In an effort to make the use of laparoscopic power morcellators a safer and more effective choice in gynecologic surgeries, the FDA has released a statement that it will be putting a handful of strategies and recommendations in place.
In an effort to make the use of laparoscopic power morcellators (LPMs) a safer and more effective choice in gynecologic surgeries, the FDA has released a statement that it will be putting a handful of strategies and recommendations in place.1,2
The efforts include an updated draft guidance document with specific safety information to product labeling for LPMs, marketing authorization for updated labeling of the PneumoLiner containment system, and a Safety Communication that will allow LPMs to only be used in select surgeries with an LPM-compatible containment system.
The updates follow findings demonstrating significant risks with the use of LPMs during surgery. Data have indicated that cancerous tissue may be present in uterine fibroids presumed to be benign.3 When LPMs are used in surgeries where unsuspected cancerous tissue is present, morcellation could potentially spread cancerous tissue throughout the body, thereby decreasing long-term survival outcomes.
“We believe that the inclusion of accurate and detailed information in the labeling for LPMs, such as what is recommended in the draft guidance, will help both healthcare providers and patients understand the risks of using these devices, and aid in their decision to determine whether morcellation could be appropriate for them,” the FDA stated in a press release.
The agency has taken steps in prior years, citing the assistance of expert opinions, issuing an FDA guidance to recommend adding safety statements to the labeling for LPMs, and providing up-to-date information of LPMs in gynecologic surgery on the FDA’s website.
In its recent announcement, the FDA stated that it would issue a draft guidance proposing to update their recommendations regarding the content and format of certain labeling information for LPMs; this would include a boxed warning, contraindications, and warnings regarding the risk of LPM use.
The risks to include are: the risk of occult cancer, including uterine sarcoma, especially in women >50 years old; the spread of parasitic myomas and disseminated peritoneal leiomyomatosis with uncontained power morcellation; to only use a LPM-compatible containment system; that LPMs are contraindicated in gynecologic surgery, in which tissue to be morcellated is known or suspected to be cancerous; and that LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in postmenopausal patients or those who are >50 years old, or are eligible for en bloc tissue removal.
In 2016, the FDA approved PneumoLiner, a tissue containment system, to be utilized only in specific patient populations undergoing gynecologic surgery: women without uterine fibroids undergoing hysterectomy and premenopausal women with fibroids who wish to maintain their fertility.
In its latest statement, the FDA stated that it provided marketing authorization for the PneumoLiner containment system with updated labeling. This now includes a statement that the device should only be used in women who have fibroids if they are premenopausal and <50 years old.
“The likelihood of unsuspected cancer in women undergoing hysterectomy or myomectomy increases with age such that the benefit-risk profile of using LPMs is worse in older women when compared to younger women,” the FDA stated in a press release.
In its third action item, the FDA issued an updated Safety Communication to provide patients and healthcare providers with information related to LPM-associated risks. The updated statement now includes a recommendation to be used in certain surgeries with an LPM-compatible containment system. The Safety Communication is also designed to include recommendations for those considering the use of LPMs to determine whether or not the device is appropriate to use.
“In taking these actions and making these recommendations, we considered available scientific information pertaining to the risk of spreading uterine tissue with uncontained power morcellation during gynecologic surgeries,” the FDA stated in the press release. “We will continue to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and are committed to continued communication to the public regarding our current thinking.”
These guidelines do not apply to LPMs that are specifically used for non-gynecologic surgery nor do they apply to hysteroscopic morcellators.
After the draft is finalized, it will override the FDA’s guidance document on LMPs that was published on November 25, 2014. All comments on the draft guidance are due by April 27, 2020.