The Food and Drug Administration is asking doctors to stop using a procedure performed on tens of thousands of American women each year during uterine surgery, because it poses a risk of spreading cancerous tissue.
In an FDA safety advisory, surgeons are discouraged from using a powered cutting tool -- power morcellators -- to remove uterine fibroids.
With laparoscopic power morcellation, a tube-shaped blade is used to grind and shred uterine tissue so it can be removed through a small incision in the abdomen. The technique is widely used to treat painful uterine fibroids, either by removing the noncancerous growths themselves or the entire uterus.
According to the Wall Street Journal, morcellators, introduced in the 1990s, help gynecologists perform about 50,000 fibroid-removal procedures each year through tiny holes rather than longer incisions that can lead to bigger scars and a longer recovery time.
Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma.
If laparoscopic power morcellation is performed on these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
Since uterine sarcoma can't be reliably detected before they are removed, they can be mistaken for fibroids. The cancer is typically discovered only after the mass has been removed and tissue sent to a pathologist.
Between 500,000 and 600,000 women each year undergo hysterectomies, up to 40 percent for painful uterine fibroids. It’s unclear how many involve morcellation but it’s estimated to be between 50,000 and 150,000.
Dr. William Maisel, deputy director for science and chief scientist at the Center for Devices and Radiological Health told the New York Times that although the FDA had the authority to ban power morcellators, it chose not to because some women may still see the procedure as a good option.
When fibroids are large, morcellation may be required if a patient wants minimally invasive surgery, which avoids longer incisions, shortens recovery time and reduces the risk of blood loss, infections and other complications.
Companies that make equipment for the procedure were urged to ensure that accurate information about the risks is on their product materials. Dr. Maisel said that doctors should also explicitly tell patients about the risks.
In addition, doctors should discuss all options for treating fibroids with their patients, including traditional surgery and less invasive procedures that do not use power morcellators advised the FDA. This was reported by StarTribune.com.
Sources:
Cortez, Michelle Fay. "FDA Discourages Common Uterine Procedure on Cancer Threat." Bloomberg.com. Bloomberg, n.d. Web. 23 Apr. 2014.
http://www.bloomberg.com/news/2014-04-17/fda-discourages-common-fibroid-removal-approach-on-cancer-threat.html
Grady, Denise. "F.D.A. Discourages Procedure in Uterine Surgery." The New York Times. The New York Times, 17 Apr. 2014. Web. 23 Apr. 2014.
http://www.nytimes.com/2014/04/18/health/fda-tells-doctors-to-stop-procedure-used-to-remove-uterine-fibroids.html?emc=edit_hh_20140422&nl=health&nlid=30319163
Kamp, Jon, and Jennifer Levitz. "FDA Advises Against Morcellator Use in Hysterectomies." The Wall Street Journal. Dow Jones & Company, n.d. Web. 23 Apr. 2014.
http://online.wsj.com/news/articles/SB10001424052702304626304579507642833016758
Kowalczyk, Liz. "FDA issues safety warning “discouraging” power morcellation for fibroids, hysterectomies. - The Boston Globe." BostonGlobe.com. N.p., n.d. Web. 23 Apr. 2014.
http://www.bostonglobe.com/lifestyle/health-wellness/2014/04/17/fda-issues-safety-warning-discouraging-power-morcellation-for-fibroids-hysterectomies/TvASpwy85K4Plx3LRC75DM/story.html
Perrone, Matthew. "FDA discourages electronic fibroid procedure due to risk of cancer spread in some women." StarTribune.com: News, weather, sports from Minneapolis, St. Paul and Minnesota. N.p., n.d. Web. 23 Apr. 2014.
http://www.startribune.com/lifestyle/health/255665051.html
"U.S. Food and Drug Administration." FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids. N.p., n.d. Web. 23 Apr. 2014.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm
Reviewed April 24, 2014
by Michele Blacksberg RN
Edited by Jody Smith