Source: US Food and Drug Administration
Date issued: December 29, 2020
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.
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.
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. The recommendations for health care providers below have been updated from the February 2020 safety communication consistent with the FDA’s guidance Product Labeling for Laparoscopic Power Morcellators.
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.
The FDA continues to recommend limiting the use of laparoscopic power morcellation to certain appropriately selected women undergoing myomectomy or hysterectomy. In addition, the FDA recommends that when morcellation is appropriate, only contained morcellation be performed.
Recommendations for 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.
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; 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.
- 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.
Making Surgeries with Laparoscopic Power Morcellators 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. While unsuspected cancer can occur at any age, 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, the 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.
A containment system cannot prevent all cases of benign tissue spread as some cases may occur spontaneously without morcellation.
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. To support marketing, the containment system manufacturer must conduct testing to support the compatibility criteria described in the labeling.
To find more information about FDA-cleared tissue containment systems for gynecologic surgery, go to either the De Novo database or the 510(k) Premarket Notification database, type PMU in the Product Code field, and click Search.
The FDA continues to encourage development of innovative ways to better detect uterine cancer and the development of containment systems designed for gynecologic surgery. The FDA will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care providers, gynecologic and surgical professional societies, and medical device manufacturers. We will inform the public of any significant new information.
For historical information about the FDA’s actions, see Laparoscopic Power Morcellators.
Reporting Problems to the FDA
If you suspect or experience a problem with laparoscopic power morcellation, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a morcellator or specimen bag has malfunctioned or contributed to a serious injury or adverse outcome, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care professionals employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Hospitals are required to report some adverse events related to medical devices. Federal regulations require user facilities to report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must also report a medical device-related serious injury to the manufacturer or to the FDA, if the medical device manufacturer is unknown.
Hospitals should report the spread of unsuspected cancer when using laparoscopic power morcellation for hysterectomy or myomectomy in women with symptomatic uterine fibroids, as a serious injury.
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100.