In final guidance, FDA advises boxed warning for power morcellators

Regulatory NewsRegulatory News | 04 January 2021 |  By 

A boxed warning and more explicit and detailed information about the risks associated with laparoscopic power morcellators should be included in labelling of the gynecologic surgery device, according to newly finalized guidance from the US Food and Drug Administration (FDA).
The guidance follows a February 2020 draft version issued in the wake of “numerous” published reports and Medical Device Reports (MDRs) describing “iatrogenic disseminarion, implantation, and subsequent growth of unsuspected neoplastic tissue within the peritoneal cavity following laporascopic morcellation of uterine tissue” presumed to contain uterine fibroids, according to the guidance. (RELATED: FDA seeks to make laparoscopic power morcellators safer, Regulatory Focus 25 February 2020)
This final document updates an earlier 2014 guidance to recommend that manufacturers of laparoscopic power morcellators (LPMs) include more specificity about how the risk of the devices increases with the age of patients. Labels should now also give detailed information about the risk of spreading benign uterine tissue and make clear that LPMs should always be used with containment systems. (RELATED: Fears over device surveillance amid talk of deregulation, Regulatory Focus 20 June 2017)
By way of example, FDA included text of a sample warning, to be bounded within a black box, reading, “WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
Labeling for physicians using LPMs should also contain information about specific contraindications for their use, including use when malignancy is known or suspected and for removal of suspected fibroids in post-menopausal patients or those over 50 years of age, or for whom en bloc tissue removal is an option. The guidance also provides examples of warnings related to these contraindications, as well as other considerations in using LPMs.
Concurrent with the final guidance, FDA also issued an updated safety communication aimed at health care providers and patients detailing considerations for safe us of LPMs during gynecologic procedures.
“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 the director of FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, MD, JD in a press statement. “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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Tags: devices, FDA, US

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