We commend Sens. Gillibrand and Warren for their continued efforts in this matter, and hope that the FDA takes their letter into account as it continues its review of uterine morcellation.
New York, New York (PRWEB) November 19, 2014
The controversy surrounding power morcellators (http://www.morcellatorlawsuit2015.com) shows no signs of abating, as Bernstein Liebhard LLP notes that two U.S. Senators are once again asking the Food & Drug Administration (FDA) to act quickly to mitigate the cancer risks associated with the devices. In a letter dated November 18th, Sens. Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) write that they remain concerned “that women around the country are not receiving clear information about the potential risks associated with morcellating undetected malignancies during laparoscopic procedures." *
Among other things, the letter notes that both Senators have met with constituents who have been impacted by the spread of gynecological cancers via uterine morcellation, and implores the FDA to consider the voices of these women and their families as it prepares to address this issue. Finally, the Senators ask the agency to provide them with information regarding the methods it is using to gather data on the injuries and deaths that may be associated with power morcellators.
“It has been more than six months since the FDA issued an alert discouraging doctors from using power morcellators in uterine surgeries. We commend Sens. Gillibrand and Warren for their continued efforts in this matter, and hope that the FDA takes their letter into account as it continues its review of uterine morcellation,” 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.
This is not the first time Sens. Gillibrand and Warren have confronted the FDA on the issue of uterine morcellation. In August, Sen. Gillibrand, along with Sen. Charles Schumer (D-NY), wrote to the FDA asking that it ask morcellator manufacturers to pull the devices from the market.** As the November 18th letter notes, Sen. Warren submitted questions on the matter to the FDA in March.
Court records indicate that a growing number of morcellator cancer lawsuits have been filed in U.S. courts on behalf of women who allegedly experienced the spread of uterine cancers due to the devices. Just last month, one such case was filed in the U.S. District Court for the Eastern District of California on behalf of a woman who allegedly developed seven cancerous tumors in her abdomen after undergoing uterine morcellation to remove fibroids. (Nielsen, et ux. v. Gyrus Acmi LLC, No. 2:14-2375)
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.
*https://dl.dropboxusercontent.com/u/109043810/Warren%3AGillibrand_FDA.pdf, Sens. Gillibrand and Warren, November 18, 2014
**democratandchronicle.com/story/news/2014/08/19/schumer-gillibrand-back-greece-mans-crusade/14304213/, Democrat and Chronicle, August 19, 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