Is morcellation banned?
FDA STOPS SHORT OF A BAN In laying out its concerns, the FDA stopped short of an outright ban on power morcellation. Instead, it stated that, “based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
What is morcellation of pelvic mass?
Conclusion. Uterine morcellation is a surgical technique that is performed to remove a uterus or leiomyomas through small incisions and facilitates minimally invasive surgical approaches. Morcellation may be performed during vaginal, laparoscopic, or abdominal surgery using a scalpel, scissors, or a power morcellator.
What is contained morcellation?
Tissue containment systems used during laparoscopic power morcellation are intended to isolate and contain tissue that is considered benign. Based on premarket bench and animal testing, use of a containment system confines morcellated tissue within the containment system.
Can laparoscopic hysterectomy be done without morcellation?
Other studies suggest that the benefits of laparoscopic hysterectomy with power morcellation may still outweigh the risks for younger women, for whom the risk of unexpected uterine cancer is much lower. The researchers add that it is also often possible to perform laparoscopic hysterectomy without power morcellation.
Does Davinci hysterectomy use morcellation?
Power morcellators are medical devices used during da Vinci hysterectomies, as well as laparoscopic supracervical hysterectomies and myomectomies for removal of uterine fibroids.
When did FDA issue final guidance for power morcellators?
On December 29, 2020, the FDA issued a final guidance, Product Labeling for Laparoscopic Power Morcellators, providing recommendations concerning the content and format for certain labeling information to better inform patients and health care providers of the device’s risks. Read the final guidance.
When to use a containment system for morcellation?
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.
Is it safe to use laparoscopic power morcellation?
The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures.
What do you need to know about power morcellators?
The FDA recommends that health care providers use tissue containment systems when using laparoscopic power morcellators, and that they ensure the laparoscopic power morcellator and tissue containment system are compatible.