SENATORS URGE THE F.D.A. TO REMOVE POWER MORCELLATORS FROM THE MARKET

Power morcellators are used by gynecologists to perform hysterectomy and myomectomy procedures.  A hysterectomy is the surgical removal of the uterus and sometimes the ovaries.  A myomectomy is a procedure to remove uterine fibroids.  During these procedures, surgeons place the morcellator through a small abdominal incision.  The morcellators have small rotating blades that break down tissue so it can be easily removed.

Recent evidence shows that morcellators can spread cancerous tissue throughout the abdominal area and seed new cancer.  The device can also spread benign tissue that can cause unnatural growths in the abdomen.  The F.D.A. determined that approximately 1 in 350 women who undergo hysterectomy and myomectomy procedures have an unsuspected type of uterine cancer called uterine sarcoma.  The use of power morcellation devices in these women creates a risk that the cancerous tissue will spread within the abdomen and pelvis which significantly worsens the patient’s likelihood of long-term survival.

As a result of these new concerns, the F.D.A. sent a safety communication in April 2014, to discourage doctors from using morcellators to remove uterine fibroids because of the increased cancer risk.  The safety communication prompted Johnson & Johnson’s Ethicon division to suspend worldwide sales of three of the company’s morcellator devices and ask hospitals to return the devices.  However, many other morcellator devices from other manufacturers remain on the market.

In July 2014, an F.D.A. health advisory panel held a meeting to discuss the health risks associated with use of morcellation devices.  During the two day meeting, the F.D.A. heard from injured patients and their families.  In addition, two U.S. senators from New York urged the F.D.A. in a letter to stop use of the devices and request that all of the manufactures recall their devices from the market.

Ultimately, the F.D.A. health advisory panel concluded that there wasn’t enough evidence to immediately recall all of the morcellators from the market.

Click below to view the F.D.A. Safety communication:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm