Morcellation During Uterine Tissue Extraction AAGL Advancing Minimally Invasive Gynecology Worldwide 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. Dr. Ceana Nezhat, President of AAGL, voluntarily recused himself from discussion of the Tissue Extraction Task Force report and from any vote related to the report in accordance with the AAGL Conflict of Interest Disclosure and Dissociation Policy for Executive Committee Members. I. Introduction: Minimally Invasive Surgery, most uterine cancer cases preoperatively, rare subtypes of Morcellation and the Scope of the Problem uterine cancer (i.e. sarcomas) may mimic the appearance The benefits of minimally invasive surgery (MIS) of benign myomas on imaging. Second, preoperative for treating a variety of gynecologic conditions are well diagnostic testing may not discriminate between benign documented [1-10]. Nearly half of the estimated 400,000 and malignant conditions in these cases [25,26]. Third, inpatient-based hysterectomies performed annually in morcellator device safety and critical understanding of the United States for benign indications employ these how to mitigate morcellator-associated injury continues to innovative techniques [11]. Thousands more women evolve. However, despite our incomplete understanding benefit from MIS in uterus-sparing procedures such of these issues, MIS employing morcellation remains safe as myomectomy. The ability to offer less invasive when performed by experienced, high-volume surgeons surgery to women often requires the removal of large in select patients who have undergone an appropriate tissue specimens through small incisions, which may preoperative evaluation. be facilitated by morcellation. The term morcellation While the U.S. Food and Drug Administration (FDA) encompasses a variety of surgical techniques, some used approved the first electromechnical morcellation device in concert with specific devices, used to enable removal of in 1995, it recently issued a statement discouraging the large specimens from the peritoneal cavity, avoiding the use of “power” or electromechanical morcellation for need for laparotomy. hysterectomy and myomectomy in most women with Manual morcellation with a scalpel or electro- uterine myoma [27]. The Administration cited safety mechanical morcellation (EMM) with a device specifically concerns, specifically the potential for dissemination of designed to fragment tissue specimens should only occult uterine cancer that may occur with the morcellator be considered in women at low risk for a gynecologic technology. The FDA’s recommendations must be taken malignancy and when an appropriate preoperative very seriously, as patient safety and avoiding preventable assessment is suggestive of a benign disorder. When harm are of paramount importance. However, the studies occult malignancy is inadvertently encountered, analyzed by the FDA in formulating this recommendation EMM hinders the ability to perform a comprehensive were not stratified by risk factors for sarcoma and were not histopathological evaluation of a uterine specimen. necessarily performed in the setting of reproductive-age Additionally, dissemination of tumor or uterine fragments, women with presumed benign leiomyomata [13,28-35]. either benign or malignant, throughout the intraperitoneal Further, in addition to the risk-benefit ratio of morcellator cavity may necessitate further surgical interventions or technology per se, one must also consider the implications other treatment and may worsen prognosis [12-24]. The of alternative surgical options for women if morcellator possibility of this complication may have been previously use is suspended nationwide. The alternatives for women underestimated. with large uteri or uterine myomas would, in some cases, Multiple factors may limit our understanding regarding involve abandoning MIS or the ability to morcellate and the full scope of potential risks associated with tissue potentially deny the clear benefits this approach provides morcellation. First, although it is possible to diagnose to hundreds of thousands of women around the world each Page 2 Morcellation During Uterine Tissue Extraction year. In considering these scenarios, laparotomy as an regarding comparative safety of this approach do not alternative carries its own set of clearly defined risks, some yet exist. of which are serious and life threatening. In an effort to • Minimally invasive surgery (MIS) as defined in minimize all associated procedural risks, research aimed this article encompasses vaginal, conventional at optimizing MIS approaches in the greatest number of laparoscopic, single-site laparoscopy or robotic women and the development of diagnostic tools to identify surgical approaches. more accurately those women who may be potentially • The quality of evidence and strength of the harmed by morcellation are urgently needed. recommendations made in this document were With any surgical technology or intervention, assessed using United States Preventive Services unanticipated risks may not be realized for years after Task Force (USPSTF) guidelines (Appendix) and are implementation. Thus, surgical innovation should be outlined throughout the manuscript [36]. linked with ongoing safety evaluation [16]. To ensure that gynecologic surgeons have the ability to provide MIS for the majority of their patients in a safe manner, AAGL II. Defining the Issue convened a task force to conduct a critical appraisal of the existing evidence related to the practice of uterine tissue Minimally Invasive Surgery in Gynecology extraction and morcellation in the setting of hysterectomy Several prospective studies demonstrate that minimally and myomectomy. Recommendations for the gynecologic invasive surgical approaches (MIS) to hysterectomy for surgeon are provided herein and areas in need of further gynecologic conditions confer improved surgical and investigation are identified. disease-related outcomes compared with laparotomy [1] (Level I). The benefits of MIS are well-documented Definitions and Points of Clarification: and include fewer perioperative complications, shorter • This review exclusively addresses the practice of hospital stays, less pain, improved quality of life and a uterine tissue extraction, and not extraction of other faster return to work [1-10]. In many instances, both vaginal reproductive organs. and laparoscopic hysterectomy can be safely performed • This review primarily focuses on uterine as an outpatient procedure. A Cochrane systematic leiomyosarcoma (LMS) because of its unique clinical review analyzed 27 randomized clinical trials comparing features and how those relate to morcellation (e.g. its laparoscopic or vaginal hysterectomy to abdominal aggressive nature and ability to mimic benign uterine hysterectomy [1] (Level I). Significantly shorter hospital leiomyoma). To provide a global and comprehensive stays and speedier return to normal activities, as well as review, other tumor types and complications related other improved secondary outcomes (less blood loss, to EMM are highlighted as well. fewer abdominal/incisional infections or febrile episodes), • For the purposes of this review, morcellation were achieved in women who underwent either vaginal or will refer to any surgical technique involving laparoscopic surgery. fragmenting a surgical specimen into smaller pieces. Given the abundance of Level I data that strongly Electromechanical Morcellation (EMM, also known support the use of a vaginal or laparoscopic approach for as “electronic” morcellation, “electric-generated” hysterectomy when possible, both the American College of morcellation, and “power” morcellation) is a specific Obstetrics and Gynecology (ACOG) and the AAGL issued subtype of morcellation in which tissue is mobilized position papers on the route of hysterectomy for benign through a spinning or electrosurgical blade to cut it into disease [9,10]. In 2011, the AAGL recommended “that most smaller strips. The specifics are not yet fully delineated hysterectomies for benign disease should be performed in the literature, but various methods of morcellation either vaginally or laparoscopically and that continued may have inherent differences in risk profile. efforts should be taken to facilitate these approaches. • The technique under question by the FDA is EMM Surgeons without the requisite training and skills required (or “power” morcellation). Other methods of tissue for the safe performance of vaginal or laparoscopic extraction that will be reviewed in this document hysterectomy should enlist the aid of colleagues who do include contained (in a specimen retrieval bag) or should refer patients requiring hysterectomy to such or uncontained morcellation, mini-laparotomy, individuals for their surgical care.” laparotomy and vaginal extraction. Approximately half of the estimated 400,000 • The use of specimen retrieval pouches or bags for hysterectomies completed annually in the United States contained morcellation (electromechanical or for benign indications are performed via a MIS approach otherwise) will be addressed in this review, but data [11]. Many more women undergo minimally invasive Morcellation During Uterine Tissue Extraction Page 3 myomectomy surgery and