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As Power Morcellator Concerns Mount, Bernstein Liebhard LLP Notes New Study Advocating Use of Inflated Containment Bags in Uterine Morcellation
Date:8/9/2014

//www.prweb.net/Redirect.aspx?id=aHR0cDovL3d3dy5mZGEuZ292L21lZGljYWxkZXZpY2VzL3NhZmV0eS9hbGVydHNhbmRub3RpY2VzL3VjbTM5MzU3Ni5odG0=" onclick="linkClick(this.href)" rel="nofollow">U.S. Food & Drug Administration (FDA) issued an alert discouraging doctors from using power morcellators to shred tissue during minimally-invasive gynecological surgeries, due to the risk that the devices can spread undetected cancer cells into a woman’s peritoneal cavity. This can result in an upstaging of the cancer greatly reducing a patient’s chances of long-term survival. At the time, the FDA estimated that 1 in 350 women with uterine fibroids actually have undetected uterine sarcoma cells within that tissue.

Last month, the FDA’s Obstetrics and Gynecology Devices Panel met for two-days to discuss the risks associated with uterine morcellation. According to a report from The Boston Globe, the panelists heard emotional testimony from cancer victims and their families, many of whom said they were never told that a power morcellator had the potential to spread uterine cancers. The use of an inflated containment bag was also addressed during the meeting, with some advisors questioning whether inflating the bag would prevent a morcellator from cutting into it.**

In the wake of the FDA meeting, a power morcellator recall was announced by Johnson & Johnson’s Ethicon, Inc. unit. In a notice posted on its website, the company said it was pulling its Gynecare Morcellex, Gynecare X-Tract and Morcellex Sigma morcellator systems from the market because the risks and benefits associated with such devices remain uncertain.***

Women who were allegedly victims of cancer spread due to uterine morcellation may be entitled to file a morcellator lawsuit against the manufacturer of their device. To learn mor
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