From the FDA.
“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,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “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.”
A new FDA review of recent medical studies suggests that approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (“fibroids”) may have “occult” or hidden uterine cancers known as sarcomas. This is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1100, again in general agreement with our previous assessment of 1 in 498. Ranges in incidence represent estimates based on differing statistical analyses of available study data.
Recent literature also continues to suggest that women with occult cancers who received laparoscopic power morcellation have higher rates of cancer recurrence and worse outcomes compared to women whose cancer was treated with manual morcellation or without any morcellation. The FDA acknowledges other organizations have different estimates, which are based on differing study methodologies and research questions.
In addition to summarizing the FDA’s evaluation of the latest data, the white paper issued today by the FDA also provides an update on medical device reports the FDA 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. This data demonstrates that overall, use of laparoscopic power morcellators has decreased since the FDA warned about it in 2014.
The FDA continues to monitor and evaluate the risks and benefits of laparoscopic power morcellation and the agency’s recommendations for patients and health care 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.
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.
Dec. 14, 2017