AAGL clinical guidelines for safe morcellation — YRD

AAGL clinical guidelines for safe morcellation (1392)

Kathy Huang

The benefits of minimally invasive surgery for treating a variety of gynecologic conditions are well known.  Nearly half of the estimated 400,000 inpatient-based hysterectomies performed annually in the United States for benign indications are completed minimally invasively. 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 electro-mechanical morcellation 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. The possibility of this complication may have been previously underestimated.

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. 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. 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 year.