Concerns Over Cancer Following Uterine Fibroid Removal Surgery Ignored

Prior to the FDA’s announcement last week that morcellators should not be used for uterine fibroid removal surgery, concerns had been building within the medical community for years that use of the minimally invasive surgical devices may spread cancer cells and cause women to be diagnosed with advanced stage leiomyosarcoma (LMS) or other cancers.  

Power morcellators have been in use since the 1990s, but the devices have become increasingly popular in recent years during laparoscopic hysterectomy and myomectomy procedures to remove the uterine fibroid tumors or the entire uterus through small incisions.

Minimally invasive surgery is made possible by morcellators, which cut the tissue into small pieces that are able to be removed through the port incision.

In recent years, concerns have surfaced about the risk of leiomyosarcoma cancer with morcellation uterine fibroid removal surgery, as a number of women with undiagnosed sarcoma had the cancerous cells spread during the procedures to the bladder, rectum or other distant organs.

Last week, the FDA issued a safety communication discouraging laparoscopic power morcellation during uterine fibroid removal surgery, since here is no reliable way for doctors to determine whether women have undiagnosed uterine sarcoma prior to the procedure.

Estimates suggest that about 1 out of every 350 women undergoing a laparoscopic hysterectomy or myomectomy may have unsuspected sarcoma that is contained within the uterus prior to the procedure. Morecellation may cause the spread of cancerous tissue within the abdomen or pelvis, shortening the woman’s chances for long-term survival and overall quality of life.

A number of critics are now raising serious questions about why the manufacturers of these devices did not take prior steps to warn women and the medical community about the risk of cancer spreading from morcellation during uterine fibroid removal surgery, as it appears that the problems could have been discovered and avoided.

Morcellation Risk of Leiomyosarcoma Cancer

The FDA warnings came after several months of media attention about the cancer risk with morcellation surgery, which has largely been the result of recent efforts by married doctors from the Boston area, Drs. Amy Reed and Hooman Noorchasm.

After Reed underwent a morcellation procedure that caused her cancer to spread, the couple has become a vocal critic of the use of morcellators during minimally invasive uterine fibroid removal and robotic hysterectomy procedures. A petition posted by the couple on change.org has generated nearly 8,500 supporters.

Prior to the recent actions of Drs. Reed and Noorchasm, earlier reports within the medical community have voiced concerns about the risk of spreading leiomyosarcoma cancer following uterine fibroid surgery with morcellation.

In 2011, researchers from South Korea noticed a disturbing trend in mortality among women who had leiomyosarcoma tumors removed using morcellators, with a 44% death rate identified after 39 months. This compared to a mortality rate of just 19% for women who had tumors removed intact.

That research was followed by a study published in the medical journal PLoS One in November 2012, in which doctors examined the frequency and clinical consequences associated with morcellation of uterine tumors that were unexpectedly found to be leiomyosarcomas.

Following a review of data involving 1,091 incidents of uterine morcellation at Brigham & Women’s Hospital (BWH) between 2005 and 2010, researchers found a much higher rate of disseminating unexpected malignancy than previously thought within the medical community. The rate of unexpected sarcoma after laparoscopic morcellation was 9 times higher than the rate typically quoted to patients during pre-procedure briefing, and researchers found that disseminated disease occurred in 64.3% of such cases.

Although researchers and doctors have indicated that additional study is warranted, it appears that the manufacturers largely ignored the signs of problems and failed to provide adequate information for doctors about the potential risk, so that alternatives may be considered for treatment of uterine fibroids.

The FDA has indicated that a panel of outside experts in obstetrics and gynecology will be convened to look at data and collection additional information on power morcellation.

In the meantime, a number of women are now considering potential morcellation lawsuits following the spread of leiomyosarcoma during uterine fibroid removal surgery.