Guidance issued to increase safety of laparoscopic power morcellators used in gynaecologic surgeries

MedTech News: The U.S. Food and Drug Administration (FDA) has updated important safety communication on laparoscopic power morcellators (LPMs) regarding its safe and effective use for gynaecologic procedures due to the risk that the treatment may spread previously undetected cancer.

Studies have established a link to increased rates of malignancy in women undergoing LPMs. The rate of malignancy is approximately 1 in every 350 women who underwent these procedures.

The FDA has now issued draft guidance on updated product labelling for LPMs.

Making Surgeries with Laparoscopic Power Morcellators (LPMs) Safer Through Containment Systems

Use of laparoscopic power morcellators allow for minimally invasive surgical procedures, which, when compared to open abdominal surgery, typically reduce the risk of infection and shorten the post-operative recovery period. However, when used in myomectomy (surgical procedure to remove uterine fibroids, which are noncancerous growths in a woman’s uterus) or hysterectomy (surgical procedure to remove a woman’s uterus) procedures, there is an increased risk of spreading unsuspected cancer and benign tissue within the abdomen and pelvis.

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The risk of unsuspected cancer increases with age, particularly in women over 50 years of age. Women with unsuspected uterine sarcoma who undergo morcellation of presumed fibroids are at risk for cancer to spread within the abdomen and pelvis.

Due to this increased risk, 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.

One strategy to mitigate this risk is to use a tissue containment system during laparoscopic power morcellation procedures. The containment system is intended to isolate and contain tissue that is considered benign. Based on testing, use of a containment system confines morcellated tissue within the containment system, which may prevent the peritoneal spread of cancerous tissue

A containment system cannot prevent against the potential spread of cancer that might result from:

• Tissue that spreads due to manipulation of the tissue before it is placed into the tissue containment system or
• Cancer that may have already spread through the blood, lymphatic system or fallopian tubes (transtubal transport) before the surgical procedure.

Laparoscopic power morcellators should be used with compatible containment systems. Currently, the Olympus PneumoLiner​ device is the only containment system that has received FDA marketing authorisation.

Johnson & Johnson’s Ethicon division withdrew their laparoscopic power morcellator products from the global market in 2019. 

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