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Morcellation Containment System Guidance Stresses Leak Detection, Prevention

 
• By Elizabeth Orr

A new US FDA draft guidance explains what the agency wants to see in submissions for the devices, which are used to contain potentially cancerous tissue during laparoscopic surgery. Strength, permeability and leakage testing are all key considerations.

Sign outside of FDA's headquarters in White Oak, MD
• Source: Alamy

New draft guidance from the US Food and Drug Administration lays bare the types of non-clinical testing the agency hopes to see in support of premarket submissions for gynecologic and general laparoscopic power morcellation containment systems.

The systems are used during laparoscopic power morcellation procedures, particularly gynecological procedures such as hysterectomy or the removal of uterine fibroids. Tissue removed during those procedures may include undetected cancerous...

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