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See today's BioWorld MedTech
Home » FDA wraps up morcellation containment bag guidance, containment use still down
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FDA wraps up morcellation containment bag guidance, containment use still down

May 30, 2023
By Mark McCarty
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
BioWorld MedTech Regulatory Cancer U.S. FDA

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