FDA Safety Communication: Laparoscopic Power Morcellation Only With Use of a Tissue Containment System
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
Additional Recommendations for Health Care Providers
Do not use laparoscopic power morcellators
In gynecologic surgery when the tissue to be morcellated is known or suspected to contain malignancy
For removal of uterine tissue containing suspected fibroids in patients who are
Postmenopausal or >50 years of age or
Are candidates for removal of tissue (en bloc) through the vagina or via a mini-laparotomy incision
About the risk of occult cancer (cancer that cannot be identified during pretreatment evaluation) and
That use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease their long-term survival
That the risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age
Containment System Limitations
A containment system cannot prevent against the potential spread
of cancer that might result from
Tissue that spreads due to manipulation of the tissue before it
is placed into the tissue containment system or
Cancer that may have already spread through the blood, lymphatic
system or fallopian tubes (transtubal transport) before the surgical procedure
AAGL Endorsement of Draft Guidance
AAGL endorsed the initial draft recommendations and states
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
ACOG Committee Opinion
ACOG emphasizes the importance of shared decision with patients
In addition, a thorough preoperative work-up is required
While endometrial sampling should be performed, “leiomyosarcoma is not reliably identifiable preoperatively”
ACOG includes the FDA recommendations regarding the requirement that power morcellation for myomectomy or hysterectomy be performed only with a tissue containment system
However, the ACOG document notes the following
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
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