The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems used with gynecological and other types of laparoscopic power morcellators (LPMs). The guidance is meant to ensure containment systems are reasonably designed to catch cancerous tissue to prevent its spread.
The agency finalized the guidance less than a year after releasing the draft version for comment. FDA notes that LPMs may increase the risk of spreading cancer cells and can also spread benign uterine tissue that could require additional surgery due to abdominal pain and distension, as well as abscesses and infections. (RELATED: Draft guidance outlines FDA’s testing requirements for tissue containment systems, Regulatory Focus, 22 June 2022)
“While a tissue containment system cannot prevent all cases of tissue spread, as some cases may occur without morcellation or due to manipulation of the tissue before it is placed into the tissue containment system, it can provide an important mitigation for this risk,” said FDA. “Tissue containment systems should only be used with compatible LPMs that have received FDA marketing authorization.”…
