New York, New York (PRWEB) July 14, 2014
As the Firm continues to evaluate morcellator lawsuits (http://www.gynecaremorcellatorlawsuit.com/) on behalf of women who were allegedly harmed by uterine morcellation, Bernstein Liebhard LLP notes that a U.S. Food & Drug Administration (FDA) advisory panel tasked with making recommendations on mitigating the cancer risks associated with power morcellators was unable to reach a consensus on whether or not the devices should be banned. However, according to a report from The Boston Globe, the members of the agency’s Obstetrics and Gynecology Devices Panel did conclude that there was no way physicians could entirely eliminate the danger that uterine morcellation would spread and upstage undetected uterine sarcomas and other cancers in women undergoing the procedures.*
“Our Firm monitored this meeting very closely, as we have heard from a number of women whose cancers were allegedly spread by power morcellators. We are pleased that the panelists acknowledged the serious health issues associated with these devices, and await further action by the FDA,” 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 cancers due to uterine morcellation.
Morcellator Cancer Risk
Power morcellators are surgical tools used during laparoscopic hysterectomies and other minimally-invasive gynecological procedures to cut up tissue so that it can be removed from the body via a small abdominal incision. In April, the 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.
Women who allegedly experienced the spread of uterine cancers due to power morcellation may be entitled to file a morcellator lawsuit 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.
*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
**hosted.ap.org/dynamic/stories/U/US_FIBROID_TREATMENT_CANCER?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT, Associated Press, July 11, 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