UPDATE: Draft Guidance: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
On June 17, 2022, the FDA issued this draft guidance: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures for public comment on recommendations on non-clinical test methods, test parameters, and test acceptance criteria to support premarket submissions for gynecologic and general use of laparoscopic power morcellation tissue containment systems. Read the draft guidance.
Laparoscopic power morcellators are Class II medical devices used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or less).
These devices are commonly used in hysterectomy (surgical procedure to remove a woman's uterus) and myomectomy (surgical procedure to remove uterine fibroids which are noncancerous growths in a woman's uterus).
Laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to a hysterectomy or myomectomy done through an abdominal incision.
On this page:
- What Women and Their Health Care Providers Need to Know About Using Laparoscopic Power Morcellators to Treat Uterine Fibroids
- Making Surgeries with Laparoscopic Power Morcellators Safer Through Tissue Containment Systems
- Reporting Problems Related to Laparoscopic Power Morcellators and Laparoscopic Power Morcellator Tissue Containment Systems to the FDA
- Contact Us
- Resources on FDA Actions Related to Using Laparoscopic Power Morcellators to Treat Uterine Fibroids
What Women and Their Health Care Providers Need to Know About Using Laparoscopic Power Morcellators to Treat Uterine Fibroids
Uterine sarcoma (a type of cancer) is more common in women undergoing surgery for uterine fibroids (noncancerous growths in a woman's uterus) than previously thought, and it can be hard to distinguish between a uterine sarcoma and a uterine fibroid before surgery with available tests. When laparoscopic power morcellators are used for myomectomy or hysterectomy in women with presumed uterine fibroids that are actually uterine sarcomas, the surgical procedure poses a risk of spreading cancerous tissue beyond the uterus, worsening a woman's chance of long-term survival.
The FDA estimates that a hidden uterine sarcoma may be present in approximately 1 in 225 to 1 in 580 women undergoing surgery for uterine fibroids based on published literature. The FDA also estimates that a leiomyosarcoma (a specific type of uterine sarcoma) may be present in approximately 1 in 495 to 1 in 1,100 women undergoing surgery for uterine fibroids based on recent studies. Before 2014, the clinical community estimated uterine sarcomas to be present much less often, in as few as 1 in 10,000 women undergoing surgery for uterine fibroids.
Several studies show that using a laparoscopic power morcellator during gynecologic surgery in women with hidden uterine sarcomas is associated with lowering their chances of long-term survival without cancer. While these studies have limitations, women who have had fibroid surgery with a laparoscopic power morcellator later found to have a hidden uterine sarcoma, have lower disease-free survival (less time without any sign or symptom of cancer after surgery), when compared to women who were treated with manual morcellation or without morcellation. In addition, there are data to suggest an increase in rate of occult sarcoma (cancer that cannot be identified during pretreatment evaluation) for women undergoing surgery for presumed fibroids.
The FDA recommends health care providers share this information with patients and warn against using laparoscopic power morcellators in gynecologic surgeries to treat patients with suspected or confirmed cancer and in women over 50 years of age having a myomectomy or hysterectomy for uterine fibroids.
Uterine sarcomas and uterine fibroids may have similar signs and symptoms, so it may be difficult to determine whether cells are cancerous. At this time, there is no reliable method for predicting or determining whether a woman with fibroids may have a uterine sarcoma. Patients should talk with their health care provider about preoperative screening and whether using a laparoscopic power morcellator for their gynecologic surgery is appropriate for them.
Health care providers and informed patients can work together to choose the best treatment approach based on known risk factors for uterine sarcoma (for example, age, exposure to pelvic radiation therapy, prior use of the drug Tamoxifen, and race). For some patients, the benefits of minimally invasive surgery with a laparoscopic power morcellator may outweigh the risks. These patients may include some younger women who wish to maintain their fertility.
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. The FDA previously issued the guidance, Product Labeling for Laparoscopic Power Morcellators recommending that laparoscopic power morcellator labeling include a statement that the device should only be used with a containment system.
The FDA granted marketing authorization for two tissue containment systems that are intended for use during gynecologic surgery and has now issued the draft guidance on Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures to provide recommendations that may help manufacturers develop test methods and acceptance criteria that will support additional premarket submissions. Legally marketed laparoscopic power morcellation tissue containment systems are intended to isolate and contain tissue that is considered benign (noncancerous). Based on non-clinical testing, use of a tissue containment system confines morcellated tissue within the containment system.
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 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.
Because of this increased risk, the FDA recommends use of laparoscopic power morcellation only in appropriately selected women undergoing myomectomy or hysterectomy and only if a tissue containment system is used. See the UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication for more patient and health care provider recommendations.
To find more information about FDA-cleared tissue containment systems for gynecologic surgery, go to the De Novo database or the 510(k) Premarket Notification database, type PMU in the Product Code field, and click Search.
Reporting Problems Related to Laparoscopic Power Morcellators and Laparoscopic Power Morcellators Tissue Containment Systems to the FDA
The FDA calls for patients, health care providers, and manufacturers to continue to report events associated with laparoscopic power morcellators and laparoscopic power morcellator tissue containment systems to the Agency. This information helps the FDA monitor the safety of marketed medical devices.
If you suspect a problem resulting from the use of a laparoscopic power morcellator or a laparoscopic power morcellator tissue containment system, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
If you have questions about this issue, please contact the Center for Devices and Radiological Health's Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
- Final Guidance: Product Labeling for Laparoscopic Power Morcellators
- FDA In Brief: FDA Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries
- 2020 Updated Safety Communication: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate
- 2020 Updated Safety Communication: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate
- FDA Statement: FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries
- 510(k) Summary More-Cell-System
- 510(k) Summary PneumoLiner
- De Novo Summary PneumoLiner
- 2014 Safety Communication
- 2014 Meeting Materials of the Obstetrics and Gynecology Devices Panel
- 2014 FDA Executive Summary from the Obstetrics and Gynecology Devices Panel