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When and how to place an autologous rectus fascia pubovaginal sling
Mickey Karram, MD; Dani Zoorob, MD (Surgical Techniques, November 2012)
The current surgical options for managing stress urinary incontinence (SUI) include:
These options—specifically MUS, which are the predominant SUI surgical procedure and the clear standard of care—remain in the surgeon’s armamentarium after the July 2011, FDA safety warning.1
Confusion persists
A common misunderstanding is that full-length MUS were included in the FDA warning; however, the warning was about transvaginal mesh for prolapse and was titled, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”1 In this document, it was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” In early 2012, when the FDA sent letters to industry for postmarketing approval study requests,2 full-length MUS (but not single-incision mini-slings), were excluded from further study.
On page 24 of this issue, the technique for a pubovaginal sling is very well described by Drs. Karram and Zoorob in their article, “When and how to place an autologous rectus fascia pubovaginal sling.” There may be a place for this pubovaginal sling procedure for women with previous urethral surgery or radiation, but studies are needed to determine if repeat MUS or pubovaginal slings are the best procedure for recurrent incontinence. You should not get the impression that the current mesh controversy justifies abandoning the full-length MUS for a pubovaginal sling.
Unfortunately, television ads by law firms trawling for potential clients with any mesh in their vagina have created confusion among patients that synthetic MUS for incontinence is the same as transvaginal mesh for prolapse. In most clinical scenarios, rather than validating the patients’ concerns about the safety of synthetic mesh and performing a pubovaginal sling procedure, the most appropriate course of action is detailed, evidence-based patient education about MUS safety and efficacy to counter the patient’s misperceptions of safety concerns.
A bit of history on MUS
The first retropubic MUS was the tension-free vaginal tape (TVT) procedure published by Ulmsten in 1996.3 This minimally invasive outpatient procedure using a 1-cm wide strip of polypropylene mesh has revolutionized the management of SUI and has been the most studied surgical procedure in all of gynecology. A PubMed search of “tension- free vaginal tape” reveals more than 2,000 publications.
MUS vs pubovaginal slings. In a recent updated systematic review of 39 randomized controlled trials comparing different SUI procedures, midurethral slings and pubovaginal slings had similar cure rates. Pubovaginal slings, however, had more postoperative lower urinary tract symptoms and a higher reoperation rate.4
Pubovaginal slings require an 8-cm lower-abdominal incision, general or regional anesthesia, and hospitalization (usually). They also have higher risks of intraoperative bleeding and wound complications (including incisional hernias) than MUS. By contrast, MUS require 3 small 1-cm incisions and can be performed on an outpatient basis with local anesthesia and sedation. Postoperative recovery is significantly easier and shorter with MUS than with pubovaginal slings. Pubovaginal slings performed with human cadaveric material and porcine material have inferior outcomes to autologous material.5
Modifications to MUS included transobturator approaches, which have comparable efficacy to the retropubic approach.6 In this century, the full-length MUS procedures are the predominant SUI surgical procedure and the clear standard of care.
In a recent study involving 53 urologists and urogynecologists (of whom >90% were fellowship-trained), use of full-length MUS was the preferred procedure in 93% of primary stress incontinence surgical procedures.7 In fact, full-length MUS have been so successful and safe that extrapolation of a small ribbon of mesh under the midurethra to larger sheets of mesh for the entire vagina is what produced our current transvaginal mesh controversy. The vaginal erosion rates of 10% that have been seen with much larger pieces of transvaginal mesh are only 1% with MUS.8 Studies have not demonstrated common or significant vaginal pain or pain with intercourse after MUS.
Let’s educate our patients
In my clinical practice, I have found that educating patients about the safety and efficacy of synthetic MUS is extremely successful. I urge you to not replace on a widespread basis the most studied, safe, and successful treatment for SUI with a procedure that is considerably more invasive and complicated and can be more painful and require a longer recovery. We all must do our best to clear up the confusion created by misleading television advertisements by law firms. Full-length synthetic midurethral slings remain the current standard of care for stress incontinence surgery.