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Morcellation During Uterine Tissue Extraction AAGL Advancing Minimally Invasive Gynecology Worldwide

The benefits of minimally invasive surgery (MIS) for treating a variety of gynecologic conditions are well documented [1-10]. Nearly half of the estimated 400,000 inpatient-based hysterectomies performed annually in the United States for benign indications employ these innovative techniques [11]. Thousands more women benefit from MIS in uterus-sparing procedures such as myomectomy. The ability to offer less invasive surgery to women often requires the removal of large tissue specimens through small incisions, which may be facilitated by morcellation. The term morcellation encompasses a variety of surgical techniques, some used in concert with specific devices, used to enable removal of large specimens from the peritoneal cavity, avoiding the need for laparotomy. Manual morcellation with a scalpel or electromechanical morcellation (EMM) with a device specifically designed to fragment tissue specimens should only be considered in women at low risk for a gynecologic malignancy and when an appropriate preoperative assessment is suggestive of a benign disorder. When occult malignancy is inadvertently encountered, EMM hinders the ability to perform a comprehensive histopathological evaluation of a uterine specimen. Additionally, dissemination of tumor or uterine fragments, either benign or malignant, throughout the intraperitoneal cavity may necessitate further surgical interventions or other treatment and may worsen prognosis [12-24]. The possibility of this complication may have been previously underestimated. Multiple factors may limit our understanding regarding the full scope of potential risks associated with tissue morcellation. First, although it is possible to diagnose most uterine cancer cases preoperatively, rare subtypes of uterine cancer (i.e. sarcomas) may mimic the appearance of benign myomas on imaging. Second, preoperative diagnostic testing may not discriminate between benign and malignant conditions in these cases [25,26]. Third, morcellator device safety and critical understanding of how to mitigate morcellator-associated injury continues to evolve. However, despite our incomplete understanding of these issues, MIS employing morcellation remains safe when performed by experienced, high-volume surgeons in select patients who have undergone an appropriate preoperative evaluation. While the U.S. Food and Drug Administration (FDA) approved the first electromechnical morcellation device in 1995, it recently issued a statement discouraging the use of “power” or electromechanical morcellation for hysterectomy and myomectomy in most women with uterine myoma [27]. The Administration cited safety concerns, specifically the potential for dissemination of occult uterine cancer that may occur with the morcellator technology. The FDA’s recommendations must be taken very seriously, as patient safety and avoiding preventable harm are of paramount importance. However, the studies analyzed by the FDA in formulating this recommendation were not stratified by risk factors for sarcoma and were not necessarily performed in the setting of reproductive-age women with presumed benign leiomyomata [13,28-35]. Further, in addition to the risk-benefit ratio of morcellator technology per se, one must also consider the implications of alternative surgical options for women if morcellator use is suspended nationwide. The alternatives for women with large uteri or uterine myomas would, in some cases, involve abandoning MIS or the ability to morcellate and potentially deny the clear benefits this approach provides to hundreds of thousands of women around the world each The Tissue Extraction Task Force members had no commercial, proprietary, or financial interest in the products or companies described in the report. On May 6, 2014, the report was approved by members of the AAGL Board of Trustees who have no commercial, proprietary, or financial interest in the products or companies described in the report.