FDA Warns about Uterine Morcellation, May Cause Spread of Cancerous Tissues

The U.S Food and Drug Administration (FDA) released a safety warning on the use of laparoscopic power morcellation during uterine procedures. This is backed up by earlier studies linking the procedure to potential spread of cancerous tissues.

Laparoscopic power morcellation is a surgical procedure that uses a morcellator to remove large masses of tissues, or uterine fibroids, in the walls of the uterus.

According to the Centers for Disease Control and Prevention (CDC), uterine fibroids are the most common noncancerous tumors in women. Experts have not yet determined its cause, but they have observed that it is common in African-American and overweight women. Doctors often recommend hysterectomy (removal of the uterus) or myomectomy (removal of the fibroids) depending on the severity of the tumors.

However, the federal agency issued a warning against these procedures because of the results of their data analysis. The researchers found that less than one percent of the women who underwent these procedures have malignant tumors, or uterine sarcoma, on their uterus. They worried that morcellation may spread the cancer tissue to other parts of the reproductive system such as the abdomen and pelvis; thus making the condition of the patient worse.

"The FDA's primary concern as we consider the continued use of these devices is the safety and well-being of patients," said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in a press release. "There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals."

On the other hand, the FDA is not prohibiting doctors in performing laparoscopic power morcellation. However, they recommend that doctors should explain the risk and provide other treatment options to the patients.

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