PA Widower Files Morcellator Cancer Lawsuit
On March 14, 2014, a Pennsylvania-area widower filed a wrongful death complaint in in the U.S. District Court for the Eastern District of Pennsylvania against power morcellator manufacturer LiNA Medical US, et al. The lawsuit stems from the tragic death of his wife allegedly caused by the use of the controversial morcellation technique in laparoscopic uterine fibroid surgery.
The victim, a 53-year old mother of two, had undergone the procedure in 2012 as part of a hysterectomy, and thereafter developed an aggressive form of uterine sarcoma. Reportedly, the plaintiff suffered no symptoms of metastatic cancer prior to or during the procedure, and was diagnosed with leiomyosarcoma just nine days later.
Problems with the power morcellator device
The power morcellator is a highly controversial medical device used in minimally-invasive gynecological surgeries. In the context of the hysterectomy procedure, surgeons are able to achieve removal of fibroids and tissue either vaginally or laparoscopically. In the laparoscopic procedure, doctors make a series of small incisions in the abdomen and essentially use the morcellator to break up the tissue until it is extractable.
For some women, the need for a full or partial hysterectomy is necessitated by the presence of uterine fibroids – which can cause difficult menstrual cycles, pain, and discomfort. Accordingly, doctors target these fibroids for removal during the hysterectomy procedure, with many using the power morcellator to breakdown the tissue. However, it is not uncommon for the morcellator to cause undetected fragments of fibroid tissue to travel throughout the abdomen, including undiagnosed malignant cancer cells.
Plaintiff alleges wrongful death and negligence
Despite warnings by a number of medical experts, practitioners continue to use the power morcellator device in surgeries involving the removal of uterine fibroids. In the Pennsylvania case, the plaintiff has alleged that the manufacturer of the morcellation device knew or should have known that its device could cause potentially deadly results in women with uterine fibroids, and failed to warn patients of this problem. More specifically, the plaintiff asserts that his wife’s cancer was “seeded” by the morcellator’s rotating cutting blades, causing cancer tissue to rapidly spread to other areas of the body.
In his morcellator cancer lawsuit, the plaintiff further contends that the manufacturers of the devices market the product as a completely safe option for minimally-invasive gynecological procedures, which includes approximately 10 percent of the 600,000 annual hysterectomies in the U.S.
Power morcellation under scrutiny by FDA
In November, 2014, the Food and Drug Administration (FDA) issued a Safety Communication with regard to power morcellator devices, specifically highlighting its findings that approximately 1 in 350 women having undergone fibroid removal surgery or a myomectomy were subsequently diagnosed with aggressive uterine sarcoma. The communication further explained that “[i]f laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.” In conclusion, the FDA warned against the use of power morcellators for removal of uterine fibroids, and encouraged all patients and physicians to consider alternative methods.
- Thomsonreuters.com, women died of cancer spread by surgical tool, husband says http://blog.thomsonreuters.com/index.php/woman-died-of-cancer-spread-by-surgical-tool-husband-says/
- FDA.gov, Safety communication - Power morcellators http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm