Power Morcellators to be investigated by GAO
According to MassDevice, the Government Accountability Office has announced that it will investigate laproscopic power morcellators in order to assess their safety and regulatory issues. Power morcellators have been a major subject of federal scrutiny for the past year.
What Are Laproscopic Power Morcellators?
Laproscopic power morcellators use small blades to break up tissue masses into smaller fragments for laproscropic removal.
In the past, these devices have often been used in the removal uterine fibroids; however, research has shown thif the patent has an undetected cancerous growth, power morcellation procedures can cause the cancer to spread.
It is unclear what actions the Government Accountability Office may take following their investigation.
FDA Adds Black Box Warning to Morcellators
Last November, the U.S. food and Drug Administration (FDA) ordered that laproscopic power morcellators carry a black box warning label addressing the potential spread of undetected cancers.
Black box warnings are the most severe warning a product can carry and is reserved for products that have been associated with adverse events which could lead to serious injury or death.