The FDA issued final guidance in a safety communication regarding laparoscopic power morcellators for gynecologic procedures (2020). The FDA communication states
The FDA continues to recommend 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
The specification of age-related risk is consistent with scientific data and reflects clinical experience, allowing power morcellation in low risk patients when performed with a containment system compatible with the laparoscopic power morcellator
Utility of a contained tissue extraction system in a low risk population appears to mitigate the risk of poor outcomes that may be associated with uncontained power morcellation
This new guidance is reportedly based on bench and animal testing
Although the American College of Obstetricians and Gynecologists acknowledges the FDA’s new recommendation, more information is needed. It is still unknown whether the use of a containment system prevents the spread of benign or malignant tissue
In addition to concern that the bags may leak, bags may make morcellation more cumbersome, resulting in increased operative time
FDA Safety Communication: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate
FDA: Product Labeling for Laparoscopic Power Morcellators
AAGL: FDA Draft Guidance Document on Power Morcellators
ACOG Committee Opinion 822: Uterine Morcellation for Presumed Leiomyomas
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