Selasa 25 Nov 2014 05:21 WIB

FDA: Doctors should not use laparoscopic power morcellators

Red: Yeyen Rostiyani
Female reproductive system (illustration)
Foto: en.wikipedia.org
Female reproductive system (illustration)

REPUBLIKA.CO.ID, TRENTON -- US regulators on Monday 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 updated its April safety warning, 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 said there are safer options for the procedures for most patients. But he said the device may be appropriate for a small number of women who need to have fibroids removed, but want to protect their uterus in case they decide to have a baby in the future. Fibroids are benign, but sometimes painful, tumors in the wall of the uterus.

Maisel said the FDA is recommending that makers of laparoscopic power morcellators immediately include in the detailed product guide new safety information: a boxed warning on the risks and two contraindications on when the devices should never be used, which would cover most patient cases.