FDA's Center for Devices and Radiological Health (CDRH)'s most recent assessment of using laparoscopic power morcellators (LPM) to treat presumed uterine fibroids confirms concerns outlined in our 2014 safety communication which discouraged the use of these products for that use. Women with unsuspected uterine sarcoma who undergo morcellation of presumed benign fibroids are at risk for mechanical spread of cancerous tissue and worsened clinical outcomes. As part of the FDA's ongoing efforts, CDRH conducted an updated review to assess:• the prevalence of sarcoma in women undergoing myomectomy or hysterectomy for presumed benign uterine fibroids; • clinical outcomes for patients who were diagnosed with cancer following morcellation (power or manual) during myomectomy or hysterectomy to treat presumed uterine fibroids; and, • differences in patient outcomes for women who have undergone electric power morcellation compared to manual (e.g., scalpel) morcellation and/or no morcellation.In addition, we reviewed Medical Device Reports (MDRs) received by FDA for dissemination of malignancy following LPM use as well as information related to changes in rates of hysterectomy or myomectomy procedures performed since our 2014 communication.Key to our reassessment are data suggesting the prevalence of uterine sarcoma in women undergoing surgery for presumed fibroids to be in the range of approximately 1 in 225 to 1 in 580 and that for leiomyosarcoma (LMS) to be approximately 1 in 495 to 1 in 1100, depending on the analytical methodology used. In addition, there continues to be evidence for differences in patient outcomes (e.g., disease-free survival and overall survival) between those with occult malignancy who receive morcellation and those who do not receive morcellation.While minimally invasive surgery conveys several advantages over open surgery for women with fibroids including reduced recovery time and rate of wound infection, the use of LPMs during these surgeries poses a risk due to unsuspected uterine sarcoma. The FDA continues to caution against the use of LPMs in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.1 Ebner, F., et al., Is open surgery the solution to avoid morcellation of uterine sarcomas? A systematic literature review on the effect of tumor morcellation and surgical techniques.