The safety and effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse have been questioned recently by numerous international regulatory offices and specialized societies, due to the accumulated risks revealed by medical devices reports and recently published studies [1]. Upon that, these products were stopped from distribution in the US [2] , Australia [3], Canada [4] , and the UK [56][57].

In this review, the safety and effectiveness of polypropylene transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse (POP) via transvaginal route will be evaluated, with the purpose of deriving current-evidence recommendations to better regulate these products for protecting the patients safety.

Pelvic Organ Prolapse (POP)

The organs of the women pelvis (uterus, bladder, and rectum) are supported by muscles, known as the pelvic floor, as shown in figure 1A, which depicts the normal pelvic anatomy. Pelvic organ prolapse is a condition that happens when the muscles are weakened and no longer hold the pelvis organs in their normal places, which result in drops (prolapse) of these organs into the vagina [5].

There are different types of prolapse, which are classified in reference to which organ is dropping (bulging). Cystocele, or anterior wall prolapse, occurs a bladder drops from its normal position, as illustrated in figure 1B, while rectocele –posterior wall prolapse- refers to the drop of the rectum, figure 1C. Another prolapse type refers to the drop of the uterus into the vagina, which is known as uterine prolapse or procidentia, figure 1D. Also, it is common that more than one organ at the same time [5].

Pelvic organ prolapse is a common medical condition in women, with a prevalence rate of 41-50% of women, as reported in the US FDA report [1]. Patient age and obesity are major risk factors, which were reported to be associated with increased risk [6], beside other factors, such as, previous vaginal delivery, sexual activity, family history, and ethnicity [6].

Treatment options for POP

 Pelvic organ prolapse can be treated in multiple ways, depending on the stage and type of the prolapse beside the patient characteristics. Treatment can be done either surgically or non-surgically. Non-surgical options involve using pessary -a plastic device that fits into the vagina to support the pelvic organs-, physiotherapy –special training to strengthen the pelvic muscles-, or by a medication –oestrogen therapy [6]. On the other hand, surgical options can be performed transabdominally –known as sacrocolpopexy-, or transvaginally, where both options aim to surgically correct the prolapsed organ [6].

Transvaginal surgical repair is used commonly to correct the anterior wall prolapse – figure 1B, which will be the focus of this review. Transvaginal repair can be done through two ways; either by using tissue and suture alone in a procedure known as anterior colporrhaphy -native tissue repair-, or through using surgical mesh, i.e. polypropylene, to augment the prolapsed organ [1] [5] [6].  Polypropylene mesh is a thin sheet of material, which can be in a non-configured form or a pre-configured form with legs to aid fixing the mesh into the desired area, as shown in figure 2. [1] [6]. The mesh can either be used alone, or with a mesh kits that facilitate the insertion and placement of the mesh.

Medical devices reports provide real world evidence that aid in guiding the attention to the device risks. The US FDA declared that in the period of 2008-2018, there were a total of 11,274 MDRs, all relate to surgical mesh placed transvaginally in the anterior compartment to treat POP [1]. These reports included 77 report of deaths, and around 10,000 serious injuries [1]. Table 1 demonstrate the most five patient problems reported to the US FDA database.

The safety and effectiveness of transvaginal mesh for the treatment of POP were evaluated considering two directions: a review of the recently published papers in the topic, and the feedbacks of Saudi related society and experts.

Part 1: Clinical paper review

1.1 An overview of the search criteria

      A systematic review and meta-analysis were conducted to compare the safety and effectiveness of transvaginal mesh and the alternative treatment option, native tissue repair. Using a defined inclusion criteria, a total of 151 articles were obtained and screened, which resulted in 43 articles for the quantitative analysis, and 19 articles (RCTs) for the meta-analysis, figure 2.

1.2 Results of calculating the mesh exposure weighted average

• A total of 41 articles (25 RCTs and 16 prospective and retrospective studies) were considered to calculate the weighted average of polypropylene mesh exposure. The total cases belong to 4896 patients, who were followed for at least 12 months.
• The weighted average of polypropylene mesh exposure was found to be 9.5% (465/4896), with an interval of 2.4-42% and a median of 9%, as illustrated in table 2.
• Mesh exposure was analyzed alone as only transvaginal repair by mesh is encounter of this risk, whereas women undergoing colporrhaphy have no risk of mesh exposure.

1.3 Results of comparing the risk of De novo dyspareunia when using TVM vs NTR

• Data of 15 RCTs were included in this analysis, which represent 854 patients in the mesh group, in contrast to 867 patients in the NTR group.
• Figure 3 shows the forest plot with the statistical analysis between the two groups.
• Pooled risk ratio (RR) is 1.44 in favor to NTR group (95% CI, 1.11-1.85), which clearly indicates that the mesh group is 44% more likely to cause de novo dyspareunia relative to the NTR group.

1.4 Results of comparing the risk of De SUI when using TVM vs NTR

• Data of 10 RCTs were included in this analysis, which represent 728 patients in the mesh group, in contrast to 725 patients in the NTR group.
• Figure 4 shows the forest plot with the statistical analysis between the two groups.
• Pooled risk ratio (RR) is 1.43 in favor to NTR group (95% CI, 1.10-1.87), which clearly indicates that the mesh group is 43% more likely to cause de novo SUI relative to the NTR group.

1.5 Results of the effectiveness of TVM vs NTR considering the prolapse recurrence

• Data of 10 RCTs were included in this analysis, which represent 740 patients in the mesh group, in contrast to 735 patients in the NTR group. Note: Prolapse recurrence of all types were included in this analysis.
• Figure 5 shows the forest plot with the statistical analysis between the two groups.
• The result is not significant (p=0.36), and heterogeneity is very high (86%) between the results of the included studies, which suggest that the result is not reliable, and cannot for sure be interpreted. Yet, the pooled result suggest that mesh group demonstrated an enhancement of 8% in reducing the risk of prolapse recurrence relative to the NTR group.

1.6 Results of the effectiveness of TVM vs NTR considering the need for reoperation

• Data of 6 RCTs were included, which represent 590 patients in the mesh group, in contrast to 565 patients in the NTR group. Note: Surgery reoperation of all types were included in this analysis.
• Figure 6 shows the forest plot with the statistical analysis between the two groups.
• The result is not significant (p=0.15), and heterogeneity is moderate (58%) between the results of the included studies, which suggest that the result is moderately reliable, and cannot for sure be interpreted. Yet, mesh group is 34% more likely to require reoperation relative to NTR group.

1.7  Overall results

      The overall results are summarized in table 3, which shows that the risks of using synthesis polypropylene mesh for the treatment of POP outweigh the benefits.

Part 2: Saudi user experience

2.1 The opinion of the Saudi Urological Association

In the 2nd of February, 2020, the SFDA team conducted a consultation meeting with the Saudi Urological Association (SUA), represented by Dr. Badr N. Almosaieed, to discuss the safety of transvaginal mesh for POP. Following the discussion, SUA officially submitted its position regarding the case, which indicate that these products carry risks that outweigh the benefits, and due to the availability of other safer treatment options, the society recommend suspending these products from the Saudi market, for the sake of the patients safety.

2.2 Device related incidents as provided by some Saudi users

Experts from the Saudi Voiding Dysfunction Group-Saudi Urological Association, beside other Saudi consultants, were asked to submit an evaluation assessment to clarify if they experienced any incidents with patients who were treated for POP using polypropylene mesh products. A number of 23 responses were received, with a reporting of 20 serious mesh-related incidents, which correspond to 9 mesh erosion cases, 9 dyspareunia cases, and 2 cases of organ perforation.

Part 3: Overall conclusion

Considering the results of the published papers, the recommendation of the Saudi Urological Association, and the incidents reported by the Saudi users, the overall evaluation suggests that the risk of using polypropylene mesh for the transvaginal repair of POP is outweighing the benefits.

Considering the results of the post-market evaluation of the safety and effectiveness of transvaginal mesh for the treatment of POP, the following actions were taken by SFDA:

1. Suspending the marketing authorization of surgical mesh products whose sole use is the treatment of pelvic organ prolapse (POP) through transvaginal implantation.
2. Stop authorizing new surgical mesh products whose sole use is the treatment of pelvic organ prolapse (POP) through transvaginal implantation.
3. Request a label change for synthetic surgical mesh devices indicated for the treatment of POP to include the warning: Do not use transvaginally.
4. Review the technical file and the product instructions for use (IFU) of some polypropylene products that are used for other purposes, i.e. the treatment of hernia, to ensure that the products are not indicated for the treatment of POP through transvaginal implantation, otherwise, the products are to be treated as indicated in recommendation number 3.

Grateful thanks to Eng. Bader Aloufi for designing, reviewing the up to date articles, and writing up the context of this study. Thanks to the post-market clinical evaluation team for their supports in conducting this work.

For further information or inquiries related to this study, you may contact us at: cia.md@sfda.gov.sa

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