FDA MedWatch - UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication AUDIENCE: Patient, Health Professional, Risk Manager, Gynecology  ISSUE: The 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. On December 29, 2020, the FDA issued the final guidance, Product Labeling for Laparoscopic Power Morcellators. The final guidance provides recommendations concerning the content and format for certain labeling information to better inform patients and health care providers of the device's risks. BACKGROUND: Use of laparoscopic power morcellators allows 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. RECOMMENDATIONS: Patients Discuss all options available to treat your condition with your health care provider. There are benefits and risks associated with all medical devices and procedures. If your health care provider recommends laparoscopic hysterectomy or myomectomy, ask: If power morcellation will be used Why power morcellation use is appropriate for you Whether a containment system will be used, and If other treatment options are available. If you have undergone a myomectomy or hysterectomy for fibroids, be aware that tissue removed during the procedure is usually tested for the presence of cancer. If you were informed these tests were normal, continue routine follow-up with your health care provider. If you have any questions or concerning symptoms, consult your health care provider. Know that additional surgical treatment options are available for women with symptomatic uterine fibroids. These include traditional surgical hysterectomy and myomectomy, performed either vaginally or abdominally, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision in the abdomen 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; when morcellation is appropriate, only contained morcellation should 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 while unsuspected cancer can occur at any age, the risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age. Updated Recommendations  Be aware that uncontained power morcellation has also been associated with the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, potentially requiring additional surgeries. Conduct a thorough preoperative screening. As part of shared decision-making, discuss the risks and benefits of all relevant treatment options with your patients. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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