As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Notes Growing Speculation Over FDA Plans to Address Morcellator Cancer Risks
New York, New York (PRWEB) November 13, 2014 -- As the controversy over the use of power morcellators (http://www.morcellatorlawsuit2015.com) in gynecological surgery continues to mount, Bernstein Liebhard LLP notes that a new report is suggesting that federal health regulators are considering taking a number of steps aimed at mitigating the cancer risks associated with uterine morcellation. According to a report from FierceMedicalDevices, those actions could include the institution of a “registry of outcomes" or a "probationary period” for the devices. It does not appear that the U.S. Food & Drug Administration (FDA) intends to impose a power morcellator ban at this time, despite growing calls for such action.*
“Our Firm continues to hear from women who allegedly experienced the spread and upstaging of uterine cancers following hysterectomies and fibroid removals that involved the use of a power morcellator. We will be monitoring the FDA’s actions in this matter very closely,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now evaluating potential 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
This past April, the U.S. Food & Drug Administration (FDA) publically discouraged doctors from using power morcellators in minimally-invasive gynecological surgeries, due to the risk that the devices can spread undetected cancer cells into a woman’s peritoneal cavity. At the time, the FDA estimated that 1 in 350 women with uterine fibroids actually have undetected uterine sarcoma cells within that tissue. According to the agency, screening for these cancers prior to surgery is difficult, and not always successful. Dissemination of any malignancy will greatly reduce a patient’s chances of long-term survival.
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. Sens. Kirsten Gillibrand and Charles Schumer, both of New York, have since written to the FDA urging it to ask all manufacturers of power morcellators to recall the devices.***
While a morcellator ban may not be imminent, Johnson & Johnson’s Ethicon Inc. unit did announce a withdrawal of its Gynecare Morcellex, Gynecare X-Tract and Morcellex Sigma morcellator products following the FDA’s July meeting. ****
Women who allegedly experienced the spread of uterine sarcoma or other cancer 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.
*fiercemedicaldevices.com/story/power-morcellation-ban-unlikely-other-fda-restrictions-coming-soon/2014-11-07, FierceMedicalDevices, November 7, 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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Bernstein Liebhard LLP
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Felecia L. Stern, Power Morcellator Lawsuit Information, http://www.morcellatorlawsuit2015.com, +1 800-511-5092, [email protected]
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