Draft Guidance: Product Labeling for Laparoscopic Power Morcellators
On February 25, 2020, the FDA issued a draft guidance, Product Labeling for Laparoscopic Power Morcellators, proposing recommendations concerning the content and format for certain labeling information to better inform patients and health care providers of the device’s risks.
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 gallbladder, kidney, liver, and spleen removal surgery. They are also used in hysterectomy (surgical procedure to remove a women’s uterus) and myomectomy (surgical procedure to remove uterine fibroids which are noncancerous growths in the lining of a women’s uterus).
Laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to 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 Containment Systems
- Considerations for Manufacturers of Laparoscopic Power Morcellators
- Using Real-World Data to Compare Treatments for Uterine Fibroids on Patient Outcomes
- Reporting Problems Related to Laparoscopic Power Morcellators 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 the lining of a women’s uterus) than previously thought, and it can be hard to distinguish between a uterine sarcoma and a uterine fibroid prior to 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 currently 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 recent publications. The FDA also estimates that a leiomyosarcoma (a specific type of uterine sarcoma) may be present in approximately 1 in 495 to 1 in 1100 women undergoing surgery for uterine fibroids based on recent studies. Prior to 2014, the clinical community estimated uterine sarcomas to be present much less frequently, 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.
Uterine sarcomas and uterine fibroids may have similar signs and symptoms. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.
The FDA recommends health care providers share this information with patients and warns against using laparoscopic power morcellators in gynecologic surgeries to treat patients with suspected or confirmed cancer, and in women over age 50 having a myomectomy or hysterectomy for uterine fibroids.
Health care providers and informed patients can work together to choose the best treatment approach based on known risk factors for uterine sarcoma (e.g., 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. Legally marketed laparoscopic power morcellation containment systems are intended to isolate and contain tissue that is considered benign. Based on testing and clinical data, use of a containment system confines morcellated tissue within the containment system.
Laparoscopic power morcellation (with a compatible containment system) should only be used in the appropriate patient population, women without uterine fibroids undergoing hysterectomy and pre-menopausal women under age 50 with fibroids.
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.
Due to this increased risk, the FDA continues to recommend use of laparoscopic power morcellation only in appropriate women undergoing myomectomy or hysterectomy. In addition, the FDA now recommends that when morcellation is appropriate, only contained morcellation be performed.
Laparoscopic power morcellators should be used with compatible containment systems. Currently, 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. Laparoscopic power morcellators marketed in the U.S. for gynecologic surgery, with the exception of the ROTOCUT G1 Electromechanical Morcellator marketed by Karl Storz Endoscopy-America, Inc., are compatible with the available containment system.
To find more information about FDA-cleared tissue containment systems, 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 recommends that manufacturers of laparoscopic power morcellators with a general indication or a specific gynecologic indication include more information in their device’s labeling to inform health care providers and patients about the risk of these devices are used on uterine tissue.
Manufacturers have added the information below to the labeling on their devices:
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy;
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision; and,
- A specific boxed warning that states that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
New Labeling Recommendations in the Draft Guidance, Product Labeling for Laparoscopic Power Morcellators
- The risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50 years of age. This information should be shared with patients when considering surgery with the use of these devices.
- Uncontained power morcellation has been associated with the spread of benign uterine tissue, i.e., parasitic myomas and disseminated peritoneal leiomyomatosis.
- Laparoscopic power morcellators should only be used with a containment system. The containment system should be compatible with the laparoscopic power morcellator.
In addition, the draft guidance also recommends a revision to the second contraindication such that Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are:
- post-menopausal or over 50 years of age, or
- candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.
The FDA is collaborating with Duke Clinical Research Institute, patients and patient advocacy groups, health care providers, professional associations, and other federal agencies on the COMPARE-UF registry to gather real-world data from women having any treatment for uterine fibroids. Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
The registry will collect information about clinical outcomes, quality of life, need for additional procedures, and issues related to pregnancy for women aged 18-54 through three years post-fibroid treatment. This information will be used to help future patients, clinicians, and others make the most informed decisions about the best type of treatment for each patient's situation.
The FDA calls for patients, health care providers, and manufacturers to continue to report events associated with laparoscopic morcellators to the Agency; such information is critical in helping us learn as much as possible about the adverse events associated with these devices.
If you suspect a problem resulting from the use of a laparoscopic power morcellator, 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.
- 2020 Updated Safety Communication
- FDA Statement: FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries
- 510(k) Summary PneumoLiner
- 2014 Safety Communication
- 2014 Meeting Materials of the Obstetrics and Gynecology Devices Panel
- 2014 FDA Executive Summary