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Tissue Containment Systems[edit]

Tissue containment systems are devices that isolate and contain tissue during laparoscopic surgeries, using either power or manual morcellation techniques. These systems are designed to safely remove tissue during morcellation, a process where tissue, such as uterus tissue or fibroids, is cut into smaller pieces for easier removal. Tissue containment systems are crucial for preventing the spread of potentially unsuspected cancerous cells within the body during gynecological procedures such as hysterectomies or myomectomies.

Development and FDA Involvement[edit]

After receiving reports in December 2013 regarding the spread of an unsuspected cancer following the use of power morcellators in surgeries to treat fibroids, the United States Food and Drug Administration (FDA or US FDA) issued a safety communication in November 2014 warning against certain uses of power morcellators — specifically in treating uterine fibroids.[1]

The FDA estimates that about 1 in 350 women undergoing a hysterectomy or myomectomy for fibroids has an unsuspected uterine sarcoma.[2] The FDA's focus on improving safety measures in surgical procedures, particularly for power morcellation, led to a call to develop tissue containment systems.

In May 2023, the FDA provided final guidance that healthcare providers use tissue containment systems when using laparoscopic power morcellators.[3] Furthermore, they must ensure the laparoscopic power morcellator and tissue containment systems are compatible.[4]

Impact of FDA's Ban on Uncontained Morcellation[edit]

The FDA's 2014 warning and subsequent decision to ban "uncontained" morcellation in gynecologic laparoscopic surgery led to the use of power morcellation ceasing at many institutions. Physicians returned to performing open abdominal surgery with an increase in associated complications and a significant decrease in minimally invasive laparoscopic surgery.[5]

Laparoscopic procedures have been found to have fewer complications in appropriately selected patients, with advantages including less postoperative pain, faster recovery and shorter hospital stays compared to open surgery.[6][7]

In the following years, to promote minimally invasive laparoscopic surgery, the use of tissue containment solutions emerged as a means of preventing tissue spillage during tissue extraction.

Both contained manual morcellation and power morcellation in laparoscopic surgery have been adopted by physicians, with a growing percentage of manual morcellation procedures.[8]

A study in 2023 further supported the use of manual morcellation. Patients who had in-bag abdominal manual morcellation during laparoscopic myomectomy had shorter operation and morcellation times compared to those who had contained power morcellation, and costs were significantly lower.

FDA-Cleared Tissue Containment Systems[edit]

PneumoLiner, by Advanced Surgical Concepts Ltd., is a tissue containment system for use with certain laparoscopic power morcellators.[9]

Ark Surgical's LapBox is a tissue containment system for manual morcellation designed with a double wall for secure, enclosed morcellation. This next generation system also employs an easy-to-use delivery technology for improved control and maneuverability.[10]

The Alexis Contained Extraction System (CES) creates a contained environment for transabdominal and transvaginal tissue extraction during minimally invasive surgery.

Controversy – Procedures Are Still Performed Without a Containment System[edit]

Contained tissue extraction techniques have been developed in an effort to mitigate morcellation-related risks. However, data shows that most procedures, including power morcellation, are still performed without a containment bag.[11]

With hospitals focused on cost savings and an increased awareness of the potential for unsuspected cancer spread, surgeons have searched for low-cost, novel solutions. The use of commercially available solutions such as tissue containment bags or insufflated specimen bags have been adopted.[12]

These unapproved solutions have not undergone rigorous evaluation for cancer cell leakage. In fact, several clinical studies evaluating bag damage during surgery found evidence of leakage. There are many potential causes for this failure, including low-quality permeable bag material, punctures by surgical instrument, tear due to excessive pressure, or user error.

  1. ^ Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling." GAO-17-231. Published: February 07, 2017. Publicly Released: February 08, 2017. https://www.gao.gov/products/gao-17-231
  2. ^ Von Mühlenbrock, M., Navarrete-Rey, P., Kovoor, E., Guzman-Rojas, R., Troncoso, F., & Miranda-Mendoza, I. (2021). "Incidence of occult uterine sarcoma and other unexpected pathologies in patients having surgery for presumed myomas: A retrospective observational study." Journal of Gynecology Obstetrics and Human Reproduction, Volume 50, Issue 7, September 2021, 101992. https://www.sciencedirect.com/science/article/abs/pii/S2468784720303627
  3. ^ FDA. (2023, May). "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration Staff." Guidance Document. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-performance-assessment-tissue-containment-systems-used-during-power-morcellation
  4. ^ FDA. (2023, May 26). "UPDATE: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures." Final Guidance Issued. [Laparoscopic Power Morcellators]. https://www.fda.gov/medical-devices/surgery-devices/laparoscopic-power-morcellators
  5. ^ Güven, C. M., & Uysal, D. (2023). In-bag abdominal manual morcellation versus contained power morcellation in laparoscopic myomectomy: A comparison of surgical outcomes and costs. BMC Surgery, 23, 106. https://bmcsurg.biomedcentral.com/articles/10.1186/s12893-023-02007-5
  6. ^ American College of Obstetricians and Gynecologists. Choosing the Route of Hysterectomy for Benign Disease. Committee Opinion (CO) Number 701. June 2017. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/06/choosing-the-route-of-hysterectomy-for-benign-disease
  7. ^ Liu, F. W., Galvan-Turner, V. B., Pfaendler, K. S., Longoria, T. C., & Bristow, R. E. (2015). A critical assessment of morcellation and its impact on gynecologic surgery and the limitations of the existing literature. American Journal of Obstetrics and Gynecology, 212(6), 717–724. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4457589/
  8. ^ Dotson, S., Landa, A., Ehrisman, J., & Alvarez Secord, A. (2018). Safety and feasibility of contained uterine morcellation in women undergoing laparoscopic hysterectomy. Gynecologic Oncology Research and Practice, 5, 8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6208173/
  9. ^ Olympus Announces New FDA Guidance and Labeling Changes Affecting PneumoLiner, the Only 510(k)-Cleared Containment Device, March 13, 2020. https://medical.olympusamerica.com/articles/olympus-announces-new-fda-guidance-and-labeling-changes-affecting-pneumoliner-only-510k
  10. ^ Ark Surgical Receives FDA Clearance for the LapBox Tissue Containment Removal System for Manual Morcellation, September 13, 2022. https://www.prnewswire.com/news-releases/ark-surgical-receives-fda-clearance-for-the-lapbox-tissue-containment-removal-system-for-manual-morcellation-301622861.html
  11. ^ Cohen SL, Morris SN, Brown DN, Greenberg JA, Walsh BW, Gargiulo AR, Isaacson KB, Wright KN, Srouji SS, Anchan RM, Vogell AB, Einarsson JI. Contained tissue extraction using power morcellation: prospective evaluation of leakage parameters. Am J Obstet Gynecol. 2016 Feb;214(2):257.e1-257.e6. doi: 10.1016/j.ajog.2015.08.076. https://www.sciencedirect.com/science/article/abs/pii/S0002937815010248
  12. ^ Herman A, Duraiswamy N, Nandy P, Myers MR, Price V, Gibeily G, Hariharan P. In Vitro Leakage Testing of Tissue Containment Bags When Subjected to Power Morcellation Forces. J Minim Invasive Gynecol. 2020 Mar-Apr;27(3):655-664. doi: 10.1016/j.jmig.2019.05.006. https://pubmed.ncbi.nlm.nih.gov/31125722/
source: https://en.wikipedia.org/wiki/Draft:Tissue_Containment_Systems

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