Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy

Abstract

II.

A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System

“…In an era in which physicians are increasingly performing more invasive hysterectomies and myomectomies in the wake of the US Food and Drug Administration guidance regarding laparoscopic power morcellation, it is important that women continue to have options for uterine fibroid therapy that are less invasive and preserve their choices with regard to uterine conservation [42]. The Sonata System, by virtue of being a transcervical procedure that has a wider range of treatable fibroid types than existing transcervical options, could significantly change the current paradigm in which women either lose their uteri or potentially undergo surgical and radiologic procedures that have significant drawbacks in terms of invasiveness and recovery time or require multiple treatment sessions.…”

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroids: an updated decision analysis following the 2014 Food and Drug Administration safety communications

“…These communications resulted in significant changes in practice patterns among gynecologic surgeons 2,3 and increasing rates of abdominal hysterectomy (AH), 4 possibly leading to more complications for patients. 5,6 We previously published a decision analysis that attempted to incorporate risks associated with AH and laparoscopic hysterectomy (LH) using estimates of LMS available to the FDA at the time of the initial communications.…”

Transvaginal contained tissue extraction after laparoscopic myomectomy: a cohort study

“…Barron et al. reported a 19% decrease in minimally invasive myomectomies, performed over the course of 8 months after the FDA warning statement on the use of power morcellation, at six operating centres in the Florida Hospital medical system . Weighing the risk of common and sometimes serious, life‐threatening complications (blood transfusion, surgical site infection, venous thrombosis, length of hospital admission, and postoperative pain) against the risk that morcellating a fibroid will result in the spread of a leiomyosarcoma should be considered.…”

“…Although some case series have demonstrated transvaginal contained tissue extraction to be feasible and safe, there are no large‐scale studies to rigorously evaluate potential complications and outcomes. Such studies are urgently needed in the best interest of our patients to avoid them being deprived of the benefits of minimally invasive surgery . In this study, we describe our experience with transvaginal tissue extraction after laparoscopic myomectomy.…”