The FDA cleared updated labeling requirements for the Olympus PneumoLiner for use with power morcellators. (Image from Olympus)
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women who have suspected fibroid tumors and are under 50 years of age.
Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by mincing them. In some cases, the procedure ended up seeding undetected malignant cells throughout the abdomen, drastically accelerating the cancer’s advance. The agency began requiring a black box warning on the devices in 2014.
The draft guidance released today recommends updated labeling to include contraindications and warnings, including:
- Laparascopic power morcellators should only be used in certain gynecologic surgeries with a compatible containment system for morcellated tissue.
- Uncontained power morcellation has been associated with the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis.
- Laparascopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy, and in uterine tissue containing suspected fibroids in patients who are post-menopausal, over 50 years of age, or who are candidates for en bloc tissue removal through the vagina or via a mini-laparotomy incision.
The draft guidance also warns that the risk of occult cancer, including uterine sarcoma, increases with age, particularly in women over 50. The agency wants healthcare providers to share this information with patients.
The FDA also announced it has cleared Olympus to update the labeling of its PneumoLiner containment system to state that it should only be used in women who have fibroids if they are pre-menopausal and under 50 years old. The agency approved the device in 2016 to contain tissue that is not suspected to be cancerous and targeted for morcellation. This device was initially only authorized for use in specific patient populations, including women without uterine fibroids undergoing hysterectomy and pre-menopausal women with fibroids who wish to maintain their fertility. Its initial labeling was required to carry warnings about the risks of morcellation during certain gynecologic procedures.
The likelihood of unsuspected cancer in women undergoing hysterectomy or myomectomy increases with age, according to the FDA.
“Ensuring the safety of women’s health devices, including (laparascopic power morcellators), remains a top priority for the agency,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “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. 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.”
You can read the updated draft guidance here.
