Transvaginal Mesh for pelvic organ prolapse in Taiwan (2004-2025): Outcomes and safety in the wake of the 2019 FDA licensing halt.

Abstract

<h4>Objective</h4>To review the evolution, outcomes and safety of transvaginal mesh (TVM) use for pelvic organ prolapse (POP) repair in Taiwan from January 2004 to May 2025.<h4>Materials and methods</h4>A systematic literature search in PubMed using MeSH terms "transvaginal mesh" AND "Pelvic organ prolapse", yielding 856 articles. Of these 96 Taiwanese studies were included, comprising 10 prospective trials, 1 meta-analysis, and the remainder retrospective studies. A total of 88 study cases involving various mesh types were analyzed.<h4>Results</h4>Objective cure rates exceeded 90% at 1-year across most mesh types, with significant improvements in quality of life measured by validated questionnaires (POPDI-6, IIQ-7, UDI-6, PISQ-12). Mesh extrusion rates with newer generation meshes (2019-2023) ranged from 0.8% to 4.8%. Most complications, such as urinary tract infections and voiding dysfunction, were minor and manageable. Surelift, Calistar-S and MIPS, the only currently approved meshes for transvaginal use in Asia, showed promising one-year cure rates, all exceeding 92%. Surelift demonstrated superiority more than native tissue repair at 5 years, with success rates of 89.1% vs. 64.4% (p = 0.002). Older age was associated with increased risk of voiding dysfunction and recurrence (HR 1.07, if > 64 years). Obesity did not increase mesh-related complications but has greater postoperative symptom burden. Concomitant MUS effectively reduced de novo stress urinary incontinence from 31.2% to 5%.<h4>Conclusion</h4>TVM continues to be a reliable and effective option for POP management. Taiwan's experience highlights the importance of proper training, patient selection, and surgical refinement in minimizing complications. Long-term follow-up and awareness of red-flag symptoms remains essential.