Our contemporary healthcare establishment is driven by a productive marriage between corporate medicine and medical utilitarianism. The aim of the corporate arm is to maximize profitable transactions, while utilitarian practice aims to achieve products and practices that result in “the greatest benefit to the greatest numbers” of people. But a serious danger is lurking in this partnership, because the time-tested principles of medical ethics do not easily, or always, lend to such a marriage.
A paradigm of this tension between ethics and corporate utilitarianism was recently put on display in a public battle in women’s health. It was a battle in which my wife, Dr. Amy J. Reed, and I were, unfortunately, drawn . In October 2013, as a result of a personal misfortune, we became aware of the oncological hazard of morcellation, a standard of practice used by gynecologists.
Morcellation is a gynecological procedure using a medical device known as the “power morcellator.” It is used with minimally invasive surgery for uterine resection and myomectomy in women with symptomatic uterine fibroid tumors. It involves mincing enlarged tumors inside a woman’s abdomen in order to extract the diseased and enlarged tissue from small skin incisions.
Of course, the benefits of minimally invasive surgery are quite clearly established: smaller, more cosmetic incisions, lower wound infection rates, less tissue desiccation, faster recovery, and better visualization of anatomy. There is no question that when minimally invasive surgery is performed safely, it is beneficial to the patient. Certainly, performing high volume procedures via minimally invasive techniques could be both good for the patient and good for business.
But morcellation during minimally invasive surgery posed a serious downside with a major ethical red flag, a consideration the gynecology specialty neglected until 2013. This oversight in gynecology evolved because only a small fraction of uterine fibroid tumors actually harbor a malignancy. The trouble with such occult malignancies in fibroid tumors is that they are not detectable by the current conventional pre-operative diagnostics gynecologists use. So, when a uterine fibroid with an occult malignancy is minced up by morcellation, an early stage and contained cancer can be unleashed to become a loco-regionally disseminated abdominal sarcomatosis, with poor or deadly outcomes.
From a surgical perspective, it’s clear that indiscriminate morcellation of any tumor with malignant potential inside a patient’s body poses a prohibitive danger. When morcellation leads to the spread of benign or malignant tissues inside a patient’s body, most non-gynecological surgeons consider it a serious, but avoidable, complication.
Yet in 2013, far from being a rarely used technique, morcellation was the centerpiece of an expanding practice of minimally invasive hysterectomy and myomectomy. So, when the Wall Street Journal, alerted to its risk, first reported the oncological hazard in 2013, the American College of Obstetrics and Gynecology (ACOG), the Society of Gynecologic Oncologists (SGO) and the American Association of Gynecologic Laparoscopist (AAGL) went on the defensive.
A coalition of prominent minimally invasive gynecologists from across the country rose in defense of the practice. But then, in April 2014, the Food and Drug Administration (FDA) issued a warning against the use of power morcellators in gynecology and called for a public hearing. The battle lines were drawn.
The main defense of morcellation was a utilitarian argument set forth by ACOG, AAGL, SGO, and many leading gynecologists. The argument is that minimally invasive uterine resection and myomectomy benefits the vast majority of patients. Thus, the occasional complication resulting from “inadvertent” upstaging of an occult or missed malignancy, despite being an unfortunate and avoidable mortality risk, is one of myriad routine trade-offs we make in the practice of medicine. This unethical defense of morcellation persists to date.
Sadly, the public attention focused on protecting the subset of women in harm’s way from morcellation, as my wife had been, was portrayed as being “emotional,” “irrational,” and “hype-based.” The power of this argument by many of our colleagues was on full display when the New England Journal of Medicine (NEJM) published a perspective piece calling the FDA’s action on power-morcellators “N-of-1 policymaking.” Worse, the NEJM article defended the utilitarian position by critiquing the FDA action, saying it was based on an “unfortunate” but “anecdotal” and “emotional” publicity campaign by two physicians and the lay press. Of course, this perspective ignored both the epidemiological data and the fact that literally hundreds, if not thousands, of women worldwide had been subjected to cancer upstaging by morcellation for well over two decades.
Aside from the troubling position taken by NEJM, the error in the specialty’s utilitarian argument was that morcellation was being referred to synonymously with “minimally invasive surgery” — at least this seems to be the case from our perspective. Of course, the point of this interchangeable language was clear. A large number of gynecological surgeons saw that their minimally invasive flagship operation was compromised with the demise of morcellation. Yet, there is nothing “minimally invasive” about mincing up a tumor with malignant potential inside a human body. It is simply a surgical error, incorporated into gynecology as a standard. How could such a thing be the centerpiece of an operation offered to tens of thousands of women across the United States every year?
Another point was also clear from the gynecological defense of morcellation. Gynecologists seemed to be assuming that the frequency of uterine fibroid tumors with occult malignancy was negligible — otherwise, how could anyone accept oncological risk of morcellation? It is certain that this incorrect “assumption of benignity” regarding uterine tumors had caused morcellation to evolve as the centerpiece of a high-volume, minimally-invasive surgical practice.
So, a tug of war began between the FDA, the AAGL, and minimally invasive gynecological surgeons as they argued over the precise frequency of occult sarcomas in women with symptomatic fibroid tumors requiring surgical intervention. Initially, the AAGL claimed that only 1 in 7,000–8,000 women with symptomatic fibroids harbored an occult malignancy. This starkly contrasted the FDA estimate of 1 in 350. Later, the AAGL modified its risk estimate to be roughly 1 in 2,000 women. To date, the FDA continues to estimate 1 in 350. Moreover, a number of independent retrospective studies, using insurance databases and medical records, have determined the occurrence to be even more common: 1 in 200–500.
Yet we must ask, is the precise frequency of an occult uterine cancer, as it pertains to an avoidable and potentially mortal iatrogenic oncological risk, ethically relevant? Especially when the practice is a violation of a basic surgical tenet in universal oncological precautions when resecting any tumor: i.e., en bloc resection with good margins.
The second argument in defense of morcellation was that of “informed consent.” Most minimally invasive gynecologists viewed morcellation as a technical detail of their operation. So, the vast majority of women were not being informed of its risks until after the Wall Street Journal publicized the hazard. When confronted with this problem, the AAGL and ACOG proposed informed consent as a solution to the oncological hazard of morcellation. In other words, as long as a woman is willing to take on the risk of an occult malignancy being spread and upstaged, the practice is justifiable.
However, the troublesome issue lingers as to how informed consent protects a woman with an occult or missed malignancy from upstaging by morcellation, because, clearly, it does not. When a woman’s occult or missed uterine cancer is morcellated, her having consented to the procedure does nothing to protect her.
The broader question is, which one of the core principles of medical ethics would permit a physician to accept avoidable harm to a minority subset of patients for the “benefit of the majority,” especially when it comes to an avoidable hazard posed by a practice that many surgeons view as an error? My answer is, none!
Utilitarian truths are clearly important in designing cogent public policy. Seeking “informed consent” is definitely consistent with the principle of patient autonomy. But adherence to neither of these precepts justifies violating the principles of beneficence, non-maleficence, or justice that physicians owe every patient.
In the morcellation debate, a potentially deadly but avoidable practice was accepted because it served to streamline a high volume surgical practice in gynecology. When an oncological risk was exposed to the public, it was defended by appealing to the utilitarian concepts of “majority benefit” and “patient choice.” Because of this, and in spite of the FDA warning and the many visible faces of harm, morcellation has survived and remains in the armamentarium of gynecologists, despite a significant reduction in its use.
The products of utilitarian thinking and science in medicine can lead to major strides in public health. But the exercise of utilitarianism in medicine ought to be foremost regulated by the core principles of medical ethics in practice. Beneficence, non-maleficence, justice, and autonomy are not simply marketing clichés.
The public health battle over gynecological morcellation serves as an important paradigm of a wider, masked, struggle in contemporary American medicine. When “majority benefit” and “patient choice” are posited by entire groups of physicians to justify a medical practice, medical ethics can easily take a back seat. It is in this space that iatrogenic harm, even systemic injustices, are born. Let us beware.
This article was written with input from, and in loving memory of, Amy Josephine Reed MD, PhD — mother, wife, daughter, physician, scientist and defender of women.
Hooman Noorchashm, MD, PhD is a physician in the Philadelphia area. He earned his MD and PhD degrees from the University of Pennsylvania, School of Medicine. He went on to complete his residency training in General and Cardiothoracic Surgery at the Hospital of the University of Pennsylvania and Brigham and Women’s Hospital.