The Food and Drug Administration has announced that it will allow 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.
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.
However, Dr. William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, warned, “We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”
The FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If morcellation is performed on these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
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, and 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.
“The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option, and only if patients have been appropriately informed of the risks,” continued Maisel. “However, the device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”
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.