WASHINGTON (AP) — U.S. regulators have strengthened their warning against use of a once-popular device for gynecologic surgery that can spread unsuspected cancer, saying its risk is only justified in a fraction of patients.
The Food and Drug Administration is updating its April safety warning, now saying doctors should not use the devices, called laparoscopic power morcellators, for performing a hysterectomy or removing uterine fibroids "in the vast majority of women."
The FDA's Dr. William Maisel says there are safer options for the procedures for most patients — but he said the device may be appropriate for some women.
One manufacturer, Johnson & Johnson, directed surgeons to stop using its device for the procedures in April, when concerns about inadvertently spreading cancer inside women's abdomens first arose. It's now conducting a worldwide recall.