FDA Seeks to Make Laparoscopic Power Morcellators Safer
The US Food and Drug Administration (FDA) on Tuesday took a few different steps to make laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, as the devices have been linked to cancer.LPMs are used during minimally invasive surgeries to cut tissue into smaller pieces so it can be removed through a small incision site, according to FDA. The devices can be used in a variety of surgeries, including various gynecologic surgeries such as a surgical procedure to remove uterine fibroids from a woman’s uterus.
“When LPMs are used in surgeries where unsuspected cancerous tissue is present, there is a risk that morcellation could spread cancerous tissue throughout the body, decreasing a woman’s long-term survival,” FDA said.
A Government Accountability Office report in 2017 raised questions about FDA's handling of reports linking power morcellators to the spread of unsuspected uterine sarcomas.
The actions taken Tuesday include the release of draft guidance calling for safety information to be added to LPM labels, updated labeling for one type of containment system, known as the PneumoLiner, and an updated safety communication recommending that an LPM only be used in certain gynecologic surgeries with a compatible containment system.
The 6-page draft guidance, which provides an update on a guidance from 2014 on LPM labeling, also calls for further safety information to be included in the labels, including contraindications and warnings highlighting the following information:
- “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.”
- LPMs should only be used with a compatible containment system.
- LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
- LPMs “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.”
Meanwhile, the updated labeling for the PneumoLiner containment system is intended to better define the appropriate patient population for the device, noting that it should only be used in women who have fibroids if they are pre-menopausal and under 50 years old.
The updated safety communication, previously released in 2014, explains how FDA recommends using LPMs for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the US for use during laparoscopic power morcellation and performing these procedures only in appropriately selected patients.
FDA Statement
Product Labeling for Laparoscopic Power Morcellators: Draft Guidance
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate