Upcoming plans to share outcomes data
We are in the process of performing a retrospective review of all of the cases we have performed at our institution using this technique of permanent suture bridging to the SSL within the arm of the biograft. Given the relatively recent FDA announcement, we have yet to establish any long-term outcomes data. However, the preliminary results at 6-month follow-up are promising and demonstrate a low (2.6%) failure rate, without significant safety concerns. We hope to publish these data as well as more data on longitudinal outcomes in the future.
In summary
Many women are at risk for native-tissue repair failure or are not well suited for an abdominal procedure to correct their pelvic support defect and restore their quality of life. As expert pelvic surgeons, we play an important role in the search for innovative solutions for these women. There is ample opportunity for future research and clinical trials to determine the best biologic materials and their optimal use in pelvic reconstructive surgery.
Originally, polypropylene mesh was designed for use in augmenting abdominal hernia repairs and later was adapted by manufacturers for use in POP repair. The FDA removal from the market of existing transvaginal synthetic mesh kits was a unique catalyst that challenged our community to develop transvaginal repairs using biologic grafts that are genuinely tailored to the unique needs of the female pelvic anatomy. ●