Our Firm has heard from numerous women who allegedly experienced the spread of undiagnosed uterine cancers due to power morcellators.
New York, New York (PRWEB) November 25, 2014
Federal regulators have issued a new warning against the use of power morcellators (http://www.morcellatorlawsuit2015.com) in gynecological surgeries, in light of their potential to spread and upstage undiagnosed uterine cancers, Bernstein Liebhard LLP reports. According to a safety communication issued by the U.S. Food & Drug Administration (FDA) on November 24th, the agency is warning against the use of uterine morcellation in the vast majority of women. The FDA has also asked the manufacturers of power morcellators to add a new black box warning – the agency’s strongest safety alert – to their product’s labels regarding their risks.
Among other things, the FDA said the new boxed warning should caution against the use of power morcellators in women who are entering menopause, as well as those who have already been through menopause. The new warning should also advise against such procedures for women who are good candidates for intact removal of the uterus, either through the vagina or via a procedure known as a mini-laparotomy. These new contraindications would apply to the vast majority of women who require a hysterectomy or fibroid removal surgery, the agency said.
“Our Firm has heard from numerous women who allegedly experienced the spread of undiagnosed uterine cancers due to power morcellators. We are pleased that the FDA has decided to take significant steps to mitigate the potentially life-threatening risks associated with these devices,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancers following uterine morcellation.
Power Morcellators and Cancer
Power morcellators are used in laparoscopic hysterectomy and fibroid removal procedures to shred tissue so that it may be removed via a small abdominal incision. The FDA has been investigating the association between morcellators and cancer since April, when the agency first issued an alert discouraging doctors from using the devices in gynecological surgeries. According to the FDA, dissemination of undetected uterine cancer cells during morcellation can upstage the disease and greatly reduce a woman’s chances of long-term survival.*
In yesterday’s safety communication, the FDA noted that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or fibroid removal surgery is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. Both of these estimates are higher than the clinical community previously understood.
In July, 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 a number of cancer victims and their families who urged the agency to ban power morcellators.** U.S. Senators Kirsten Gillibrand and Charles Schumer, both Democrats from New York, have also urged the agency to ban the devices.***
Just weeks after the FDA convened its advisory panel meeting, Johnson & Johnson’s Ethicon Inc. unit did announce a withdrawal of its Gynecare Morcellex, Gynecare X-Tract and Morcellex Sigma morcellator from the market.****
Women who allegedly experienced the spread of uterine sarcoma or other cancers due to a power morcellator may be able to take legal action against the manufacturer of the 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.
*fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm, FDA, April 17, 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
***democratandchronicle.com/story/news/2014/10/09/power-morcellation-fibroid-gillibrand-schumer/16975935/, Rochester Democrat and Chronicle, October 10, 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