The U.S. Food and Drug Administration (FDA) has issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus (Hysterectomy) or uterine fibroids (Myomectomey) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas beyond the uterus.
Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellaton is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long term survival.
The FDA urged doctors to stop using power morcellators for uterine fibroid removal, and earlier this month an FDA advisory committee split on deciding whether to recommend severe power morcellator safety warnings or a total power morcellator recall. The committee agreed, however, that there was no known way to make morcellation for uterine fibroid removal safe. – See more at: http://www.aboutlawsuits.com/johnson-ethicon-morcellator-recall-68708/#sthash.XRGrg0Yw.dpuf
In face of mounting concerns about the risk of laparoscopic power morcellators spreading cancer concerns during the uterine fibroid removal, Johnson & Johnson’s Ethicon division announced that it is recalling all of the devices they have manufactured in recent years, and will be getting out of the power morcellator business.
The Strick Injury Law and Mediation are reviewing potential lawsuits for women throughout the United States who have been diagnosed with the spread of aggressive cancer following a laparoscopic hysterectomy or uterine fibroid removal surgery where a power morcellator was used.
