Today, the FDA announced their approval for marketing of a new, first of its kind, containment system that can be used to potentially isolate uterine tissue during laparoscopic power morcellator surgery. It is noted in the announcement that the “Agency continues to warn against use of laparoscopic power morcellators for removal of uterus or uterine fibroids in the vast majority of women.” So even while approving this device, the FDA continues to warn against using Power Morcellators where cancer is present. In fact, The FDA is requiring the Ireland manufacturer of PneumoLiner to warn health care providers and patients that this medical device hasn’t been proven to reduce the risk of spreading cancer.
Our product liability attorneys have been investigating the power morcellator lawsuit for over the past year. This medical device is estimated by the FDA to contribute to the spread of unsuspected uterine sarcoma in approximately 1 in 350 women. Power morcellator devices have been used in hysterectomy or myomectomy surgeries. Visit our power morcellator lawsuit page to learn more about this.
The PneumoLiner is intended to contain morcellated tissue during surgery that doesn’t have suspected cancerous tissue. According to the FDA the PneumoLiner should only be used for patients undergoing a hysterectomy without uterine fibroids or pre-menopausal women with fibroids who want to maintain their fertility (myomectomy).
The medical device is made up 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.” The risks that were mentioned are the spreading of the morcellated tissue, injury to the surrounding tissue or organs, infection and prolongation of the surgery. In order for the device to be used physicians have to complete a validated training program.
There are a few label warnings being required by the FDA and they are as follows:
- “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.”
- 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.
As mentioned previously, our product liability lawyers are investigating the power morcellator lawsuit. We are happy to discuss questions about this recent announcement or the current litigation. Contact us today toll-free at 888-841-9623 or fill out our form on the power morcellator lawsuit page for a free case evaluation.