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Morcellator Lawsuit News: Bernstein Liebhard LLP Notes Disagreement Among FDA Panel Members Regarding Power Morcellator Ban
Date:7/14/2014

0eS9hbGVydHNhbmRub3RpY2VzL3VjbTM5MzU3Ni5odG0=" class="trackingLink" rel="nofollow" trackingLink="http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm" >FDA issued an alert discouraging doctors from performing uterine morcellation because of the risk that the devices can spread undetected uterine cancer cells into a woman’s peritoneal cavity. According to the agency, this results in an upstaging of the cancer and greatly reduces a patient’s chances of long-term survival. A review conducted by the FDA suggested that 1 in 350 women with uterine fibroids actually has undetected uterine sarcoma cells within that tissue.

The FDA’s Obstetrics and Gynecology Devices Panel took up the question of uterine morcellation during a two-day meeting convened on July 10th and 11th. According to the Boston Globe, the panelists heard emotional testimony from more than a dozen women and family members of those who died from cancers after undergoing morcellation. Many revealed that their doctors had never told them that such procedures had the potential to spread undetected cancers. After hearing their testimony, several of the 15 panelists called for a ban on the use of power morcellators, but others asserted the devices should remain on the market because they could still benefit certain women.

In the end, the advisors did agree that women should be fully informed of the safety issues associated with power morcellators, and sign a consent form indicating that they understand these risks.

According to the Associated Press, they also agreed that there was no evidence that the use of a containment bag to catch tissue would mitigate this danger.**

The Associated Press report noted that the FDA had not said when it might make a final decision on the status of power morcellators. While the agency is not required to follow recommendations put forth by its advisory panels, it usually does so.

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