As trial lawyers, we usually get involved in situations after the fact.
One of the goals of our blog is to be more proactive and share our expertise
before a problem occurs. Today we want to share information on a little
known but growing women's health problem related to the removal of
uterine fibroids. Procedures to remove uterine fibroids are very common.
Hopefully this information will help you, a family member, or a friend
make more informed decisions and potentially avoid a serious cancer risk.
The U.S. Food & Drug Administration (FDA) has warned the public about
a surgical device that may be linked to the spread of uterine cancer cells
in women. FDA Safety Alerts issued in
November 2014 described the potential harm caused by
laparoscopic power morcellators. These are devices used in
laparoscopic surgeries which may include hysterectomies (removal of the uterus) and
myomectomies (removal of
uterine fibroids, with subsequent reconstruction of the uterus).
Uterine fibroids are benign muscular tumors that grow within the wall of the uterus, according
to the Mayo Clinic. The
American Cancer Society reports they are almost always harmless and extremely common during a
woman’s reproductive years. In fact, most women won’t even
know the fibroids exist because there are typically no symptoms and no
adverse effects on their health. However, women may opt to have the fibroids
removed through either a hysterectomy or myomectomy if the
symptoms become problematic, which is rare. (See U.S. Dept. of Health & Human
Services, Office on Women’s Health
Credit: The Wall Street Journal
Electric or power morcellation is a minimally invasive gynecological
FDA describes the morcellator as using a rotating blade to cut or shred the
fibroids into smaller fragments. This enables a laparoscope to suction
out the pieces of tissue via very small incisions in the abdominal area.
But the power morcellator could spray and scatter these fragments like
seeds throughout the pelvic and abdominal region. Uterine cancer cells
can be deceptive – they might appear to be uterine fibroids or otherwise
hide within the uterus. If they remain undetected prior to surgery, the
malignant cells also will be dispersed within the pelvis and abdomen,
“significantly worsening the patient’s likelihood of long-term
survival.” ( FDA Updated Safety Communication). According to the
New York Times, “there is no certain way to tell before [the fibroids] removal
if they harbor a
cancer, which happens in 1 in 400 to 1 in 1,000 cases.” It is strongly
advised that any “tissue suspicious for malignancy should never
be morcellated.” (See
We tend to assume – often correctly – that less invasive procedures
can be safer than traditional operations. The latter brings to mind scenarios
involving anesthesia, lengthy hospital stays, pain, and a complicated
recovery period. However, the FDA’s findings on power morcellators
remind us that even well-known, standard procedures can be risky.
With potentially dangerous devices on the market, being a proactive advocate
for your care and treatment is crucial. In 2014,
Forbes reported a study conducted by Yale which revealed that reproductive knowledge
among women was generally low, and out of 1,000 female participants, only
50 percent have ever discussed their reproductive health with their provider.
It is important to maintain communication with your health care provider
about the drugs or medical devices he/she is using. Discuss your questions,
concerns and personal preferences. Ask about the different treatment options
available, and the risks and benefits of each, so you can make informed
decisions that will help keep you happy and healthy.
** See the FDA’s recommendations for health care providers and women