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Dr. Daniel Elliott, Mayo Clinic Urology, Rochester MN
As part of an ongoing series: Doctor Directory, Mesh News Desk will bring you interviews with the leading doctors involved with the current transvaginal mesh issue. Most of the doctors interviewed have been chosen because they recognize mesh injuries as real and deserving of attention, however, those profiled here may have different attitudes toward treatment.
A doctor profile does not imply an endorsement.
The choice of a doctor should be an individual decision based on a variety of factors based on a personal interview, insurance coverage, compatible philosophies and patient confidence, among other factors.
Dr. Daniel S. Elliott-Urology Department
Mayo Clinic, Rochester, MN
http://www.mayoclinic.org/biographies/elliott-daniel-s-m-d/bio-20053374
Dr. Daniel Elliott is with the Urology Division of Mayo Clinic in Rochester, Minnesota. Dr. Elliott says the philosophy at the Rochester Mayo Clinic is that no one in the urology department use polypropylene transvaginal mesh for prolapse. Dr. Elliot signed the Public Citizen Petition in 2011 to have pelvic mesh removed from the market. The Food and Drug Administration recently denied that petition.
The urology division is separate the distinct from the urogynecology division of the Mayo Clinic, which might not share the same philosophy. And the philosophy in Rochester MN may not extend to the other Mayo Clinics in Scottsdale, Arizona and Jacksonville, Florida.
He spoke to Jane Akre, editor of Mesh News Desk.
“When it was introduced in 2005 we said “No” to all synthetic mesh kits. No one at Mayo used transvaginally- placed synthetic meshes for pelvic organ prolapse. We perform standard repairs, such as the anterior and posterior colporophy with absorbable stitches and not synthetic meshes."
Q: And the treatment for incontinence at Mayo?
“Most of us have tried the synthetic slings and we have written papers about the complications. No one in the urology department uses mesh slings but I cannot speak for the urogynecologists. They may at times still do it but the numbers have dramatically been reduced.”
Q: What are you seeing in terms of mesh complications?
“We are seeing a marked increase in those referred to us both in the sheer numbers and in the complexity of the complications. I see about two to five per week maybe more than that sometimes. We are dealing with a variety of complications ranging from erosion into the urethra or bladder and/or pain syndrome. Pain is the biggest thing I deal with. Going back five to six years we didn’t see it as often. Now we see it a lot. Complications due to meshes are frequently, but not always, related to time. The longer they are in, we are seeing more complications. Even five to ten years later we are seeing problems.
I'm of the opinion that we are seeing the tip of the iceberg of problems especially with mesh kits. Individuals not having problems now, we might see down the road.”
Q: Should POP (pelvic organ prolapse) mesh be reclassified?
“Absolutely. I’ve been working with Public Citizen to reclassify this all. I’m in favor of that. That’s why we are having all these problems. Mesh flew through the approval process. It has to be reclassified.”
Q: How about SUI (stress urinary incontinence) mesh?
“Obviously, there is conflicting data out there. What we don’t know are the long-term complications. The pain syndromes following mesh slings are especially difficult to treat. In my practice, I do not put in transvaginal mesh including that for incontinence.”
Q: Should it be off the market?
“Polypropylene mesh used for transvaginal prolapse should never have been put on the market. For selected individuals who have failed standard treatment for incontinence, there may be a role for meshes. However, it is my belief that it represents a small number of select of individuals who have been counseled very well on the risks of meshes. There is a swing of the pendulum going on that is away from the use of these meshes as time goes on.”
Q: What can we do for these women?
“That is a very, very difficult question. Some women when you can localize the pain right to the mesh you excise the mesh and you have a chance of curing them, however, surgery in a large number does not work and a complete explant is not an easy surgery. It does not guarantee success.
Dr. Philippe Zimmern, a urologist at University of Texas, Southwestern found that 20-35% percent of women who had meshes and were operated on for pain, still had pain after surgery. This is a very discouraging finding. Mainly because Dr. Zimmern is a highly talented pelvic surgeon, and in this extremely talented surgeon’s hands, 20-35% of patients still suffered from pain after removal of their meshes."
Q: Do you agree with some who say the complications are doctor error and not the mesh itself?
“I can’t speak about doctor error and any individual situations. If you are working with a product that is going to scar and cause chronic inflammation and in the hands of low-volume surgeons, you are set up for trouble. But, importantly, even high volume “experts” still report an unexpectedly high complication rate."
Q: Can you get the arms out with, let’s say, a TVT (transvaginal tape)?
“Removal of mesh arms is a very big, very difficult surgery. These mesh kit arms are scarred in all over the pelvis. It’s is nearly impossible to get all the mesh out. It’s a highly challenging area of the anatomy.”
Q: I understand insurance will pay $1,000 for an implant but only $250 to do a four-hour explant procedure. Is that why many doctors don’t want to deal with complications?
“Insurance and billing is not an issue that I have enough knowledge to answer correctly. However, I suspect the doctors are more commonly turning patients away because it’s a very complicated surgery to remove meshes. Individuals are in a lot of pain and surgery does not guarantee it will help. It’s not straightforward what should be done with these individuals. We know that five to ten years down the road we will be seeing complications. Meanwhile a lot of doctors are putting in these devices and very few are treating complications.”
Q: Many patients never return to the doctor who caused the problems?
“Many patients have the implant and they go elsewhere for their definitive care. The doctor who put in the mesh may never knows it’s a problem. I make sure I send a follow-up letter to the implanting physician. I make the point that the doctor knows so he or she does not assume things went great and everything is fine with the mesh.”
Q: You mean a weekend cadaver clinic won’t do it?
“Exactly. Female pelvic anatomy is very complicated. Just because you passed a board exam or a weekend cadaver lab does not mean the surgeon understands the complexity of the pelvic anatomy."
Q: Medical societies, what can they do to help the situation?
“They need to police themselves and take an honest look at the complications that arise from procedures. But it is important to note that just because medical societies come out in support of mesh products does not mean that all surgeons within the societies agree with that decision. I’m a member of the American Urogynecologic Association, the International Urogynecological Association, SUFU, AUA, all of the societies that support mesh products. That doesn’t mean all members within those societies support what the society’s official opinion is.”
Q: Are we seeing a great deal of conflict of interest among the higher ups?
“Anytime money is involved that definitely muddies the waters. That’s why at Mayo they have such strict rules against working with medical industry. If we are paid any money by industry, we have to declare it to Mayo. This is a very strict rule and it’s a very good rule. ”
Q: I had one doctor describe this as a ‘dark chapter’ in women’s pelvic medicine?
“That's a good description. It’s a disappointing development especially because meshes have been around for a long time. Polypropylene has been used for hernia repair, abdominal wall and thoracic wall hernias and the complications with that are well documented. There are hundreds of papers or more dealing with the complications of hernia mesh.
“But take the same polypropylene mesh and put it in the vagina where we have alternatives, so it’s a tragic preventable development. Just take a look at general surgery data and anyone could have predicted these vaginal complications would happen, and they did. The vagina is a curved area and add to that the bacterial introduction of the implant and the stresses causing mesh to be pulled everywhere – It’s a sad chapter and hopefully we are at the end of new implantations in terms of prolapse."
Q: I’m hearing doctors say to patients that this is the “New Mesh” and the old ones have been recalled to talk them into the procedure?
“That is a major problem and it’s a disappointing problem. At Mayo you are taught from day one the needs of the patient come first. William Mayo said that. If you strictly follow that then ties associated with industry fall away. It’s also not just tragic for the individual patient but the vast wasted medical resources for Medicare and insurance they are paying for something that is no better than traditional surgery.
"I would think the insurance companies should be seriously involved with this issue. I’ve sent letters to senators and representatives because Medicare is looking at vast amounts of money wasted because they paid for the product and surgeries and a doctor could have done a traditional repair with $8 worth of suture and not face these complications. I didn’t get anywhere with Congress with the money aspect. If we had insurance companies leading the charge making sure of the safety of new products, then this wouldn’t happen.” #
Learn More:
Dr. Daniel S. Elliott-Urology Department
Mayo Clinic, Rochester, MN
http://www.mayoclinic.org/biographies/elliott-daniel-s-m-d/bio-20053374
Dr. Elliott signed onto the original Public Citizen Petition in 2011 to have mesh taken off the market. The Food and Drug Administration recently denied that petition.
Dr. Elliot's Statement in Support of Public Citizen Petition
http://www.citizen.org/documents/1963-Elliott_statement_in_support_of_HRG_petition.pdf
Public Citizen Press Release:
http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3405
