Morcellator Gets FDA’s Toughest Warning

November 28, 2014, 1:30PM. By Heidi Turner

Washington, DCThe US Food and Drug Administration (FDA) has given laparoscopic power morcellators the strongest warning possible, requiring the morcellators to have a black box warning concerning the risk of using power morcellators. The agency warned that most women should not undergo laparoscopic power morcellation hysterectomy because of the risk of spreading cancer.

According to information from the FDA (11/24/14), the black box warning alerts patients and medical professionals about the risk of spreading unsuspected cancer, which can decrease the patient’s survival chances. Meanwhile, two contraindications were also included on the label. Those contraindications include that the laparoscopic power morcellator should not be used in women who are peri- or post-menopausal or who could have the tissue removed in tact, and those women in which the tissue being morcellated is known or suspected to be cancerous.

“Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma,” the FDA noted. “If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

According to The Wall Street Journal (11/21/14), even before the FDA announcement, some doctors and hospitals had stopped using the morcellator. Since the announcement, HCA Holdings, a company that runs almost 300 hospitals and medical centers in the US and England, said it was banning morcellators in its facilities, Bloomberg (11/25/14) reports. In July 2014, the FDA convened an advisory panel to discuss concerns about the power morcellator.

Power morcellators are used as a minimally invasive procedure to remove fibroids. There is no issue with using the morcellators on benign fibroids, but benign fibroids are difficult to distinguish from uterine sarcoma (a cancer). Morcellators break up the tissue so it can be removed, but doing so can cause the tissue to spread through the abdomen. In the case of uterine sarcoma, which cannot be detected prior to surgery, the tissue that is being spread is cancerous, resulting in a spread of the cancer.

Although some hospitals have reportedly stopped using power morcellators, the FDA has not banned them. The FDA said there are still a few women who may experience benefits that outweigh the risks of using the morcellators, such as young women who want to maintain their ability to have children. In its statement, however, the FDA noted that there are other options for women with uterine fibroids, including traditional surgery, laparoscopic hysterectomy and myomectomy without morcellation.