New York, New York (PRWEB) August 09, 2014
As concerns over the health risks associated with power morcellators (http://www.injurybeacon.com/power-morcellator/) continue to grow, Bernstein Liebhard LLP notes the publication of a new study suggesting that the use of inflated containment bags might mitigate the risk that uterine morcellation will result in the spread of undiagnosed cancers. Writing in Obstetrics & Gynecology, doctors from Massachusetts General Hospital looked at uterine morcellations performed at four institutions in Minnesota, Maryland and Massachusetts. Surgeons performing the procedures utilized the technique for off-label use of an inflated containment bag that was developed by of the study authors.*
The surgeons reported that the procedure was “successful in all cases,” and that visual inspection suggested no spread of tissue beyond the isolation bag and no evidence of additional punctures to the bag during the procedure. However, the authors of the report acknowledge that they were unable to confirm if the procedure could result in tiny punctures in the bag or could spread microscopic cells beyond the bag.
“Our Firm has heard from numerous women who allegedly experienced the spread of uterine cancers due to power morcellators. While these findings are interesting, it should be noted that federal regulators have not endorsed any sort of containment bag system for use in uterine morcellation,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now evaluating potential legal claims on behalf of women who may have experienced the spread of undiagnosed cancers due to uterine morcellation.
Uterine Morcellation and Cancer
In April, the 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 more about the risks potentially associated with power morcellators, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092.
*journals.lww.com/greenjournal/Abstract/publishahead/Contained_Power_Morcellation_Within_an_Insufflated.99365.aspx, Obstetrics & Gynecology, August 6, 2014
**bostonglobe.com/lifestyle/health-wellness/2014/07/11/agreement-reached-whether-fda-should-ban-hysterectomy-cutting-tool/EkXZaFAUUnT5HZ7DBQvWbM/story.html, Boston Globe, July 11, 2014
***ethicon.com/sites/default/files/managed-documents/Ethicon%20Morcellation%20Devices%20Customer%20Letter%20Final.pdf, Ethicon, Inc., July 30, 2014
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs’ Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP