April 27, 2020
National Center for Health Research’s Public Comments on Product Labeling for Laparoscopic Power Morcellators; Draft Guidance for Industry and Food and Drug Administration Staff
[FDA-2014-D-1804]
We are writing to express our views on the draft guidance on product labeling for laparoscopic power morcellators. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
We are disappointed that the FDA’s plan to update the 2014 recommendations for the labeling of laparoscopic power morcellators (LPMs) does not adequately strengthen the warnings.
We are particularly disappointed that the FDA is not planning to strengthen the black box warning. We strongly urge the following addition (noted in red below) in order to clarify that use of power morcellation can be dangerous for women under the age of 50 in addition to those over 50, and that power morcellators can be dangerous for women undergoing hysterectomies as well as those treated for uterine fibroids. One of the lessons of the current coronavirus pandemic is that when a warning specifies that older people are most at risk, that is misinterpreted to mean that younger adults are not at risk. That is not true for coronavirus and it is not true for the risks of power morcellation.
WARNING: Uterine tissue may contain unsuspected cancer. This is especially likely for women ages 50 and older, but has been documented for younger women as well. The use of laparoscopic power morcellators during fibroid surgery or hysterectomy 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.
Similarly, the text of the label should include the following caveats:
- That patients undergoing a hysterectomy may have undiagnosed uterine cancer that could be spread if power morcellation is used.
- That patients over 50 years of age with presumed fibroids have an increased risk of occult cancer, including uterine sarcoma. However, these risks have also been documented in women under 50.
- That the uncontained use of LPMs can spread benign uterine tissue (such as parasitic myomas and disseminated peritoneal leiomyomatosis) potentially requiring additional surgeries. Containment devices are intended to reduce the risk of spreading benign or cancerous uterine tissue, but have not been proven to reduce or eliminate that risk.
We are especially concerned that containment systems have not been tested in clinical trials to demonstrate their effectiveness at reducing the risk for cancerous tissue or benign uterine tissue to spread. For that reason, any reference to the use of a containment system should clearly state that they have not been demonstrated to reduce or eliminate risk. Until studies demonstrate that they are safer, such a claim should not be stated or implied.
We strongly agree that the label should also clearly state that malignancies cannot reliably be detected pre-operatively, as the draft guidance points out. The use of these devices should therefore be avoided during the removal of uterine fibroids, regardless of the age of the patient. In addition to this updated warning, an Informed Consent Checklist that is short and easy-to-understand should be signed by all patients and their physicians at least a week prior to surgery that might include power morcellation, and training and certifications should be required for physicians, before they can use power morcellators to ensure that risk mitigation techniques have been mastered.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.