ACOG Statement on Power Morcellation
November 24, 2014
Washington, DC – Hal C. Lawrence, MD, Executive Vice President and CEO of the American College of Obstetricians and Gynecologists (ACOG), released the following statement addressing the Food and Drug Administration’s Immediately-in-Effect guidance regarding power morcellators:
“The American College of Obstetricians and Gynecologists shares the Food and Drug Administration’s commitment to the health and well-being of American women. We are pleased that the FDA’s action takes steps to enhance patient safety while allowing the appropriate use of power morcellation in gynecologic surgery for select women.
“As we have said in the past, we continue to believe that power morcellation has a role in gynecologic surgery. Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure. The FDA’s clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation. However, we look forward to working with the FDA to provide additional clarification regarding certain language within the contraindications that could be confusing to patients and physicians.
“Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.
“Moving forward, ACOG welcomes the collection of meaningful new data that will help provide for the safe and effective use of power morcellation in the future, and we plan to continue providing the agency with input on the appropriate role of power morcellation in gynecologic surgery.”
For more information, please read ACOG’s Special Report on Power Morcellation and Occult Malignancy in Gynecologic Surgery and ACOG’s Committee Opinion on Choosing the Route of Hysterectomy for Benign Disease.
The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 58,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org