Electromechanical morcellators' black-box warning: tribulations, expectations and solutions

Abstract

Laparoscopic minimally invasive gynecologic surgery (MIGS) for benign conditions results in decreased morbidity, and faster recovery, compared with laparotomy. Tissue fragmentation by electromechanical morcellation permits the removal of large specimens through small laparoscopic incisions. Since the US Food and Drug Administration (FDA) published its safety warning about the risk of power morcellators spreading cancer during fibroid surgery in 2014, power morcellation has become rare. MIGS for fibroids and other large tissue specimens has declined. Current alternatives to preserve MIGS for large specimens include intact specimen retrieval through periumbilical mini-laparotomy incisions, vaginal removal, or in-bag manual morcellation, have limitations. Innovative intracorporeal containment tissue extraction system (ICTES) prototypes capable of enclosing, manipulating, morcellating, and removing tissue, while avoiding intraperitoneal leakage and maintaining pneumoperitoneum, are being evaluated. There is ample opportunity to optimize efficacy of ICTES by scientific study in clinical trials.