Important Safety Alerts

The United States Food and Drug Administration (FDA) has posted a safety communication and a press announcement concerning 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 United States 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 is issuing the following recommendations for health care providers:

• Perform laparoscopic power morcellation with a legally marketed laparoscopic power morcellation containment system when morcellation is appropriate. The containment system should be compatible with the laparoscopic power morcellator.
• The FDA continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy, and when morcellation is appropriate, only contained morcellation be performed.
• Do not use laparoscopic power morcellators in gynecologic surgery when the tissue to be morcellated is known or suspected to contain malignancy.
• Do not use laparoscopic power morcellators for removal of uterine tissue containing suspected fibroids in patients who are:
  • post-menopausal or over 50 years of age, or
  • candidates for removal of tissue (en bloc) through the vagina or via a mini-laparotomy incision.
• Tell patients about the risk of occult cancer (cancer that cannot be identified during pretreatment evaluation) and inform them that use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease their long-term survival.
• Tell patients that the risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age.
• Be aware that uncontained power morcellation has been associated with the spread of benign uterine tissue, such as, parasitic myomas and disseminated peritoneal leiomyomatosis.

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 or hysterectomy procedures, there is an increased risk of spreading unsuspected cancer and benign tissue within the abdomen and pelvis. 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.

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 FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area. The containment system labeling describes the types of morcellators that are compatible with it.

For details, please refer to the following link:
https://www.fda.gov/medical-devices/safety-communications/update-fda-recommends-performing-contained-morcellation-women-when-laparoscopic-power-morcellation
https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-increase-safety-laparoscopic-power-morcellators-when-used-gynecologic-surgeries

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 26 February 2020