Power Morcellator Recall Due to Cancer Concerns
the MPR take:
Johnson & Johnson has announced that it is initiating a worldwide voluntary recall of its Ethicon power morcellators due to uncertainty regarding the risk-benefit assessment associated with the use of the device in the removal of fibroids. Earlier this year the FDA issued a statement discouraging the use of laparoscopic power morcellation for the removal of the uterus or uterine fibroids in women based on an analysis of currently available data. Later, an FDA advisory panel also stated that there was no guarantee that undetected cancer could not be spread to other parts of a woman's body during use of laparoscopic power morcellation for uterine fibroid removal or hysterectomy. Johnson & Johnson suspended sales of the power morcellators in April 2014.
J&J's Ethicon unit in April suspended sales and distribution of the devices while their role in treating symptomatic fibroid disease is reviewed by the U.S. The FDA had advised doctors not to use the devices pending further review. On Thursday, J&J will take the further step of reaching out to ...
READ FULL ARTICLE From Reuters