Evidence-Based. Clearly Delivered.
Evidence-Based. Clearly Delivered.
The FDA issued final guidance in a safety communication regarding laparoscopic power morcellators for gynecologic procedures (2020). The FDA communication states
The FDA recommends limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy
In addition, the FDA recommends that when morcellation is appropriate, only contained morcellation be performed
Be aware that uncontained power morcellation has also been associated with the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, potentially requiring additional surgeries
This FDA guidance was reportedly based on bench and animal testing
Although ACOG acknowledged the FDA’s recommendation, more information is needed. It is still unknown whether the use of a containment system prevents the spread of benign or malignant tissue. ACOG has reaffirmed its guidance on this topic
In addition to concern that the bags may leak, bags may make morcellation more cumbersome, resulting in increased operative time
FDA: Product Labeling for Laparoscopic Power Morcellators
ACOG Committee Opinion 822: Uterine Morcellation for Presumed Leiomyomas
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