The power morcellator, a type of surgical cutting tool, was publicly identified as a health threat in 2014, when the FDA warned against its use in the “majority of women” for its most common applications–minimally invasive hysterectomy and myomectomies–due to the risk of upstaging an undetected uterine cancer.
Stages of uterine cancer are primarily defined based on the localization of cancerous cells, with each progressive stage indicating greater spreading of the cancer and exerting more debilitating effects on the patients.
If a woman has undiagnosed uterine cancer and undergoes an operation involving morcellation, the cancerous tissue may be dispersed throughout her abdomen and/or pelvic region by the power morcellator’s spinning blades, potentially escalating an early stage cancer to an advanced stage.
Tragically, advanced stages of uterine cancer often have fewer effective available treatment methods and low survival rates, according to the American Society of Clinical Oncology.
Find related content: Myomectomy: Background and Surgical Options
It would seem that doctors should be able to safeguard patients by testing for uterine cancer prior to surgery.
However, this precaution is not currently a feasible solution because some types of uterine cancer cannot be reliably detected without surgery.
Carcinomas are cancers that originate in epithelial cells, the cells that comprise organ linings. The most common types of uterine carcinomas are endometrial uterine cancers, which affect the inner lining of the uterus, the endometrium. According to the U.S. Center for Disease Control (CDC), 97% of all uterine cancers are endometrial.
The survival rates for endometrial uterine cancers can be high compared to that of other types, depending on factors such as the stage at the time of detection. The American Cancer Society lists a five-year survival rate of 95% for detection at a localized stage (i.e. when the cancer has not left the uterus), 68% for regional spread, and 18% for distant spread, which translates to an overall survival rate of 82% for these cancer types.
The relatively high survivability is likely due both to the typically non-aggressive nature of these cancer types and to the possibility of early detection and successful treatment.
If a woman has risk factors for uterine cancer and/or is experiencing possible symptoms such as irregular or excessive vaginal bleeding, there are a number of methods that are commonly used to screen for these endometrial uterine cancers.
Two of these methods, transvaginal pelvic ultrasound, and MRI scanning, measure the thickness of the patient’s uterine lining, which is a crucial piece of information in diagnosis. If the uterine lining is of a normal thickness, then the presence of cancer is very unlikely. A higher-than-average thickness may indicate either a benign growth (such as uterine fibroids, polyps, or hyperplasia) or uterine cancer, and so much a measurement would require further investigation on uterine lining cells sampled via an endometrial biopsy or dilation and curettage (D&C).
No testing methods can offer 100% certainty of the absence or presence of cancer, but they are helpful tools that can be used in conjunction with the knowledge of a patient’s reproductive health and family history for a well-rounded diagnosis.
Sarcomas are cancers that begin by affecting muscle, bone, fat, or fibrous tissue cells.
The most common uterine sarcomas are leiomyosarcomas, which occur in the myometrium, the smooth muscle wall of the uterus. Uterine sarcomas are rare, only comprising about 3% of uterine cancers. However, they are known to be extremely aggressive and difficult to detect, and have much worse survival rates than those of endometrial uterine cancers, even if caught at an early stage.
The five-year survival rates for leiomyosarcomas are 63% for localized cases, 36% for regionalized cases, and 14% for distant cases.
Due to the fact that leiomyosarcomas originate in the uterine muscle wall, they cannot be reliably diagnosed without surgery, since the muscle cells cannot be sampled vaginally the way endometrial cells can. Testing on endometrial cells can detect a leiomyosarcoma only if the cancer has already spread from the muscle wall to the uterine lining.
Also, imaging techniques tend to have low efficacy in diagnosing leiomyosarcoma because the tumors often closely resemble benign tissue masses when examined with such techniques.
The only sound method for detecting leiomyosarcoma currently is pathological testing by an experienced pathologist, which is not a feasible option pre-surgery, for reasons outlined here by Dr. William Parker, a board-certified Fellow of the American College of Obstetricians and Gynecologists.
The instances in which power morcellators have been found to spread uterine cancer in research studies and in recent lawsuits have all involved deadly leiomyosarcomas rather than carcinomas, which is likely because of the difficulty in screening for these cancers.
Risk factors are an important component of any diagnosis, and given the implications of the alarming research that led to the FDA safety alerts, medical practitioners should take uterine cancer risk factors into special consideration when deciding whether power morcellators should be used for uterine surgeries.
According to the Cancer.net Editorial Board, women are at a higher risk of uterine cancer if they possess the following characteristics:
As we have seen, it is virtually impossible to diagnose the deadly uterine cancer leiomyosarcoma before surgery, and furthermore many prospective patients for uterine surgeries possess multiple risk factors for uterine cancer from the list above.
The FDA estimates, based on recent research, that about 1 in 350 women undergoing surgery for treatment of uterine fibroids has undetected uterine sarcoma. This is much higher than the 1 in 10,000 figure that was previously believed and given to patients as a risk estimate.
Claims have been filed by affected patients and their families in federal courts across the U.S., alleging that device manufacturers should have been aware of the risks inherent in their products, and should be held liable for failing to properly inform consumers.
These cases describe tragic stories of women selecting morcellator-aided surgery to treat their fibroid condition, thinking the option to be a safe improvement over open surgery, only to later face an advanced uterine cancer diagnosis and eventually, for some, an early death.
If you think you may want to file a claim regarding power morcellators, don’t hesitate to schedule a meeting with our team of experienced attorneys to explore your legal options in a complimentary case evaluation. Our New York firm has a wealth of experience in getting the compensation you need and deserve.