The FDA has announced a series of actions aimed at limiting the use of power morcellators in gynecologic surgeries—such as recommendations that they only be used in certain laparoscopic procedures, and that they always be used with equipment designed to contain the spread of any minced-up tissue.
This includes a revised contraindication warning against their use in women over age 50. Previous contraindications included peri- or post-menopausal women, as well as those who could have their tissue removed via a different surgical route.
The agency also updated the labeling and appropriate patient populations for such an add-on containment device—Olympus’ PneumoLiner system, which received de novo clearance in 2016 and remains unchanged—to better tailor its use to pre-menopausal women, under age 50, who have uterine fibroids.
According to the FDA, the chances of a fibroid harboring unsuspected cancerous tissue, such as sarcomas that could be spread and upstaged through an uncontained morcellation procedure, increases with age and provides a poorer risk-benefit profile in older women.
The PneumoLiner includes a containment bag that seals around the area where tissue will be removed to stop any pieces from being spread throughout the abdominal cavity. Previously it had only been authorized for specific patients and with warnings that patients and healthcare providers be aware of the risks of the procedure.
The FDA also issued a new draft guidance that updates its 2014 recommendations for manufacturers’ labeling of power morcellators, saying the devices should carry more detailed warnings about their use.
This would include information about the risks of uterine sarcoma, particularly in women over 50, and that uncontained morcellation has been associated with the spread of benign, yet harmful tissues as well, such as parasitic myomas.
The FDA’s 2014 final guidance on morcellator labeling included a black box warning about the risks of hidden cancer tissue within uterine fibroids.