There are many product liability lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.
There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices to grind up the uterus or remove the uterine fibroids, which is also known as myomectomy procedure. Accordingly, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014.
Power morcellators spread this cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors have stopped the use of power morcellators over the past year.
Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer, earlier this summer. J&J, acknowledged that the devices pose an unreasonable risk of disseminating uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
Morcellator Black Box Warning
The FDA announced November 24 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device. Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices.
Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Power Morcellator Cancer Litigation
Recently, complaints were filed in the federal court system, bringing the total to about twenty hysterectomy morcellator lawsuits filed nationally. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.
Romona and Randolph Gourdine filed a morcellator lawsuit in the U.S. District Court for the District of South Carolina against morcellator manufacturer Karl Storz.
Gourdine alleges that she underwent a laparoscopic supra-cervical hysterectomy involving the Rotocut morcellator in 2011, to remove a fibroid and her uterus. Then she found out that the fibroid was a leiomyosarcoma, an aggressive form of uterine cancer that is much more difficult to treat once it is spread outside the uterus.
Jennifer and Randall Sanders, filed a similar morcellator lawsuit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson and it’s Ethicon subsidiary.
Sanders underwent a hysterectomy with morcellation to remove uterine fibroids, fallopian tube and ovary in 2012, during which surgeons used an Ethicon Gynecare Tissue Morcellator. Sanders soon discovered that her fibroid contained cancer, which was spread during the morcellator surgery to advanced stage metastatic serous carcinoma. Sanders had to undergo several chemotherapy treatments.
Timothy Schroeder filed in the U.S. District Court for the Middle District of Tennsessee for wife, Cynthia, who died in December 2013. Cynthia underwent laparoscopic supra-cervical hysterectomy morcellator surgery in 2008, and an Ethicon Gynecare Morcellex was used to remove her uterus, fibroids and ovaries.
Cynthia Schroeder was diagnosed with the metastatic spread of leiomyosarcoma cancer in 2010. After three years of aggressive chemo therapy, she died of the metastatic cancer.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.