Sales of Power Morcellator Suspended Pending Review

Washington, DCIn response to a safety bulletin issued by the US Food and Drug Administration (FDA) April 17, pharmaceutical and device giant Johnson & Johnson (J&J) has suspended sales of a device used in Laparoscopic Power Morcellation, until more information can be gathered and analyzed.

It’s a global suspension, although the manufacturer is not recalling the power morcellators. The FDA, according to Reuters (4/30/14), hasn’t issued a recall, either - given that the US drug and medical device authority still holds the view that for some patients in need of treatments for fibroids, the minimally invasive, laparoscopic uterine surgery via power morcellator remains the most appropriate.

Pundits believe that laparoscopic power morcellation hysterectomy, and related treatments for the removal of fibroids, will remain once the medical community and the FDA better define the role of the procedure. However, it might wind up with a black box warning.

Laparoscopic Power Morcellation is a procedure whereby non-cancerous fibroids, or growths on the uterine wall, are cut and removed through a small incision. It should be noted that fibroids are common and don’t prove a problem for the majority of women. For many, however, fibroids can be very painful and require removal in an attempt to obtain relief from pain and discomfort. With painful fibroids that recur, a hysterectomy often results.

Minimally invasive surgery has become the bastion of the medical community, given advancements in technology and the discovery years ago that smaller, less-invasive surgery requires less recovery time, minimizes complications and speeds healing - thereby freeing up beds in hospitals.

The problem has been, for some, that a simple procedure for the removal of laparoscopic fibroids can become much more serious given the presence of undetected cancer.

Power morcellation fostered the spreading of undetected cancer

That’s what happened to anesthesiologist Amy Reed. According to the Philadelphia Inquirer (4/19/14), Reed underwent fibroid removal and a hysterectomy in Boston, and soon after developed stage-four leiomyoscarcoma. The aggressive cancer has since required Reed to go through extensive surgery and five of an expected six rounds of chemotherapy in an attempt to eradicate the cancer from the 40-year-old mother of six.

Reed’s husband, cardiothoracic surgeon Hooman Noorchashm, noted in comments posted at Philly.com (4/19/14) that there was no evidence that the cancer had spread prior to the laparoscopic power morcellation hysterectomy. Power morcellation is a procedure whereby a specialized tool is inserted through a small incision and a rotating tip cuts away fibroids and fibrous tissue from within.

The problem, say critics, is that the procedure has the potential to spray cancerous cells that had thus far been confined, out to a wider area where they could further spread. Noorchashm told the Inquirer that there had been no evidence of the spread of cancer before the power morcellation procedure.

According to the FDA, an analysis determined that one in 350 women who undergo a hysterectomy or laparoscopic power morcellation myomectomy for the removal of what are believed to be fibroids, are not even aware they carry a uterine sarcoma. Thus, the procedure involved in the sectioning of fibroids without making an attempt to contain errant fibroids and cells, has the potential for further spreading of cancer to the abdominal cavity from within.

According to the report, there are alternatives to power morcellation to remove fibroids. A spokesperson for Temple University Hospital, for example, noted in a statement back in February that the facility does not have a power morcellator available - and if morcellation was employed, it would be undertaken manually with a scalpel and contained within an isolation bag.

Brigham and Women’s Hospital, where Reed was treated, is amongst a growing collection of hospitals that have begun to restrict the use of morcellation.

It remains a growing concern that what were thought to be cutting-edge advancements in medicine, turn out to be dangerous medical procedures. While it may be too soon to define power morcellation as such, nonetheless, actions undertaken by various hospitals, the FDA and the manufacturer of the power morcellator ensures that the procedure will be re-defined by the medical community, before it is re-introduced.

According to the American Congress of Obstetricians and Gynecologists, 11 percent of the 500,000 hysterectomies each year in the US involve morcellation and/or laparoscopic power morcellation hysterectomy.