Call for Comments due 4/27/2020: FDA Draft Guidance Document on Power Morcellators
The following statement was authored by Dr. Jubilee Brown, President of the AAGL, and summarizes the AAGL’s Endorsement of the FDA Draft Guidance Document on Product Labeling for Laparoscopic Power Morcellators. This statement was approved by the AAGL Board of Directors.
The AAGL endorses the Draft Guidance Document released today by the FDA on power morcellation. The document can be found here and includes product labeling for laparoscopic power morcellators and provides draft guidance for industry and FDA Staff. This guidance document includes recommended labeling on laparoscopic power morcellators to inform physicians that these devices are: contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy; are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are post-menopausal or over 50 years of age, or candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision; that the risk of occult cancer increases with age, particularly over age 50; that uncontained power morcellation has been associated with the spread of benign uterine tissue; and that these devices should only be used with a containment system compatible with the laparoscopic power morcellator.
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 updated guidance document and the associated labeling allows physicians and their patients to make informed decisions based on the most current scientific information and provides expanded safe options for minimally invasive gynecologic surgery in appropriate, low-risk, screened patients after informed consent.
The AAGL encourages its members to contribute their opinions by submitting electronic comments to the FDA’s Federal register here during the 60-day window. The FDA will consider these responses as they finalize this guidance document.
Jubilee Brown, MD