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FDA Warnings

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy

On April 17, 2014, the Food and Drug Administration (FDA) issued a safety communication concerning the use of power morellators during laparoscopic uterine hysterectomy and myomectomy.

The FDA warned as follows:

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids are found to have an unsuspected uterine sarcoma.

Read the Entire Communique

Updated Warning

On Nov. 24, 2014, the FDA undated its safety communication concerning the use of power morellators during laparoscopic uterine hysterectomy and myomectomy.

The FDA estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids are found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.

The FDA strongly warned on the risk of power morellators spreading unsuspected cancer, and the recommended that doctors share this information directly with their patients. The guidance strongly urges manufacturers to include this new information in their product labels.

There is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.

Read the Entire Communique

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