On April 17, 2014, the U.S. Food and Drug Administration (FDA), released a safety communication discouraging the use of laparoscopic power morcellation for removal of the uterus or uterine fibroids.  The basis of their concern was the potential risk of inadvertent spread of undiagnosed leiomyosarcoma tissue.  Although studies are small and flawed, if morcellation occurs whether via electronic power morcellation at laparoscopy, or cold knife morcellation at the vagina, the disease free period and overall survival are thought to be decreased.

While many hospitals and hospital systems throughout the United States immediately called for a moratorium on electronic power morcellation, many institutions have developed an improved informed consent policy.  Unfortunately, yielding to the FDA safety communication, Johnson & Johnson, one of the leaders in electronic power morcellation, halted world-wide sales, distribution and promotion of their power morcellation systems. 

The FDA originally quoted a risk of one in three hundred and fifty-one patients.  At subsequent FDA hearings, a more robust evaluation of the literature noted a more likely risk of over one in eight thousand.  Despite the more thorough research, on November 24, 2014, the FDA released a statement recommending a boxed warning to provide informed consent and a warning against the use of laparoscopic power morcellation to treat uterine fibroids – “Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal through the vagina or mini-laparotomy”.

In light of the latest FDA news release, one must question our long term ability to perform a laparoscopic myomectomy.  It is clear that this will not only affect minimally invasive gynecologic surgeons in the United States, but will become a worldwide concern as well.

This discussion centers on the current options available to fibroid extraction and how electronic power morcellation can be performed despite the FDA warnings.