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FDA Finalizes Guidance for Power Morcellators

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FDA Finalizes Guidance for Power Morcellators 2

Power morcellators can be safely used for some gynecologic surgeries, according to recent guidance from the US Food and Drug Administration (FDA), but doing so requires careful patient selection and use of a legally marketed tissue containment system.

The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.

In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “Candidates for removal of tissue (en bloc) through the vagina or via a mini-laparotomy incision,” the agency said.

The safety communication, which was issued on December 29, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on December 29.

Risk of Disease Spread

Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.

Even among women who do not have malignant uterine tissue, containment is important. The agency notes an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.

In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.

“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough pre-operative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”

“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”

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