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  • Regulatory NewsRegulatory News

    Fears Over Device Surveillance Amid Talk of Deregulation

    A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts. In a viewpoint published in JAMA on Thursday, Joshua Sharfstein of Johns Hopkins Bloomberg School of Public Health, and Rita Redberg and Alison Jacoby of the University of California, San Francisco Medical Center, point to the recent debate over power morcellators as ...
  • Regulatory NewsRegulatory News

    GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators

    The Government Accountability Office (GAO) on Wednesday released the results of its year-and-a-half long investigation into the US Food and Drug Administration's (FDA) handling of laparoscopic power morcellators following reports that the devices spread cancer in patients being treated for uterine fibroids. In August 2015, a bipartisan group of 12 US Representatives wrote to GAO calling on it to investigate the FDA's handling of the issue. The report finds that FDA may ...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Puts Major Restrictions on Power Morcellators Following Cancer Concerns

    US regulators today announced major restrictions on laparoscopic power morcellator (LPM) devices following major concerns that the devices could be harming patients. Background The restrictions, announced on 24 November 2014 by the US Food and Drug Administration (FDA), follow months of major concern that the devices could be harming women more than they helped. Power morcellators were primarily used to remove non-cancerous uterine fibroids by morcellating the tissue ...