FDA Issues Additional Warnings Regarding the Use of Laparoscopic Power Morcellation
The U.S. Food and Drug Administration has issued a safety communication notice discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women. This procedure poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
“Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “
ADDITIONAL INFORMATION RELEASED FROM THE FDA (4.22.2014)
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.
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.
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.