On July 10 and July 11, 2014, the US Food and Drug Administration's (FDA) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to evaluate the risks and benefits of the use of laparoscopic power morcellators during minimally invasive hysterectomy for symptomatic uterine fibroids and myomectomy.
The discussion at this meeting demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma; the risk of disseminating unsuspected malignant tissue while using power morcellation devices; and methods to mitigate this risk.
The company believes that Ethicon morcellation devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.
Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices s the appropriate course of action at this time until further medical guidelines are stablished and/or new technologies are developed to mitigate the risk.
The FDA has been notified of this letter.