FDA Reaffirms Advice Against Use of Morcellators for Fibroids

Megan Brooks

December 14, 2017

The latest information continues to indicate that women with occult cancers who receive laparoscopic power morcellation have higher rates of cancer recurrence and worse outcomes relative to those whose cancer is treated with manual morcellation or without any morcellation, the US Food and Drug Administration (FDA) said today in a white paper

"Since the FDA first issued warnings about the risk of spreading unsuspected uterine cancer from the use of laparoscopic power morcellators, we have continued to review new research to ensure our recommendations reflect the most current scientific evidence. Our latest analysis found a similar incidence of these hidden cancers to our estimate three years ago," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in statement.

"We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety," said Dr Shuren.

The updated review of recent studies suggests that about 1 in 225 to 1 in 580 women who undergo hysterectomy or myomectomy for presumed benign uterine fibroids may have occult uterine sarcoma, the FDA said. This is generally in line with the 1 in 350 incidence estimated by the FDA in a 2014 review.

The FDA also estimates the rate of occult leiomyosarcoma to be roughly 1 in 495 to 1 in 1100, again in line with their previous assessment of 1 in 498.

In addition to summarizing the latest data on this topic, the FDA's white paper provides an update on medical device reports the agency received through April 2017 related to the use of laparoscopic power morcellators and how hysterectomy and myomectomy procedure selection has changed since the FDA's 2014 warning against the routine use of morcellators to treat suspected uterine fibroids.

Overall, the data demonstrate that use of laparoscopic power morcellators has decreased since the FDA warned about it in 2014, the agency reports.

The FDA continues to monitor and evaluate the risks and benefits of laparoscopic power morcellation, and the agency's recommendations for patients and healthcare providers remain unchanged.  

"The FDA continues to believe the use of power morcellators to remove uterine fibroids should be limited to a small number of women, typically young women who wish to bear children and otherwise could not without use of a morcellator, and who choose this option after being informed of the risks," they advise.

"The FDA encourages patients, health care providers and manufacturers to continue to report events associated with laparoscopic power morcellators to the agency; such information is critical in the agency's ongoing evaluation of the risks and benefits of these devices," they said.

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