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  • Regulatory NewsRegulatory News

    Experts Call on FDA to Rescind or Revise Power Morcellator Warning

    Leading gynecology experts sent an open letter to the US Food and Drug Administration (FDA) Tuesday calling on the agency to rescind or revise a warning it issued that restricted use of a device in minimally invasive procedures to treat uterine fibroids. The warning on laparoscopic power morcellators (LPM) followed FDA concerns that if a presumed benign fibroid is later found to be a malignancy called a leiomyosarcoma, fragments of the cancer will be scattered by a LPM,...
  • Regulatory NewsRegulatory News

    Study Finds Fewer Michigan Women Getting Minimally Invasive Hysterectomies after FDA Warning

    A new retrospective study has found that following calls from the US Food and Drug Administration (FDA) discouraging the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids, the use of morcellation decreased in Michigan, though major complications and 30-day hospital readmissions increased. Background Laparoscopic power morcellation is a minimally invasive method of removing fibroid tumors from the ut...