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

OBJECTIVE

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.

MATERIALS AND

METHODS

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.

RESULTS

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%.

CONCLUSION

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.