Guardenia™ Contained Extraction System is a novel, FDA-cleared medical device for manual extraction of tissue following laparoscopic multiport, robotic, or single port hysterectomy and myomectomy.
Guardenia is simple and easy to use. The tissue containment bag itself can be inserted through a standard 12mm trocar under pneumoperitoneum and provides far better retraction of the incision compared to it's nearest competitive device, increasing surgical working space by 50% with the same 2.5cm incision. Guardenia's unique built-in scalpel guard automatically conforms to the shape and size of the surgical incision, providing maximal protection of the containment bag and patient from scalpel laceration during the procedure without compromising working space.
This in-service video demonstrates the ease of use and steps to using Guardenia in gynecologic surgery.
Fair Balanced Statement to be incorporated into discussions, weighing risk / benefit:
Potential complications associated with the use of the Guardenia™ device are the same as those associated with the use of tissue or specimen bags, morcellation and laparoscopic surgery in general and include but are not limited to superficial lesions, injury to internal vessels, bleeding, hematoma, injury to the abdominal wall, injury to bowel, infection, peritonitis and spread of benign or malignant tissue.
