The potential dangers of power morcellation have been studied for years, yet the procedure continues to be used. Morcellation is a surgical technique to reduce the size of the uterus or myomas (“fibroids” or “leiomyomas”) by cutting tissue into tiny pieces to allow removal through small incisions or with laparoscopic instruments. While manual morcellation has been used for decades, power morcellation using electromechanical devices was introduced in 1993. Power morcellation has significant benefits, but open or uncontained morcellation performed without first placing the specimen into a containment bag poses significant risks. In 2014, the FDA issued a black box warning on the use of power morcellation in the treatment of presumed leiomyomas but did not ban its use. As a result, the procedure is still used resulting in continuing litigation.
The advantages and disadvantages of power morcellation can complicate a lawsuit. The use of a power morcellator allows doctors to treat fibroids using minimally invasive incisions rather than abdominal surgery. This results in faster and less painful healing and fewer complications. However, if the fibroid is cancerous, the morcellator can disperse cancerous cells throughout the body. It is particularly dangerous if there is an unsuspected uterine leiomyosarcoma, a rare form of cancer, that is highly aggressive and prone to spreading to other parts of the body.
While there are risks of using morcellators, there are conflicting studies regarding the level of absolute risk of a presumed leiomyoma (benign tumor or fibroid) actually harboring a leiomyosarcoma (malignant tumor). In addition, evidence that morcellation of a leiomyosarcoma worsens a patient’s prognosis is limited. Lawsuits against manufacturers are likely to require the use of expert witnesses in Gynecologic Oncology to discuss these studies. Gynecologic Oncology is a surgical subspecialty dealing with both operative and non-operative management of cancers of the female reproductive system.
With respect to medical malpractice claims, current guidelines provide that a preoperative evaluation should be done to evaluate whether a woman is at increased risk of malignancy of the uterus. A Gynecologist or Gynecologic Oncologist can testify regarding the appropriate use of imaging, cervical cancer screening, and endometrial tissue sampling to identify malignancy in addition to risk stratification for leiomyosarcoma that may not be reliably identifiable preoperatively.
Since no test can completely rule-out the diagnosis of leiomyosarcoma preoperatively, the issue of informed consent is also an area of potential malpractice. The physician must provide appropriate information regarding the risks of morcellation versus alternative procedures, such as abdominal surgery, morcellation through suprapubic or umbilical incisions with containment bags, hand-assisted morcellation through a mini-laparotomy, and vaginal manual morcellation. Again, Gynecologic Oncologists offer valuable insight and testimony on standards of care for the technical performance of uterine morcellation and informed consent.
If you are considering a lawsuit or defending against one involving a power morcellator, please contact Elite Medical Experts. We can help you find nationally recognized university experts for your case.