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FDA Study Highlights Variability in Tissue Containment Bag Performance Under Morcellation Forces
A peer-reviewed study conducted by researchers at the U.S. Food and Drug Administration (FDA) evaluated the performance of commercially available tissue containment bags under conditions simulating laparoscopic power morcellation. The in vitro study assessed seven legally marketed tissue containment bags using dye and bacteriophage penetration testing to determine their ability to prevent leakage of fluid and cell surrogates. The results demonstrated significant variability i
Ark Surgical
Mar 19


Containment Is a Governance Decision: New Institutional Risk Review Published
Laparoscopic morcellation used in hysterectomy and myomectomy procedures remains an important tool in minimally invasive gynecologic surgery. However, tissue fragmentation without effective containment may disseminate malignant or viable tissue within the peritoneal cavity, with potential implications for oncologic outcomes, benign disease burden, informed consent defensibility, and institutional liability exposure. In an era of heightened scrutiny around tissue disseminatio
Ark Surgical
Feb 23


Closing the Containment Gap: Protecting Patients in Gynecologic Surgery
Society of Gynecologic Oncology Newsletter In 2014, the U.S. Food and Drug Administration (FDA) issued a safety communication cautioning against uncontained laparoscopic power morcellation for hysterectomy and myomectomy due to the risk of spreading unsuspected uterine malignancy. Hospitals responded by removing powered devices from operating rooms. But in many cases, this shift simply replaced power with manual morcellation through small abdominal or vaginal incisions — ofte
Ark Surgical
Oct 1, 2025


LapBox: Advancing Contained Tissue Extraction with a Novel Technological Design
July 2025 DOI: 10.13140/RG.2.2.21948.76162 Authors: Shabnam Gupta Brigham and Women's Hospital Abstract Contained tissue extraction is a...
Ark Surgical
Jul 28, 2025
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