Based on an analysis of currently available data, 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. At this time, the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.
“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,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “This new 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.”
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, Maisel 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 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.
To alert women and health care providers to the risks associated with power morcellation of uterine tissue, the labeling for PneumoLiner must include the following boxed warning, which is similar to the recommended warning for laparoscopic power morcellators:
- “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
The labeling must also contain the following important contraindications regarding the limited patient population in which the device is to be used:
- Do not use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
- Do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.
The FDA continues to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and will communicate publically on any developments that are pertinent to the agency’s thinking on this issue.
The FDA reviewed PneumoLiner through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind. The device is manufactured by Advanced Surgical Concepts Ltd. located in Bray, Ireland.