The Absurd Defense of “Contained Morcellation” And the Pneumoliner Power Morcellator in Gynecology

Hooman Noorchashm
Aug 23, 2017 · 7 min read
Dr. Jason Wright, chief of Gynecologic Oncology at Columbia University, knows that “we don’t really know the true incidence of rupture of the bag and spillage of the contents” when “contained power morcellation” is performed in women. Yet, he is advocating for a clinical trial of Olympus’ Pneumoliner power morcellator, which with certainty emulsifies occult/missed cancers and risks iatrogenic spread and upstaging if/when the bags break or leak. But how is it acceptable for a medical device to cause the very hazard that it is designed to eliminate or mitigate against in the same operation? This is an example of gynecological “group think” in attempting to defend/resurrect the practice of morcellation. How can even high level academics in GYN-oncology not see the dramatic flaw in their specialty’s reasoning?

In November of 2014 the United States Food and Drug Administration (FDA) issued an “Immediately In Effect (IIE)” warning regarding the use of a medical device known as a power morcellator in gynecology.

The reason for this serious warning was that the power morcellator causes an unacceptable and avoidable risk of spreading and upstaging deadly cancers in women with occult or missed cancers of their uterus. Literally, hundreds if not thousands of women in the United States, and globally, have been harmed or had died prematurely, or unnecessarily, because of this iatrogenic cancer risk.

But an entire industry of Gynecologists, led by the American Association of Gynecologic Laparoscpists (AAGL) and the American College of Obstetrics and Gynecology (ACOG) rose immediately to defend this practice as being “beneficial to the majority of women” and being a matter of “patient choice”— this, despite the severe, epidemiologically undeniable and avoidable harm it had caused to many unsuspecting women.

The vast majority of gynecologists and medical industry guardians attributed the FDA’s action to a publicity stunt, blown out of proportion by “availability entrepreneurs”. This was a disturbing example of industry protectionism and defamation of a serious women’s health campaign, by a very powerful academic institution — The New England Journal of Medicine. Some low level operatives also followed suit.

Dr. Willaim Maisel, the FDA device section’s chief scientist said of the newly FDA approved Pneumoliner power morcellator, “although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”

In a puzzling move, and despite the severe cancer-related warning FDA had issued in 2014, the agency subsequently acted on the recommendation of AAGL and ACOG to clear a new version of the power morcellator. But it did so without any real clinical data to prove the oncological safety of new device.

In fact, the chief scientific officer at FDA’s device section, Dr. William Maisel, shockingly stated “we want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.” Yet the morcellator device is being marketed and sold by Olympus. As a result many gynecologists are currently using this device in women without any real assurance of oncological safety — and it is virtually a certainty that the vast majority of women undergoing this procedure, most of whom are lay-persons, do not truly understand the nature of the oncological hazard they are being exposed to.

The Pneumoliner’s clearance by FDA’s device section (i.e., CDRH) was highly inappropriate and did not seek any guidance from the agency’s Oncology Center of Excellence, where it could and should have. The CDRH made its decision to clear the Pneumoliner despite a clear and pointed criticism in the form of a citizen’s petition to the agency’ commissioner — this petition went basically unanswered by the commissioner’s office.

Of course, given the large number of product liability and wrongful death legal cases filed against makers of power morcellators and the GYNs responsible for harming their patients, the industry and many GYNs recognize that there is serious liability exposure in their use of this product.

But, many GYNs are nonetheless using “contained morcellation”, with other unproven and unapproved alternatives to the pneumoliner containment system — again, without any evidence of oncological safety. So, the entire industry is legally exposed to a striking degree. Amazingly, excluding a few rogue GYNs who recklessly expose even women with known cancers to morcellation, the vast majority quietly understand how terribly exposed this practice leaves them to lawsuits. Yet, instead of abandoning the practice and veering towards taking universal oncological precautions, as others surgeons do, most GYNs are continuing to hope for a resurrection.

Olympus’ Pneumoliner power morcellator — this device creates a deadly iatrogenic cancer risk by morcellating tumors with malignant potential, which it is attempting to then contain at the same time. But the real question is, why expose women to the deadly cancer risk of morcellation to begin with? This device exemplifies poorly informed thinking on the part of corporate executives at Olympus and an absence of input from good lawyers at that company.

So, it is no surprise that the AAGL (and Olympus) have been quietly seeking to create a legally defensible environment by doing a clinical trial on the Pneumoliner. If only they could point to a clinical study and make the claim that their new device is “reasonably safe” then they would be in a legally defensible space with morcellation. And it seems that after “shopping around” for a “suitable IRB” that would unwittingly take on such a serious risk, they’ve managed to convinced the University of North Carolina’s (UNC) Medical Center to serve as the testing ground for the Pneumoliner.

Recently, I had an opportunity to review this trial’s design and objectives. Unfortunately, it is quickly evident to anyone who understands the “morcellation controvery” that this trial’s design is highly misleading and critically flawed in its ethical constitution. I publicly shared my concerns with the UNC legal team, the UNC IRB and Olympus last month.

Appropriately, I received an immediate email response from UNC’s Associate Vice Chancellor for Research, Dr. Robin L. Cyr, stating “Thank you for reaching out to us, the university is looking into this matter.”

Later on, as I more publicly involved a group of journalists and plaintiff’s lawyers focused on bringing cases against GYNs and morcellator manufacturers, I got another email from UNC’s Vice Chancellor stating, “Thank you for contacting us regarding your concerns with the upcoming clinical trial at the University. We wanted to take this opportunity to provide you with a brief update.

The University is committed to protecting the rights, safety and welfare of research participants. Consistent with this commitment, we take seriously any questions or concerns arising from third parties about our research studies. Our Institutional Review Boards are charged with reviewing, approving and overseeing all research studies involving human participants to ensure risks are properly identified and disclosed to research participants. Our IRB is currently reviewing the matters you have raised. At the conclusion of this review, we will provide further information.”

In a somewhat subtle last sentence in her email, Dr. Cyr stated “As you may have seen from the study page on clinicaltrials.gov, this study is not currently open for participant recruitment.” — perhaps indicating that UNC is tuning in to the serious nature of the ethical violation and liability concerns I’ve raised with them. But maybe I am reading too much into this statement.

Within two weeks of my communication with UNC’s IRB, academically decorated industry advocates started their defense of the Pneumoliner trial. As a prominent example, in comments to HemOnc Today Dr. Jason Wright Chief of GYN-Onclogy at Columbia University, stated “This is the type of data we need. We know minimally invasive surgery offers a lot of benefits and we want to be able to offer it to as many women as possible. These types of devices and innovation need to be tested. Theoretically, this should be a safe procedure, morcellating in a bag and trying to limit interabdominal dissemination. But, until this is thoroughly investigated, we won’t know the safety of this.”

This is a shocking attestation on the public record, which should set off serious red flags for any reasonable attorney and bioethcist reviewing my critique of the Pneumoliner trial. As Dr. Wright states, “We don’t really know the true incidence of rupture of the bag and spillage of the contents”, which is why he and his GYN colleagues in the AAGL are endorsing such a trial. BUT, we do know that morcellation (especially power morcellation) of an occult cancer can cause dangerous and potentially lethal spread and upstaging of cancers. Therefore, testing these bags to determine the incidence of “spillage of contents”, by which professor Wright actually means “spillage of cancer”, would be to expose study subjects with occult or missed cancers to a potentially deadly (and avoidable) iatrogenic hazard.

In fact Dr. Wright readily concede that “One of the problems with morcellators is that they’ve been diffused in practice without solid scientific evidence”.

So, the parameter being tested in the UNC trial (i.e., Penumoliner bag spillage) is the prevention of an iatrogenic hazard caused by the Pneumoliner power morcellator itself during the proposed operation — not by the patient’s intrinsic disease process (i.e., cancer). In other words, this trial itself creates the very hazard/problem (i.e., potentially malignant tissues processed by the power morcellator) it is attempting t0 mitigate or eliminate. This simple but dangerous cognitive error in ethics and logic is one being committed by the entire GYN specialty when it comes to the idea of “contained morcellation”. And it is the domain of attorneys and bioethicists to restrain and contain the harm being done by this error. Specifically, now, at the University of North Carolina, where the AAGL seems to have found a friendly foothold. Very certainly, this is a critical flaw in Dr. Jason Wright’s thinking and his defense of the UNC trial.

But in the end, what would be most disconcerting is if UNC’s bioethicists and attorneys do not see the surreal level of recklessness being promoted at their institution by the GYN industry. In approving this dangerous study, the UNC IRB seems either to have farmed this trial application out to a third party IRB provider, or the IRB members were kept in the dark about the real controversy surrounding the power morcellator. In either case, UNC’s only cogent and ethical option is to formally terminate this hazardous clinical trial.

The outcome of the UNC deliberation on my critique of their Pneumoliner trial will have very serious implications as a litmus test of the institution’s own ethical and legal integrity. But more importantly, it will serve as a statement from bioethicists and lawyers on the practice of “contained morcellation”, which is continuing unabashedly across the country — despite the fact that most GYNs readily concede, as Jason Wright did, that “we don’t really know the true incidence of rupture of the bag and spillage of the contents”.

So why are a huge number of women still being exposed to such a hazard by AAGL and ACOG practitioners, on a systemic level? The answer, I am afraid, is incorrect and unethical “group think” by the gynecological specialty about the practice of morcellation — this must change in the name of Amy Josephine Reed MD, PhD and the many thousands of women harmed, and prematurely or unnecessarily dead.

Amy Josephine Reed MD, PhD and family — Summer 2015.

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Hooman Noorchashm

Written by

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.

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