GAO issues report on power morcellators
A new review of power morcellators by the US Government Accountability Office (GAO) has found that the US Food and Drug Administration’s (FDA) system for evaluating the devices is reliant on adverse events reporting. The assessment, prepared for Congress, looked at 501(k) submissions for power morcellators, FDA’s understanding of concerns about the devices and the agency’s responses, and professional standards and guidance for physicians about power morcellators and information that manufacturers provided.
For the analysis, published in GAO Highlights, GAO also conducted a search for articles published between January 1980 and March 2016 on prevalence of uterine cancer and risks of spreading cancer when power morcellation is used to treat uterine fibroids. In addition, 10 professional societies were contacted as were other stakeholder organizations. Organizations whose representatives were interviewed or that provided information were AAGL, the American Board of Obstetrics and Gynecology, the American College of Obstetricians and Gynecologists, America’s Health Insurance Plans, The Joint Commission, and the Society of Gynecologic Oncology.
Between 1991 and 2014, the report says, FDA cleared 25 submissions for laparoscopic power morcellators for marketing in the United States and with the first approval, the agency was aware of the potential for the devices to spread tissue. Before any adverse event reports about them were received, “FDA understood the risk of having unsuspected cancer that could be spread using a power morcellator was low.” Since the emergence of reports of spread of unsuspected cancer following use of power morcellators to treat fibroids in 2013, FDA has issued a safety communication and guidance to manufacturers and conducted inspections to ensure hospital compliance with medical device reporting requirements.
Discussions by GAO with the professional societies found a lack of professional standards specific to use of power morcellators but availability of some guidance and educational resources on surgical procedures to treat fibroids that involve power morcellation. Some of the professional societies had concerns about FDA’s estimate of cancer risk in women undergoing surgical treatment for uterine fibroids. Of 12 manufacturers contacted, three provided information about the instructions for use for their devices. GAO said that its interviews with stakeholders underscore the ongoing questions about the long-term impact on patients of FDA’s guidance about power morcellators.