Medical Malpractice

FDA Warns Against Power Morcellators

The US Food and Drug Administration (FDA) has issued a safety communication warning against the use of laparoscopic power morcellation for hysterectomy or myomectomy (uterine fibroid removal). Of concern are reports of the spread of unsuspected cancerous tissue—specifically, uterine sarcoma—during laparoscopic hysterectomy.

The FDA has warned that approximately 1 in 350 women who are undergoing power morcellation for benign fibroids in fact have an unsuspected type of cancer known as a uterine sarcoma. The use of laparoscopic power morcellation increases the risk that cancerous tissue within the uterus will be spread throughout the patient’s abdomen and pelvis, decreasing the patient’s chances of survival.

When the FDA issued its warning, it noted that women undergoing hysterectomy or myomectomy for uterine fibroids should not have surgery that involves the use of a power morcellator. There is currently no way to determine prior to surgery whether a patient’s fibroids are in fact cancerous. Meanwhile, there are other surgeries to perform successful hysterectomy or myomectomy for fibroids that do not share a risk of spreading cancer, though they may have longer recovery times.

Manufacturers of power morcellators have been requested by the FDA to update their warning to include two contraindications and a boxed warning on the product label.

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