HCA’s announcement came just one day after the U.S. Food & Drug Administration confirmed the cancer risks associated with uterine morcellation.
New York, New York (PRWEB) November 29, 2014
Healthcare providers may be reassessing their use of power morcellators (http://www.morcellatorlawsuit2015.com ), in light of a new warning regarding the potential for the devices to spread and upstage undiagnosed uterine cancers cells when used in minimally-invasive gynecological surgeries, Bernstein Liebhard LLP reports. According to Reuters, HCA Holdings, Inc., the nation’s largest for-profit U.S. hospital operator, has announced that uterine morcellation will no longer be performed at any of its facilities, which include 160 hospitals and 115 surgical centers.*
“HCA’s announcement came just one day after the U.S. Food & Drug Administration confirmed the cancer risks associated with uterine morcellation. This decision is not surprising, as a number of other hospitals had already banned or placed limits on these procedures prior to the FDA’s most recent warning,” 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. On November 24th, the FDA issued an alert that warned against the use of the devices in most women who require these procedures, and asked power morcellator manufacturers to add a new black box warning – the strongest possible safety notice – regarding this life-threatening complication to their labels.
According to the agency, 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. A power morcellator can disseminate these cells beyond the uterus, upstaging the disease and greatly reducing a woman’s chances for long-term survival, the FDA said.
The FDA has been reviewing the association between uterine morcellation and cancer since April, when it first discouraged the use of the devices.** Since then, Johnson & Johnson’s Ethicon, Inc. unit announced a market withdrawal of its Gynecare Morcellex, Gynecare X-Tract and Morcellex Sigma morcellator from the market.*** The initial FDA alert also prompted a number of hospitals, including The Cleveland Clinic, Brigham and Women's Hospital in Boston and the Cleveland Clinic, to stop using the devices.****
Alleged victims of uterine sarcoma or other cancers allegedly spread via power morcellation may be entitled to compensation for their injury-related damages. To learn more about filing a morcellator lawsuit, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092.
*reuters.com/article/2014/11/25/us-hca-holdings-morcellation-idUSKCN0J92MZ20141125, Reuters, November 25, 2014
**fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm, FDA, April 17, 2014
***ethicon.com/sites/default/files/managed-documents/Ethicon%20Morcellation%20Devices%20Customer%20Letter%20Final.pdf, Ethicon, Inc., July 30, 2014
****cleveland.com/healthfit/index.ssf/2014/04/surgical_tool_for_hysterectomy.html, Cleveland Plain Dealer, April 28, 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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