Changes in the Japanese Transvaginal Mesh (TVM) Surgery Have Reduced the Rates of Complication and Recurrence

Fujisaki A1, Shimoinaba M1, Kinnno K1, Hiramoto Y1, Honda S1, Yoshimura Y1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 775
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Pelvic Organ Prolapse Surgery Female Grafts: Synthetic Prolapse Symptoms
1.Yotsuya Medical Cube
Links

Abstract

Hypothesis / aims of study
Since the US Food and Drug Administration (FDA) alert [1], we have further developed the Japanese transvaginal mesh (TVM) surgery concept and procedure. The aim of this study was to compare the postoperative outcomes of the previous large-mesh TVM and the current small-mesh TVM.
Study design, materials and methods
From 2008 to March 2013, we inserted a large Gynemesh® mesh into the anterior vaginal wall and anchored four arms to the tendinous arches of the pelvic fascia with an obturator foramen approach, and we actively selected the posterior mesh for repair (large-mesh TVM: L group). There was a period of trial and error from March 2013 to March 2015. Subsequently, starting in April 2015, without an obturator foramen approach, we began to insert a small Polyform® mesh into the anterior vaginal wall and anchored two arms to the sacrospinous ligaments. We avoided inserting a mesh into the posterior vaginal wall as much as possible and instead performed native tissue repair (NTR) as posterior colporrhaphy in cases of posterior wall repair (small-mesh TVM: S group). 

We conducted a retrospective chart review of patients who underwent TVM with a transvaginal anterior wall mesh implantation and followed up with them until the end of the first postoperative year. We compared the two groups’ outcomes (L group: 357 cases; S group: 466 cases).
Results
There were no statistically significant differences between the two groups in terms of the patients’ background information, such as age, BMI, parity number, history of total hysterectomy, and pelvic organ prolapse quantification (POP-Q) stage.  

There were significant differences found in terms of the concomitant procedure required with the transvaginal anterior wall mesh implantation. These were as follows: posterior colporrhaphy (L group: 74.2%; S group: 15.9%), posterior wall mesh implantation (L group: 49.3%; S group: 3.2%), and midurethral sling operations (L group: 28.0%; S group: 48.3%). 

There were also significant differences found in terms of the time required for the operations. The median duration of surgery was 83 min in the L group and 46 min in the S group. The median duration of anesthesia was 111 min in the L group and 85 min in the S group (Table 1). 

The overall rates of intraoperative and postoperative complications, including minor ones, were 11.5% in the L group and 4.5% in the S group, indicating a significant difference between the groups.
Among complications, minor and major injuries to adjacent organs (e.g., the bladder, ureter, and rectum) showed a significant difference (L group: 5.9%; S group: 0.2%). Among procedures causing the injuries, stripping the vaginal wall did not show a significant difference (L group: 0.8%; S group: 0.2%). However, the puncture procedure for anchoring points showed a significant difference (L group: 5.0%; S group: 0.0%). There was no significant difference in blood transfusions, pelvic pain requiring analgesia for more than one month, postoperative de novo dyspareunia, or subcutaneous abscesses; all occurred in less than 0.3% of either group. Postoperative total mesh removal was not performed in any case in either group.   

The incidence rate of vaginal wall mesh extrusion, which was reported to be high by a previous study [2], was 2.8% in the L group and 0.9% in the S group—low in both groups, but significantly lower in the current small-mesh TVM group. Although the anatomical recurrence rate, which is defined as the lowest point of the prolapse reaching the hymen, was 11.5% in the L group and 4.5% in the S group, indicating a significant difference, the symptomatic recurrence rate did not show a significant difference between the groups (L group: 2.8%; S group: 1.7%) (Table 2).
Interpretation of results
Although there was no significant difference in the background of the patients between the previous and current surgical methods, the durations of surgery and anesthesia were shortened. The complication rate and the anatomical recurrence rate were already low with the previous large-mesh TVM; however, they are even lower with the current small-mesh TVM.
Concluding message
Based on our data, which covered only up to the early postoperative period, our Japanese method of small-mesh TVM surgery is a preferable option for pelvic organ prolapse repair surgery.
Figure 1
Figure 2
References
  1. FDA: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse. 2011.
  2. Maher C, Feiner B, Baessler K et al: Transvaginal mesh or grafts compared with native tissuerepair for vaginal prolapse. Cochrane Database of Systematic Reviews2016, Issue 2. Art. No.: CD012079.
Disclosures
Funding None Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee Yotsuya Medical Cube IRB Helsinki Yes Informed Consent Yes