We reached out to the American Congress of Obstetricians and Gynecologists and asked them the following question:
The FDA is discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. How do you respond to their recommendation?
In response the American Congress of Obstetricians and Gynecologists provided the following press release regarding a special report on the issue which they published, and a copy of recent remarks presented to the FDA during their advisory committee hearing on morcellation:
ACOG Releases Special Report on Power Morcellation and Occult Malignancy in Gynecologic Surgery Power Morcellation Remains an Option for Some Women; Informed Consent Critical May 9, 2014
Washington, DC — Today, the American College of Obstetricians and Gynecologists (ACOG) released a Special Report, “Power Morcellation and Occult Malignancy in Gynecologic Surgery.” The Special Report presents the findings and recommendations of a task force of obstetrician-gynecologists representing key areas of expertise including laparoscopic surgery, gynecologic oncology, and urogynecology. The task force reviewed and analyzed available scientific evidence on power morcellation and occult malignancy in gynecologic surgery.
Gynecologic power morcellation involves the use of a device to cut uterine or fibroid tissue into pieces, facilitating its removal through small incisions during minimally invasive surgery for the removal of the uterus (hysterectomy) or the removal of fibroids (myomectomy). Minimally invasive surgery can help reduce a patient’s overall operative risk; patients who undergo abdominal hysterectomy have three times the risk of dying than those who undergo laparoscopic hysterectomy.
In recent months, power morcellation in gynecologic surgery has come under scrutiny because of concern about the risk of spreading an undiagnosed uterine sarcoma – including leiomyosarcoma – which may worsen a patient’s outcome. Unfortunately, the risk of this is difficult to assess because of the rarity of uterine sarcomas, the sample size, and other reasons.
The Special Report’s findings include the following:
- Minimally invasive surgery, including gynecologic power morcellation, continues to be an option for some patients undergoing hysterectomy or myomectomy;
- In women with strongly suspected or known uterine cancer, power morcellation should not be used;
- Preoperative evaluation and diagnosis play an important role when power morcellation is being considered; and
- Patient counseling and the informed consent process also play an important role. Physicians and patients considering power morcellation as an option during gynecologic surgery should discuss the risks, benefits, and alternatives.
In the Special Report, ACOG also calls for:
- Further research into the development of reliable tools for preoperative diagnosis of uterine malignancies;
- Development of more effective and safer methods to reduce the risk of disseminating tissue during surgery;
- A continual focus on training, including techniques for morcellation, inspection for tissue fragments after morcellation is performed, and determination of when morcellation is considered an appropriate therapeutic options; and
- The establishment of a national prospective gynecologic power morcellation surgery registry to help acquire consistent and reliable data.
Addressing the release of the Special Report, Hal C. Lawrence, III, MD, Executive Vice President and CEO of ACOG, said, “Every day, ob-gyns across the country strive to provide the best care at the lowest risk to their patients. As the leading health care organization dedicated to the health of women, it is incumbent upon ACOG to ensure that gynecologic practice is guided by science, and in the best interest of all women.”
He added, “It’s critical that we not severely restrict treatment options for women who would benefit from minimally invasive gynecologic surgery while minimizing the risk for the small number of women who may have an occult or hidden cancer.”
Representatives from ACOG plan to take part in the FDA’s upcoming advisory committee meeting on the topic of power morcellation.
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.