Morcellator Lawsuit | Power Morcellator Lawsuits
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Women who undergo minimally-invasive hysterectomy or myomectomy (uterine fibroid removal) with a power morcellator should be aware that these surgical tools may spread and upstage any uterine cancer cells that lie undetected in the morcellated tissue. The U.S. Food & Drug Administration (FDA) has issued two morcellator warnings since April 2014, and currently advises against the use of uterine morcellation for the vast majority of women who require hysterectomy and myomectomy. Dozens of morcellator lawsuits have since been filed against the manufacturers of these devices by women who allegedly experienced the spread of undetected uterine sarcoma known as leiomyosarcoma and other cancers due to a power morcellator.
Southern Med Law Filed One Of The First Power Morcellator Lawsuits In The Country
Dr. François Blaudeau and his colleagues at Southern Med Law are currently representing women in power morcellator lawsuits, as well as their surviving family members. Dr. Blaudeau serves on the Plaintiffs’ Steering Committee in the federal morcellator litigation, and represented the plaintiff in the first morcellator cancer lawsuit case to reach a settlement. Few morcellator lawsuit attorneys understand the devastating toll power morcellator side effects take on victims and their families as well as Dr. Blaudeau. He and the entire staff at Southern Med Law are dedicated to achieving justice for women who were harmed by these devices. If your life and the lives of your family were shattered by a power morcellator, please call Dr. Blaudeau for a FREE morcellator lawsuit legal review of your case.
What Are Power Morcellators?
Power morcellators are used to shred uterine tissue and fibroids during minimally-invasive hysterectomies and myomectomies. Medical device companies that have marketed these surgical tools include:
Ethicon / Johnson& Johnson Morcellators
- Gynecare Morcellex Morcellator
- Gynecare X Tract Morcellator
- Morcellex Sigma Morcellator
- Diva by FemRx Morcellator
Lumenis Ltd. Morcellators
- VersaCut+Tissue Morcellator
- PKS PlasmaSORD Morcellator
- VarioCarve Morcellator
Karl Storz GmbH Morcellators
- KSE Steiner Electromechanic Morcellator
Richard Wolf GmbH Morcellators
- Morce Power Plus Morcellator
Cook Urological Inc. Morcellators
- Cook Tissue Morcellator
Smith & Nephew Morcellators
- TRUCLEAR Morcellation System Morcellator
LiNA Medical Morcellators
- Xcise Morcellator
Blue Endo Morcellators
- MOREsolution Morcellator
FDA Morcellator Warnings
When tissue is cut into tiny pieces, as it is in morcellation, there is always a risk that undetected malignancies, such as uterine sarcoma or leiomyosarcoma cells, will be disseminated outside of the uterus, into the peritoneal cavity and beyond. Should this occur, the cancer will progress to a much more advanced and dangerous stage very quickly. Unfortunately, there really is no reliable way to test for hidden malignancies prior to uterine morcellation.
Since April 2014, the U.S. Food & Drug Administration (FDA) has issued two public safety alerts about the potential for power morcellators to spread and upstage uterine cancers. The first discouraged doctors from using the devices due to this risk. At the time, the FDA estimated that 1 in 350 women with uterine fibroids actually has uterine sarcoma, while 1 in 498 has leiomyosarcoma. These numbers are significantly higher than what was previously understood.
The FDA’s second alert strongly warned doctors against the use of power morcellators in most women who require uterine surgeries. Those most at risk for these cancers include:
- Women over the age of 60
- Women of African-American heritage
- Women who have undergone long-term treatment with tamoxifen for breast cancer
- Women who have undergone pelvic irradiation
- Women with a history of childhood retinoblastoma
The FDA now requires morcellator manufacturers to include a black box warning on their product labels. According to the agency, morcellation is contraindicated in women:
- Who are peri- or post-menopausal
- Are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision
- Whose tissue is known or suspected to contain malignancy
Power Morcellator Lawsuit Litigation
In July 2015, Dr. Blaudeau was able to reach a morcellator settlement on behalf of a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013. The settlement was the first in the nation to involve power morcellators and their potential to spread uterine cancers. The power morcellator lawsuit case, which was filed in the U.S. District Court, Eastern District of Pennsylvania, named LiNA Medical APS, Kebomed AG and LiNA Medical as defendants. Scott Burkart stated in this power morcellator lawsuit that there was no evidence of disseminated cancer in his 53-year-old wife, Donna Burkhart, prior to having a robot-assisted hysterectomy in March 6, 2012. She was diagnosed with the aggressive uterine cancer just nine days after her surgery. (No. 5:14-cv-1557).
In October 2015, more than two dozen federally-filed morcellator lawsuits filed against Ethicon, Inc. were centralized in the U.S. District Court, District of Kansas, in order to allow these and any future cases to undergo coordinated pretrial proceedings. In November, Dr. Blaudeau was appointed to the power morcellator litigation’s Plaintiffs’ Steering Committee. As a member of this Committee, Dr. Blaudeau will continue to play a key role in the prosecution of morcellator cases as the federal litigation moves forward.
Legal Help for Those Harmed by Power Morcellators And Filing A Power Morcellator Lawsuit
Even before the FDA issued its warnings, Dr. Blaudeau and Southern Med Law were fighting for justice on behalf of morcellator lawsuit plaintiffs. If you or a woman you care about were diagnosed with advanced uterine cancer following morcellation, Southern Med Law is ready to help you and your family find justice. Please call at 1-205-547-5525 for a FREE power morcellator lawsuit legal review and the expert and compassionate legal advice you truly need.