Power Morcellator Recall: FDA Not Prepared to Issue Morcellator Recall at This Time, Bernstein Liebhard LLP Reports

Share Article

The Firm is evaluating potential morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine sarcoma and other cancers due to the use of power morcellators in laparoscopic hysterectomy and fibroid removal.

Free Case Review
Since the FDA first warned the public about the potential for power morcellators to spread undiagnosed uterine cancers, our Firm has heard from numerous women who were allegedly harmed by the devices. We also hope for swift action from the agency.

Federal health regulators investigating the potential link between the use of power morcellators (http://www.injurybeacon.com/power-morcellator/) and the spread of undiagnosed uterine sarcoma and other cancers are not ready to take further action on the matter, Bernstein Liebhard LLP reports. In a letter to U.S. Senator Kirsten Gillibrand (D-NY), the U.S. Food & Drug Administration (FDA) said that while it continues to discourage the use of the devices in laparoscopic hysterectomy and fibroid removal surgeries, for the time being it will only continue its internal analysis and review, and will issue a public communication if it decides to take further steps in regard to the matter.*

According to a report from The Rochester Democrat and Chronicle, the FDA was writing in response to a letter sent to the agency by Senator Gillibrand and co-signed by Senator Charles Schumer (D-NY) that asked the FDA to seek a voluntary morcellator recall. The Senators were the first to weigh in on the controversy surrounding uterine morcellation. Since then, U.S. Senator Robert Casey (D-PA) has also written the FDA asking that it act swiftly on the issue.**

“Since the FDA first warned the public about the potential for power morcellators to spread undiagnosed uterine cancers, our Firm has heard from numerous women who were allegedly harmed by the devices. We also hope for swift action from the agency,” 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 in laparoscopic hysterectomies and fibroid removals to shred 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 gynecological procedures could spread undetected uterine cancer cells throughout a woman’s body. According to the agency, roughly 1 in 350 women with fibroids has uterine sarcoma cells within that tissue. Current screening methods do not always detect these malignancies prior to surgery, and dissemination of cancer cells outside of a woman’s uterus via a power morcellator can result in the upstaging of the disease, greatly reducing a patient’s chances of long-term survival.

In July, Johnson & Johnson’s Ethicon, Inc. unit did withdraw three of its morcellators from the market because of the uncertainty surrounding their safety.*** The move came just weeks after the FDA convened an advisory panel meeting to address the issue, at which time a number of cancer patients and their loved ones urged the agency to ban the devices. ****

Women who allegedly experienced the spread of uterine sarcomas and other cancers due to power morcellation may be entitled to take legal action against the manufacturer of the device used in their surgery. 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.

*democratandchronicle.com/story/news/2014/10/09/power-morcellation-fibroid-gillibrand-schumer/16975935/, Rochester Democrat and Chronicle, October 10, 2014
**roc.democratandchronicle.com/assets/pdf/A22230361010.PDF, U.S. Senator Robert Casey, October 6, 2014
***ethicon.com/sites/default/files/managed-documents/Ethicon%20Morcellation%20Devices%20Customer%20Letter%20Final.pdf, Ethicon, Inc., July 30, 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

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.

Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092

ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP
info(at)consumerinjurylawyers(dot)com
http://www.injurybeacon.com
https://plus.google.com/115936073311125306742?rel=author

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Felecia L. Stern
Follow us on
Visit website