Pharmaceutical

FDA still to decide whether to ban power morcellators for hysterectomy, fibroid removal

morcellator FDA still to decide whether to ban power morcellators for hysterectomy, fibroid removalThe Food and Drug Administration (FDA) has yet to announce whether it will ban power morcellators, a surgical tool used to grind away and remove uterine fibroids or entire uteruses, due to reports that the devices can cause previously undiagnosed uterine cancer to spread, lessening the odds of survival.

Meanwhile, doctors have begun to debate the value of power morcellation and whether it is worth the risk.

Power morcellation is typically used with a tube-shaped blade that minces and removes uterine fibroids or entire uteruses. The tools were introduced in the 1990s and quickly fell into favor for myomectomies (removal of fibroids) and hysterectomies because they were less invasive than traditional surgical methods, resulted in less scarring and required less recovery time than traditional surgery. About 50,0000 procedures using power morcellators are done each year.

In April, however, the FDA urged doctors to stop using the devices for fibroid removal and hysterectomies because of the risk of cancer spread. The agency said that about 1 in 350 women who undergo power morcellation procedures develop a type of uterine cancer known as uterine sarcoma. It is believed that in women with previously undiagnosed uterine cancer, power morcellation can cause cancer cells to spread throughout the abdomen, which can lesson the odds of survival.

The FDA said that there is no reliable method for predicting whether a woman’s fibroids are cancerous until they are removed, thus power morcellators should not be used to remove fibroids. Doctors who wish to continue to do so should be sure their patients are made aware of the risks before the procedure is performed, the agency said.

The FDA also recommended that doctors follow up with patients who have undergone power morcellation procedures even if their lab results came back normal and they are not showing any symptoms of uterine cancer. Women who have undergone power morcellation and have persistent or recurrent symptoms should see their doctors for further testing.

Symptoms of uterine cancer, also called uterine sarcoma, include abnormal bleeding, abnormal vaginal discharge, pelvic pain or lumps/masses in the pelvic region.

Source: Democrat & Chronicle