Draft:Tissue Containment Systems

Tissue Containment Systems
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
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. The FDA estimates that about 1 in 350 women undergoing a hysterectomy or myomectomy for fibroids has an unsuspected uterine sarcoma. 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. Furthermore, they must ensure the laparoscopic power morcellator and tissue containment systems are compatible.

Impact of FDA's Ban on Uncontained Morcellation
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.

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.

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.

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

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.

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
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.

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.

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.