An Emerging Threat to Medical Professional Liability Insurers: Gynecological Morcellation.
I write this article as a formal and public warning to medical professional liability insurers — and to the members of the National Association of Insurance Commissioners’ (NAIC) Medical Professional Liability Working Group.
I write as a surgeon and public health advocate in the United States. And I sincerely hope that all attorneys and executives representing the interests of medical professional liability insurers will take the time to read this message an act upon it.
As many of you might know, the FDA recently placed prohibitive restrictions on a widely used medical device in Gynecology, known as a power morcellator. Many manufacturers and physicians are currently being litigated in courts across the nation in product liability and medical negligence cases over the use of this product to perform a procedure known as morcellation.
Fundamentally, the power morcellator was designed and used to mince up or “morcellate” enlarged tumors of the uterus for the primary purpose of extracting them from small skin incisions. However, the gynecological industry neglected to consider a very serious problem when adopting morcellation and “power morcellators” as a standard of practice decades ago: that some of these tumors of the uterus harbor deadly occult (or missed) cancer — at a rate of one in 200–500, as confirmed since 2014 by the FDA and several prominent academic institutions. When such tumors of the uterus are subjected to morcellation by gynecologists, contained and early stage cancers are iatrogenically, and avoidably, spread and upstaged — leading, in many cases, to premature or unnecessary deaths from iatrogenically upstaged cancers.
It is a fact that these complications were not reported to FDA for nearly 2 decades by gynecologists and that the deadly harm to unsuspecting women went unchecked. This, until Dr. Amy J. Reed publicized her own complication and engaged in a public health campaign to end gynecological morcellation starting in November 2013. The results of this campaign are widely publicized and well known to industry experts — Dr. Reed’s actions triggered an unprecedented FDA action, a GAO investigation and caused a sharp curtailment in the use of power morcellators across the world. J&J, the largest manufacturers of the device seeing the liability as being too great, withdrew from the global morcellator marketplace entirely. And many health insurance providers stopped reimbursing providers of power morcellator operations.
But, underlying the negligent design and marketing of the power morcellator was the gynecological professionals, themselves. Before the evolution of the power morcellator, these physicians had adopted “morcellation” as a widely used surgical technique. Power morcellators were simply the “mechanization” of an already accepted technique.
Of course, this negligent practice, though accepted by the gynecology guild, violates of a core surgical principle other surgical disciplines accept as a patient safety dictum: That no tumor with malignant potential should ever be disrupted, minced up, emulsified or morcellated inside a patient’s body cavity. But systematic and deliberate morcellation of uterine fibroid tumors did precisely this to the unsuspecting women undergoing it — this, in a setting where almost all gynecologists will readily admit that there is no good way to definitively rule out the presence of cancer in the tissues they morcellate.
So, it appears that instead of adhering to the bedrock principles of medical ethics and sound surgical principles, gynecologists were comfortable accepting the utilitarian position that the “vast majority of women” benefit from morcellation, because it makes pin-hole surgery for uterine tumors possible. But this position compromises the unsuspecting lives of those at this avoidable risk.
It is also worth your noting that gynecological operations for uterine fibroid tumors are one of the most common ones in American surgery. So the sheer number of women undergoing these operations annually ought to give you pause about the “absolute number” of the one in 200–400 women at risk. According to ACOG, somewhere in the neighborhood of 500,000 women undergo operations for management of their symptomatic uterine fibroids annually in the US. Therefore, with one in 200–400 at risk, somewhere around 1,250-2,500 women are at risk of having their occult or missed uterine cancers spread and upstaged by morcellation, which could cause their premature or unnecessary deaths.
This negligent position was legally defensible until the FDA blew the cover off the oncological danger posed by power morcellation in November 2014 — And with this, it was clarified that many GYNs knew the risk but ignored it. This is a classical instance of professional negligence — occurring at a systemic level. And it is indefensible negligence your industry is now in the position of having to defend.
The main purpose of this message to you, as leaders in the medical professional liability insurance industry, is to inform you that a serious threat to your investments is brewing in the specialty of gynecology. Specifically because despite the fact that FDA has curtailed the use of the power morcellator, many GYN surgeons continue to believe that the risk is “small” and “negligible” — this is a delusion. And, many gynecological leaders will attempt to convince you that the public health campaign led by Dr. Amy J. Reed was nothing but a savvy “publicity stunt” by “availability entrepreneurs”. Unfortunately, this negligent orientation is promoting the continued morcellation of uterine fibroids in unsuspecting women by gynecologists . But, This is a catastrophic error whose cost is not only borne by the women victimized by cancer spread and upstaging, but also by the insurance investments in your industry.
I am formally informing you, here, that as I write, many skillful plaintiff’s lawyers are lining up to identify and represent women whose occult or missed cancer have been morcellated, spread and iatrogenically upstaged by negligent gynecologists who have not been able to incorporate a fundamental principle into their “standards of care” for management of symptomatic uterine fibroids: that mincing up tumors with malignant potential inside a patient’s body cavity is a potentially deadly act of surgical recklessness.
I suspect that you will all understand and agree that when law-suits are filed against any physician in court, it is your investment interests that are being threatened. And I assure you that as GYNs resist voluntarily abandoning morcellation of uterine tumors, an increasing number of lawsuits will start being filed against your gynecologist clients: for avoidable iatrogenic spread and upstaging of deadly cancers in unsuspecting women.
Therefore, your organizations and corporate entities must carefully examine their justification for continuing to provide liability protection and legal defense to the vast number of gynecologists who are continuing to perform morcellation of uterine tissues in women — be it using power morcellators, manually or in any incarnation.
Here, I am hopeful that you will see the emerging danger I am pointing to with clarity and will rise to not only protect your insurance investments — but also to protect the unsuspecting lives of women and their families we must all protect. Because when a group of professionals is blinded by a lucrative revenue stream and professional egos into accepting negligence as a “standard”, it is only external market regulation that will serve to bring sanity —external regulation by patient advocates,bioethicists, other physicians, insurers, the courts and federal agencies.
I ask for your conscientious attention and action to terminate the totally avoidable and dangerous practice of morcellation in gynecology — to protect your investments and the many unknown women at risk of cancer from a negligent medical specialty’s specific and avoidable practice.
Please do not hesitate to contact me at firstname.lastname@example.org.