Ten-year survival impact of FDA warning on power morcellation in occult uterine leiomyosarcoma diagnosed after minimally invasive surgery.

Objective: To evaluate the impact of 2014 Food and Drug Administration (FDA) warning against power morcellation (PM) on survival outcomes of patients with incidentally found uterine leiomyosarcoma (uLMS) after minimally invasive surgery (MIS). Methods: Patients who underwent hysterectomy or myomectomy via MIS for presumed uterine leiomyoma and were pathologically diagnosed with stage I uLMS between 2003 and 2022 were retrospectively reviewed. Survival outcomes and clinicopathologic factors were compared between the 2 groups of which the initial MIS was performed before and after the FDA statement: pre-FDA vs. post-FDA. Results: Thirty-two women were included: 12 in the pre-FDA group and 20 in the post-FDA group. Median follow-up period was 63.1 months. There were no significant differences in stage, type of surgery, tumor size, mitotic counts, resection margin status, lymphovascular space invasion, additional surgery, and adjuvant treatment between the 2 groups. The frequency of PM decreased in the post-FDA group compared with the pre-FDA group (33.3% vs. 10.0%, p=0.165), while endobag use (16.7% vs. 50.0%, p=0.075) and umbilical knife morcellation (KM) (0.0% vs. 20.0%, p=0.271) increased despite statistical insignificance. Of note, however, vaginal KM was significantly increased between the 2 period (16.7% vs. 65.0%, p=0.012). There was significant difference neither in recurrence-free survival (RFS) (2-year RFS rate, 72.7% and 63.3%; p=0.451) nor in overall survival (p=0.348) between the 2 groups. Conclusion: Despite seemingly decreased use of PM and increase of KM with endobag use for the last 10 years after the FDA warning compared with pre-FDA era, we failed to demonstrate significant survival improvements in patients who were incidentally diagnosed with uLMS after MIS between the 2 periods. [ABSTRACT FROM AUTHOR]