Is transvaginal mesh surgery with polytetrafluoroethylene mesh ORIHIME® feasible for anterior pelvic organ prolapse?-Randomized comparative study between ORIHIME® and Polyform™

Objective: Transvaginal mesh surgery for pelvic organ prolapse has been widely performed in Japan, but polypropylene mesh has not been used in Japan since the ban on TVM using polypropylene mesh in the United States. Currently, polytetrafluoroethylene mesh ORIHIME (R) is the only mesh available for TVM in Japan. Although polytetrafluoroethylene is a safe material, its low coefficient of friction and insufficient adhesion to the surrounding tissue make it difficult to maintain the mesh position when it is used in the transvaginal mesh surgery. The aim of this study was to evaluate the feasibility of TVM-A2 using ORIHIME (R). Methods: One hundred cases of TVM-A2 were included in the study. The patients were randomly assigned to two groups: the ORIHIME (R) group (Group O) and the Polyform (TM) group (Group P). With 50 patients in each group, the complications and recurrences up to the fourth year were compared. Surgeries were performed using the TVM-A2 method. Statistical analysis was performed using EZR. Results: There were no significant differences in baseline parameters between the two groups. We observed no perioperative complications, and saw one case of postoperative abscess formation in Group O, which resolved successfully after incision and drainage. The 4-year recurrence rate was significantly higher in Group O. Conclusion: As the recurrence rate was significantly higher in Group O, we conclude that TVM-A2 using ORIHIME (R) which is the same procedure as TVM-A2 using polypropylene mesh is not feasible in repairing the pelvic organ prolapse.