Transvaginal Mesh Implant Procedures: Use Them or Not?

Introduction

Treatment for pelvic organ prolapse (POP) involves a multidisciplinary team. In 2017, the Pelvic Floor Medicine and Reconstructive Surgery working group of the International Federation of Gynecology and Obstetrics (FIGO) described the different treatments for POP, based on literature evidence, cost-effectiveness, and degree of difficulty; summarized these concerns; and offered expert recommendations. ¹ Among conservative treatment options, the pessary has been most successful for centuries, with a low complication rate and low cost. Vaginal procedures are well-described, with favorable outcomes and cost–benefit profiles. ¹ In addition, the vaginal approach is a shorter procedure than the abdominal approach with quicker resumption of activity for patients. ²

In addition to a few indications necessitating prolapse treatment (e.g., obstructed upper urinary tract, urosepsis, rectal prolapse, and incarcerated bowel) the majority of interventions are based on relative indications, primarily on addressing symptoms of the prolapse itself. The lesser the extent of prolapse is, the more difficult its correlation to symptoms (e.g., bulging and difficulties during intercourse) will be. Data on the association between the extent of a prolapse and related symptoms are weak. Furthermore, there is yet no clear cut-off between “normal” and “abnormal” anatomy especially in multiparous women. ³

In general, female pelvic floor disorders and POP at less than stage II need careful assessment of the relationship between symptoms and the prolapse before treatment, especially when surgery is performed. ³

Currently, pelvic surgeons deal with the choice of using transvaginal mesh or classical techniques to treat these pathologies. The success and failure of each approach needs to be assessed in the context of individual patients, their circumstances, and the surgeon's ability.

Materials and Methods

This article discusses major reviews and recommendations of medical societies with respect to treatments for POP. Individualized choices for treatment are suggested.

Results

Current data suggest that the use of nonautologous durable materials in surgery has well-established benefits but also has risks, which are specific to the conditions and locations they are used for when a patient has POP. Various graft-related complications have been described, including infection, chronic pain, dyspareunia, exposure in the vagina, and shrinkage and erosion into other organs. ⁴

Discussion

The use of synthetic mesh implanted transvaginally for urogynecologic indications is associated with recognized risks, including exposure (∼ 10%) and contraction, which can usually be managed successfully with local estrogen in-office or by surgical excision of the exposed or contracted segment. ⁵

In 2011, the U.S. Food and Drug Administration (FDA) released a public-health notification with concerns regarding vaginal mesh for treating POP. ⁶ The number of patient-perceived mesh complications increased after the FDA notification.^6–8

Despite this, treatment of stress urinary incontinence (SUI) has been revolutionized over the past 2 decades with the advent of midurethral slings. The use of synthetic tapes for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity, and is considered a “gold standard” treatment with high cure rates. ⁹ In a recent study comparing efficacy and safety of a mini-sling with a transobturator midurethral sling as surgical treatments for female SUI, the transobturator produced better objective cure rates than the mini-sling over a 3-year follow-up, although satisfaction rates were similar. ¹⁰

It seems that synthetic mesh for POP should be used only in complex cases with recurrent prolapses in the same compartment and restricted to those surgeons with appropriate training who work in multidisciplinary referral centers. ⁴

Scotland's Chief Medical Officer, noting the same evidence, accepted the recommendations of a final independent report on the use of transvaginal mesh implant procedures. For this report, a Scottish independent review group considered all available evidence on the safety and effectiveness of these transvaginal mesh implants. ¹¹

The report set out a number of conclusions to improve the available safeguards. These included: mesh not to be offered routinely to women with POP; mandatory reporting of all procedures and adverse events; and extra steps to ensure that patients have access to clear, understandable advice to help them make informed choices. In addition, for surgical treatment of SUI, all appropriate treatments should be available to patients and subject to informed choices and assessments. Improved training for clinical teams involved in using transvaginal mesh and improved research on the safety and effectiveness of the products are important. ¹¹

Before surgery for genital prolapse, patients should be counseled about the different existing techniques (abdominal and vaginal surgery with and without mesh), other nonsurgical treatments (pelvic floor rehabilitation and pessary), and reasons why the surgeon might offer placement of a synthetic mesh. These interventions must be preceded by assessment of patients' pelvic, urinary, digestive, and sexual symptoms. ¹²

According to the guideline for surgery for primary POP from medical French societies, it is useful to evaluate the symptoms, their impact, and women's expectations, and to describe the prolapse prior to surgery. ¹³

In a 2016 Cochrane Database Systematic Review to determine the safety and effectiveness of surgery for anterior-compartment prolapse, biologic graft repair or absorbable mesh provides a minimal advantage, compared to native tissue repair. Native tissue repair is associated with increased awareness of prolapse, increased risk of repeat surgery for prolapse, and recurrence of anterior-compartment prolapse, compared to polypropylene mesh repair. However, native tissue repair is associated with a reduced risk of de novo SUI, reduced bladder injuries; and reduced rates of repeated surgery for prolapse, SUI, and mesh exposure (composite outcome). ¹⁴

Current evidence does not support the use of mesh repair, compared to native tissue repair for anterior-compartment prolapse, owing to the increased morbidity involved. Many transvaginal polypropylene meshes have been removed from the market voluntarily, and newer lightweight transvaginal meshes that are available have not been assessed in randomized clinical trials. Clinicians should be cautious when utilizing these products, as their safety and efficacy have not been established. ¹⁴

In another study, the researchers do not argue for systematic use of mesh for treating primary cystocele, ¹⁵ and the use of a synthetic mesh placed by a vaginal route is not recommended routinely. This should be discussed on a case-by-case basis, considering the risk–benefit ratio. However, in patients presenting with cystocele recurrences, placement of a synthetic mesh is a reasonable option for reducing the risk of additional cystocele recurrences.^12,13,15

In apical prolapses—according to the FIGO Working Group “Pelvic Floor Medicine and Reconstructive Surgery”—among the vaginal operative procedures, sacrospinous ligament fixation and uterosacral ligament suspension showed comparable outcomes and efficacy with, however, different rather-low complication patterns and favorable cost–benefit profiles. ¹

Recommendations about the posterior compartment refer to the fact that posterior vaginal wall repair might be better than transanal repair for managing a rectocele, in terms of recurrence of the prolapse. The evidence is not supportive of any grafts at the time of posterior vaginal repair. Adequately powered, randomized, controlled clinical trials with blinding of assessors are urgently needed to address a wide variety of issues, and these trials particularly need to include women's perceptions of prolapse symptoms. Following the withdrawal of some commercial transvaginal mesh kits from the market, the generalizability of the findings—especially related to anterior-compartment transvaginal mesh—should be interpreted with caution. ¹⁴

With the exception of a few situations (rectocele recurrence), placement of a synthetic mesh is not recommended as first-line therapy for surgical treatment of rectocele by a vaginal route. In the case of uterine or vaginal-vault prolapse, repositioning the vaginal vault or uterus using synthetic mesh arms transvaginally is not recommended as first-line surgical therapy.^12,13 It seems that there is no support for using rectovaginal mesh systematically to prevent rectoceles. ¹³

However, sacrocolpopexy using nonabsorbable meshes produces a POP cure with very good results and few complications in terms of prosthetic exposure and infection. Thus, this approach is now considered as the referent prosthetic surgical technique for POP. ¹⁶

Sacrocolpopexy—independent of open abdominal, laparoscopic, or robotic-assisted laparoscopic techniques—has good durability and quality of life (QoL) performance. The minimally invasive techniques are as effective as the open abdominal techniques, and there is no difference in mesh exposure. ¹

Sacrocolpopexy produces superior outcomes for a variety of vaginal procedures, including sacrospinouscolpopexy, uterosacralcolpopexy, and transvaginal mesh. These benefits must be balanced against a longer operating time, a longer time to return to daily activities, and increased cost of the abdominal approach. ¹⁴

Thus, it seems very important to establish clear recommendations on the numerous operating technical variants that have been developed around the original technique. ¹³

Conclusions

Some of the most important things in the approach to pelvic prolapse surgery are patient information and training of pelvic surgeons. Patients seeking surgical treatment of genital prolapses must be fully informed about the specific risks related to each technique. ² These patients must also be informed about the long-term results of each technique or about the lack of available data regarding techniques using native tissue or prostheses, as well as satisfaction rates. ² Currently, there is a tendency worldwide to consider subjective findings, QoL, satisfaction rates, and desire for additional treatments as more relevant than objective outcomes to evaluate efficacy and success. ¹⁰

Before a patient undergoes any procedure for correction of recurrent genital prolapse, with the option of using synthetic mesh derived from polypropylene, it is important that the surgeon point out that this material has a record of risks and adverse effects. To date, synthetic mesh material for surgical correction of recurrent prolapse—despite offering improved QoL when well-indicated and used by experienced surgeons—requires long-term studies; and Material Safety Data Sheets for these materials lack recommendations for use in humans.

Finally, it is believed that the data regarding transvaginal mesh use are controversial and incomplete. Its use should be studied tirelessly in terms of material development and clinical/scientific results. ¹⁷ Surgeons should be aware of recently recognized risk factors for exposure development and select patients carefully for mesh implantation based on risk–benefit assessment. ⁵ Awareness, evidence-based recommendations, safety, and self-criticism are excellent criteria for the use of mesh implants for POP.