An Open Critique to the Royal College of Obstetrics and Gynaecologists: On Laparoscopic Morcellation
To: The Royal College of Obstetricians and Gynaecologists
From: Hooman Noorchashm MD, PhD
Re: RCOG’s Patient Information Leaflets for Morcellation in Laparoscopic “Hyster-ectomy” and Myomectomy
November 9, 2018
Honorable members of the Royal College of Obstetricians and Gynaecologists,
I write, here, in response to your request for public comment upon morcellation in laparoscopic “hyster-ectomy” and myomectomy.
The public may view this request for comments from the Royal College, HERE.
Though I write to you as a citizen of the United States of America, I feel especially compelled, justified and qualified to do so — a premise on which I hope you can agree.
As you likely know, my wife, Dr. Amy Josephine Reed, and I helped carry the public health campaign for elimination of morcellation in gynecology in the United States. Therefore, I know that the RCOG’s current focus on this issue stems, at least in part, from the international outcry generated on behalf of women by Dr. Amy Josephine Reed, and because of the deadly oncological hazard posed by this practice to unsuspecting women. As you know, Dr. Amy Reed died from oncological complications related to her laparoscopic morcellation on May 24, 2017. You will meet Dr. Reed Here and Here.
I am certain that all gynecological surgeons, and any other clinicians familiar with the practice of morcellation, will agree that morcellating uterine tissues inside a woman’s peritoneal cavity poses a 100% risk of tissue dissemination. This disseminating effect of morcellation can lead to the spread and ectopic invasion and growth of both malignant and benign tissues in a not insignificant subset of women. Of course, the former is an avoidable iatrogenic mortality risk from upstaged cancer and the latter is a well described and frequently devastating morbidity in those who fall to it (i.e., parasitic leiomyomatosis).
As it pertains to “contained” morcellation, it remains unclear and totally hypothetical, as to whether the novel containment technologies (i.e., Olympus’ Pneumoliner and PK morcellator devices) or “manual morcellation in a bag” protect the at risk women from spread and upstaging of deadly malignancies.
It is also no slim fact that a prospective randomized control trial to demonstrate the oncological safety of “contained” morcellation techniques will be impossible to design and perform from an ethical perspective. So performing such procedures in women represents, at best, medical experimentation — at worst, Russian Roulette.
As it related to the RCOG’s request for public comment on the present leaflets, I must sadly inform you that these documents, as drafted, are dangerously deficient — and that these are, from a rhetorical, an ethical and, likely, a legal perspective critically flawed. Please accept that I write this critique for the legal and historic records, and for the archives of the Royal College. I ask that you indulge my elaboration of why this is the case, below:
• Nowhere in either pamphlet does the RCOG inform women with uterine fibroid disease requiring a “hyster-ectomy” or myomectomy, that the current state of diagnostic technology in gynecology does not allow a malignancy to be definitively ruled out. It is critical that women understand this problem and that the RCOG emphatically underscores this diagnostic incapacity.
• Because it is virtually impossible to rule out a cancer in uterine fibroids preoperatively, it is correct to state and must be stated, that all uterine fibroids, symptomatic or not, but especially those that are symptomatic and requiring surgery, must be considered potentially malignant tumors. This fact is not sufficiently highlighted in the language the Royal College has chosen to construct its pamphlets. You will recognize that, currently, several well-powered studies from around the world are placing the risk of sarcomatous malignancy in symptomatic uterine fibroids in the range of one in 150–500. But when all cancers of the gynecological tract susceptible to iatrogenic spread and upstaging by morcellation are considered, the risk is even higher.
• Nowhere in either pamphlet does the RCOG inform women that morcellation of malignant or potentially malignant tumors is violation of a foundational principle in surgical oncologic practice.
• Nowhere in the pamphlet does the RCOG inform women that morcellation of uterine tissue involves a 100% risk of tissue dissemination within the peritoneal cavity. Irrespective of whether the tissue is benign or malignant and whether the disseminated tissue is permanently seeded in the peritoneum or systemically, morcellation poses a total risk of tissue dissemination. Specifically, this is definitively true of the “uncontained” version of the practice.
• Therefore, if morcellation has such an inordinately high risk of disseminating tissues in women, as it does, and if the targeted tissue cannot be definitively proven to be non-malignant, “informed consent” does not protect the women at risk of cancer upstaging by morcellation. This logical conclusion is one that every member of the RCOG must consider with care.
• From a legal perspective, because all uterine fibroid tumors are potentially malignant, because a malignancy cannot be definitively ruled out and because morcellation has an extremely high risk of spreading and upstaging such cancers, endorsing or performing morcellation, with or without patient consent, is a professionally negligent act. Negligence, both in United Kingdom and in the United States, has a specific legal definition — and the above logical sequence is demonstration of it.
I respectfully remind the RCOG that there have been times in the history of our profession when dangerous practices have been systematized and practiced by physicians — often with consent from trusting and desperate patients. It is the nature of the art that, as medicine evolves, errors will be inevitably made and that lives will be lost to professional prejudices and incorrect clinical or ethical assumptions. But, shame on us if upon recognizing the folly of our ways, of our assumptions, and of our technique we fail to halt or to change course in order to save lives. Shame on us, if for the sake of convenience, comfort or profit, we fail to eliminate that which is unreasonably dangerous and harmful to our patients. Nowhere, in the archives of our profession’s ethos has it been written that it is justified to sacrifice the lives of a minority subset of patients for the benefit of the majority using an avoidable and elective practice. Nowhere, in the hallowed halls of medical ethics is it written that negligent practice is justified by patient request or consent. It is not!
Colleagues, morcellation of potentially malignant uterine tissues in women passes neither ethical nor legal muster — and it, certainly, is a violation of surgical technique in the management of potentially malignant tumors. Most definitely, when a woman is harmed by gynecological morcellation and her cancer is iatrogenically spread and upstaged, her premature or unnecessary death from cancer is demonstration of an abject failure in clinical and ethical judgment by the gynecologist.
I will conclude by stating that RCOG’s continued promotion of this practice and the College’s present attempt to steer discussion of this practice into the realm of “informed consent” is an historic error in ethical and legalistic reasoning by your society.
I trust that you will add this letter for the legal and historic record into the archives of the Royal College of Obstetricians and Gynaecologists. It gives me no pleasure to inform you that if and when any other unsuspecting women within the jurisdiction of RCOG practitioners is harmed or dies because of gynecological morcellation, it will not have been for lack of knowledge or warning to the honorable leadership of the Royal College. Of course, starting in 2013, this exact warning was vocally delivered to the American College of Obstetrics and Gynecologists, by my wife Dr. Amy Josephine Reed. Your American counterparts have yet to compose themselves in the best interest of women in response to outcry and outrage by the women harmed and the issue has been left to be adjudicated by the courts in the United States— perhaps, The Royal College will do better in the UK.
It is my sincere hope that mindful minds and souls with professional clarity at the RCOG can prevail on this issue and accept the critique put forth in this document as valid: Morcellation in laparoscopic gynaecology is bad and negligent medicine — and no woman anywhere in Britain, or elsewhere, deserves it.
With sincerest respect,
Hooman Noorchashm MD, PhD.