https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellation?utm_campaign=2020-02-25%20Safety%20Comm%20laparoscopic%20power%20morcellators&utm_medium=email&utm_source=Eloqua

FDA acts to increase the safe use of laparoscopic power morcellators

Today, the U.S. Food and Drug Administration (FDA) is announcing two actions to promote the safe and effective use of laparoscopic power morcellators during gynecologic surgery: Clearance of updated labeling information for a containment system used with laparoscopic power morcellators during gynecologic surgery. Availability of a draft guidance, "Product Labeling for Laparoscopic Power Morcellators." Facts about the draft guidance When finalized, this guidance will provide device manufacturers with recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators to better inform patients and health care providers of the device’s risks, including: greater specificity regarding the risk of use as it relates to age of the patient, information regarding the risk of spreading malignant and benign uterine tissue, and information regarding the use of laparoscopic power morcellation containment systems.

Read the updated Safety Communication

The draft guidance includes a recommendation for a boxed warning that uterine tissue may contain unsuspected cancer and the use of laparoscopic power morcellators during fibroid surgery may spread cancer. The draft guidance also recommends contraindications against using laparoscopic power morcellators in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain cancer, and for removal of uterine tissue containing suspected fibroids in certain patients, including patients who are post-menopausal or over 50 years of age. The safety statements discussed in the draft guidance (boxed warning, contraindications and warnings) are important labeling recommendations to help ensure the safe use of laparoscopic power morcellators. Submit comments on this draft guidance This draft guidance will be open for public comments for 60 days to submit comments on this draft guidance by 4/27/2020. Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.