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FDA continues to caution against use of power morcellators
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In an updated assessment, the FDA warned against the use of laparoscopic power morcellators for the majority of women undergoing myomectomy or hysterectomy for treatment of uterine fibroids.
As HemOnc Today previously reported, in 2014 the FDA released guidance cautioning against the use of morcellators in hysterectomies or myomectomies due to the potential that they can spread undetected uterine sarcomas.
This decision sparked controversy among the oncology community, and some oncologists thought the FDA overstated the risk. Johnson & Johnson, a leading manufacturer of the device, pulled their morcellator off the market, and several large health care institutions stopped performing the procedure.
The FDA’s Center for Devices and Radiological Health conducted an updated review to assess the risks of power morcellators in light of new data.
In a review of 23 studies published since the 2014 guidance was released, the FDA estimated risks of 0.328% (95% CI, 0.303-0.352) for uterine sarcoma and 0.175% (95% CI, 0.148-0.202) for leiomyosarcoma for women who underwent myomectomy or hysterectomy for presumed fibroids. For women aged older than 60 years, risk rates for sarcoma ranged from 2% to 3%.
Overall, fixed effects models showed an estimated one in 305 women treated for uterine fibroids have any hidden uterine sarcoma, and one in 570 women have unknown leiomyosarcoma.
These numbers are consistent with those cited by the FDA in 2014.
The FDA also reviewed 12 studies that assessed the impact of power morcellation on OS and DFS. Overall, the studies showed increased risk for disease recurrence and mortality among women who underwent power morcellation compared with no morcellation.
The FDA also found that use of laparoscopic power morcellators decreased after the 2014 guidance, according to review of two studies and electronic health care data.
Limitations of this updated review included reliance on retrospectively collected data, heterogenous studies and small sample sizes in some studies.
“While minimally invasive surgery conveys several significant advantages over open surgery for women with fibroids, the use of [laparoscopic power morcellators] during these surgeries poses a risk due to the potential presence of unsuspected sarcoma in this population. FDA continues to caution against the use of [laparoscopic power morcellators] in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids,” the FDA wrote in updated assessment.
The FDA continues to recommend that the advantages and risks of power morcellators be discussed with patients.