ACOG Statement on FDA Regulation of Morcellation
December 8, 2015
Washington, DC — The following is a statement from Hal C. Lawrence, MD, executive vice president and chief executive officer of the American College of Obstetricians and Gynecologists (ACOG) regarding morcellation:
"The commentary published today in Obstetrics & Gynecology regarding the Food and Drug Administration (FDA) warning on power morcellation during laparoscopic myomectomy or hysterectomy represents a thorough review of data combined with the clinical experience of several dozen gynecologic surgeons.
"The conclusions of the paper's authors largely reflect positions that ACOG has reiterated during the ongoing discussion about potential safety concerns with morcellation as well as its value in facilitating minimally invasive gynecologic surgery.
"Without question, morcellation of an undiagnosed sarcoma can disseminate malignant tissue. However, by allowing some women to avoid the higher morbidity and mortality associated with open abdominal surgery, morcellation can also save lives.
"As a result of the continuing conversation about morcellation, obstetrician-gynecologists are better able to evaluate each individual woman's risk of an undiagnosed sarcoma, and to counsel her to receive the right approach for her own unique medical needs.
"Moreover, recent research has focused on improved screening for potential malignancies prior to surgery and on innovative new methods during surgery to further reduce risk of disseminating malignant tissue.
"For two years, we have thoroughly evaluated the use of morcellation as one tool in laparoscopic gynecologic surgery. We will continue ACOG's careful, thoughtful examination and to monitor additional research moving forward."
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