Safety issues with laparoscopic uterine/fibroid procedure

Today, FDA issued a safety communication discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women.  This type of procedure poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, a type of uterine cancer.

Laparoscopic power morcellation is one of several available treatments for fibroids.  It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces so it can be removed through a small incision in the abdomen.  Prior to treatment, there is no reliable method for identifying whether a woman may have an unsuspected uterine sarcoma instead of, or in addition to, fibroids.  Published studies suggest that morcellation of an unsuspected uterine sarcoma increases the risk of cancer spread.

Most women will develop uterine fibroids at some point in their lives, and, while most uterine fibroids do not cause problems for women who have them, they can cause symptoms such as heavy or prolonged menstrual bleeding and pain, requiring medical or surgical therapy.

The FDA’s primary concern as it considers the continued use of these devices is the safety and well-being of patients, and will continue looking into this issue by convening a panel of outside experts at a public meeting to discuss the clinical role of laparoscopic power morcellation in these treatments, surgical techniques, and labeling related to these devices. Information on this meeting will be posted as soon as it becomes available.

In today’s safety communication, the FDA made specific recommendations on this topic for health care providers and women.

If you have questions about this communication, please contact the Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.