You may be hearing on television and online about the cancer risk associated with power morcellators. Here is what you need to know.
How the Device Works
A power morcellator is a surgical tool that can be used to remove fibroids from a woman’s uterus (known as a myomectomy procedure) or to remove the entire uterus (hysterectomy).
The cancer risk relates to the way in which the device removes tissue from the body when employed during these procedures.
Morcellators utilize a set of spinning, cylindrical blades at the end of a long shaft. The shaft is inserted through small incisions in the patient’s abdomen to reach the uterus. The blades then cut up and extract fibroid tissue or cut up and remove the uterus. In either case, the tissue is cut apart while still inside the patient’s body and extracted in small fragments.
Morcellation is known as a laparoscopic procedure since it uses only small incisions in the abdomen to insert the device and remove tissue as opposed to open surgery. This makes the procedure less invasive, easier for surgeons to perform, and allows patients a speedier recovery time.
But the dangers are significant.
Why is it Dangerous?
The danger associated with morcellation arises when suspected fibroids actually turn out to be cancer cells.
Uterine sarcoma is a serious type of cancer that can be mistakenly identified as benign (or relatively harmless) fibroids before surgery. Doctors can only identify and accurately diagnose uterine sarcoma through a biopsy of the extracted tissue once surgery has already been performed.
This means some patients undergo a laparoscopic myomectomy or hysterectomy to remove fibroids, but find out after surgery that their fibroids were actually a form of uterine cancer.
When this occurs, power morcellators can play a dangerous role in spreading the cancer cells. The spinning blades of a morcellator mince up these cancer cells inside the patient’s body and spray malignant tissue fragments throughout the abdomen and pelvis.
As a result, patients can develop sudden, advanced stage cancer with a significantly worsened prognosis for survival.
Am I at Risk?
An estimated 55,000 women undergo a myomectomy or hysterectomy procedure using power morcellation each year. Among these women, 1 in 350 will have hidden uterine sarcoma.
While this represents a minority of patients overall, the risk is much greater than previously understood.
In November 2014, the FDA issued an urgent safety communication to warn women and health care providers against using power morcellators to remove uterine fibroids in almost all cases. The agency urged women with symptomatic fibroids to consider alternatives such as traditional surgery, laparoscopic procedures without morcellation, and mini-laparotomy.
The Lawsuit Against Morcellators
The first power morcellator was approved for sale in the United States in 2005. This means hundreds of thousands of women underwent morcellation procedures before the FDA issued its safety warning in 2014.
Evidence suggests that in the meantime, the manufacturers of the devices were aware of the cancer-spreading risk associated with morcellation but continued to promote the devices as safe and effective.
Lawsuits are now underway to compensate victims and their families alleging fraud and negligent failure to warn consumers, among other legal claims.
Consultations for Victims
If you have been affected, our medical device attorneys can provide a free and confidential evaluation of your potential case. Call (866) 808-2424 or send us a message online at any time.