Synthetic Sling Is the Correct Choice for Index Patients With SUI
- Moderator - Victor W. Nitti, MD
- Debater - Pro: Michael J. Kennelly, MD
- Debater - Con: Jerry G. Blaivas, MD
- Debater - Pro: Eric S. Rovner, MD
- Debater - Con: Helen Elizabeth O'Connell, MD
Dr. Nitti began by stating the 2 essential questions of the debate. The first one focuses on the safety and effectiveness of the midurethral synthetic sling. Is it worth the risk? Although it is the most widely studied operation for SUI in history, it is associated with rare yet devastating complications such as urethral erosions. Also, are serious complications the result of inherent problems with mesh or due to poor surgical technique and perhaps poorly trained or careless surgeons?
The AUA has issued a position statement on the use of vaginal mesh for the surgical treatment of SUI in 2011 and 2013. Suburethral synthetic polypropylene mesh sling placement is the most common surgery currently being performed for SUI. There is extensive data to support the use of synthetic polypropylene mesh suburethral slings for the treatment of female SUI, with minimal morbidity compared with alternative surgeries. The advantages include shorter operative time/anesthetic exposure, reduced surgical pain, and reduced hospitalization and voiding dysfunction.
Mesh-related complications can occur following polypropylene sling placement, but the rate of these complications is acceptably low. Furthermore, it is important to recognize that many sling-related complications are not unique to mesh surgeries and are known to occur with non-mesh sling procedures as well. It is the AUA’s opinion that any restriction of the use of synthetic polypropylene mesh suburethral slings should be a disservice to women who choose surgical correction of SUI.
Both the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the AUA support the use of multi-incision monofilament midurethral slings for the treatment of SUI. Patients must be properly selected and appropriately counseled regarding this surgical procedure by surgeons who are trained in the placement for such device, as well as the recognition and the management of potential complications associated with their use. Multiple case series with randomized controlled trials attest to the efficacy of synthetic polypropylene mesh slings based on 5- to 10-year data.
The AUA strongly agrees with the FDA that a thorough informed consent should be conducted prior to synthetic sling surgery and that surgeons who wish to perform synthetic sling surgery should undergo rigorous training in the principles of pelvic anatomy and pelvic surgery and be properly trained in specific sling techniques. They should also be able to recognize and manage complications associated with synthetic mesh sling placement.
Midurethral synthetic sling placement is the most popular operation for SUI (70,000 -74,000/year in US based on Nationwide Inpatient Sample). It is the most popular procedure performed by certifying/recertifying urologists based on the ABU data.
In 2012, 86% of procedures performed for SUI were midurethral sling, 15% were urethral bulking, and <1% were traditional procedures.
Pro: Michael J. Kennelly, MD
Dr. Kennelly argued that midurethral sling placement is probably the ideal procedure for SUI because it is minimally invasive, durable, has good longevity/persistence in situ, offers immediate results, has few complications, has a rapid learning curve for surgeons, is easy to use, can be performed with local anesthesia, has minimal recovery time, and is suitable for a wide range of patients type and conditions. The available options for patients with SUI include retropubic suspensions (open Burch suspensions alone and laparoscopic suspension), slings (autologous fascial slings, cadaveric slings, and synthetic slings), injectable bulking agents, and artificial urinary sphincters. Dr. Kennelly argued that the optimal choice for patients with SUI is a multi-incision mid-urethral synthetic sling (MUS) synthetic sling.
In 1995, Ulmsten et al. reported on the development of synthetic midurethral slings. They reported that this was a tension-free vaginal tape made of a woven Prolene tape, positioned “without fixation” in a “tension-free manner” in the “mid-urethra” restoring support to the urethra and reinforcing the pubourethral ligament. It is an ambulatory procedure that takes 22 minutes under local anesthesia with 84% success rate at 2 years, equivalent to a Burch urethropexy.
There are 3 types of midurethral slings: retropubic, transobturator, and single incision. The sling is made of Type 1 macroporous monofilament polypropylene mesh: it allows for tissue ingrowth without the need for suturing and is a proven material with a long history of implantation and clinical success. Furthermore, it is non-reactive in-vivo, fosters rapid tissue in-growth and minimizes the risk of chronic inflammation and infection.
Dr. Kennelly argued that the correct choice for the index patient with SUI is a multi-incision synthetic sling, which offers durable efficacy backed by substantial outcomes data. The MUS is the most studied surgical treatment for SUI with over 2000 articles published. Numerous randomized controlled trials and meta-analyses compare different types of MUS and other established SUI procedures (eg, UK and Ireland TVT Trial Group, 2004; Cochrane Database Review 2009; Systematic Review Eur Urol, 2010; TOMUS Trial – UITN 2010; Society of Gynecologic Surgeons Review, 2014)
MUS is minimally invasive, offering an enhanced patient experience. It is performed under IV sedation and local anesthesia. Ninety percent of patients void in the recovery room and go home without a Foley catheter within 3 hours with minimal use of postoperative analgesics.
It is versatile and effective for all types of SUI. It can be performed on obese patients, elderly patients, patients who failed prior surgery, and with concurrent prolapse repair.
It has a low rate of complications (eg, hematoma, infection, bowel injury, urethral injury, retention, and bladder perforation), and the risk of revision/removal for either mesh erosion or urinary retention has been reported to be 3.7% over 9 years.
It is endorsed by professional societies and national guidelines. The AUA has issued a position statement concluding that synthetic slings are an appropriate treatment choice for women with stress incontinence with similar efficacy but less morbidity than conventional non-mesh sling techniques. The American Urogynecologic Society and SUFU have also stated that the polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence: the procedure is safe, effective, and improves quality of life of millions of women.
Con: Jerry G. Blaivas, MD
Dr. Blaivas argued that although mesh slings have faster recovery, less perioperative morbidity, lower minor complications and lower major complications, they may cause unique complications that may have refractory life-altering long-term consequences.
The complications unique to mesh slings include adjacent organ injury from trocar passage, vaginal mesh exposure/extrusion, bladder and urethral erosion, and vesicovaginal/urethrovaginal fistula. Synthetic meshes are significantly more difficult to remove and may cause refractory pelvic pain, dyspareunia, refractory overactive bladder and refractory voiding dysfunction. Furthermore, sling complications are underreported: the cumulative incidence of sling revision/removal has been reported to be 3.7% at 9 years according to published series (Am J Obstet Gynecol, 2013): there should therefore be 23,224 mesh removals reported, which is much higher than the actual reported number in the US. For example, 66,265 mesh lawsuits have been filed in the US. Dr. Blaivas estimates the total underreported cases to be at 66,616 cases.
Dr. Blaivas argued that autologous slings remain the gold standard. They are safe, effective, and cause practically no lifestyle-altering complications. Mesh slings have at least a 3-5% incidence of major complications sufficient to warrant revision. The complications increase over time since surgery, may be refractory to treatment and life altering and include potentially serious long-term consequences that have not been studied in humans. Mesh slings are effective, but may be hazardous to patients’ health; they should be considered experimental.
Pro: Eric S. Rovner, MD
Dr. Rovner stated that MUS are superior in OR time, hospitalization time, pain, convalescence, recovery/return to work, incision size, and scientific data. Autologous (fascial) pubovaginal slings (aPVS) are superior in that they carry a lower risk of mesh exposure.
Although meshes carry life-altering complications, many of these complications are not unique to meshes (eg, obstruction, chronic pain, vascular/bowel injury, GU/genital injury). Complications unique to meshes are mesh erosions and mesh exposure, and those unique to aPVC are hernia of the abdominal wall.
Dr. Rovner argued that perhaps worrisome results are currently being reported for synthetic meshes because they are being performed in greater number than aPVS, by surgeons that are non-experts; are currently under an increased legal, medical and governmental scrutiny; and have a longer term follow-up. Furthermore, the bar seems to be unusually high when it comes to rates of complications for meshes; for example, Dr. Rovner compared its outcomes to those of an RRP for prostate cancer which carries a 2.5-69% rate of incontinence, >50% rate of erectile dysfunction, and a 32% risk of a need for a secondary GU procedure in 5 years.
Con: Helen Elizabeth O'Connell, MD
Dr. O’Connell argued that we are likely underestimating the number of extrusions in synthetic meshes and that national registries are probably required. For example, more than 1 in 4 mesh revisions have chronic pain. Furthermore, synthetic meshes carry complications that never occur with fascia such as dyspareunia in men and occult mesh extrusion. In fact, fascia may be used to fix mesh failures. Dr. O’Connell argued that the invasive nature of mesh is a disaster in some patients, such as mesh obliterating vas. Although some may blame poor training on complications, Dr. O’Connell argued that many of the most complex cases started as a simple SUI procedure in the hands of expert mesh implanters and that major problems may present years after primary surgery. We are now seeing a rising number of mesh revision cases: from 2.4 cases/month/100,000 women in 2008 to 5.7 cases/month/100,000 women in 2012. Women deserve a better choice: fascial slings are alive and well, and a synthetic sling is not the correct choice for an index patient with SUI.
Closing thoughts:
- If complications of MUS are underreported, so are those from PVS
- Either operation should be performed by a properly trained surgeon
- Patient and surgeon must assess risks and benefits for that individual patient and decide on appropriate treatment