Fibroid Controversy

Most fibroids are benign conditions. Rarely, a fibroid can be something called a leiomyosarcoma (LMS) or a cancerous process. In 2013, there was one case in Boston where a women underwent a hysterectomy for presumed benign fibroids and as part of the surgery electromechanical morcellation (EMM) was performed. EMM has been a standard part of minimally invasive gynecologic surgeries for about 20 years. Unfortunately in this one case the uterus had LMS disease. The patient and her husband were very upset and started a movement to end EMM for fear that it can spread the disease process.

Part of this movement was a request for the FDA to review the use of EMM for hysterectomies and myomectomies. The FDA complied and issued a safety communication stating that LMS can occur in 1 out of every 458 women undergoing fibroid surgery (although the methodology of this review has been questioned by the Society of Gynecologic Oncologists). In November 2014, the FDA issued an updated communication which states that only women that meet specific guidelines are candidates for EMM.  These guidelines state that EMM is contraindicated in perimenopausal or menopausal women, women whom have known cancer of the uterus or cervix, or women in whom the tissue can be removed enbloc (without cutting up) through a small incision.  

This controversy has brought important attention to the need to find better ways to identify LMS versus fibroid tissue prior to surgery. Additionally, this case has highlighted the importance to appropriately inform patients of risks, and to develop newer techniques for fibroid removal. However, the benefits of minimally invasive surgery (band-aid surgery) must be balanced against the risk of EMM when it is necessary. Recent evidence suggests that when appropriately used, EMM actually saves lives as compared with open or big incisions.  

Additionally, a recently published article in the premier Ob/Gyn national journal reviewed all the appropriate studies concerning fibroids and LMS. The article found that 1 in every 1,550 patients could have LMS, however that is the highest estimate and the actual rate is probably even less frequent. We do note that LMS diagnosis is much more common in older patients (the average age of diagnosis of LMS is 60 years), so the risk for young women is likely even lower.  

All the major medical associations continue to support EMM when used for appropriate patients and with the informed consent of the patient. These organizations include American College of Obstetricians and Gynecologists (ACOG), American Association of Gynecologic Laparoscopists (AAGL) and the Society of Gynecologic Oncology (SGO).  

After careful consideration and evaluation of all the literature, our physicians continue to offer EMM for appropriate patients that fall within appropriate FDA guidelines. We have a very complete consent process and respect that all patients will have different desires. If a patient does not want EMM we will honor that request and perform the surgery per the patient preference.

We have instituted an additional measure in response to LMS concern by offering contained EMM. In contained EMM, This the fibroids into a specimen bag inside the abdomen for the portion of EMM.[MC1] This contains the disease process and limits the spread. While the technique is being perfected, the studies demonstrating ideal containment are still being studied.