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