If you had a gynecological operation using a power morcellator and were later diagnosed with cancer, you could be entitled to compensation from the manufacturer. Contact Stern Law today to speak with one of our experienced medical device attorneys, who can help you understand your options.
What is a Power Morcellator?
A power morcellator is a surgical instrument, resembling a drill with a long wand on the end, used during gynecological operations, like hysterectomies, removal of uterine fibroids, and removal of other pelvic masses. Ordinarily, these procedures are performed through an invasive, open procedure. The morcellator was designed to facilitate laparoscopic removal of organs and tissue through a small incision in the abdomen.
At the end of the wand-like extension on the device is a grabber and a blade. The surgeon first dissects the tissue to be removed, then inserts the morcellation device through the small abdominal incision. The grabber retrieves the tissue and brings it into the blade, which essentially cuts the tissue into tiny pieces that travel back up through the wand and out of the body. This allows surgeons to remove large organs or tissue that would not otherwise fit through a small incision.
One of the most widely used morcellation devices is called the Gynecare Morcellex™. The Gynecare Morcellex™ is manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson, and is indicated for cutting, coring, and extracting tissue during operative laparoscopy, including general surgical procedures, urologic procedures, and gynecologic procedures.
Why are Morcellator Lawsuits Being Filed?
Power morcellators have frequently been used for removal of benign pelvic masses or to perform hysterectomies in women with no indications of cancer. During function of the device – grabbing and rapidly slicing tissue – some tissue (even microscopic tissue) is propelled away from the device, and some tissue is left behind. If then doctors discover the removed, morcellated tissue is in fact cancerous, they have potentially dispersed tissue throughout the body or left tissue inside the body that will grow and metastasize. This can lead to poorer prognoses for patients, including death.
Aware of this issue with its Morcellex™, Ethicon began suggesting use of a bag during the morcellation process when surgeons knew the pertinent tissue was or could possibly be cancerous. Surgeons were to dissect the tissue, insert a bag, place the tissue inside the bag, then morcellate the tissue, and remove the bag. However, Ethicon did not manufacture such a bag (rather, relying on surgeons to acquire one from another company), and the bag did not completely remedy the potential of leftover cancerous tissue. The bag also carried its own risks of complications, including death.
In 2014, the U.S. Food and Drug Administration (FDA) issued a statement warning patients and the medical community that data showed one in every 350 women undergoing hysterectomy or fibroid removal was found to have unsuspected uterine sarcoma. It went on to state that laparoscopic power morcellation carries a risk of spreading cancerous tissue within the pelvis, significantly worsening a patient’s long-term chances of survival.
The FDA warned against using morcellators for the majority of women undergoing pelvic mass removal or hysterectomy for treatment of fibroids. It further stated morcellation should be contraindicated in menopausal or post-menopausal patients and in all laparoscopic procedures in which any tissue to be removed was suspicious for cancer.
Power Morcellator Litigation Details
The majority of Morcellex™ cases were consolidated into one court in the U.S. District Court for the District of Kansas. This is referred to as a Multidistrict Litigation (MDL). This Court oversaw pretrial matters, including exchange of corporate documents and medical records between the parties.
In 2016, Ethicon moved to settle the cases pending in the MDL for a confidential amount. The MDL has been closed in the meantime, but the cases have not yet been fully resolved.
If you or a loved one underwent laparoscopic surgery using a morcellation device and received a subsequent cancer diagnosis, the time to act is now. You likely do not know the name of the exact device used during your procedure or who manufactured it, but the attorneys at Stern Law can investigate that information for you. When you sign with our firm, our legal team will immediately order your medical records from the day of your surgery, including a list of all surgical instruments used. From these records, we should be able to determine whether your surgeon used a Gynecare Morcellex™ device.
Contact Stern Law, PLLC
At Stern Law, we understand that your cancer diagnosis has been devastating, especially upon learning your surgical device potentially made it worse. We are committed to holding the manufacturer accountable and bringing you the justice you deserve. Contact Stern Law, PLLC, today for a free consultation concerning your claim by calling (844) 808-7529.