Hysterectomy or Fibroid Removal Tool can Increase Risk of Cancer

Over 600,000 hysterectomies are performed each year in the United States, and nearly half of the procedures are minimally invasive. Over the years, a growing number of these procedures are performed with the aid of power morcellators.

Power morcellators are cutting tools used by general and gynecological surgeons in minimally invasive laparoscopic hysterectomy and myomectomies. In a myomectomy, surgeons use power morcellators to remove uterine fibroids, which affect approximately 250,000 women each year. The risk of developing fibroids, also known as leiomyomas, increases after age 50; however, they are also common in young
women. When fibroids are removed, doctors can relieve pain, bleeding and other uncomfortable symptoms without removing a woman’s uterus. In hysterectomies, surgeons use tissue morcellator to remove a woman’s uterus.

These tools do much of the cutting involved in laparoscopic and robotic surgeries. The morcellators, which are tiny devices w/ rotating blades, break large tissue masses into small fragments by making incisions of less than 2 centimeters. These small tissue fragments are then vacuumed away and out of the body. In laparoscopic surgeries, when the surgeon drills into the woman’s abdomen, the shredding of the tissue occurs in an open environment, which can cause tissue, including cancer cells, to spray into the abdomen and pelvic cavity.

Unfortunately, the use of power morcellators creates a serious health risk for women with undetected uterine cancer because the morcellator essentially acts as a hand blender and potentially accelerating the growth of the cancer and/or seeding of the cancer cells to the abdomen and pelvis. The United States Food and Drug Administration (“FDA”) has estimated that as many as 1 in 350 women undergoing a hysterectomy or myomectomy may have undetected uterine cancer.

In April of 2014, the FDA warned doctors not to use the power morcellators that have since been recalled by Johnson & Johnson. This warning came in advance of a June 2014 meeting where an advisory panel to the FDA discussed the safety issues related to the use of power morcellators, as well as possible changes to the regulatory status applied to these tools. Shortly after this meeting, another advisory panel met to discuss possible ways that the dangers posed by power morcellators could be avoided.

On November 24, 2014, the FDA issued a Safety Communication in which they attached a “Black Box” warning to power morcellators because of the extreme risks they pose to patients. This warning stated that the risks outweighed any potential benefits that, in almost all circumstances, the use of these devices should not be used.

If you or a loved one had a hysterectomy, fibroid removal or other surgical procedure where a power morcellator was used and were subsequently diagnosed with cancer, including: uterine sarcoma, leiomyosarcoma, or other cancers, significant financial compensation may be awarded. Please contact our office for more information.