Morcellation defense doesn't bode well for women's health

by By: Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD

Published Jul. 7, 2016, 4:45 p.m. ET

Recently, an astonishing editorial was published by the 2015 president of the American Association of Gynecologic Laparoscopy (AAGL) - Dr. Arnold Advincula, also serves as Professor and chief of Gynecology at Columbia University Medical Center.

The statement laments the recent demise of morcellation in gynecologic surgery, claiming that a "decision-tree analysis" predicts "fewer overall deaths for laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy."

About the FDA's April 2014 advisory against morcellation in women's health, the professor states to his colleagues that "Whether we liked it or not, minimally invasive gynecologic surgery as we knew it had changed forever on that fateful day."

Later in the article, Professor Advincula states "it would seem that the damage done to minimally invasive gynecologic surgery over the past 2 years is irreparable."

These are remarkable statements from a leader in gynecological surgery – because it appears that the demise of morcellation has cause a lot of discomfort for the profession.

But what is the source of this discomfort? Is it the recognition that the specialty was doing something wrong for over 2 decades? Or is it that a comfortable and lucrative practice pattern has been virtually eliminated?

The professor goes on to describe the "silver linings" for minimally invasive gynecologists, in this tragedy for their specialty. Three are delineated.

First, thatthey"have updated estimates for incidence of unsuspected leiomyosarcoma." He seemingly rejects the multiple studies that now put the risk of occult uterine cancers at one in 350, consistent with the FDA's estimate. He prefers the incidence of 2 in 8,720 (0.023%) to 1 in 1,550 (0.064%) – delineated by his colleagues with a professional stake in defending morcellation. As if the one-in-however-many incidence could justify accepting an avoidable mortality hazard when a surgeon emulsifies a potentially cancerous tumor inside a woman's body. This is an unethical stance towards the women at risk – no matter how "minority" a subset they might be.

Second, that they "are speaking with the FDA"- and,specifically, that the AAGL is guiding the Center for Devices and Radiological Health (CDRH) to a more correct orientation towards their specialty. Of course, this relationship is emblematic of the problem with the FDA's CDRH. Industry and the medical profession have an inordinate sway over the agency's actions, while the harmed "go home, go bankrupt or die."The public holds virtually no sway at CDRH. In truth, the campaign against morcellation was unique not because of the ultimate CDRH action, but because the catastrophe impacted us, a family of doctors, who knew exactly what the problem is, how to speak about it, and to whom.

Third, that they "have been innovating techniques" for contained morcellation. The professor admits that current "containment systems" have about a 10% leakage rate – so one out of 10 women remain susceptible to the possibility of a cancer spreading.

The article then goes on to praise the FDA's recent action in approving a containment device known as the "Pneumoliner". But he admits, as did the FDA, that "It is important to note, however, that it has not been shown to reduce the risk of spreading cancer during this procedure." So, in effect, without any clinical trials or demonstration of oncological safety both the CDRH and gynecological surgeons are endorsing a product, which may or may not prevent the spread of morcellated tumors. One is left wondering whose wife, daughter, sister or mother will be the guinea pig in this FDA sanctioned experiment.

But most disturbing, is that not once does the editorial mention the women whose lives were prematurely or unnecessarily lost to an upstaged cancer using an incorrect surgical practice for 20 years.

Is this professional hubris? Or, is it simply suboptimal education in correct surgical technique and medical ethics? Even now, after many harmed women have shown their faces to the public, most gynecological surgeons continue to maintain that this practice does not lead to worse outcomes.

In fairness to the AAGL president, he does state that, "an ability to weigh the benefits and risks of procedure-related complications that are associated with [an open incision], including death, should have been part of the conversation from the beginning." Of course, the AAGL president ought to rest assured that precisely such a risk analysis was done and the AAGL's "decision-tree" analysis was fully considered by the FDA's public health experts during the July 2014 FDA hearing. But in the end, the notion that open operations will lead to a higher mortality risk than the avoidable risk imposed by morcellating and spreading a malignant tumor, did not hold water.

Either way, it is clear that most gynecological surgeons continue to believe that the campaign to eliminate morcellation was a publicity stunt by "availability entrepreneurs". But, the women whose lives were lost to gynecological carelessness are real – and these "guardians" are watching from the other side.

In the end, we are left wondering why the statement by an AAGL president not once mentioned the fact that hundreds, if not thousands, of women were harmed.

We are reminded of an immature teenager, unable to take responsibility for a mistake. But when gynecological leaders behave this way, one wonders if women's health is in even more trouble than meets the eye.