Michele Giana1 - Stefano Caccia2 – Nicola Surico2
1,2,3 Clinica Ginecologica e Ostetrica
Centro di Chirurgia ginecologica oncologica avanzato
Università degli Studi del Piemonte Orientale “A. Avogadro”
A.O.U. “Maggiore della Carità”– Novara
Among women aged 50–79 years in the Women’s Health Initiative, 41% had POP, with cystocele being the most common. Nearly 25% of women in the US suffer
from pelvic floor disorders, and the lifetime risk of undergoing a surgical procedure for prolapse or urinary incontinence is high. In the US alone, approximately
200,000 women undergo surgery annually for prolapse, and approximately 29% require reoperation for recurrent prolapse. Recent projections estimate that
the number of women undergoing surgery for POP will increase to approximately 250,000 by 2050. Thus, the estimated direct costs of prolapse surgery are
over $1 billion per year and will likely increase.
Pelvic organ prolapse (POP) is a global health care problem. While this condition is not fatal, it can significantly interfere with women’s quality of life (Qol). Most patients need pelvic reconstructive surgery to regain normal anatomy and function, and improve Qol. Because of the high recurrence of POP following traditional vaginal repair, biomaterials are increasingly used for pelvic reconstructive surgery. However, evaluation of complex interventions has not kept pace with the rapid development of novel invasive therapies that use synthetic implants. Several observational studies have shown lower failure rates after biomaterial-augmented surgery, as compared with traditional repair methods for POP. However, mesh has been associated with serious surgical complications including infections, mesh erosion, vessel perforation and vaginal scarring. There is limited data available to support specific treatment recommendations. Abdominal and transvaginal mesh repair seemed to be more reliable procedures for the cure of genital prolapse. Clinical practice guidelines for vaginal graft use from the Society of Gynecologic Surgeons concluded that there is an absence of good evidence for guiding clinical selection of nonabsorbable synthetic grafts versus native tissue for repair of pelvic organ prolapse.
For women with prolapse, one of the biggest clinical challenges is selecting which surgery to perform. In addition to the route of surgery, the woman and her surgeon must decide on whether a native-tissue or graft-augmented repair is preferable. If a graft-augmented repair is chosen, there may be choices of different biologic grafts and synthetic mesh materials. Since there are risks and benefits to any approach, surgical counseling requires comprehensive knowledge of types of procedures, as well as the rates of prolapse recurrence and rate of adverse events for each procedure. Choosing between treatment options, particularly surgical options, involves weighing risks and benefits of each type of intervention. In addition to the anatomic location and severity of the prolapse, factors such as the overall health and activity level of the patient and other concurrent pelvic floor symptoms all contribute to the decision of treatment choice.
The landscape of available transvaginal mesh products is rapidly changing, particularly following the 2011 US Food and Drug Administration (FDA) safety communication (“FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”), which expressed concern regarding adverse events and complications associated with transvaginal mesh prolapse repairs. In this communication, an FDA-sponsored systematic review found that erosion of mesh through the vagina was the most consistent and common mesh-related complication, and that mesh contraction (shrinkage) was a previously unidentified risk of transvaginal mesh repairs. These complications may lead to pelvic pain, dyspareunia, or the inability to achieve vaginal intercourse.
The FDA’s aims in this update were to inform that: serious complications with surgical mesh for transvaginal repair of POP are not rare and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. The results of the literature review, summarized in the FDA Safety Communication, were: mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair; mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; there is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh; and while transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
Notably, the FDA did not find conclusive evidence that transvaginally placed mesh improves outcomes any more than traditional prolapse repair without mesh, and may expose patients to greater risk. Ultimately, despite fewer reoperations for prolapse, total reoperations are highest for transvaginal mesh compared to other procedures, and these are mainly due to mesh complications. In the face of these findings, the US FDA has recommended that surgeons obtain specialized training for each mesh-placement technique and counsel patients thoroughly about potential mesh-related complications. In addition, the FDA recommends that health care providers choose mesh surgery only after weighing the risks and benefits against other alternatives. Surgeons and researchers recognize that mesh augmentation aids in durability of prolapse repair, but it is essential also to minimize complications. Therefore, researchers are keenly interested in investigating the optimal materials for mesh or graft augmentation that would maintain a long-lasting and durable prolapse repair, while minimizing risk of erosion through the vaginal tissue or surrounding organs.
Newer transvaginal mesh techniques continue to be developed, these newer techniques continue to be evaluated, and are the focus of a current US National Institutes of Health-sponsored randomized trial. Given that abdominal and minimally invasive sacrocolpopexy has inherent surgical risks of increased operating time, cost, and surgical risks associated with the intra-abdominal technique, interest will continue in optimizing transvaginal prolapse-repair techniques with improved graft augmentation.
Treatment of POP is clinically challenging because of the need to address pelvic floor symptoms, provide a high quality of life, and minimize complications. There is a wide range of surgical options that may be used. The surgeon who treats prolapse should be able to discuss and offer native-tissue procedures for prolapse. In addition, for clinically challenging situations or women with recurrent prolapse, mesh-augmented repairs may be considered. A thorough knowledge of mesh and graft options, as well as knowledge of prolapse recurrence and adverse event rates, can help guide clinicians in counseling their patients effectively. Ultimately, this will allow surgeons to choose personalized treatment options that best align with a woman’s lifestyle and treatment goals.
Maher’s 2013 Cochrane Review concluded that sacral colpopexy has superior outcomes to a variety of vaginal procedures including sacrospinous colpopexy, uterosacral colpopexy and transvaginal mesh. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living, and increased cost of the abdominal approach. The use of mesh or graft inlays at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse on examination. Anterior vaginal polypropylene mesh also reduces awareness of prolapse, however these benefits must be weighted against increased operating time, blood loss, rate of apical or posterior compartment prolapse, de novo stress urinary incontinence, and reoperation rate for mesh exposures associated with the use of polypropylene mesh. Posterior vaginal wall repair may be better than transanal repair in the management of rectocele in terms of recurrence of prolapse. The evidence is not supportive of any grafts at the time of posterior vaginal repair. Meher concluded that data from randomised trials are currently insufficient to guide practice and suggested that: