New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries
For Immediate Release:
February 25, 2020
Director – CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD
Today, we are taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization for updated labeling of the PneumoLiner containment system (a device that contains tissue to be morcellated during certain gynecologic surgeries), releasing a draft guidance recommending the addition of specific safety information to the product labeling for LPMs, and issuing a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the LPM.
LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site. These devices can be used in a variety of surgeries, including various gynecologic surgeries such as a myomectomy, a surgical procedure to remove uterine fibroids from a woman’s uterus. While laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to traditional surgery, there are known risks associated with the use of LPMs, specifically in gynecologic surgeries. For example, current scientific evidence indicates that cancerous tissue may be present in uterine fibroids presumed to be benign (non-cancerous). When LPMs are used in surgeries where unsuspected cancerous tissue is present, there is a risk that morcellation could spread cancerous tissue throughout the body, decreasing a woman’s long-term survival.
The FDA has taken many actions over the years to ensure the safe and effective use of LPMs. Some of these actions include the issuance of a Safety CommunicationExternal Link Disclaimer, holding a panel meetingExternal Link Disclaimer to seek outside expert opinions, issuance of an FDA guidance recommending the addition of safety statements to the labeling for LPMs, and ensuring that up-to-date information regarding LPMs for gynecologic use is publicly available on the agency’s website.
Read the full article here.
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate
The U.S. Food and Drug Administration (FDA) is updating our 2014 safety communicationExternal Link Disclaimer on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures. The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the U.S. for use during laparoscopic power morcellation and performing these procedures only in appropriately selected patients. Tissue containment systems used during laparoscopic power morcellation are intended to isolate and contain tissue that is considered benign. Based on bench and animal testing, use of a containment system confines morcellated tissue within the containment system.
The FDA continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy. In addition, FDA recommends that when morcellation is appropriate, only contained morcellation be performed.
Read the full article here.