New York, New York (PRWEB) July 09, 2014
As the Firm continues to evaluate morcellator lawsuits (http://www.morcellatorlawsuit2015.com/) on behalf of women who allegedly experienced the spread of uterine cancers due to the use of power morcellators in gynecological surgeries, Bernstein Liebhard LLP notes that the U.S. Food & Drug Administration (FDA) has issued a new report detailing the risks associated with uterine morcellation. The report notes that those risks include the spread of unsuspected malignant uterine tissue to places outside the uterus, as well as injury to local tissue and organs. *
“Our Firm is investigating a number of legal claims on behalf of women whose uterine cancers were allegedly spread by power morcellators. This report provides an excellent overview of the safety concerns surrounding these devices,” 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.
Power Morcellators and Cancer
Power morcellators are used during laparoscopic hysterectomies and fibroid removals to shred tissue so that it can be removed via a small incision in the uterus. In April, the FDA issued an alert discouraging doctors from using the devices in minimally invasive gynecological surgeries due to the potential that they can spread undetected uterine cancer cells into the pelvis and abdominal cavity. This can result in an upstaging of the cancer, and greatly reduces a woman’s chances for long-term survival. According to the FDA, about 1 in 350 women undergoing fibroid removal has undetected cancer cells in their fibroids.
According to the FDA’s report, power morcellators currently on the market were cleared for sale via the agency’s 510(k) program, which does not require clinical trials if it is shown that a device is substantially equivalent to a product already on the market. The report notes that the risk of tumor spread was not identified during pre-market reviews for power morcellators. As a result, “no risk-reducing measures were required for pre-market clearance.”
The FDA’s report was issued in advance of a two-day meeting of the agency’s Obstetrics and Gynecology Devices Panel that is scheduled to begin tomorrow. According to the document, the panel will be asked to make recommendations on ways to mitigate the risks associated with power morcellators, including possible modifications to their designs, or changes to their labelling and directions for use.
Women who allegedly experienced the spread of uterine sarcoma or other cancer due to power morcellation may be entitled to compensation for their injury related damages, including medical bills, lost wages, emotional distress, and pain and suffering. To learn more about filing a hysterectomy cancer lawsuit, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092.
*fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/obstetricsandgynecologydevices/ucm404148.pdf, FDA, July 8, 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