The increasing incidence of pelvic organ prolapse (POP) represents an important health issue in developed countries. This is due to the higher perspectives and to increasing demands regarding the quality of life and also to the higher life expectancy among women. The use of synthetic transvaginal mesh (polypropylene mesh) in the treatment of POP has increased in popularity until the end of the last decade, and then plateaued in 2008 after the US Food and Drug Administration released a notification about mesh-related complications(1). The second FDA warning from 2011 regarding mesh-related complications lead to a decrease in mesh use. Concurrently, the number of sacrocolpopexy procedures increased considerable starting 2008, as the use of laparoscopic/robotic technique and the interest regarding transvaginal mesh increased(2).
In general, the life-time risk of undergoing surgery for POP in women is estimated between 11% and 19%. The rate of reoperation after the use of native tissue repairs after 20 years is approximately 11%. Polypropylene mesh implants were designed to improve the anatomic outcomes and rapidly gained popularity. However, the use of polypropylene meshes in urogynaecological procedures has been reevaluated by the US Food and Drug Administration.
In 2008, the FDA issued a public health notification (PHN) which underlined that complications of mesh insertion for POP and stress urinary incontinence (SUI) were not as rare as previously reported, and that various situations must be met before their use. These included having enough surgical training, improved disclosure to the patient of the risks and benefits of synthetic versus native material used in repairs, and creation of a better adverse outcomes reporting system. The FDA released a PHN in July 201, followed by a Committee Opinion No. 513.9. These emphasized the importance of appropriate training of physicians, the significance of the surgeons’ awareness on the risks of the procedures, the demand to be vigilant for side effects, and the need for patients to be informed about the permanent nature of these products, that secondary surgery may be required, and this surgery may not correct the complication. The patient must be informed that the quality of life can be affected if a complication occurs, and that she should be offered a written copy of the patient labelling on her mesh. In addition to the informed report of serious side effects or death, hospitals were encouraged to declare lesser forms of complications to MedWatch (the FDA safety information and adverse event reporting program)(3).
In summary, all these events have showed the strengths and weaknesses of the way the public is protected by federal health agencies, health care institutions, and health care providers(4).
As a result, the FDA recommendations are that women considering surgery for pelvic organ prolapse should:
Before surgery – be aware of the risks associated with transvaginal POP repair; to know that having a mesh surgery can increase the risk for secondary surgery because of the mesh-related complications; be informed by their surgeons about all POP treatment options; understand why their surgeon recommends the treatment with mesh for POP(5).
After surgery – continue with annual and regular check-ups and follow-up care; notify the appearance of any complication; in case of secondary surgery, inform the health care providers about previous mesh implants; discuss their concerns and ask their surgeons at their next routine check-up whether they received mesh for their POP surgery if they are unaware a mesh was used(5).
In the European Commission’s SCENIHR report, the most recently database about the use of surgical meshes, it is suggested that the use of synthetic materials in surgery has well-established benefits, but also major risks. It is stated that the risk is dependent on the location of mesh placement and the condition it is used for. Numerous complications related to synthetic mesh have been mentioned, such as infection, erosion into other organs, chronic pain and dyspareunia, exposure in the vagina, and shrinkage of polypropylene meshes(6).
To evaluate the risks for mesh use, it is important to differentiate between indications: SUI and POP.
For most patients with moderate-to-severe SUI, the SCENIHR admits the efficacy and use of polypropylene meshes. Most complications associated with mesh insertion are related to the route of insertion. In conclusion, SCENIHR states that meshes for SUI have lower risks compared to meshes inserted for POP implanted vaginally. Following evidence based on clinical guidelines, its use must be restricted for selected patients.
A significant point is to evaluate the available options when surgical treatment for SUI is an option. The choices may include: synthetic midurethral slings (MUSs) using polypropylene tapes, bulking agents, colposuspension, and autologous sling surgery. In complex cases with recurrent prolapse in the same compartment, only synthetic mesh for POP should be used. The utilization of synthetic mesh should be restricted to those surgeons who are working in multidisciplinary referral centers, with appropriate training. The patients need to be aware of the possible risks and complications of this therapy, and to be informed about alternative therapies(7).
Currently, there is no consensus on mesh use in transvaginal surgical repairs for the treatment of POP. According to FDA, mesh erosion through the vagina, chronic pelvic pain, local infection, bleeding, dyspareunia, organ perforation, and urinary problems are the most frequent complications. Mesh contraction may be associated with vaginal shortening, tightening, and pain(8). The majority of complications occur in the first five years after the surgical procedure. The information regarding the FDA’s reports on the use of synthetic mesh in POP repair should be made available to patients at the time of surgical planning and should be used as an adjunct in the process of obtaining informed consent(9).
To mesh or not to mesh?
The surgical options for POP have traditionally encompassed colporaphy and/or vaginal colpopexy or sacrocolpopexy.
The surgical procedures were classified by compartment (anterior, posterior and apical). The patients with simultaneous multi-compartment repair were classified under “multiple” compartment repair(10).
The placement of polypropylene mesh for POP was introduced in order to decrease the failure rate of native tissue repair and make POP surgery easy to learn and to perform(11-13). In the following section, we have reviewed the current recommendations for mesh in POP surgery use for each compartment.
1. Stress urinary incontinence
The involuntary loss of urine is a common health condition which can affect the quality of life. Up to 77% of women residing in nursing homes and ten to twenty percent of women have urinary incontinence, but only 25% look for or obtain treatment(14,15). Stress urinary incontinence is a prevalent condition and has an impact on a woman’s quality of life. There are a lot of treatment options available for patients with symptomatic stress urinary incontinence. There is no optimal therapy for all patients with SUI. Options include colposuspension, slings (pubovaginal and midurethral), and periurethral bulking. While evidence supports each of these options in the treatment of SUI, each is associated with various rates of success(16).
Tension-free vaginal slings in retro-pubic, single-incision or transobturator techniques reveal a high success rate, with few complications, and have almost completely replaced the more invasive abdominal surgical techniques for the operative management of stress incontinence. Ten years ago, the use of vaginally-placed mesh for SUI was supported by level I evidence. The safety and efficiency of mesh for mid-urethral support in the treatment of SUI is not controversial, as it has been proven in long-term clinical trials(17). Retropubic or transobturator placement of mid-urethral mesh slings has become the standard of care for SUI. Single-incision slings combine the proven functional principle of suburethral slings with a high success rate and the advantages of using less material, while eliminating the blind passage during insertion.
2. Anterior compartment
The most common site of POP is the anterior compartment, followed by posterior and apical defects. Polypropylene anterior compartment mesh offers improved results compared with native tissue repair; however, these benefits must be considered in the context of increased morbidity associated with anterior polypropylene transvaginal mesh(19). Native tissue anterior compartment prolapse repair remains an important surgical procedure for pelvic prolapse. Native tissue repair has been well-studied and is successful in relieving vaginal bulge symptoms and reducing prolapse within the vagina(20).
3. Apical defects – gold standard
The gold standard, for over 50 years, has been established as the use of abdominally placed artificial materials, including mesh for apical vaginal support. Sacropexy is a well known technique and currently the gold standard in the repair of apical defects. It is considered to be the most adequate approach for restoring the vaginal apex and length(21,22). Especially for recurrent prolapse, the use of polypropylene mesh leads to an improved anatomic and functional result(23,24). However, in most cases of complex POP, different procedures can be necessary in order to correct all compartments(25). Erosion rates are significantly lower while meshes are inserted by laparoscopic or abdominal way compared to vaginal route. Several studies emphasized an increase rate of the novo cystocele after promontopexy due to the modification of the normal vaginal axis and exposure of the vaginal anterior wall to the abdominal pressure. Other techniques for the correction of the apical compartment, such as laparoscopic pectopexy, were reported by Noe et al.(26,27). Compared to sacropexy, the suspension point is lower, at the level of ilio-pectineal ligaments, but there is no change in the normal vaginal axis(28).
4. Posterior compartment
Posterior vaginal wall prolapse is a weakness in the strong tissue layers that divides the vagina from the lower part of the bowel, causing the back wall of the vagina to bulge into the vagina. Most often, patients with prolapses complain of bowel symptoms. Due to their high incidence in women, these symptoms demand a careful evaluation before surgery in order to link them to the prolapse. Posterior repair is a surgical procedure to repair or reinforce the weakened layers between the rectum and the vagina. For mid rectoceles by vaginal route, it is recommended to repair the rectovaginal fascia without levatorplasty. The transvaginal approach is superior to the transanal approach for repairing the posterior wall prolapse. The biological grafts are not recommended. In the first-line surgical procedure of posterior compartment prolapse to the transvaginal approach, there is no indication for the using of polypropylene meshes due to lack of evaluation and morbidity. In the symptomatic low rectocele, only superficial colpoperineorrhaphy must be suggested. Sacrocolpopexy is the procedure of choice for vaginal vault prolapse, but there is still a place for non-prothetic vault suspension by vaginal route according to the age of the patient, the comorbidities and associated surgical procedures(29). In symptomatic posterior vaginal wall prolapse, there is only one option to propose: surgical option by vaginal way. In order to avoid worsening of preoperative symptoms or a de novo fecal incontinence, which can lead to a dramatic decrease of the patients’ quality of life in this functional surgery, an anorectal evaluation can be required before surgery.
Provided there is sufficient support for the anterior wall and apex of vagina with mesh, posterior compartment repair without mesh may be as effective as repair with mesh for anatomical recovery while providing better anorectal function(30).
Pelvic organ prolapse treatment = hysterectomy?
Hysterectomy during the treatment for POP has been currently practiced for a long time, in many cases the removal of the uterus being the sole procedure used for POP treatment. Hence, during the last decade, attention has been brought to uterus-sparing surgery. First of all, simple hysterectomy does not solve the problem of POP, and several studies have highlighted the potential benefits of uterus preservation in treating POP, such as decreased operative time and avoidance of complications related to the hysterectomy procedure. The results in pelvic floor status appear to be similar in the total and subtotal hysterectomy groups, and some advocate that the preservation of the cardinal ligaments could be beneficial for pelvic floor static. The disadvantages of uterus preservation are related to the risk of developing cervical or endometrial cancer, risks that are the same as in the general population(31-33).
International recommendations – American and European current guidelines
In Great Britain, the total number of POP procedures has increased since 2005, with a peak in 2014 (N=29,228). With regard to vaginal prolapse, surgical meshes were considered in a few selected cases, whereas native tissue repairs represented more than 90% of the procedures. The number of sacrospinous ligament fixations (SSLFs) grew more than three times over the years, whereas sacrocolpopexy remained the same. To treat vault prolapse, transvaginal surgical meshes have been gradually abandoned. We also noted a permanent increase in uterine-sparing and obliterative procedures. According to FDA, in 2010, approximately 300,000 women underwent surgical procedures for POP and approximately 260,000 underwent surgical procedures to fix stress urinary incontinence in the USA.
In approximately one-third of patients the synthetic mesh was used, and in one-quarter the surgical procedure was performed transvaginally(34).
The lack of experience and the lack of proper training in reconstructive pelvic surgeries, as well as the availability of easy-to-handle kits are considered to be related to the exponential increase in the number of mesh-related complications. Since the introduction of mesh in pelvic surgeries, the incidence of postoperative complications has remained elevated, despite improvements in short- and long-term outcomes. An algorithm was developed to speed up the prompt recognition and the treatment of vaginal mesh exposure, aiming to help gynecologists and urologists to achieve better outcomes and success rates(35).
Based on a review of adverse events reported to the FDA and on the assessment of scientific literature, US Food and Drug Administration has identified serious safety and effectiveness concerns with the use of surgical mesh for the transvaginal repair of pelvic organ prolapse.
Following FDA and SCENIHR warnings, a secure trend for meshes has only been seen in uterine-sparing surgery. Currently, synthetic mesh implants remain the gold standard for the treatment of SUI and apical defects, whereas for the anterior and posterior defects, full disclosure must be offered to the patient before performing the procedure and, at the same time, native tissue repair should be taken into consideration for these types of defects. Shifts in surgical practice should be taken into account for urogynaecologists’ training.
Conflict of interests: The authors declare no conflict of interests.