Morcelamento – FDA

Executive Summary

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.