Version May 2024
INTRODUCTION — Synthetic mesh is frequently used in transabdominal pelvic organ prolapse (POP) repair. However, transvaginal mesh is more controversial. Concerns have been raised about the safety of transvaginal synthetic mesh, which renews debates that attempt to balance the durability of surgical repair with synthetic mesh against the risk of mesh-related complications.
This topic will discuss issues related to transvaginal mesh for surgical treatment of POP. Related discussions on synthetic mesh for the treatment of urinary incontinence, complications of synthetic vaginal mesh, and management of mesh exposure and pain are presented separately:
●(See "Transvaginal synthetic mesh: Use in stress urinary incontinence (SUI)".)
●(See "Transvaginal synthetic mesh: Complications and risk factors".)
●(See "Transvaginal synthetic mesh: Management of exposure and pain following pelvic surgery".)
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. However, we encourage the reader to consider the specific counseling and treatment needs of transgender and gender expansive individuals.
MESH PRODUCTS
Synthetic mesh — Synthetic materials are available as both absorbable and nonabsorbable mesh. These reconstructive materials can be part of trocar-guided synthetic mesh inserts or kits (figure 1). Nonabsorbable synthetic materials are generally described by type and classified based on pore size and weave [1]. Type 1 macroporous monofilament polypropylene mesh is typically preferred for reconstructive pelvic surgery [2]. Type 1 mesh can be further subdivided into heavy-, mid-, and lightweight materials. There is preliminary evidence suggesting that heavyweight synthetic mesh is associated with more frequent graft-related complications and interventions compared with lightweight mesh [3-5]. (See "Reconstructive materials used in surgery: Classification and host response".)
Transvaginal mesh kits — We do not use commercial mesh kits (referred to as mesh kits or trocar-guided mesh kits (figure 1)) because of high rates of complication and reoperation without a demonstrated benefit in patient awareness of prolapse recurrence [6,7]. In a meta-analysis of three trials that compared native tissue repair with a variety of mesh kits for surgical prolapse repair, of the women who received a mesh kit, 18 percent had a mesh exposure and 9 percent underwent surgical correction of mesh exposure [6]. The total reoperation rate was three times greater for women with mesh kits than women with native tissue repair (relative risk [RR] 3.1, 95% CI 1.3-7.3). While the prolapse recurrence rate on examination was higher for the native tissue group than the mesh group (RR 2.0, 95% CI 1.3-3.1), there was no difference in patient perception of prolapse between the groups (RR 1.3, 95% CI 0.6-1.7). Thus, the women receiving mesh kits had higher complication rates but similar outcomes from the patients' assessments. Challenges to definitive conclusions based on the body of evidence include a limited duration of follow-up and limited data on nonsurgical patient outcomes (ie, a woman may have a recurrent bulge but not elect repeat surgical repair).
Early iterations of mesh kits involved insertion of precut graft material between the vaginal epithelium and underlying fascia. However, this approach results in split thickness of the overlying vaginal tissue, which may contribute to mesh erosion. Proponents of mesh kits now suggest a full thickness dissection, placing the mesh between the fascia and underlying organ (bladder/rectum), in attempts to decrease mesh erosion. Supporting data are not yet available. (See "Transvaginal synthetic mesh: Complications and risk factors", section on 'Surgical technique'.)
The graft is suspended in a tension-free manner with polypropylene mesh arms that are typically passed through a supportive connective tissue structure (eg, arcus tendineus fascia, obturator membrane, iliococcygeus fascia, or sacrospinous ligaments) (figure 1). Transvaginal mesh kits are available in different versions that treat one or multiple anatomic sites within the same procedure [8-12].
ISSUES SURROUNDING SYNTHETIC MESH FOR POP
Advisory statements — Medical societies and regulatory agencies around the world have released statements regarding the use of synthetic mesh in gynecologic surgery [2,13-18]. In 2019, the US Food and Drug Administration (FDA) banned the sale and distribution of surgical mesh for use in transvaginal anterior compartment prolapse (ie, cystocele) repair because they were unable to confirm that the probable benefits outweighed the probable risks [19]. The ban followed the 2016 reclassification of transvaginal synthetic mesh from a class II to a class III (ie, high risk) device [17]. The classification change was made in response to increased reporting of adverse events from mesh-based transvaginal POP repairs [20]. While the 2019 National Institute for Health and Care Excellence (NICE) guideline did not ban the use of synthetic mesh for transvaginal prolapse repair, the organization did advise use of a decision aid for women considering surgery, detailed counseling for women considering mesh-based procedures, and tracking of data on surgery and complications [18]. Of note, the FDA mesh ban does not apply to transvaginal mesh used in the treatment of stress urinary incontinence or to transabdominal mesh for prolapse repair [21].
For women who have already had transvaginal mesh inserted for POP repair, the FDA advised they continue with their annual and other routine check-ups and follow-up care [17]. No action is needed if the patient is satisfied with her surgery and is not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. For English women desiring mesh removal because of complications, a network of specialist mesh removal centers is being established [22]. Mesh related complications and removal are discussed separately.
●(See "Transvaginal synthetic mesh: Complications and risk factors".)
●(See "Transvaginal synthetic mesh: Management of exposure and pain following pelvic surgery".)
A review of the original FDA approval process for 61 mesh POP devices reported approval for all was based on claimed equivalence to the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific) [23]. No clinical trial data were available at the time of the approval of the 61 devices. Published trial data were reported a median of 5 years after device approval (range 1 to 14 years).
Recommendations to health care providers — Regulatory agencies around the globe have released recommendations on the use of synthetic mesh in treating POP [13-16,18,19,24]. Additionally, prior to the 2019 FDA decision to remove transvaginal mesh from the United States market, surgical societies had published guidelines regarding surgeon training [25,26]. Some key points are:
●Should a clinician wish to use surgical mesh to treat POP, awareness of the FDA restrictions and specialized training for the specific mesh technique are paramount [13,14,24,25,27].
●In most cases, POP can be treated successfully without mesh and thus can avoid the risk of mesh-related complications [13,14,24]. However, the surgeon must also acknowledge that approximately 20 percent of women undergoing any type of prolapse repair will experience prolapse recurrence [28-30]. Thus, choose transvaginal mesh-based repairs only after weighing the risks and benefits of surgery with mesh versus all surgical and nonsurgical alternatives [24].
•Understand that having a transvaginal mesh surgery may put the patient at risk for requiring additional surgery or for the development of new complications, and counsel the patient accordingly [13,14,24].
•If mesh is to be used for POP repair, transabdominal mesh placement may result in lower rates of mesh complications compared with transvaginal POP surgery with mesh [24].
•Synthetic mesh should not routinely be used for repair of posterior vaginal prolapse because mesh use in this location does not improve outcomes and is associated with increased risk of complications [27,31,32].
•While transvaginal synthetic mesh repairs of anterior wall prolapse improve subjective outcomes and anatomic success rates, women with mesh-based anterior repairs have the same risk of undergoing repeat prolapse surgery and an increased risk of mesh-related complications compared with women having native tissue repairs [27,31]. Thus, mesh repairs of anterior prolapse are limited to women with a high risk of prolapse recurrence in whom the potential benefits justify the risks [27].
●Inform patients that implantation of surgical mesh is permanent and that some mesh-related complications may require additional surgery that may or may not correct the complication [13,14,24].
●Clinicians performing transvaginal mesh POP repairs should remain vigilant for potential adverse events from the mesh, especially exposure and infection [17]. (See "Transvaginal synthetic mesh: Complications and risk factors", section on 'Complications by procedure'.)
Professional society guidelines — Several gynecologic surgical societies have released guidelines regarding transvaginal placement of surgical mesh for POP repair [25,33-38], including:
●International Urogynecological Association
●American Urogynecologic Society
●Society of Obstetricians and Gynaecologists of Canada
●Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
●British Society of Urogynaecologists and Royal College of Obstetricians and Gynaecologists
DECISION TO USE SYNTHETIC MESH — In general, native tissue repair without synthetic mesh is the preferred approach for transvaginal POP surgery because of the higher risk of complications and repeat surgery with mesh-based repairs [28,31,39-44]. Challenges in comparing native tissue with synthetic mesh repairs include variations in types of anatomic defects and repair surgeries, types of synthetic materials, definitions of success, and duration of follow-up. For example, a prospective cohort study reported noninferiority of native tissue prolapse repair compared with transvaginal mesh repair for the objective end point [43]. However, the mesh arm was superior to native tissue repair at 36 months for the subjective end point (POP-Q points Ba <0, C <1/2 total vaginal length, no vaginal bulging symptoms, and no retreatment). There was no difference in serious adverse events between groups, with a 4.9 percent mesh exposure rate. Whether or not improved efficacy detected in some comparative trials for mesh-based repairs outweighs mesh-related risks is a point of debate [31,40]. However, in the prospective cohort study, there were no differences in subjective success, retreatment for recurrence, and complications between the two groups [43]. Participants in this study were over 60 years of age (mean age 66.6 and 62.4 years, respectively).
●Factors influencing use of transvaginal mesh – The choice of native tissue or synthetic mesh repair must be tailored to the individual, include their preferences, and consider the patient's type of prolapse, risk of prolapse recurrence, planned surgical route (vaginal or abdominal), surgery sequence (primary or repeat), and availability of synthetic mesh products. Surgical mesh for transvaginal POP repair is available for use in European and other countries in carefully selected and counseled patients but is banned in Australia, New Zealand, Ireland, and Scotland. The United Kingdom has placed a national pause on the use of surgical mesh for POP. Clinicians should understand their local guidelines as some countries have also banned the use of transvaginal mesh/tapes for the treatment of stress urinary incontinence (SUI). In the United States, transvaginal mesh for the treatment of POP has been removed from the market based on a lack of demonstrated superiority compared with native tissue approaches [2,13-16,18,19].
●Our approach – The surgical approach for POP should be tailored to the individual, taking into account her preferences and anatomic challenges. We take the following approaches:
•Typical risk of prolapse recurrence – For patients with a typical risk of recurrent prolapse and who are undergoing a primary repair, we perform transvaginal prolapse repair using native tissue. We counsel women that, while native tissue repairs are associated with higher rates of recurrent prolapse and repeat prolapse surgery, the overall risk for repeat surgery is lower because women with native tissue repairs will not have synthetic mesh complications, such as mesh exposure, requiring reoperation. We believe the body of evidence, exemplified by the studies below, favor no or limited use of mesh-based primary repairs outside of clinical trials. (See "Pelvic organ prolapse in females: Epidemiology, risk factors, clinical manifestations, and management", section on 'Risk factors'.)
Supporting data include:
-In an observational study from a New York state database including over 41,000 women that compared the rates of clinically significant mesh complications and repeat surgery to treat mesh-related complications within 12 months of the original surgery, vaginal mesh repairs had higher rates of mesh erosion and repeat surgery compared with non-mesh vaginal repairs, regardless of concomitant sling surgery for SUI (percentages of women having repeat surgery were 5.6 percent for vaginal mesh plus sling, 4.3 percent for vaginal mesh alone, 3.8 percent for non-mesh prolapse repair with sling, and 2.5 percent for sling alone) [39]. Strengths of the study included the large number of women, use of a statewide database (which helps capture women who change providers), and use of repeat surgery as an end point (and thus focuses on erosions that require intervention and not asymptomatic mesh exposures). Of note, women with a history of prior POP or SUI surgery were excluded from this study. Importantly, this study also reconfirmed the relative safety of synthetic mesh suburethral slings for urinary incontinence.
-A European trial including over 1300 women reported that mesh-augmented repairs for POP were associated with a greater than 1 in 10 risk of mesh-related complications but demonstrated no improvement in outcome [40].
•Increased risk of prolapse recurrence – For patients who have increased risk of recurrent prolapse (eg, those with procidentia or with a known connective tissue abnormality) or who have prior unsuccessful primary repair and who desire transvaginal surgical repair, surgical correction with synthetic mesh, where available, is reasonable in carefully counseled women because synthetic mesh repair is associated with lower rates of recurrent prolapse and repeat prolapse surgery compared with native tissue repair. We suggest counseling these women that the risk of mesh-related complications and overall repeat surgery rates for mesh-related complications are higher with synthetic mesh repairs [28,31].
Our approach is based on evidence from a systematic review and meta-analysis comparing transvaginal mesh or grafts with native tissue repair for vaginal prolapse that reported the following outcomes [31]:
-In the analysis of 21 trials comparing synthetic transvaginal mesh with native tissue repair for POP, the risk of recurrent prolapse, defined as stage 2 or greater prolapse on examination at any vaginal site, was lower in women undergoing synthetic mesh repairs than for native tissue repairs (relative risk [RR] 0.40, 95% CI 0.30-0.53, n = 2494 women). When the subanalysis was limited to women with anterior compartment repair, synthetic mesh repairs were associated with an even lower risk of recurrent prolapse compared with native tissue repairs (RR 0.33, 95% CI 0.26-0.40, 15 trials, n = 1748 women).
-In the analysis of 12 trials assessing repeat prolapse surgery, repeat surgery for any prolapse was less common in women undergoing synthetic mesh repairs than for native tissue repairs (RR 0.53, 95% CI 0.31-0.88, n = 1675 women).
-In the analysis of seven trials assessing the combined rates of repeat surgery (ie, repeat surgery for prolapse, urinary incontinence, or mesh exposure), women with synthetic mesh repairs had more than double the risk of repeat surgery compared with women with native tissue repairs (RR 2.40, 95% CI 1.51-3.81, n = 867) because of the increase in mesh-related complications that required surgery.
●Data limitations – The above approaches are based on data with inherent limitations and thus may change as the body of evidence continues to evolve.
•Duration of follow-up – One major limitation of the studies in the above meta-analysis is their relatively short period of follow-up. Data are needed comparing the long-term cumulative risk of surgery for mesh-related complications with the risk of repeat surgery for recurrent prolapse after a native tissue repair. In a five-year prospective cohort study of a vaginal mesh support kit, optimal apical support decreased from 94 percent at one year to 83 percent at five years [45]. It is possible that the risks will cross at some future time point.
•Unknown impact of apical repair – A number of the trials included in the above meta-analysis did not allow for concomitant apical repair in the native tissue arm; hence, it remains unclear if, and by how much, this omission contributed to the above findings.
•Surgeon volume – The studies did not include information on surgeon volume. As with other gynecologic surgeries, it is possible that surgeon volume will impact complication and success rates [46-48].
•Surgical route and impact of apical prolapse – Prolapse repair with synthetic mesh can be performed via transabdominal or transvaginal routes. The choice of route partly depends on the anatomic defects that are present. For those with concurrent apical prolapse, we prefer abdominal repair (open, traditional laparoscopic, or robot-assisted prolapse repair) with macroporous type 1 synthetic mesh. However, others prefer native tissue repair [44]. Discussion of the benefits and risks of abdominal and vaginal repair is presented elsewhere.
Specific discussions of native tissue and synthetic mesh repair by anatomic site of prolapse are presented separately.
•(See "Surgical management of posterior vaginal defects", section on 'Graft augmentation'.)
ALTERNATIVES TO SYNTHETIC MESH — It is not necessary to use any form of biologic or synthetic material to repair POP. Native tissues repairs are discussed elsewhere.
●(See "Surgical management of posterior vaginal defects", section on 'Choice of procedure'.)
While biologic materials are available, we do not use allograft or xenograft materials in our practice for POP treatment because they do not appear to mitigate complications and have mostly underperformed compared with synthetic materials [49-51]. Other types of reconstructive materials (autograft, allograft, xenograft) are described elsewhere. (See "Reconstructive materials used in surgery: Classification and host response", section on 'Types of materials'.)
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 permanent. Alternative nonsurgical options and other surgical treatments are reviewed. Potential complications of synthetic mesh that may require additional intervention and may not be completely resolved with mesh removal are discussed. This discussion is documented on the procedure consent form and in the medical record.
Antibiotic prophylaxis — We agree with professional society guidelines [52,53] recommending antibiotic prophylaxis for all procedures for treatment of POP.
Antibiotic prophylaxis has typically been used for procedures involving reconstructive materials; there are few data regarding the infection rate if antibiotics are not administered. The utility of antibiotic prophylaxis is based upon indirect data from other procedures involving mesh. Mesh use in inguinal or femoral hernia repair is the most similar clinical use. A meta-analysis of six randomized trials in which reconstructive material was used for inguinal hernia repair demonstrated that infection rates were significantly lower when antimicrobial prophylaxis was administered [54]. (See "Overview of preoperative evaluation and preparation for gynecologic surgery", section on 'Antibiotic prophylaxis'.)
For transvaginal placement of reconstructive materials, the risk of infection is likely higher than with inguinal or femoral hernia repair. A vaginal incision is classified as a clean-contaminated procedure, which is associated with a 2.4 to 7.7 percent rate of surgical site infection, and antibiotic prophylaxis is typically used for this risk of infection. (See "Antimicrobial prophylaxis for prevention of surgical site infection in adults", section on 'Wound classification'.)
Use of reconstructive materials does not affect the need for antibiotic prophylaxis of bacterial endocarditis.
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 pelvic organ prolapse repair – Materials available for the treatment of pelvic organ prolapse (POP) include synthetic mesh, transvaginal mesh kits, and autologous grafts. (See 'Mesh products' above.)
•Synthetic mesh – Macroporous polypropylene mesh is the most common type of synthetic mesh used for POP repair. Materials with microporous structure are associated with increased complications rates and should be avoided. (See 'Synthetic mesh' above.)
•Biologic materials – Biologic materials (xenograft and allografts) are less commonly used because they are less effective for treatment of POP compared with synthetic materials yet have comparable rates of complications. (See 'Alternatives to synthetic mesh' above.)
•Commercial synthetic mesh kits – Commercial transvaginal mesh kits for POP (referred to as mesh kits or trocar-guided mesh kits) are rarely used because of high complication rates. (See 'Transvaginal mesh kits' above.)
●Advisories for use of synthetic vaginal mesh – Some countries have banned the use of mesh for transvaginal POP repair. Clinicians should understand their local guidelines. The FDA has restricted sale of transvaginal mesh for POP repair. Other regulatory agencies have issued statements regarding use of synthetic mesh in gynecologic surgery and made recommendations for health care providers on training, mesh use, patient counseling, and postoperative follow-up. (See 'Advisory statements' above and 'Recommendations to health care providers' above.)
●Decision to use synthetic mesh – In general, native tissue repair without synthetic mesh is the preferred approach for transvaginal POP surgery because of the higher risk of complications and repeat surgery with mesh-based repairs. The approach is tailored to the patient. (See 'Decision to use synthetic mesh' above.)
•Individuals with average risk of prolapse recurrence – For women with a typical risk of recurrent prolapse who are undergoing primary transvaginal POP repair, we recommend native tissue reconstruction rather than synthetic mesh repair (Grade 1B). Although native tissue repairs are associated with higher rates of recurrent prolapse on examination and repeat prolapse surgery compared with synthetic mesh repairs, native tissue surgery does not have synthetic mesh complications and thus has lower overall reoperation rates. (See 'Decision to use synthetic mesh' above.)
•Individuals with increased risk of prolapse recurrent – For women who have experienced recurrence after prior reconstructive surgery or who have high future risk of prolapse, we offer transabdominal prolapse repair with synthetic mesh, particularly if the woman has concurrent apical prolapse. We do not recommend the use of transvaginal mesh for POP outside of clinical trials in lieu of the 2019 US Food and Drug Administration (FDA) ban of these products. (See 'Decision to use synthetic mesh' above.)
In countries where transvaginal mesh for POP repair is available, we believe transvaginal mesh repair of POP may be considered by experienced surgeons after carefully counseling patients. Transabdominal synthetic mesh repairs are associated with lower rates of recurrent prolapse and repeat prolapse surgery.
●Surgical preparation
•Patient consent – A detailed informed consent process should be documented before using synthetic mesh. The informed consent includes information regarding (1) benefit and risk of complications with mesh use, (2) permanence of polypropylene mesh, (3) alternative nonsurgical options and other surgical treatments, and (4) potential complications of synthetic mesh, which may require additional intervention and may not completely resolve with mesh removal. (See 'Informed consent' above.)
•Antibiotic prophylaxis – We recommend antibiotic prophylaxis for surgical site infection for surgical procedures for treatment of POP that utilize surgical mesh (Grade 1B). (See 'Antibiotic prophylaxis' above.)
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