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 April and 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 publication).
Credit: The Wall Street Journal
Electric or power morcellation is a minimally invasive gynecological procedure. The 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 http://sarcomahelp.org/articles/uterine-morcellation.html).
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 here.