Does informed consent justify risk of surgical procedure?

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

Published Sept. 6, 2016, 3:36 p.m. ET

Last month the Journal of the American Medical Association (JAMA) published a study showing that the demise of morcellation in gynecology led to no rise in complication rates in women undergoing hysterectomy.

This study came from the same group at Columbia University that also deciphered the nearly 30-times higher risk of cancer upstaging by morcellation than previously assumed – and they published this landmark recognition in JAMA.

Over the last three years, both the leadership of the American College of Obstetrics and Gynecology (ACOG) and other well-decorated gynecologists across the country, have been defending morcellation.

They predicted gloom and doom for the women undergoing hysterectomy without access to power morcellators. The spokesperson for the American Association of Gynecologic Laparoscopists even went as far as to claim that a rise in open hysterectomies would be more "deadly" than morcellation.

And now comes the JAMA article from a respected gynecological group at Columbia University demonstrating that, in fact, with the demise of morcellation women are not being catastrophically harmed at unprecedented rates. Instead, the study showed that there may even be a slight improvement in outcomes – presumably because the GYN surgeons are being more careful now.

It is important to note that complication rates for both minimally invasive and vaginal surgeries were under 5 percent, while open abdominal hysterectomy complication rates were about 18 percent. These complications vary in their seriousness ranging from wound infections, to blood clots to death. Nevertheless, the rate of complications, and certainly mortality, did not increase with the decline of morcellation over the past three years.

Undeniably there are clear advantages to minimally invasive and vaginal operations over open surgery, but we must take care not to equate minimally invasive options with the act of morcellating tissues inside a patient's body cavity – a frequent and incorrect claim by most proponents of morcellation. In fact, non-GYN surgeons routinely practice minimally invasive surgery and resect diseased or damaged tissues without morcellation to extract these from the body.

Even the CEO of ACOG, Dr. Hal Lawrence, who was vigorously defending morcellation, has toned down. He told the Wall Street Journal that "many doctors were already able to take that approach without the power morcellator." Quite a change in tune!

We know that this latest study by Dr. Jason D. Wright's group vindicates our position that morcellation is an excessively hazardous and totally avoidable practice in gynecology – and must, therefore, be avoided.

But we remain astonished at the continued inability of the gynecological surgeons and their professional society to admit their terrible error. ACOG CEO's comment to the WSJ highlights this confused medical ethical calculus on the part of gynecological surgeons. He stated, "Women need to have the autonomy after informed consent to decide what procedure and what method they would want to have done for themselves."

To make matters worse, with the science and data in hand, even the Columbia group, led by Dr. Wright, gets it wrong. He told the WSJ, "The big takeaway is that despite all the scrutiny women undergoing morcellation are still at risk for cancer." And "They need to be counseled about that risk and we need to think carefully about who undergoes surgery with power morcellation."

So, to be clear these gentlemen are admitting that the rate of cancer upstaging using morcellation is much higher than assumed. They are also now admitting that giving up this precious toy does not lead to an unacceptable rate of complications. But they can't bring themselves to say "Hey, maybe we shouldn't be doing this to women at all."

Instead, the entire specialty is hiding behind the concept of "informed consent" and "patient autonomy."They reason it's acceptable to inform patients of the risk and let them choose. As though there is no concept of professional responsibility. As though these folks do not believe that there is such a thing as bad medicine! And even despite the fact that they themselves are proving that morcellation of fibroids is a bad and potentially deadly practice.

In the end this whole "controversy" over morcellation is leading to an inevitable and disturbing conclusion. That gynecological surgeons, perhaps all of medicine today, has lost its capacity to humbly admit its limitations and mistakes --especially when people are harmed. And, even highly decorated academic physicians seem unable to accept that there are faces of avoidable harm.

It's a good bet that none of the leading gynecological surgeons who either defend morcellation, or with the data in hand, continue to argue for "informed consent," know the names ofVivianaRuscitto, Brenda Leuzzi, LindaInterlichia, Barbara Leary or the others. Perhaps they can't bring themselves to look at the truth of what was happening to women whose names we may never know, for over two decades.

It seems that in the struggle between medical ethics and corporate medicine, the forces of money and business are defeating empathy and reason.The cavalry of courageous medical leaders able to resist this damage and protect lives from misguided medical utilitarianism is nowhere to be found – at least for now.