The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications recommending contained morcellation when morcellation is appropriate, as well as draft guidance on revised labeling. Laparoscopic power morcellators (LPMs) had been the subject of significant safety concerns when used in certain gynecologic procedures that had led to a dramatic decline in use in recent years. FDA’s revised position points the way to safe use of these devices in women for whom power morcellation is advisable.
Updated safety recommendations
On February 25, 2020, FDA released an updated safety communication on the safe and effective use of laparoscopic power morcellation for gynecologic procedures. In a departure from earlier more extensive safety warnings, the agency now states that power morcellation with use of a containment system to isolate tissue that is considered benign can mitigate risk for spreading of unsuspected cancer. The agency’s new position is stated as follows:
The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the U.S. for use during laparoscopic power morcellation and performing these procedures only in appropriately selected patients.
FDA further states that it “continues to encourage development of innovative ways to better detect uterine cancer and the development of containment systems designed for gynecologic surgery,” noting there is only one such containment device cleared. It is noted that the safety communications and guidance (described below) were released on the same day that the FDA cleared an updated version of the PneumoLiner containment device in a 510(k) clearance (previously cleared via de novo request in 2016).
Draft Guidance on labeling
The agency simultaneously issued a Draft Guidance, Product Labeling for Laparoscopic Power Morcellators (“Draft Guidance”). The Draft Guidance when finalized will supersede the existing guidance document — Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators (2014) (“2014 Guidance”). The Draft Guidance retains the same recommended Boxed Warning and two Contraindications as the 2014 Guidance, with the exception that the FDA now recommends that Laparoscopic power morcellators be contraindicated for removal of uterine tissue containing suspected fibroids in patients who are post-menopausal or over 50 years of age, rather than peri-or post-menopausal. This is an important distinction, as the term “peri-menopausal” is not well-defined and had led to significant confusion in the medical community regarding which patients were appropriate candidates for morcellation.
Further, the Draft Guidance proposes the following additional labeling recommendations:
- 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.
Whereas the 2014 Guidance recommended specific language, the Draft Guidance presents such language as an “example,” potentially allowing for possible differences in wording.
FDA advises current manufacturers of laparoscopic power morcellators that fall under the guidance to:
1) add the information to their labeling; 2) submit both the current labeling and revised labeling to CDRH; and 3) provide updated labeling to purchasers for LPMs that have already been distributed.
FDA notes this may be via an “add-to-file” to the existing 510(k) rather than as a new 510(k).
FDA is accepting comments on the Draft Guidance through April 27, 2020.
While today’s announcements and the Draft Guidance add additional recommended Warnings to the labeling of subject morcellators, these modifications appear intended to encourage use along with containment in appropriately selected patients. Further, they clarify the appropriate patient population by eliminating the ambiguous term “peri-menopausal” from the contraindications, and adding an easier-to-follow age restriction.
Laparoscopic morcellator manufacturers should consider revisions to labeling to conform with this new guidance. Other stakeholders are encouraged to comment on the Draft Guidance.
We have been closely tracking and will continue to track FDA’s regulation of power morcellators. Please contact us if you need assistance with product development, labeling, compliance, or other regulatory issues.
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