Laparoscopic power morcellators, used during hysterectomies and for the
removal of uterine fibroids, have been given a Black Box warning by the
U.S. Food and Drug Administration (FDA). After nearly one year of debate,
the FDA decided in November to issue its strongest possible warning against
the morcellators rather than ban them. Power morcellators have been in
use since the 1990s, with their popularity booming recently with the advent
of robotic surgery. A black box warning is the strongest warning the FDA
requires and it signifies that the medical device or drug carries a significant
risk for causing serious or life-threatening complications.
Power Morcellator Risks and Side Effects
The power morcellators are used as a minimally invasive means of destroying
uterine tissue and fibroids by disintegrating the tissue for removal.
As the spinning blades of the morcellators grind up tissue, they can leave
behind small pieces. This process is not an issue on benign fibroids.
The problems arise when the fibroids are not benign, but actually uterine
sarcoma- a form of cancer, which is indistinguishable from benign fibroids
until after surgery. During morcellation, the tissue is disseminated throughout
the abdomen, literally "seeding" potentially cancerous tissue,
greatly decreasing a woman's chances for survival.
Two contraindications exist on the morcellators label:
- The power morcellators should not be used in women who are peri- or post-menopausal,
or who could otherwise have the tissue removed intact, and
- The device should not be used on women in which the tissue being morcellated
is suspected or known to be cancerous.
It is impossible to know, however, whether a fibroid is actually undiagnosed
cancer prior to surgery. It is estimated that 1 in 350 women who has surgery
for a suspected fibroid actually has uterine sarcoma, and 1 in 500 has
leiomyosarcoma- a rare, but aggressive form of uterine cancer.
Some doctors and hospitals have already discontinued use of the power morcellators.
HCA Holdings, a company that manages nearly 300 medical centers in the
United States and England, has banned the use of power morcellators in
all its facilities. Although the FDA has not banned the devices, the agency
strongly cautions that women should not undergo a power morcellation hysterectomy
due to the risk of disseminating cancer. In its report, the FDA noted
that there are other options available to women with uterine fibroids,
including traditional surgery, laparoscopic hysterectomy and myomectomy
Power Morcellator Lawsuits
In March 2014, a man filed a hysterectomy cancer lawsuit in the U.S. District
Court, Eastern District of Pennsylvania, when his wife lost her life to
uterine cancer less than a year after undergoing a power morcellation
hysterectomy to treat uterine bleeding. Meanwhile, a woman in New York
has filed a case after she was diagnosed with cancer following a robot-assisted
power morcellation hysterectomy.