Power morcellators are among the devices approved via the FDA’s 510(k) program. Unfortunately, thousands of women underwent morcellator hysterectomies before their safety issues became apparent.
New York, New York (PRWEB) October 02, 2014
As the controversy over power morcellators (http://www.morcellatorlawsuit2015.com/)
continues to grow, Bernstein Liebhard LLP notes that a new study is raising questions about the way medical devices are regulated in the U.S. According to The Philadelphia Inquirer, the study focused on the U.S. Food & Drug Administration’s (FDA) 510(k) clearance program, which allows new devices to come to market without human testing, so long as a manufacturer submits scientific evidence that the product is equivalent to a “predicate” product already on the market. But a review of the FDA’s database found that of 50 devices recently cleared through the 510(k) program, only eight were backed by scientific evidence that they are equivalent to a “predicate” product already on the market.*
Dr. Hooman Noorchashm, a cardiac surgeon who has been pushing the FDA to impose a power morcellator ban for the past year, was not surprised by the findings, and told the Philadelphia Inquirer that he believes the agency is more concerned with bringing innovative product to market than it is with patient safety.
“Power morcellators are among the devices approved via the FDA’s 510(k) program. Unfortunately, thousands of women underwent morcellator hysterectomies before their safety issues became apparent,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now evaluating potential legal claims on behalf of women who may have experienced the spread of undiagnosed cancers due to uterine morcellation.
Power Morcellators and Cancer
Power morcellators are used in laparoscopic hysterectomies and fibroid removals to shred uterine tissue so that it can be easily removed through a small incision in the abdomen. In April, the FDA warned that use of the devices in these types of procedures could disseminate undetected cancer cells outside of the uterus, resulting in the upstaging of the disease and greatly reducing a patient's chance of long-term survival. According to the agency, roughly 1 in 350 women with fibroids has uterine sarcoma cells within that tissue.
In July, the FDA’s Obstetrics and Gynecology Devices Panel met for two days to discuss the risks associated with power morcellators. But according to the Philadelphia Inquirer, the agency has yet to take any other action.
Just weeks after the meeting, Johnson & Johnson’s Ethicon, Inc. unit announced that it was withdrawing three morcellators from the market because of the concerns surrounding their safety.** The Philadelphia Inquirer also noted that the devices have been abandoned by many doctors, as well as some insurers.
Women who were diagnosed with advanced uterine cancer following a hysterectomy or fibroid removal that involved a power morcellator may be entitled to compensation from the manufacturer of the device used in their surgery. To learn more about the risks associated with uterine morcellation, please visit Bernstein Liebhard LLP’s website. To obtain a free legal review, please call 800-511-5092.
*redding.com/news/wire-news/two-more-studies-say-fda-is-bad-at-regulating-medical-devices, Philadelphia Inquirer, October 1, 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