First Power Morcellator Containment Bag Wins FDA Approval, But Uterine Cancer Warning Stands
The U.S. Food & Drug Administration (FDA) has approved the first tissue container bag for use in certain uterine surgeries that involve the use of a power morcellator. However, the agency is still cautioning doctors to avoid uterine morcellation in the majority of women who require a hysterectomy or myomectomy (fibroid removal).
Power morcellators are used to cut up uterine tissue during minimally invasive hysterectomies and myomectomies in order to facilitate its removal via a small abdominal incision. In November 2014, the FDA warned that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids are found to have an unsuspected uterine sarcoma. Power morcellators may inadvertently disseminate cancerous cells outside of the uterus, resulting in the spread and upstaging of the disease.
PnuemoLiner Not Proven to Prevent Cancer Spread
The newly approved device, called PneumoLiner, consists of a containment bag and a tube-like plunger that positions the device into the abdominal cavity. The removed uterine tissue is placed in the bag and the bag is sealed and inflated.
According to the FDA, the bag was shown to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids. Stress testing demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use. However, PneumoLiner has not actually been been proven to reduce the risk of cancer spread during surgery. As such, its use has only been approved in limited circumstances:
- When uterine tissue is not suspected to be cancerous prior to surgery
- For women without uterine fibroids undergoing hysterectomy
- For pre-menopausal women with fibroids who want to maintain their fertility
The Pneumoliner label will state that use of the device is limited to physicians who have successfully completed the manufacturer’s validated training program. The label must also include the following boxed warning:
“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.”
Finally, the following contraindications will be listed:
- 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.
Legal Assistance Available for Victims of Morcellator Cancer
Dozens of women have filed power morcellator lawsuits since the FDA began investigating the potential for these devices to spread and upstage undiagnosed uterine cancers. If you or a woman you care about were diagnosed with advanced uterine cancer following morcellator surgery, please call 877-779-1414 to obtain the legal assistance you need.