Transvaginal synthetic mesh: Use in stress urinary incontinence (SUI)

INTRODUCTION — Synthetic mesh midurethral sling procedures are the most commonly performed surgery for stress urinary incontinence (SUI) in women because of their high efficacy and low risk. However, the risk profile differs when synthetic mesh is used to treat SUI compared with pelvic organ prolapse. These different risk profiles have created confusion for clinicians and patients regarding the safely of this material in the surgical treatment of SUI.

This topic will discuss issues surrounding the use of transvaginal synthetic mesh in surgery for female SUI. Related topics on the surgical treatment of SUI in women include:

●(See "Female stress urinary incontinence: Choosing a primary surgical procedure".)

●(See "Surgical management of stress urinary incontinence in females: Choosing a type of midurethral sling".)

●(See "Surgical management of stress urinary incontinence in females: Retropubic midurethral slings".)

●(See "Surgical management of stress urinary incontinence in females: Transobturator midurethral slings".)

●(See "Surgical management of stress urinary incontinence in females: Pubovaginal sling procedures".)

In this topic, when discussing study results, we will use the terms "woman/en" or "patient(s)" as they are used in the studies presented. We encourage the reader to consider the specific counseling and treatment needs of transgender and gender-expansive individuals.

GRAFT MATERIAL FOR SUI TREATMENT — Materials used in the surgical treatment of SUI include (table 1) [1]:

●Synthetic mesh – Type 1 macroporous monofilament polypropylene mesh is most commonly used for the surgical treatment of SUI because of the lower rates of complication and voiding dysfunction compared with autologous graft, allograft, and xenograft (figure 1) [2,3]. Polypropylene mesh has not been associated with increased risk of pelvic cancer in a large retrospective database study [4]. The type of material chosen is critically important; all slings made of materials other than polypropylene have been recalled because of unacceptably high complication rates (eg, ProteGen, ObTape, and Uratape) [5]. (See "Reconstructive materials used in surgery: Classification and host response", section on 'Synthetic materials'.)

●Autologous graft – Autologous grafts can be harvested from the rectus fascia or fascia lata [1]. These materials are used in traditional suburethral slings placed at the level of the bladder neck. (See "Surgical management of stress urinary incontinence in females: Pubovaginal sling procedures".)

●Allograft and xenograft – Allo- and xenografts are less commonly used for treatment of SUI and have tended to underperform compared with polypropylene slings [6]. Allografts are processed cadaveric fascia lata or acellular dermal matrices of human donors (table 2). Xenografts include bovine dermis, ox fascia, and porcine dermis (commercial name Pelvicol) (table 3) [1,7]. (See "Reconstructive materials used in surgery: Classification and host response", section on 'Allografts' and "Reconstructive materials used in surgery: Classification and host response", section on 'Xenografts'.)

A detailed discussion of materials used in reconstructive surgery is presented elsewhere. (See "Reconstructive materials used in surgery: Classification and host response".)

OUR APPROACH TO SURGERY FOR SUI — We agree with the multiple statements that midurethral mesh sling procedures (macroporous synthetic mesh, type 1) are the preferred procedures for SUI because of their low morbidity, high efficacy, and high patient satisfaction [3,8-10]. Mesh-based sling procedures have largely replaced colposuspension, bladder neck slings (which are typically made of autologous rectus fascia), and suture-only transvaginal procedures (transvaginal needle suspensions). The selection of surgical procedure for SUI is discussed in detail separately. (See "Female stress urinary incontinence: Choosing a primary surgical procedure".)

As an example of supporting data, a national database cohort study comparing outcomes of over 16,500 women who underwent mesh (retropubic and transobturator sling) or nonmesh (open colposuspension) incontinence procedures reported an approximately 50 percent lower risk of immediate complication in the mesh group with similar five-year procedure efficacy and complication rates [11]. Importantly, this study was limited to women who underwent a first, single incontinence procedure and did not include women who underwent concomitant prolapse surgery. A large retrospective cohort study of women undergoing a retropubic or transobturator sling for primary treatment of SUI revealed low cumulative incidence of mesh revision for retention (3.2 percent retropubic versus 0.4 percent transobturator) and mesh revision for mesh exposure (1.9 percent retropubic versus 2.4 percent transobturator) at eight years of follow-up [12]. These findings reinforce the safety profiles for these procedures. (See "Female stress urinary incontinence: Choosing a primary surgical procedure", section on 'Comparison of efficacy'.)

The surgical options for SUI and treatment selection are reviewed separately.

●(See "Female stress urinary incontinence: Choosing a primary surgical procedure".)

●(See "Surgical management of stress urinary incontinence in females: Choosing a type of midurethral sling".)

STATEMENTS AND RECOMMENDATIONS — It is important to note that warnings in transvaginal mesh advisory statements differ for mesh procedures for SUI and mesh-based transvaginal prolapse repairs.

●Consensus statement of the European Urology Association and the European Urogynaecological Association – In the 2017 consensus review of published meta-analyses and reviews, the two societies concluded that the use of synthetic mesh midurethral slings for the treatment of SUI had "good efficacy and acceptable morbidity" [10]. The document noted that all available treatment options, as well as the benefits and risks of each, should be discussed with patients prior to making a treatment decision.

●US Food and Drug Administration – In 2017, the US Food and Drug Administration (FDA) categorized surgical mesh for urogynecologic procedures as a Class II device with regard to use for SUI (in contrast with Class III labeling for synthetic mesh used for transvaginal pelvic organ prolapse repair) [13]. With regard to mesh for SUI surgery, the FDA stated in its prior 2016 notification that "The safety and effectiveness of multi-incision slings is well established in clinical trials that followed patients for up to one year. Longer follow-up data are available in the literature, but there are fewer of these long-term studies compared to studies with one-year follow-up" [9].

Importantly, the FDA statements regarding safety apply to traditional multi-incision slings and not to mini-slings. The earlier 2014 FDA Safety Communication stated, "It is unclear how mini-slings compare to multi-incision slings with respect to safety and effectiveness for treating SUI. Additional studies may help the agency to better understand the safety and effectiveness of these devices" [14].

●American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction – This 2016 joint publication, updated in 2018, restated the safety of mesh midurethral slings and supported the use of midurethral slings in the treatment of SUI [15].

PREOPERATIVE PREPARATION

Informed consent — A detailed preoperative informed consent process is of paramount importance to establish appropriate patient expectations. The patient is counseled regarding expected benefit compared with risk of complications with mesh use and that polypropylene mesh is a permanent surgical material (ie, it does not degrade, but it can be removed). Alternative nonsurgical options and other surgical treatments are reviewed [16]. The preoperative discussion should include review of potential complications of synthetic mesh that may require additional intervention and may not be completely resolved with mesh removal. This counseling discussion is documented on the procedure consent form and in the medical record.

Antibiotic prophylaxis — We agree with professional society guidelines recommending antibiotic prophylaxis for surgical treatment of SUI [17,18]. A vaginal incision is classified as a clean-contaminated procedure, and antibiotic prophylaxis is typically used for this level of infection risk. (See "Antimicrobial prophylaxis for prevention of surgical site infection in adults", section on 'Wound classification'.)

While antibiotic prophylaxis has also typically been administered for procedures involving reconstructive materials, there are few data regarding the infection rate if antibiotics are not given. The utility of antibiotic prophylaxis for transvaginal mesh for SUI is also based upon indirect data from other procedures involving mesh [19]. (See "Overview of preoperative evaluation and preparation for gynecologic surgery", section on 'Antibiotic prophylaxis'.)

Use of reconstructive materials does not affect the need for antibiotic prophylaxis of bacterial endocarditis.

Use with other procedures — Many women with SUI have other pelvic floor disorders such as pelvic organ prolapse. Transvaginal mesh insertion for SUI treatment can be performed at the same time as other reconstructive procedures. The risks of transvaginal mesh when used for prolapse repair are presented elsewhere:

●(See "Transvaginal synthetic mesh: Use in pelvic organ prolapse".)

●(See "Pelvic organ prolapse and stress urinary incontinence in females: Surgical treatment".)

RESOURCES FOR PATIENTS AND CLINICIANS — The American Urogynecology Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) have jointly released FAQ (frequently asked question) sheets for patients and clinicians that are publicly available.

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Gynecologic surgery".)

SUMMARY AND RECOMMENDATIONS

●Surgical materials for SUI – Materials used in the surgical treatment of stress urinary incontinence (SUI) include synthetic mesh and autograft. Allograft and xenograft are no longer routinely used. (See 'Graft material for SUI treatment' above.)

•Advisory statements based on surgical indication – Advisory statements differ for transvaginal synthetic mesh-based SUI and pelvic organ prolapse procedures. Synthetic mesh for the surgical correction of SUI is generally considered to have good efficacy with acceptable morbidity. (See 'Statements and recommendations' above.)

•Patient counseling – Prior to any mesh-based surgery, the patient is counseled regarding expected benefit compared with risk of complications with mesh use and that polypropylene mesh is permanent. Alternative nonsurgical options and other surgical treatments should be reviewed. (See 'Informed consent' above.)

●Synthetic mesh for initial SUI surgery – For women undergoing primary surgical treatment of SUI, we recommend synthetic mesh sling procedures rather than autologous fascia sling procedures (ie, bladder neck slings) (Grade 1B). Mesh sling procedures have high efficacy, low morbidity, and high patient satisfaction. (See 'Our approach to surgery for SUI' above.)

●Prophylactic antibiotics – We recommend antibiotic prophylaxis for surgical procedures that utilize surgical mesh for the treatment of SUI (Grade 1B). (See 'Antibiotic prophylaxis' above.)

●Information sources – The American Urogynecology Society (AUGS) and the Society of Urodynamics, Female pelvic Medicine & Urogenital Reconstruction (SUFU) have jointly released FAQ (frequently asked question) sheets for patients and clinicians that are open-access. (See 'Resources for patients and clinicians' above.)