Size Does Matter: Long-term Efficacy and Safety of Minimesh in Transvaginal Pelvic Organ Prolapse Repair

Abstract

Objectives:

The Food and Drug Administration banned the use of transvaginal mesh for pelvic organ prolapse (POP) repair due to safety and efficacy concerns. The present study aimed to evaluate the safety and efficacy of a novel lightweight minimesh (SERATOM^® MN) for transvaginal repair of significant primary or recurrent POP.

Materials and Methods:

A cohort study of 134 consecutive patients (mean age: 61.7 ± 9.4 years, range: 46–88) who underwent transvaginal minimesh repair (SERATOM^® MN) for Stage III or IV POP was retrospectively analyzed. At 10 years postoperatively, a telephone survey was conducted to assess long-term outcomes. The mean postoperative follow-up was 9.8 ± 0.45 years (range: 9.4–10.9 years). A comparison was made between 99 (73.9%) patients who underwent primary mesh-assisted POP repair versus 35 (26.1%) patients who underwent mesh-assisted surgery for recurrent POP. Primary outcomes comprised postoperative complications, POP recurrence rate, and subjective long-term satisfaction.

Results:

The mean duration of surgery and blood loss was 30.8 min and 32.4 ml, respectively. Most patients (98.5%) were discharged on the day of surgery or the day after. There were no significant intra- or early postoperative complications, except for one case of postoperative perineal hematoma that was managed conservatively. Of the initial 134 patients, 110 (82%) were available for long-term follow-up. There were no mesh erosions. De novo dyspareunia occurred in 6.4%. Rates of recurrent POP repair were similar among patients who had mesh-assisted repair after previous pelvic surgery (23.3%) and those who had primary mesh-assisted repair (15%).

Conclusion:

Transvaginal SERATOM^® MN minimesh is a safe, effective, and durable surgical option for significant POP repair.

INTRODUCTION

Pelvic organ prolapse (POP) is very common among adult women. Significant POP is associated with impaired quality of life, as well as various symptoms such as lower urinary tract symptoms (LUTS), urinary tract infections (UTI), voiding dysfunction, and sexual impairment. The incidence of POP increases with aging. Approximately 11% of adult women will undergo POP surgery during their lifetime.[1] POP repair presents a surgical challenge. Numerous surgical techniques are available. The ideal POP surgery should be safe and easy to perform, with low short- and long-term complications and a high long-term success rate. Unfortunately, currently, such a surgery does not exist.

Conceptually, the two main transvaginal surgical approaches are native tissue repair (NTR) and mesh reinforcement. The NTR involves using the patient’s tissues to repair POP without adding any synthetic material. The NTR provides satisfactory outcomes and is free of mesh-related complications. However, previous studies have shown that NTR may have higher rates of POP recurrence, particularly in cases of severe POP.[2,3] Transvaginal mesh reinforcement utilizes synthetic or biological mesh materials to minimize recurrence rates. This approach is particularly beneficial in patients with significant POP or with recurrent POP after previous NTR. Disadvantages of mesh reinforcement include mesh-related complications such as mesh erosion, chronic pelvic pain, infections, and dyspareunia.[4] Some of these postoperative complications are nonreversible.

Transvaginal mesh was widely used due to its perceived benefits in providing effective and durable pelvic support and reducing recurrence rates.[2,3] However, rising concerns regarding surgical safety led the Food and Drug Administration (FDA) in 2008 and 2011 to issue warnings against using vaginal mesh for POP repair.[5] In 2019, the FDA ultimately banned the use of vaginal mesh for POP repair following the inability to demonstrate a reasonable assurance of safety and efficacy.[6] This regulatory change has led to a shift in clinical practice, reducing the use of transvaginal mesh.

Recent advancements in mesh technology aim to minimize transvaginal mesh-related complications. These advancements include changes in materials, size, and weight of the mesh, for example, lighter, partially absorbable mesh with a reduced surface area. The SERATOM^® MN PA MR (Serag-Wiessner, Naila, Germany) is a partially absorbable minimesh for tension-free transvaginal sacrospinous ligament (SSL) fixation. The mesh implant combines absorbable (polyglycolic acid-caprolactone [PGACL]) and nonabsorbable (polypropylene) materials. The PGACL is absorbed within 90–120 days, creating a lightweight mesh. Several short-term studies have suggested that this technique is safe and effective.[7,8]

Data regarding the efficacy and safety of the new, smaller, and lighter transvaginal mesh implants are scarce. This lack of evidence makes it challenging for surgeons and patients to make well-informed decisions regarding the choice of surgery. The present study aimed to evaluate the long-term safety and efficacy of the SERATOM^® MN lightweight minimesh for transvaginal repair of significant primary or recurrent POP.

MATERIALS AND METHODS

A cohort study of 134 consecutive patients who underwent transvaginal minimesh repair (SERATOM^® MN PA MR) for significant POP during 2013–2014 was retrospectively analyzed. At 10 years postoperatively, a telephone survey was conducted to assess long-term outcomes. According to POP-Quantification (POP-Q) measurements, significant POP was defined as Stage III or IV prolapse (POP-Q) measurements.[9] All patients with significant POP were offered either conservative management with a pessary, native tissue surgical repair, or mesh-augmented POP repair. Contraindications for mesh-augmented repair included Stage I or II prolapse, unevaluated uterine pathologies, active infection, active cancer, previous pelvic radiation, and concomitant pelvic pain syndrome. The current study aimed to assess the long-term outcomes of those patients who underwent the mesh-augmented repair. The study was conducted in accordance with the Declaration of Helsinki and the institutional review board approved the study protocol (Assuta Medical Center ASMC 0020-24). The patient consent was waived by the IRB.

All 134 patients underwent transvaginal POP repair using the SERATOM^® MN minimesh. The SERATOM^® MN system consists of a main 3 cm × 3 cm mesh and two pairs of arms. We removed one pair of mesh arms to further reduce the mesh surface area.[7,8] The two remaining mesh arms were used for SSL fixation. The minimesh was inserted through an anterior vaginal wall incision to repair anterior and/or apical PO or through a posterior vaginal wall, incision to repair posterior, and/or apical POP. A concomitant NTR was performed for patients with concomitant Stage I–II anterior or posterior POP. For patients with concomitant stress urinary incontinence, a midurethral sling (MUS) procedure was performed.

Demographic, clinical, intraoperative, and early postoperative data were retrospectively retrieved from a computerized database. Follow-up assessment was conducted at 6 weeks, 3 months, and 6 months postoperatively. It included pelvic examination, anatomical and functional cure rates, and symptom assessment, including pain, dyspareunia, LUTS, and UTIs. In September 2023, one of the authors (JN) conducted a long-term follow-up telephone survey. Of 134 women surveyed, one has passed away, and 23 others could not be contacted. The women were asked about mesh complications, POP complaints, and whether they had undergone additional surgery for POP since their index minimesh surgery. Patient-reported outcomes were evaluated by decision regret or satisfaction on a scale from 0 to 100 according to the Satisfaction with Decision Scale-Pelvic Floor Disorders.[10] A comparison was made between 99 (73.9%) patients who underwent primary mesh-assisted POP repair and 35 (26.1%) patients who underwent mesh-assisted surgery for recurrent POP.

Statistical analysis was performed using the Student’s t-test for continuous data or Fisher’s exact test for categorical data. The data are summarized as mean ± standard deviation, or percentage, according to the variables. All statistical tests were two-sided; P < 0.05 was considered statistically significant. SPSS software version 27 (IBM Corporation, Armonk, NY, USA) was used for the statistical analysis.

RESULTS

A series of 134 patients (mean age: 61.7 ± 9.4 years, range: 46–88) who underwent transvaginal minimesh repair (SERATOM® MN PA MR) was investigated. The clinical and demographic characteristics of the patients are presented in Table 1. Of the 134 patients, 83 (61.9%) underwent anterior SERATOM^® MN repair, 50 (37.3%) underwent posterior SERATOM^® MN repair, and one patient underwent a combined anterior and posterior mesh-assisted repair. All patients underwent a concomitant contralateral NTR, either an anterior or posterior colporrhaphy, and 63 (47%) also had a concomitant MUS procedure. Clinical characteristics were similar among patients who underwent primary mesh-assisted repair versus recurrent mesh-assisted repair, except for significantly higher severity of cystocele, measured by point Ba of POP-Q classification, among patients who underwent a primary mesh-assisted repair (+3.4 ± 2.2 cm versus + 2.2 ± 2.6 cm, P = 0.008). Accordingly, significantly more women who underwent primary repair required anterior SERATOM^® MN than women who underwent a repeated mesh-assisted repair (67.7% versus 45.7%, respectively).

Table 1.

Patient’s demographic and clinical characteristics

	n=134	Recurrent POP repair (n=35; 26.1%), mean±SD	Primary POP repair (n=99; 73.9%), mean±SD	P
Age (year)	61.7±9.4	62.9±10.2	61.3±9
Parity	3.1±1.3	2.8±1.1	3.2±1.4
BMI (kg/m2)	27.2±4.1	27.5±5.2	26.9±4.8
Severe comorbidities*	1.5±1.4	1.5±1.1	1.5±1.4
Prior hysterectomy, n (%)	18 (13.4)	18 (51.4)	0
Preoperative point C (cm)**	+0.4±2.9	+0.6±3.6	+0.4±2.8
Preoperative point Ba (cm)**	+3.1±2.4	+2.2±2.6	+3.4±2.2	0.08
Preoperative point Bp (cm)**	+0.9±1.9	+1.2±2.4	+0.7±1.8
Anterior SERATOM® MN, n (%)	83 (61.9)	16 (45.7)	67 (67.7)	0.03
Posterior SERATOM® MN, n (%)	50 (37.3)	19 (54.3)	31 (31.3)	0.018

*Severe comorbidities: Severe hypertension, diabetes, chronic obstructive pulmonary disease, ischemic heart disease, congestive heart disease, **Anterior, apical, or posterior prolapse severity was assessed in accordance with the POP-Q classification and is presented in table as measurements of points Ba, C, and Bp, respectively. POP: Pelvic organ prolapse, BMI: Body mass index, SD: Standard deviation

The mean duration of surgery and mean estimated intraoperative blood loss were similar among women who underwent primary mesh-assisted repair and patients who had previously undergone pelvic surgery (29.9 ± 7.7 versus 31.1 ± 6.9 min and 31.6 ± 7.4 versus 32.7 ± 7.1 ml, respectively). All women were discharged either on the day of surgery or the day after. Early postoperative complications included urinary retention in two patients who underwent a concomitant MUS. The patients were managed by transurethral catheterization for several days, with complete resolution after that. In addition, there was one case of early postoperative UTI and one other case of postoperative fever. Another woman, who underwent a posterior SERATOM^® MN repair, presented several days postoperatively with perineal hematoma, which did not require any surgical intervention.

Table 2 presents POP-Q measurements at 6 months postoperatively. A comparison of patients who underwent primary mesh-assisted repair versus those who had undergone previous pelvic surgery failed to reveal any statistically significant differences.

Table 2.

Pelvic organ prolapse quantification measurements at 6 months postoperatively

	All (n=134)	Recurrent POP repair (n=35; 26.1%), mean±SD	Primary POP repair (n=99; 73.9%), mean±SD
Point C (cm)	−5.4±1.3	−5.3±1.7	−5.5±1.2
Point Ba (cm)	−2.5±1.1	−2.5±1.3	−2.5±0.9
Point Bp (cm)	−2.9±0.5	−2.8±0.8	−2.9±0.4

POP: Pelvic organ prolapse, SD: Standard deviation

Long-term outcome results are shown in Table 3. Of the original 134 patients, 110 (82%) were available for long-term assessment, with an average follow-up period of 9.8 ± 0.45 years (range: 9.4–10.9 years). Among the patients who had mesh-assisted repair after previous pelvic surgery, 7 (23.3%) required additional POP repair during the follow-up period. Of the patients who had patients with primary mesh-assisted repair, 12 (15%) required additional POP repair during the follow-up period. In most patients who underwent an additional POP repair during the follow-up period, the repair was necessary for compartments not augmented with mesh. De novo mild dyspareunia was reported by 7 (6.4%) patients. The patient-reported satisfaction rate varied between 77.5% among patients who underwent primary mesh-assisted and 87.4% among those who underwent mesh-assisted repair after previous pelvic surgery. These differences were not statistically significant.

Table 3.

Long-term outcome results

	All (n=110/134), n (%)	Recurrent POP repair (n=30/35; 26.1%), n (%)	Primary POP repair (n=80/99; 73.9%), n (%)
Follow-up (years), mean±SD	9.8±0.45	9.8±0.41	9.85±0.46
De novo dyspareunia	7 (6.4)	1 (3.3)	6 (7.5)
Recurrent POP: Surgical intervention	19 (17.3)	7 (23.3)	12 (15)
Bulging symptoms: No surgical intervention	17 (15.5)	3 (10)	14 (17.5)
Total POP complaints	36 (32.8)	10 (33.3)	26 (32.5)
Satisfaction (0–100), mean±SD	85.5±13.6	87.4±14.0	77.5±13.5

POP: Pelvic organ prolapse, SD: Standard deviation

DISCUSSION

Mesh-assisted vaginal reconstruction surgery for POP has been found to be effective and is associated with lower rates of recurrent POP.[3,11,12] In terms of cost-effectiveness, there is no doubt that a transvaginal approach is more economical than a laparoscopic or robotic transabdominal approach.[13] However, there have been some concerns about significant mesh-related complications. A meta-analysis of ten studies involving 11,785 patients found a 10% incidence of mesh-related complications;[14] the same rates were found in a recent systematic review.[15] Furthermore, other studies have suggested that while anatomical correction is improved with transvaginal mesh, subjective outcomes did not show significant improvement compared to NTR techniques.[11,12,13,16]

In 2019, the FDA banned the use of transvaginal mesh for POP repair mainly due to safety concerns.[6] In 2022, the FDA stated that “the FDA continues to believe that devices of this type for transvaginal POP mesh repair present potential additional risks compared to NTR, including mesh exposure and erosion. Therefore, the FDA maintains that these devices do not have a favorable benefit-risk profile.”[17] However, several recently published studies raised doubts about the FDA’s conclusions. In 2022, Kahn et al. presented a prospective, nonrandomized, multicenter study of 225 women who underwent POP repair with transvaginal mesh compared to 485 women who underwent NTR.[16] The primary outcomes at 36 months postoperatively comprised anatomical success (defined as POP-Q measurements of Ba ≤ 0 and/or C ≤ 0), subjective success (defined as vaginal bulging symptoms by the PFDI-20 questionnaire), and rates of significant device-related or procedure-related complications. The secondary outcomes included anatomical success rates. The results show that primary outcome success rates at 36 months postoperatively were 89.3% for transvaginal mesh repair and 80.2% for NTR (P = 0.056). Using the secondary outcome criteria, the transvaginal mesh was statistically superior to NTR (P = 0.009). The safety analysis showed similar rates of significant adverse events among women who underwent transvaginal mesh repair compared to NTR (3.1% vs. 2.7%, respectively). The overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) among women who underwent transvaginal mesh repair compared with 46.4% (225/485) among women who underwent NTR. The investigators concluded that transvaginal mesh repair was as safe as NTR. Manfee et al.[18] compared three different methods to repair apical POP: sacrocolpopexy (SCP), total vaginal mesh (TVM), and NTR. Three hundred sixty women were followed for 3 years. The anatomic and subjective failure rate after 3 years was 28% in women who underwent SCP, compared to 29% in women who underwent TVM and 43% in women who underwent NTR. There was no statistical difference between SCP and TVM, but both SCP and TVM were statistically superior to NTR. The rates of mesh erosions were 3% and 5% in the SCP and TVM groups, respectively. The percentage of women who needed a repeat surgery within 3 years was 7% in the NTR group compared to 3% in the TVM group and 4% in the SCP group; all these differences were not statistically significant. A study by Sukgen and Türkay[19] that used a validated questionnaire to assess the impact on quality of life after prolapse repair with mesh involved 36 women who had previously undergone surgery for prolapse. The findings showed that approximately 18 months after the surgery, the women reported a significant improvement in their quality of life. The researchers concluded that this information should be shared with women when discussing surgical options for repairing recurrent prolapse.

These recently published data, versus the FDA warning, have highlighted the need for a new generation of safe and durable transvaginal mesh. Such a surgical approach should prioritize effective anatomical reconstruction when minimizing mesh-related complications. The SERATOM^® MN system enables the transvaginal implantation of a lightweight minimesh with minimal dissection, short operation time, and a low complication rate. A study published in 2022 investigated the short-term outcome results of 60 women who underwent transvaginal repair using the SERATOM^® MN minimesh system.[8] A successful postoperative outcome was defined as the absence of POP beyond the hymen and the lack of POP symptoms. The surgical success rate at 3 months postoperatively was 96.6%. In addition, no complaints of dyspareunia were reported. The authors concluded that transvaginal minimesh implantation is feasible and effective in POP repair and carries a low risk of surgical complications. However, the results of that study were limited by the small series and short-term follow-up.

The present study examined the safety, efficacy, and long-term outcomes of 134 women who underwent transvaginal mesh-assisted repair (SERATOM^® MN) for Stage III or IV POP. The mean duration of surgery and blood loss were 30.8 min and 32.4 ml, respectively. Most patients (98.5%) were discharged on the day of surgery or the day after. There were no cases of significant intra- or early postoperative complications. One patient who underwent a posterior SERATOM^® MN repair presented several days postoperatively with perineal hematoma, which did not require any surgical intervention and was managed conservatively. Of the original 134 patients, 110 (82%) were available for long-term assessment, with an average follow-up period of 9.8 ± 0.45 years (range: 9.4–10.9 years). Among patients who had mesh-assisted repair after previous pelvic surgery, 7 (23.3%) required additional POP repair during the follow-up period. For patients who had primary mesh-assisted repair, 12 (15%) required additional POP repair during the follow-up period. These differences were not statistically significant. Furthermore, the incidence of mesh-related long-term complications was very low. There were no mesh erosions, and the de novo mild dyspareunia rate was 6.4%. The lack of mesh erosions is much lower than previously reported[3,4,5,6] and can be attributed to the smaller size of the SERATOM^® MN mesh and its lighter weight compared to the traditional transvaginal meshes. Subjective long-term satisfaction rates were high in both patients who underwent primary mesh-assisted repair and those who had previous pelvic surgery (77.5% and 87.4%, respectively), as well as low rates of POP symptoms in both groups. The results of the present study confirm that transvaginal minimesh, such as SERATOM^® MN, does not compromise outcome results and is associated with fewer long-term complications.

The study’s strengths include a large series, long-term postoperative follow-up, and a presentation of a novel concept of smaller and lighter transvaginal mesh, resulting in fewer complications. The study is limited by its retrospective nature the inclusion of a homogeneous group of patients operated by skilled surgeons, the lack of more subjective or objective outcome tools, and the relatively small series. Therefore, the study results may not apply to other populations or less experienced surgeons. Moreover, assessing and comparing the effectiveness and safety of various POP repair methods is inherently difficult due to the numerous available methods and the significant variations within each technique. Further studies are needed to explore the role of new transvaginal mesh techniques.

CONCLUSIONS

The new generation of transvaginal meshes contains less synthetic material and is smaller in size, making minimeshes a potential transvaginal surgical alternative to the older generation of transvaginal meshes. The results of the present study show that transvaginal SERATOM^® MN minimesh is a safe and effective procedure to correct significant POP and is associated with favorable long-term subjective outcome results and lower complication rates. Nevertheless, the present study is limited by its small series and lack of objective measurements. More studies are required to enhance outcomes and address safety concerns. Clinicians should stay updated on the latest evidence and regulatory changes to manage POP effectively.

Author contributions

Conceptualization, RSG and AG; Methodology, RSG and AG; Software, RSG and JN; Validation, RSG and AG; Formal Analysis, RSG and AG; Investigation, RSG, JN, MN, and AG; Data Curation, JN and MN; Writing – Original Draft Preparation, RSG; Writing – Review and Editing, RSG and AG; Supervision, MN and AG. All authors have read and agreed to the final version of the manuscript.

Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.