FDA allows the first tissue containment system for use with certain laparoscopic power morcellators

Advanced Surgical Concepts, an Irish comapny, announced that the U.S. Food and Drug Administration (FDA) permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer, Advanced Surgical Concepts, to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.

The PneumoLiner is intended to be used only in a limited patient population, including women without uterine fibroids undergoing hysterectomy and some pre-menopausal women with fibroids who want to maintain their fertility; a small number of women may find, after consultation with their doctor, that laparoscopic power morcellation is an appropriate therapeutic option compared to more invasive surgery. For these women, the device is intended to isolate and contain tissue that is considered to be non-cancerous before surgery even if that tissue is subsequently determined to be cancerous.

The device consists of a containment bag and a tube-like plunger to deliver the device into the abdominal cavity where the tissue to be removed is placed in the bag and the bag is sealed and inflated. Inflation allows for the creation of a working space around the tissue and visualization during morcellation to help prevent breakage of the containment bag by the morcellator tip or other surgical instruments. It was tested in laboratory settings to simulate actual use and worst-case scenario conditions. The containment bag was found to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids, and other testing determined that the inflated bag provided adequate space for surgeons to perform morcellation with good visualization. Stress testing to evaluate the bag’s mechanical strength demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use.

Risks associated with the PneumoLiner device include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections and a prolongation of the surgical procedure. The required labeling for the device must state that use of the device is limited to physicians who have successfully completed the company’s validated training program.

The press release can be found from Advanced Surgical Concepts by clicking here.