Hysterectomy, Myomectomy performed with Power Morcellators
Hysterectomy and myomectomy (uterine fibroid removal) are common surgeries, and are generally considered low-risk with a predictable recovery and manageable side effects. However, recent studies and reports have highlighted the link between the use of a power morcellator and the subsequent development of cancer in hysterectomy and myomectomy patients – prompting a strong warning by the FDA against the use of these products.
As a result of this cancer link, power morcellator lawsuits have sprung up across the United States as a way for women to regain some of the financial loss associated with the medical and emotional expenses of aggressive cancer.
Hysterectomy and myomectomy
A hysterectomy is commonly prescribed by gynecologists in response to one of several issues occurring in the female reproductive system. Hysterectomies generally involve the removal of the entirety of the reproductive organs (i.e., uterus, ovaries and cervix) or may involve the removal of just one or two problematic areas. A hysterectomy may be performed to address cancer concerns, endometriosis, uterine fibroids, chronic pelvic pain and bleeding, polyps, uterine prolapse or adenomyosis (thickening of the uterus).
A myomectomy is a similar procedure used to specifically address uterine fibroids. Unlike the hysterectomy procedure, the goal of a myomectomy is to remove the fibroids only – leaving the uterus tissue intact and unharmed.
Myomectomy & hysterectomy morcellator use
The power morcellator is a medical device resembling a drill, affixed with a rotating blades that are used to break apart dense or large areas of tissue. The power morcellator is used most often in laparoscopic and robotic surgeries and allows surgeons the opportunity to minimize the incision – and scarring – allowing for an easier recovery for the patient.
Once the power morcellator has transversed through the tissue, the fragments are vacuumed out of the body and discarded. At the outset, power morcellation was considered a preferred alternative to the traditional method, which involved cutting through the patient’s core abdominal muscles. As can be expected, the traditional incision would result in a much longer recovery time, an increased risk of infection, and a more painful experience for the patient. However, over time, the power morcellator has proven to be problematic in its own right, causing thousands of women to endure aggressive cancer.
Morcellation complications and cancer risk
As explained above, the power morcellator works by essentially emulsifying tissue as it creates a pathway for the surgeon to reach the uterine area. In so doing, researchers have found that this technique actually spreads unsuspected cancer tissues throughout the reproductive areas – primarily in women undergoing the procedure to treat uterine fibroids.
Once the tissue is disbursed within the body, it begins to metamorphose into a deadly and aggressive form of uterine cancer known as uterine sarcoma. Most tragically, the rapid rotating motion of the power morcellator causes this toxic tissue to spread across multiple areas of the pelvis and abdomen, making treatment much more difficult to target and the cancer nearly impossible to eliminate completely.
In April, 2014, the Food and Drug Administration (FDA) issued a safety warning to healthcare providers and patients detailing the risks associated with the power morcellator device when specifically used during uterine fibroid surgery.
The warning detailed the increased risk of uterine sarcoma and offered several recommendations, including:
- The FDA strongly discourages the use of a power morcellator in any surgery involving uterine fibroids or uterine cancer.
- Doctors who maintain that power morcellation is the best treatment technique must thoroughly explain the risks associated with this device to their patients, allowing them to make an informed decision as to whether an alternative course of treatment may be better.
- Women considering uterine fibroid surgery should initiate clear communication with the surgeon prior to the surgery, specifically inquiring as to whether a power morcellator will be used and, if so, whether that device is necessary and safe.
- Women having already undergone uterine surgery using the power morcellator are encouraged to have follow-up cancer screenings to rule out the possibility of uterine sarcoma.
Current morcellator litigation
Injured women across the United States are beginning to understand the connection between power morcellator hysterectomy or myomectomy and the subsequent development of aggressive, deadly uterine and abdominal cancer. Ironically, a leading anesthesiologist helped spearhead the spread of awareness after she was informed, following her own personal uterine fibroid procedure, that her risk of developing leiomyosarcoma had increased up to 80 percent over that of women having never had a power morcellator operation.
In March, 2014, a wrongful death lawsuit was filed against a power morcellator manufacturer after a woman was tragically killed following a long battle with metastatic leiomyosarcoma. The victim has undergone a uterine procedure prior to developing the cancer, and her estate is alleging a causal connection between the use of the power morcellator device and her subsequent death. The suit names three prominent power morcellator manufacturers: Ethicon, Blue Endo and LiNA Medical.
In July, 2014, Ethicon – a division of Johnson & Johnson – announced it would be suspending the manufacture of the power morcellator device and pulled all power morcellators from the worldwide market. In the statement following this “voluntary” morcellator recall, Ethicon remarked that “[w]e believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.”
Morcellator attorneys are currently evaluating the cases of women who developed uterine cancer after a hysterectomy or myomectomy to adjudge if they are eligible to file product liability lawsuits against device manufacturers.
- FDA.gov, Safety communications, Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm
- Ethicon.com, Urgent medical device market withdraw, http://www.ethicon.com/sites/default/files/managed-documents/Ethicon-Morcellation-Devices-Customer-Letter-Final.pdf