Morcellation Should Be Banned, Harvard Surgeon Says

An Expert Interview With Hooman Noorchashm, MD, PhD

Stephanie Cajigal; Hooman Noorchashm, MD, PhD

Disclosures

June 10, 2014

Medscape: Why do you want to change the way that gynecologic surgeons are trained?

Dr. Noorchashm: Gynecologic surgeons get no training in general surgery within their Accreditation Council for Graduate Medical Education (ACGME) training programs. They train in an isolated silo away from other surgeons. I think this is root cause of why they accepted the practice of morcellation as a standard. It's not a standard in any other area of surgery. The solution now is for these surgeons to go back and adopt some of the fundamental conceptual algorithms that general surgeons use in managing masses.

A great example would be the algorithm we use for managing breast masses or lung masses. Those are worked out by surgeons who understand that when there's a possibility of cancer lurking inside, you cannot disrupt tissues inside the body cavity because you will spread the malignancy.

Medscape: Can you explain why the campaign will also address the issue of nonmaleficence?

Dr. Noorchashm: What the gynecology establishment is saying in defense from our critique is that this mortality hazard to a minority subset of women is acceptable for the majority benefit. Of course, this is a very poor ethical standard to claim for doctors.

One of the bedrock principles of medical ethics is that every single patient has to matter and that avoidable collateral damage is not acceptable. This is known as nonmaleficence. This philosophy is crystallized in the expression, "First, do no harm." Every single one of your patients should matter, and it's radically different from this utilitarian, "benefit of the majority" argument that's being used by the ACOG, the AAGL (formerly known as the American Association of Gynecologic Laparoscopists), and some very leading institutions and surgeons.

This status quo practice has done a lot of damage to families and women for probably close to 20 years now. First, gynecologic surgeons weren't informing patients of the risk, or they thought that the risk was 1 in 10,000 to 20,000.[3] Now, no one seems to be arguing that the risk is 20 times higher than previously thought; there's just this defensive attitude toward something that's a clear hazard, and so avoidable. It stems from the entire establishment being so invested in this now -- the training, the infrastructure, the revenue.

Medscape: To the best of your knowledge, are patients generally informed of the risk that morcellation could upstage an unsuspected cancer?

Dr. Noorchashm: Not until December 2013, which was when the first Wall Street Journal article by Jennifer Levitz came out, did it start happening on a systematic basis. Most gynecologists were viewing morcellation as a minor technical detail of the operation.

But how does informed consent make morcellation safe or ethical? It doesn't. When a woman has a sarcoma and this can't be identified with certainty preoperatively, informed consent about the oncologic risk of morcellation does absolutely nothing to protect that person from the spread of cancer. In fact, it only provides a very false sense of security for the doctor and the hospital against liability. Even in a courtroom. it does not guarantee being helpful to the defense -- and anyway, that's not the way we ought to be practicing medicine.

Medscape: One of the arguments we've heard from gynecologists is that the risks involved with open surgery are greater than the risk of morcellating an unsuspected cancer. Can you address this?

Dr. Noorchashm: In its statement, ACOG is claiming that there's a 3 times higher mortality rate when you compare open vs laparoscopic hysterectomy. They point to one study, by Wiser and colleagues,[4] to back up this claim. In doing so, ACOG is misrepresenting the data. If you look at Table 2 of this article, where the mortality data are expressed, the adjusted odds ratio is 0.69 and the 95% confidence interval crosses 1 (0.39-1.2). That is not a statistically significant difference in mortality.

This study also appears to simply include in-hospital mortality. It does not include the downstream mortality due to morcellation.

Furthermore, it is insufficient to look at the relative odds here. ACOG's statement is misleading because it does not include discussion of the absolute rates of mortality. The unadjusted raw data on hospital mortality in this article show there were 123 deaths among 389,189 women who had abdominal hysterectomy -- that is, 1 in about 3200 women who died in the hospital -- and 9 deaths among 76,609 women who had minimally invasive hysterectomies, or about 1 in about 8500 women who died in the hospital.

Remember, these are not risk-adjusted numbers. The women who got the minimally invasive procedures were younger and had fewer comorbidities. In any event, the harm from cancer upstaging is simply more common than this.

Also, if there is a comparison to be made, it's not between open vs laparoscopic hysterectomy; it's between cases with morcellation and cases without morcellation. The data in that regard are very clear. The mortality and morbidity risk from an elective open hysterectomy is nowhere near the 1 in 350 rate of morcellating cancer and the mortality hazard that's associated with this.

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