FDA Advisers Call for Black-Box Warning or All-Out Ban on Morcellators in Fibroid Removal — Physician’s First Watch
FDA Advisers Call for Black-Box Warning or All-Out Ban on Morcellators in Fibroid Removal
By Amy Orciari Herman
Power morcellators — used laparoscopically to cut uterine fibroids into smaller pieces for easier removal — should receive a black-box warning because of their risk for spreading previously undetected uterine sarcoma, said some members of an FDA advisory panel on Friday. Other members called for an outright ban on the devices.
The panel agreed that there's no evidence that using containment bags with morcellators can lower the risk for cancer spread, the Wall Street Journal reports. In addition, there's no definitive way for physicians to distinguish between a benign fibroid and a malignant tumor before performing the procedure. One panelist, however, argued that morcellation could be useful for women who want to maintain their fertility.
In April, the FDA warned that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids has unsuspected uterine sarcoma, which, in turn, could spread during morcellation.
It's not known when the agency will make a final decision about the devices, the WSJ reports.