We hope the FDA will take the points raised by Senators Schumer and Gillibrand into account as it continues to review the potential risks associated with power morcellators.
New York, New York (PRWEB) August 20, 2014
As concerns regarding the health risks potentially associated with the use of power morcellators (http://www.injurybeacon.com/power-morcellator/) in gynecological surgery continue to grow, Bernstein Liebhard LLP notes that two U.S. Senators from New York are urging the U.S. Food & Drug Administration (FDA) to seek a recall of the devices. In a letter dated August 19th, Sens. Kirsten Gillibrand and Charles Schumer, both Democrats, also implored the agency to seriously consider the testimony given during the FDA’s July hearing by individuals who had lost a loved one to cancer following uterine morcellation, as it prepares to make a final determination regarding the use of the surgical tools.*
“To our knowledge, this is the first time any lawmakers have weighed in on the controversy surrounding uterine morcellation. We hope the FDA will take the points raised by Senators Schumer and Gillibrand into account as it continues to review the potential risks associated with power morcellators,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now evaluating morcellator lawsuits on behalf of women who may have experienced the spread of undiagnosed uterine sarcoma and other cancers due to uterine morcellation.
Uterine Morcellation and Cancer
Power morcellators are used in laparoscopic hysterectomies and fibroid removals to shred tissue so that it can be easily removed through a small incision in the abdomen. In April, the U.S. Food & Drug Administration (FDA) warned that use of the devices in gynecological procedures could spread undetected uterine cancer cells throughout a woman’s body. According to the agency, roughly 1 in 350 women with fibroids has uterine sarcoma cells within that tissue. Current screening methods do not always detect these malignancies prior to surgery, and dissemination of cancer cells outside of a woman’s uterus via a power morcellator can result in the upstaging of the disease, greatly reducing a patient’s chances of long-term survival.
In July, as part of its ongoing review of uterine morcellation, the FDA convened a meeting of outside advisors to discuss the procedure’s risks and benefits. During the proceeding, the panel members heard emotional testimony from a number of cancer patients and their loved ones, many of whom urged the FDA to ban power morcellators.**
Shortly after the meeting, Johnson & Johnson’s Ethicon, Inc. unit issued a morcellator recall for three devices because of the uncertainty surrounding their safety.*** Highmark, Inc., one of the nation’s largest Blue Cross and Blue Shield insurers, also announced that it would no longer cover uterine morcellation.****
Women who allegedly experienced the spread of uterine sarcomas and other cancers due to power morcellation may be entitled to take legal action against the manufacturer of the device used in their surgery. 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.
*democratandchronicle.com/story/news/2014/08/19/schumer-gillibrand-back-greece-mans-crusade/14304213/, Democrat and Chronicle, August 19, 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
****in.reuters.com/article/2014/08/02/highmark-procedure-idINL2N0Q80IY20140802, Reuters, August 3, 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