August 6, 2014 — An advisory panel to the U.S. Food and Drug Administration (FDA) is recommending that women who choose to undergo a hysterectomy or fibroid surgery using a power morcellator should sign a document proving that they were informed about the potential risk of cancer, according to ObGyn News.
The FDA’s Obstetrics and Gynecology Devices Advisory Committee met on July 11 for two days to discuss the devices. The speakers said they were aware of at least 130 cases in which women were diagnosed with uterine cancer after being treated with a morcellator.
Dr. Carol Brown, a gynecologic cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, warned:
“There should be some labeling or special controls” to ensure that women who are being considered for treatment with this device and their physicians “get the message that we do believe there is an increased risk.”
Some members of the advisory panel supported adding a “Black Box” to the label on power morcellators. The FDA will also consider re-classifying the devices as Class III (“high risk”), which means they must undergo rigorous safety testing and premarket approval before they can be sold.
Other panelists recommended strategies to help identify patients who might have undiagnosed cancer before they are treated with a morcellator. Currently, there is no reliable way to know whether a fibroid is cancerous until after tissue is removed from the body.
One way to reduce the risk of spreading cancer is by using a protective surgical bag. Unfortunately, these bags were rarely used because they were cumbersome and never designed for hysterectomies.
Earlier this year, the FDA warned that laparoscopic power morcellators should not be used in uterine surgery because they can potentially spread undiagnosed cancer.
Roughly 1 in 350 has uterine cancer and 1 in 500 has leiomyosarcoma. If a morcellator is used, it can potentially spread cancerous cells throughout a woman’s abdomen and pelvis, greatly worsening her chances of long-term survival once the cells grow into tumors.
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