FDA Approves Container Bag For Power Morcellator Procedures
Posted on Monday, August 1st, 2016 at 2:37 pm
The PneumoLiner, a tissue container bag to be used in morcellator procedures, has been approved by the U.S. Food and Drug Administration (FDA). The device is comprised of a containment bag and tube-like plunger that delivers the device to the abdominal cavity. Removed tissue will be placed in the bag and sealed to prevent the spread of cancerous cells.
About 1 in 350 estimated women that undergo a hysterectomy or myomectomy due to fibroids may have undetected uterine cancer. The FDA still warns against the dangers of morcellators, but is allowing the use of the PneumoLiner when the uterine tissue is not suspected to be cancerous, only for women without uterine fibroids being treated with a hysterectomy, and for some pre-menopausal women with fibroids who are still hoping to have children.
William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement, “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.”
If you have faced complications from a morcellator treatment and are looking for legal options, contact the attorneys of Williams Hart at (800) 220-9341.