an answer. I was trained by people who just did not have that view of medicine. I was trained by very persistent people who are used to dealing with complications and would follow it through and see it to the end. It reminds me of what Dr. Raz told me when I was a fellow, surgery is marriage you are married to that patient and you have to see it through to the end. And I took that to heart in my fellowship. If the patient is having a problem you have got to see it through. Even if, God forbid, you can’t take care of it yourself, go find somebody who can and send that patient on to somebody who can competently take care of that problem. That’s the basics of medicine as far as I’m concerned. The patient abandonment generates a lot of the anger and discontent and upset among patients. They need to be helped along whatever problem they’re having; they need to be helped and not dismissed.”

Cystocele, FDA graphic

Cystocele, FDA graphic

Q: Would you say a 30 percent complication rate for pelvic organ prolapse for transvaginal mesh prolapse is not too far off?

A:  “The numbers I’m familiar with are around ten percent. That’s what we studied when we studied for our subspecialty certification. Especially mesh erosion we’re looking at ten percent. As far as complications overall? If it includes post-operative, urinary tract infections or bleeding, some of those complications can occur from non-mesh surgery.  Mesh or not some patients will have UTIs or pain or bleeding. Mesh specific complications – the numbers I’m getting are somewhere around 10 percent in the literature, it could be more or less that’s where the mean has been hovering.”

Q: But the literature never goes beyond 12 months for the most part. Even an Ethicon clinical trial had to be stopped early because it had a 15.6% complication rate when the outside limit was 15%. I’m asking about not post-surgical but complications, but those that do not go away – pudendal nerve damage, systemic issues, autoimmune issues, ongoing infection, lupus and chronic pain. It’s being seen among hernia mesh patients as well which would lead one to suspect perhaps it’s the polypropylene? What do you think about that?

A:  “That does concern me. If that’s true if we have significant risk of systemic systems, then maybe we don’t have the right material. Maybe we need to work on a more biocompatible material. The problem here is we’re kind of stuck between a rock and a hard place. If we abandon it completely and go back to the old fashioned repairs we know we are going to have patients coming in on a regular basis with failure and that’s also a disappointed patient. Some of the failure rates for the old fashioned suture repair surgery are approaching 50 percent or greater, that’s also not acceptable to bring to the table.  If that’s true we need to explore better materials. I guarantee there are people working on that already.

“Hopefully, if we’re lucky the whole line of research of using the patient’s own stem cells which you can harvest from adipose tissue is promising. One day maybe we can do a little liposuction, harvest your stem cells and grow you a material of your own tissue. That would be a pelvic reconstructive surgeons dream! That would be the most biocompatible material you could possibly find.”

Q: And you get liposuction too?

A: “I think that’s far off, I don’t know if we’re going to see that in our lifetime.  But that would be ideal. Until then we’ve got to try and find maybe a more suitable material. The pelvic surgeon is often caught between a rock and a hard place. Do I not offer mesh at all and commit patients who have already had prior failures to more failures, or do I counsel the patient properly and say we’re going to go down this road together and if you have a problem we’ll fix it but this is the best thing we have on the market right now.

“I don’t know. It’s a tough position for us to be in. The important thing is to sit down and counsel the patient and let them decide what they’re comfortable with. If doctors do that they have happier patients.”

Q: And the internet has made a huge difference educating patients hasn’t it?

Rectocele, FDA graphic

Rectocele, FDA graphic

A: “Yes.  Often they will search the internet and come back with a slew of questions which is exactly what should happen before surgery. We should answer all the questions and know what we are getting into and do it as a partnership between physician and patient. That’s the key in my opinion to treating patients.

Rectocele, FDA graphic

“We don’t have all the data. That’s an ongoing project.  To some degree every technology we do is the best we can, or we should do the best we can to figure out what are the potential pitfalls, determine if it’s relatively safe and put it on the market and see what happens. And that’s one thing that wasn’t happening with mesh is there were no post-market trials. * Had there been a requirement for post-market trials for mesh, we probably would have collected and disseminated data on mesh much sooner than the situation we are in now.”

Q: Unfortunately, there were no pre-market clinical trials on humans either. You spoke earlier about some rules of surgery in your opinion, which should be followed.

A: “If the patient and I have decided to implant mesh I apply the following rules: 1) Minimal mesh= only put in what is needed and trim all excess. I also use the lightest weight meshes on the market—in removing many meshes, I have learned that there is far less scarring and tissue reaction with the lightweight meshes. 2) No excessive tension or folding.  This has been associated with pain/erosion, etc. 3) I generally do not like to implant any device in someone that I’m not pretty certain I could remove if it was necessary. 4) I do not perform hydrodissection—I believe this technique increases the risk of placing the implant within the vaginal wall (where the nerve endings are located) instead of behind the vaginal wall.  5) I do not place mesh to repair rectocele.  There should be Level 1 evidence supporting the use of mesh—there is Level 1 evidence supporting the superiority of anatomic outcomes of mesh for cystocele and vaginal vault prolapse, but not for rectocele.

“The pooled evidence suggests that non-mesh rectocele repairs have favorable success rates so I continue to offer this.  I also do not feel that simply placing mesh over the rectocele adequately addresses all the anatomic defects present (e.g. the separation of the levator muscles, the widened vaginal opening and the deficient perineum— these are typically not addressed by mesh placement).  When using a biologic (non-mesh) graft, I use solvent-dehydrated cadaveric fascia lata, I believe this one has best supporting data—I follow the same principles as mesh repair.”

Q: Have you worked as a consultant for any mesh manufacturer?

A: “I have worked in a consulting capacity for AMS (American Medical Systems) in the past, but that is all I am allowed to divulge due to product-development confidentially agreements which is standard industry practice.  This primarily consists of product development teams asking our opinion regarding products and potential ideas.  I think it is good for industry to proactively troubleshoot products in this manner before final production as the alternative would be probably be less than ideal.”

Editors *Postscript– the FDA ordered 35 makers of mesh for transvaginal placement and incontinence to conduct three years of post-market studies  which were to answer some of the following questions about the severe and life-altering complications that were emerging among women treated for the relatively minor conditions of POP and SUI.

The mesh makers were to find out: the rates of mesh exposure, mesh erosion into another organ, pelvic pain, infection, dyspareunia, vaginal shortening, vaginal scarring, vaginal bleeding, fistula formation, neuromuscular problems, revision surgeries, quality of life, and recurrence of the problem, among other issues.

Initiated in January 2012, there have been no updates issued so far. See the back story here. #

Christian O. Twiss, MD, FACS

Associate Professor of Surgery

University of Arizona College of Medicine

Director of Female Urology, Pelvic Medicine, and Pelvic Reconstructive Surgery

Department of Surgery, Section of Urology

University of Arizona Medical Center

1501 N. Campbell Avenue

P.O. BOX 245077

Tucson, AZ 85724-5077

Phone: Office 520 626 6236; Clinic 520 694 4032

Fax: Office 520 626 4933; Clinic 520 694 2404

ctwiss@surgery.arizona.edu

 

32 Comments

  1. Nonie Wideman says:

    wonderful interview!! a voice of sanity ….had there been a sane decision to do extensive studies on post mesh implantation results I am certain the 10% adverse event or complication rate would be closer to 30% especially when not having a narrow view of what constitutes success….. success to women with mesh patients means at minimun doctors have done no further harm in their attempts to help us, succes post device implantation means not having to use a catheter to void, success means less pain than proir to the medical intervention, succes means no chronic inflammation and FBR……. and by being afraid or reluctant to place blame enables an unacceptible apathy to address a huge problem…. but with the vindictive nature of the ones being questioned I can see why the sober second thought doctors who disagree with the rather indiscriminate use of a risky are afraid to speak louder and longer…. those sober second thought doctors can be reasssured that the angry dissatisfied harmed women will support their voices for more second thought and re-evaluation of embracing a risky mesh implant device … there are thousands of us getting organized to protest the situation as it stands …… thankyou Chris for speaking honestly.

    • Jane Akre says:

      Hi Noni- Let’s also remember that the definition of success for such a long time was the anatomically correct placement of the pelvic organs – the woman could be screaming in chronic pain, but that was not one of the criteria…..later the Quality of Life (QOL) criteria was added but not until much later…..

  2. Patricia Shaffer says:

    Thank you so very much for the wonderful information. I am one of the mesh impaled women you speak about and greatly in need of your services. I live in Colorado but the Medicare plan I have now won’t work with me. I want everyone in the medical field to know that what you said about uncaring doctors is true when it relates to mesh removal. Six months after my revision surgery I started having butt pain that I couldn’t live with. I asked my doctor if he could remove more mesh, he got mad and said ” I cannot remove anymore or you will bleed to death”. He sent me to a pain management center. I have had seven treatments and nothing works. Well, I’m not giving up and I’m not going back him either!

    • Melynda says:

      Go see Dr. Raz at UCLA. I was told the same thing, but he was able to get all of the mesh out of me AND I lived to tell about it.

  3. Dr. Twiss, you may be the exception to the rule – you say ‘I don’t know’ and acknowledge the treatment as a failure, not the patient! Harmed patients want care, not litigation. However, the partnership between doctors and patients is toxic when there is a financial conflict-of-interest. The medical device industry has pre-negotiated patients’ loss of civil rights. Reduced regulation by the FDA and easy 510(k) clearance allows a patient to be duped into implantation with products that may not be safe or effective. Adverse events only need be FDA reported by the surgeon if there is a fatality. Patients do not have easy access to validated information of patient outcomes: just marketing materials and the advice of the surgeon. Surgeons are allowed to abandon patients without repeal. The former AMS CEO moved to Tornier and produced a failed elbow replacement for my brother which has placed him in medical and legal purgatory. The CEO paid himself $2.6 million before ‘retiring’ at age 54 to begin a new medical device “innovation”.

  4. Dawn says:

    The problem here is we’re kind of stuck between a rock and a hard place. If we abandon it completely and go back to the old fashioned repairs we know we are going to have patients coming in on a regular basis with failure and that’s also a disappointed patient. Some of the failure rates for the old fashioned suture repair surgery are approaching 50 percent or greater, that’s also not acceptable to bring to the table. If that’s true we need to explore better materials. I guarantee there are people working on that already.

    I agree with this only somewhat …… I would rather fail with my natural tissue than ever take even a 1% chance of having a FBR to the polypropylene . This material is toxic to our bodies.

    Now, I will be living with nerve damage in both of my legs probably for the rest of my life. I am only 48. And the worst thing I am now dealing with is Auto Immune Hepatitis… My good liver cells are attacking themselves. I had no health issues at age 44 when the mesh was implanted , now I have dealt with practically every adverse reaction you could have to mesh.

    I am now mesh free, my pain went from a 10 to a 1 instantly. These Dr.’s really need to listen to their patients. Only the victims of this product feel the pain . I gave birth naturally to 3 , 9 pound babies, drug free… And the pain from this mesh blew that pain away .

    I am so thankful that at least more Dr.’s are stepping up to help us. Thank you Dr. Twiss

    • Melynda says:

      Yes, the pain from this mesh IS comparable to child birth….except we don’t get a cute baby to snuggle at the end of it all, IF we ever see an end to it!

      Like you, I would rather have a native tissue sling fail than to be permanently disabled by the mesh, which is what has happened to me. I am only 40, I have a PhD, and three young children. I will never be able to work again or care for my children and home without help due to the catastrophic injuries from the mesh.

  5. Jane Akre says:

    Dr. Twiss- A woman who has had a translabial ultrasound at Stonybrook on Long Island says the technicians there cannot read it. She has been advised to get an MRI and/or a CAT scan. My understanding is those images cannot see mesh. Can this woman have someone from your facility actually read the translabial ultrasound at the U of AZ? Thank you

  6. Mary pat says:

    Does anyone know if Dr Raz or Dr Twiss can remove the tiny particles that migrate when a partial mesh removal surgery is done? Can the mesh be removed from the hip sockets where it was anchored ? Has anyone had a monarc 100 percent removed?

    • Melynda says:

      Raz was able to get all of my J&J Prolift Total out, including the mesh that was adhered to the obturator fossa.

      • Faith says:

        Hi Melynda,

        I had the total J&J Prolift in 2008. I am concerned to have it fully removed since it has been implanted so long. I am afraid I will have more pain and nerve damage after removal. Are you better after removal?

        Thanks,

        Faith

    • Christian Twiss says:

      It’s possible to remove the whole Monarch sling. This requires dissection behind the pubic bone to separate the sling off the bone and then into the obdurate muscles. The mesh often extends into the adductor brevis tendon requiring a separate groin incision to remove it from the adductor brevis. In my experience it is the piece of mesh that is fused to the bone and irritating the bone lining that definitely must be removed to resolve pain but an attempt should be made to remove the entire sling.

    • Dawn says:

      Mary pat , I had my Monarc completely removed by Dr. Rodriguez .UCLA. Just like Dr. Twists described, had to scrape the mesh off my pelvic bones. Only question I have us if any remnants of the mesh bay still have been stuck on the bones, could pieces over time flake off and be causing small cysts in the groin region? I have had 2 now in a years time. I thought they were an ingrown hair/zit, but they will not pop. I just leave them alone now. They are about pea size.

      Having my mesh removed saved my life.

  7. Beverly Martiniano says:

    Dr. Twiss is my hero. He removed 4 mesh implants, one included a rectocele. I had minimal pain after surgery and am back to pretty much a normal life. He was able to remove all of it but a very small piece adhered to the bone. I never even had to take pain meds when I got home. When I originally saw Dr. Twiss he spent almost 2 hours answering my questions, very honestly and giving all my options. I chose no more surgery at this time but could be in the future for urgency incontinence. After having been lied too in two implant surgeries and not been told of any risks, I so appreciate Dr Twill honesty. I would recommend him to anyone. A friend of mine just had mesh removed a week ago last Tues and was in Church on Sunday with her leg pain gone. Dr Twiss fellow with one of the best, Dr Raz. Dr Twiss is concern about the patient first. He is personable and truly cares. I highly recommend also the UMC hospital in Tucson. They treated me like a queen. A truly caring staff.

    • Jane Akre says:

      Beverly- it’s great to hear a success story…… too many surgeries, particularly partial removals, do not provide any relief. I believe you first brought Dr. Twiss to my attention… thank you so much for helping others. And congratulations to getting back to your life ! Enjoy!!!

  8. jade says:

    Jane – Can this be the Defendant’s strategy even though they are in mass settlement talks: What IF a Defendant claimes to be in mass settlement talks, but actually is trying to delay trial dates out as far as possible?

    Scenerio: Defendants can appoint second-tier legal representatives to appear at settlement talks, but their actual primary trial attorney (i.e. Cohen) is immersed in supposedly preparing for upcoming bellweather trials, but in actuality is preparing an optimum settlement figure to be presented to each bellweather just PRIOR, or at the onset of the trial (saving Defendants BIG revenue from actually going to trial). One by one bellweathers will be settled – delaying the MASS settlements for years and beyond. This strategy would afford each Defendant the time they need to build their “war chest” without feeling the immediate financial burdens.

    Those women in the Mass Settlement Pool, who are NOT selected for trial, could possibly never recoup any financial losses or obtain any settlement in their lifetimes.

    • Jane Akre says:

      Jade- I’m not a lawyer and don’t attempt to second guess them but I believe some things are true- A) Justice Delayed is Justice Denied B) the law firms will make a great deal of money C) the present situation of making women wait for justice has many going under either from drugs, pain or mesh injuries and D) any monies will never be enough. Sorry to be so doom and gloom but focusing on regaining your health is primary in my opinion.

      • jade says:

        Hi, Jane – Do you have the schedule for all bellweather trials scheduled for 2014? Happy New Year and thank you for your coverage.

        Best,

        Jade

  9. jade says:

    Jane – All very good points and true. I agree that our focus must be on getting better and BETTER!. Find the right kind of exercise that can relieve symptoms ( even if temporary). I recommend to try swimming – it gives relief from the “gravity” component and offers gentle stretching of the region. Don’t be discouraged if symptoms come back with a vengence after a new movement – it’s the price we pay for moving forward. The first time you engage in a new exercise is always going to be painful – but, the “inch” you gain will become a “mile” with perserverance and pushing a “little” further with the same movement the next time. Be consistant in doing movements that stretch the area and relieve the pull of gravity, eg Yoga, Pilates, Swimming.

    “Grant me the courage not to give up, even though I think it is hopeless.” – Chester W. Nimitz

  10. Aaron Leigh says:

    Dr. Twiss-

    What type of mesh complications would be likely to necessitate a laparotomy?

  11. jade says:

    What does Bill Moyer have to do with mesh?

    Thank you.

  12. Tee says:

    I had a mesh explant and had some relief in the left area but was left with a small piece in my right pelvic bone to which the surgeon “tagged” and advised he could not remove it because it was too dangerous. Since, I have had minor improvement in the left area but with sex or any strenuous activity I experience very intense stabbing groin pain and chronic infections. Also, I have been diagnosed with a labruim rip in my right hip and a rip in my right knee, I asked the Ortho surgeon could my tissues be deteriorating due to the piece being stuck in my right pelvic bone, he looked surprized but answered, “yes, it could but I am not a gyno so I cannot say for sure but the areas are very close and yes it could be related”. Now, I face a traditional repair surgery within the next two weeks with the same gyno that originally assisted the monster Urologist that implanted me. He did a diagnostic lap three months ago and had to cut my lower colon away from my bladder and suggested a dissolvable suiture repair and that would be my last resort for SUI relief. Then once I heal from this fourth surgery I face my hip rip repair and then my knee rip repair. My concern after reading all these horror stories is the FBR and if I can get the piece out of me safely. I have no income, no health insurance and no hope. Any suggestions and info would be forever gratefully accepted. I am very frightened to have this repair and the other surgeries, I am 49 now, I was 45 when all this happened to me. I was a newly wed and very happy and sexully active, now, I fear sex because I cannot walk for days if I do it with my husband. He is getting very impatient with this but standing true to our marriage which is so unfair to him. That is where the “In sickness and health” comes in play. We separated for three months and got back together thank God but its not like it was and it never will be again. I am so thankful for being alive and that at least, one gyno is still willing to help me even if he assisted the implant. He decided to go back to the original non-mesh methods after all this came out. I just hope I can trust what he is saying. I give God my trust not humans these days. I hope someone can give me some good feedback before I go under the knife again. Opinions from sufferers are more honest than any other because they can relate unfortunately to my pain and indicisons, right?

    I went to a very scary place for my explant but I had no other choice at the time, I consider myself lucky to be alive but after everything I have read lately, I maybe not be alive much longer if I do not get some caring, educated, experienced and skilled, honest help. Can anyone advise how the mesh victims without money, family, insurance can get to these honest and skilled explant surgeons? That would be a miracle.

    Money cannot replace what we all have lost but it can help us get better. Without money or health insurance most will surely not make it. That is why these lawsuits are important as well as the questions regarding the settlements. Its not that we are focusing on money solely but allot of us are desperate to get money to get to the other side of our world to get proper care. So when someone questions about the money, try to be understand and not assume they are focusing on money instead of getting well. Some of us do not have any way to get the “best” treatment, we must trust the ones willing to help at all. God bless each and everyone who understands our pain, our fight and those caring Angels who are trying to help and educate.

    • Jane Akre says:

      Tee- where are you located? Do you have your medical records? Do you have insurance and competent medical help? Do you have a lawyer? It’s important you advocate for yourself and find others to help guide you. Please provide the information and we can put you in touch with patient advocates. ~ thank you for writing , j. akre

  13. Nancy K says:

    Dr. Twiss was my doctor for 5 years and I would call him The Man.” He is excellent.

    This is “The Man” that I have seen for the past 4 years in Tucson and after 6+ surgeries, 1 botox(20 injections), countless cystoscopys, several temporary and now permanent suprapubic catheter, I am now on an as need to see basis! For my appreciation, I took a chocolate cake and a decorated wreath with some of my extras. Can you find the plastic gloves, leg bag, several different catheters,

  14. Misty D says:

    I just scheduled my new patient appointment with Dr. Twiss, I can’t get in to see him until Oct.2. I am very excited to have hope and relief from this awful Bladder Mesh. Thank you Jane for the recommendation.

    Never thought I would be so dang excited to have another surgery….I just want this out of my body, I am tired of the pain and the embarrassing incontinence. Thanks again for the hope!!!

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