FDA Addresses Power Morcellator Cancer Threat

According to a Safety Alert released November 24, 2014, from the U.S. Food and Drug Administration (FDA), the use of laparoscopic power morcellators during hysterectomy or myomectomy procedures is discouraged. There is a chance, when a power morcellator is used in the removal of uterine tissue or fibroids, that malignant cancer cells (sarcoma), which had been dormant, may be released and spread the cancer to other parts of the body. According the FDA’s report, the risk of this outcome is relatively high, since approximately 1 in 350 women who undergo a hysterectomy or myomectomy procedure involving a power morcellator will have “unsuspected uterine sarcoma”, which if spread, could be lethal.

This most recent Safety Report is an update on an earlier alert regarding power morcellators, originally released April 17, 2015, in which “The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients.”
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” continues the deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health William Maisel, M.D., M.P.H., so “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.”

The FDA Issues Guideline for New Warnings on Power Morcellators

Due to the issues urgent nature, the FDA has issued an Immediately In Effect (IIE) Guidance regarding the labeling of power morcellators. This guidance includes a boxed waning as well as two contraindications (an advisement against using the procedure on patients with higher risk factors).

As Dr. William Maisel commented in this most recent FDA Alert, “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

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The IIE guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecological indications.

Information on Power Morcellators

Laparoscopic power morcellators are medical devices that may be used during procedures to treat uterine fibroids, including hysterectomy (removal of the uterus) and myomectomy (removal of the fibroids). The devices work by dividing or fragmenting the excised tissue into small pieces for removal through the small incision sites created during a laparoscopic surgery.

One of the two most hazardous procedures power morcellators are used for is myomectomy, or fibroid removal. Uterine fibroids are benign tumors that originate in the uterus. Fibroids are fairly common, approx. 70%-80% of all women will have one before they turn 50. Usually symptomless, but in some cases cause severe pain and discomfort and will require treatment.
While myomectomy, a surgery involving a power morcellator is one treatment, but other treatments for fibroids include hormone-reducing medications, or steroids.
The agency also stated that at this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma, which could potentially be spread by a power morcellator procedure.

Contact The Weinberg Law Firm for a Free Power Morcellator Lawsuit Evaluation

The Weinberg Law Firm is currently investigating claims on behalf of women who may have been injured as the result of power morcellator use during a hysterectomy or myomectomy. We are ready to help you. For a free, nonobligatory power morcellator lawsuit evaluation please visit our page on Power Morcellator Lawsuit Help, or call us toll free at 877-934-6274.

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