The FDA has taken another step in the crusade against power morcellators, urging that they not be used in the "vast majority" of women, and advising manufacturers to include a black box warning with the devices.

In doing so, the agency is updating its April 2014 guidance, which "discouraged" using power morcellation for hysterectomies and myomectomies.

The black box warning would assert that "the use of laparoscopic power morcellators during fibroid surgery may spread [unsuspected] cancer and decrease the long-term survival of patients" and that "this information should be shared with patients when considering surgery with the use of these devices."

The FDA also recommends that manufacturers include 2 contraindications in product labeling: "Power morcellators should not be used" (1) to remove uterine tissue suspected of containing fibroids in patients who are peri- or post-menopausal, or [in] candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision; and (2) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

Based in part on hearings held this past summer, the FDA estimates that 1 in 350 women undergoing hysterectomy or myomectomy have unsuspected uterine sarcoma. However, others believe that the agency's estimates may be greatly overstated and that banning or discouraging power morcellation devices has the potential to do more harm than good.

Jim Burger