The FDA is discouraging the use of morcellation for a hysterectomy or a myomectomy (surgical procedure to remove uterine fibroids) in women after data shows it can spread “unsuspected” cancerous tissue to other parts of the body. About 1 in 350 women have an undetected form of uterine cancer also known as uterine sarcoma.
Laparoscopic Power Morcellation
Laparoscopic power morcellation is a procedure that uses an electronically-powered device known as a morcellator to cut tissue in the uterus into smaller pieces. Those fragments are then removed through tiny incisions in the stomach.
The first power morcellator was approved by the FDA in 1995. There are approximately 60,000 women who undergo this procedure every year.
Power morcellation is a minimally invasive process for women to have their uterus or uterine fibroids removed. It helps reduce scarring, bleeding, and minimizes pain and allows for a faster recovery.
Uterine fibroids are common among women, 3 out of 4 women may develop fibroids at some point in their lives. Fibroids grow from the myometrium, or uterine tissue. Some women will not experience any side effects while others may experience the following:
- Menstrual periods lasting 7 days or more
- More frequent urination
- Pelvic pain, pressure
- Heavy menstrual bleeding
- Backache, leg pain
- Difficulty emptying the bladder
There are three different places fibroids can grow. Intramural fibroids grow “within” the uterine wall. Submucosal fibroids grow into the inner cavity of the uterus, and subserosal fibroids grow on the outside of the uterus. It’s unclear exactly what causes uterine fibroids, but doctors say possible triggers may include hormones, genetic changes and taking certain medications.
Uterine Fibroid Diagnosis & Treatment
Only a doctor can determine whether or not you have uterine fibroids. This is done with a traditional ultrasound, an MRI, hysteroscopy, or use of a saline solution or dye to highlight the uterine cavity during an x-ray.
There are several different ways to treat uterine fibroids depending on the severity. Some doctors may prescribe medication, perform a non-invasive procedure, a minimally-invasive procedure, or a traditional surgical procedure.
If your uterine fibroids are not bothering you then your doctor will most likely just continue to monitor them.
FDA Discourages Women from Power Morcellation
On April 17, 2014, the FDA issued a safety announcement warning women about the dangers of laparoscopic power morcellation which is sometimes used to remove the uterus or uterine fibroids. Several studies have found that laparoscopic power morcellation can cause undetected cancerous tissue to spread to other parts of the body outside of the uterus. This can cause women to develop aggressive forms of cancer.
Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said in an FDA news release, “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.”
A study published in PLOS One in 2012, found that the risk of spreading cancerous tissues to other parts of the body was nine times higher in women who underwent power morcellation for the removal of fibroids.
Another study, Evaluating the Risks of Electric Uterine Morcellation, published in JAMA in 2014, found that from 1993-2010, 13 women developed unexpected uterine cancer.
If you or a loved one developed cancer after undergoing laparoscopic power morcellation for a hysterectomy or myomectomy you may be entitled to compensation. You should call now for a free consultation. An experienced morcellation attorney will be able to help you determine whether or not you have a case.