Approximately 50% of women who are 50 years old or older will experience pelvic organ prolapse (POP) during their lifetime.¹ Of those women affected, 1 in 5 will require corrective surgery. Prior to the 1990s, native tissue repair was the gold standard approach for POP. However, this approach was associated with high recurrence rates, leading clinicians to search for alternative methods. Physicians widely began using synthetic mesh for the transvaginal repair of POP in the 1990s, but it was only approved by the U.S. Food and Drug Administration (FDA) for that indication in 2002 (fig. 1).¹ Considered to be similar to mesh used for abdominal hernia surgery, synthetic mesh for POP was approved without the completion of a premarket approval (PMA) application.

After the FDA approval, transvaginal mesh quickly gained popularity, as it was associated with shorter surgical time, length of stay and recovery time, and a lower recurrence rate for high grade POP. Despite the benefits of mesh, a host of complications have been reported, including severe chronic pelvic pain, dyspareunia, infection, bleeding, organ perforation, vaginal mesh exposure and urinary problems from mesh eroding into surrounding tissues.¹

In 2008, the FDA released warnings about the frequency of serious complications related to transvaginal mesh for POP. As more reported mesh related adverse events were filed, a new FDA safety update was released in 2011, reiterating potential complications (fig. 2). Subsequently, in 2016, the FDA reclassified transvaginal mesh from a class II (moderate risk) to a class III (high risk) device. Moreover, mesh instrumentation kits, including trocars, needle passers and guides, fixation tools and tissue anchors, were reclassified from class I (low risk) to class II. The FDA also ordered manufacturers to submit PMAs to formally evaluate their safety and efficacy.¹

Figure 1. Regulatory history of transvaginal mesh for POP.

In April of 2019, the FDA ordered immediate cessation of the distribution of surgical mesh products for transvaginal repair of POP, stating that manufacturers failed to provide evidence that mesh prolapse repairs were superior to native tissue repairs. It is noteworthy the 2019 recall did not apply to the use of mesh for stress urinary incontinence (SUI) or transabdominal repairs of POP.¹ This ban aroused significant controversy, as the decision was made before completion of the required PMAs.

Figure 2. Postoperative extrusion (top) and erosion (bottom) of transvaginal mesh in POP cases.

In response to the 2019 ban of transvaginal mesh for POP, the Ibero-American Society of Neurourology and UroGynecology (SINUG) issued a position statement declaring that transvaginal mesh should not be offered routinely but should be reserved for high risk patients, such as those with recurrent prolapse, in whom the benefits of mesh outweigh the risks.¹ Other professional societies also released official statements, but most only addressed the use of transvaginal mesh for SUI.¹ The Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)/American Urogynecologic Society (AUGS) joint statement declared that polypropylene mesh is the gold standard for treating SUI and is safe and effective to use.² The American Urological Association (AUA) reaffirmed this sentiment in their statement, adding that physicians who perform synthetic sling surgery should be highly experienced in doing so, and must discuss the risks and benefits of mesh with patients.³

Since the 2008 and 2011 warnings, there has been a significant reduction in mesh-augmented transvaginal POP surgeries, although the total number of POP repairs performed remains unchanged.⁴ There has also been a significant increase in mesh revision surgeries.

Despite these trends, the clinical data surrounding the efficacy of transvaginal native tissue compared to synthetic mesh repairs of POP are limited and variable, subject to differences in study design, surgical technique, surgeon experience and classification of prolapse. A few trials have recently been published comparing outcomes between transvaginal mesh and native tissue prolapse repairs.

A 2020 multicenter trial randomized 122 women with severe POP to undergo synthetic mesh repair or native tissue repair. After 5 years of followup, significantly higher cure rates in all compartments, defined as a Pelvic Organ Prolapse Quantification (POP-Q) System point of <0, and improvements in quality of life scores were seen in the mesh group. The mesh group also experienced a higher complication rate, with extrusion being the most common treatment related adverse event.⁵ PROSPECT (PROlapse Surgery: Pragmatic Evaluation and Randomised Controlled Trials) reported somewhat conflicting results for recurrent POP.⁶ In this study, Glazener et al randomized 155 women with recurrent prolapse to undergo repair with either native tissue, synthetic mesh or a mesh kit. After 1 year, the majority of women indicated improvement in prolapse symptoms and prolapse on physical examination, although there were no differences between treatment cohorts. All groups had similar rates of serious adverse events, other than mesh exposure, which occurred in 13% of the mesh inlay and 8% of the mesh kit arm participants.

While these trials give some insight into the risks and benefits of each surgical approach, many questions remain. Variables that should be factored in during the evaluation of transvaginal mesh complications include study design, patient comorbidities and tissue quality, surgeon experience and level of training, and product quality, among others. Ultimately, more randomized data with larger cohorts are needed to fully evaluate the safety and efficacy of transvaginal mesh for POP repair, especially in comparison with native tissue repair. For now, in order to optimize patient outcomes and minimize complications, POP surgery is best performed by skilled surgeons with experience in managing short and long-term complications.³