‘Mesh morass’ leaves future in question

The use of surgical mesh in urology has long been the subject of debate and scrutiny, with particular concern raised about its safety in the treatment of pelvic organ prolapse. On April 16, after years of escalating actions, the FDA ordered an immediate halt to the sale and distribution of surgical mesh kit products indicated for the transvaginal pelvic organ prolapse repair. The announcement generated widespread reaction and coverage in the lay press, including The New York Times and USA Today. In this interview, Eric S. Rovner, MD, discusses the FDA’s announcement, the status of midurethral slings for the treatment of stress urinary incontinence, and how he expects his treatment of prolapse to change in the wake of the FDA’s announcement. Dr. Rovner is professor of urology at the Medical University of South Carolina, Charleston. Dr. Rovner was interviewed by Urology Times Editorial Consultant Gopal H. Badlani,MD, professor of urology at Wake Forest Baptist Medical Center, Winston-Salem, NC.

Please discuss the recent FDA announcement regarding surgical mesh products.

The FDA’s April 16 statement was limited to pelvic organ prolapse mesh, specifically for the indication of anterior vaginal wall reconstruction through a transvaginal approach. This statement did not pertain to posterior vaginal wall mesh or apical vaginal mesh used for abdominal sacral colpopexy. Posterior mesh products have not been available in the United States since 2016. In fact, at the time of the FDA statement, the only remaining products that were being commercially marketed for vaginal pelvic organ prolapse repair were for anterior vaginal wall reconstruction. In essence, the FDA gave a cease-and-desist order to the remaining two manufacturers of pelvic organ prolapse mesh-Boston Scientific and Coloplast-directing them to discontinue all sales and distribution and have a plan to do so within 10 days.

This FDA directive also did not apply to currently available transobturator and retropubic midurethral slings. Those slings currently on the market are unaffected by this FDA directive. In addition, currently used transabdominal mesh products such as those used for abdominal sacrocolpopexy, either through an open approach or through a robotic or laparoscopic approach, are not affected by this statement.

To reiterate, it is still permissible to use mesh for slings if providers are trained to do so?

That is essentially correct. The mesh used for laparoscopic, robotic, and open abdominal sacrocolpopexy was not specifically mentioned in the FDA statement. In addition, the mesh specifically used for midurethral slings such as transobturator slings and retropubic slings was not mentioned by the FDA in this particular statement.

Was the FDA’s April 16 announcement premature, given that the agency’s request for 522 postmarket surveillance data had a due date of December 2019?

The results of the FDA-mandated 522 studies have not been published in journal or abstract form to my knowledge. It is conceivable therefore that the FDA made this decision prior to the final results of these studies. The data upon which the FDA made this decision is unclear. Furthermore, whether the FDA decision is final or potentially reversible when the 522 studies are completed is speculative.

Next:"I don’t feel that sub-specialization in Female Pelvic Medicine and Reconstructive Urology is a prerequisite for doing these midurethral sling procedures"Very few urologists are board certified in female pelvic health, but sling surgery is still part of urology training. Do you feel urologists need further training in this procedure?

Whenever we ask, “Is somebody able to do a given procedure?” there are many factors that play into the answer. There is no single learning curve that applies to all surgeons. I don’t believe that any surgery we do in urology is necessarily “easy.” Some surgeons need only a few cases for proficiency, others need many. Having said that, in my personal opinion there is adequate training in many, but not all programs to do female incontinence surgery, of which stress incontinence surgery using midurethral slings is a central component. 

Read: AUA among groups urging passage of prior authorization bill

I don’t feel that sub-specialization in Female Pelvic Medicine and Reconstructive Urology is a prerequisite for doing these midurethral sling procedures, and I believe that the American Board of Urology would agree with that statement. If a given practitioner is adequately trained in the diagnosis of the condition, is adequately trained in the relevant pelvic anatomy and surgical techniques, and is competent to perform the procedure and take care of the patient postoperatively, then there is no reason that they shouldn’t be able to perform the procedure in practice and do so safely and effectively.

What do clinical guidelines say regarding this topic?

The joint AUA/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) guideline for surgical treatment of female stress urinary incontinence supports the use of midurethral slings as an option for the treatment of stress urinary incontinence. In fact, the AUA, SUFU, American Urogynecologic Society, and a variety of other organizations have reiterated their prior position statements regarding the use of midurethral slings as an important, effective, and safe procedure for the treatment of stress urinary incontinence in females.

How do urologists who are currently in practice obtain further training? Is there another path other than a formal fellowship?

That’s a very good question. Currently, I don’t know of a formal training program for practitioners who wish to learn to do these types of procedures but were not trained adequately during residency or fellowship. For an inexperienced surgeon who is not familiar with the diagnosis and management of female stress urinary incontinence, or the surgical technique, or the management of the complications that can result from the surgery, a weekend course is, in my estimation, insufficient. Additional training for such an individual is necessary. 

You’ve published a great deal in this field. What have you learned about complications from slings?

Over the past 20 or so years, dating back to the approval of midurethral slings, the number of cases of stress urinary incontinence surgery has gone way up. It is likely that there were surgeons performing these procedures who were not adequately trained, and certainly there were adverse outcomes in certain patients. For a physician who is adequately trained in the performance of these procedures, the diagnosis and treatment of the condition, and the management of the complications, I’m reasonably sure that midurethral slings are among the best procedures we’ve ever had to treat stress urinary incontinence safely and effectively.

Like any other surgery that is done poorly, or is performed in a poorly selected patient, or for the wrong indication, or in a  patient who wasn’t adequately counseled regarding the potential adverse effects, the potential outcome can be devastating. But that is not unique to mesh or vaginal surgery; that applies across all surgeries. Perhaps the number of midurethral slings that are done magnify the problem somewhat, but I don’t think it’s intrinsic at all to the procedure itself nor the material used for the procedure.

Being in the field and knowing that the percentage of complications with slings is so low, I was surprised to see in a recent JAMA commentary a statement that a lifetime of follow-up is needed before the procedure is considered safe (JAMA 2019; 321:1338-40).

Perhaps part of the perceived problem is that midurethral slings are so commonly performed and so well studied that the blemishes, if you will, are out of proportion to the positive outcomes that we see with this procedure. If you look at data from well-done trials, the complication rate for midurethral slings is less than or equivalent to all of the other procedures that we’ve historically done for this condition with the only unique complication being that related to foreign body mesh exposure or mesh erosion into the urinary tract.

Also see - New Products: Trocar allows one-handed laparoscope/hand instrument control

But even those two foreign body complications are not unique to midurethral sling incontinence surgery. For many years, surgeons performed Burch procedures with non-absorbable sutures, and the sutures eroded into the bladder. There are case reports of even autologous fascial slings being exposed vaginally. So these are not unique complications. They’re only unique in that mesh is the actual material that is eroding or being exposed to the urinary tract.

Next: How is your personal surgery for pelvic organ prolapse going to change without the use of mesh?

How is your personal surgery for pelvic organ prolapse going to change without the use of mesh?

Like you, I was trained before the era of mesh, so I can do many of these procedures without it, recognizing that the recurrence rate will be somewhat higher, the procedures may take a bit longer, and the recovery and convalescence will also be longer. It is important to recognize that the complication rate with these older procedures is not zero. The historical complication rate, even with native tissue repairs, is certainly not insignificant; I suspect that it just hasn’t been reported accurately as these older procedures were not subjected to the same scrutiny in the literature as the contemporary procedures using mesh. What we have learned in the 25 years or so that I’ve been doing pelvic reconstruction is the importance of the apex of the vagina. Maybe now that we’re better at identifying apical vaginal prolapse problems, when we go back to native tissue repairs or augmented repairs with xenografts or allografts we’ll be better at diagnosing these cases preoperatively and addressing them at the time of surgery. Attention to the apex of the vagina will likely reduce the historically high rate of  recurrence with vaginal prolapse procedures.

How concerned are you that the FDA will extend the ban of mesh to include its use in stress incontinence surgery?

As it currently stands, there is no indication that the FDA will act unfavorably toward the existing midurethral sling procedures in the same manner as it has dealt with vaginal prolapse mesh. The evidence base for the use of the midurethral sling is strong, and medical societies, as well as the vast majority of practitioners who do pelvic reconstruction, remain very supportive of the procedure.

Is there anything else you would like to add?

It’s important to recognize that midurethral slings are an important and even critical part of our armamentarium for the treatment of stress incontinence and, if done well, patients are happy and the procedure is quite durable. That’s what needs to come out of all of this mesh morass once all the litigation is finished and the regulatory problems are over. Hopefully, the procedure will survive because it’s really been a great advance in the care of women.