40-27 Bertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial

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Bertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial

Current controversy over power morcellation points to the importance of multidisciplinary education and consultation, said Monica Bertagnolli, chief of the Division of Surgical Oncology at Brigham and Women’s Hospital, and professor of surgery at Harvard Medical School.

“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter. “In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.

Bertagnolli was designated by Brigham & Women’s to discuss the clinical issues involved in morcellation.

Matthew Ong: Hi Monica, thanks so much for discussing your thoughts on the use of morcellation for management of uterine tumors.

Monica Bertagnolli: This is an interesting and important issue, and I appreciate the opportunity to weigh in. One of my clinical roles is that of a sarcoma surgeon, so unfortunately I see patients who have recurrent uterine sarcomas. Because the Dana-Farber/Brigham & Women’s Cancer Center is a referral center, we see quite a few of these patients each year.

Based upon data from our hospital, we believe that open power morcellation in the setting of a malignancy significantly increases the risk of tumor recurrence and overall death from the disease. These data were recently published in the journal Cancer (George, et al, EPub June 12, 2014).

The retrospective data from 58 patients treated at our center show that intraperitoneal morcellation, that is, cutting a tumor into small bits within the peritoneal cavity, of a leiomyosarcoma increases risk of disease recurrence and significantly shortens median recurrence-free survival. These data support what we already suspected clinically—that morcellation can lead to implantation of tumor cells, and that these tumor cells are able to establish colonies of metastatic disease.

If we know a priori that a woman has a malignancy, then every effort is made to avoid fragmenting it in ways that can spill tumor cells into the abdomen. Surgery for benign leiomyomas is very common, and beneficial to many women.

Many women benefit from morcellation of their tumor because this allows much smaller incisions, quicker recovery, and also allows tumors to be removed in ways that can preserve fertility. The big issue, therefore, lies in detecting which women have malignant disease prior to operation. Unfortunately, we don’t have a reliable method to determine whether or not a uterine tumor is malignant before it has been removed and fully examined.

MO: You’re saying it boils down to a basic risk-benefit debate.

MB: Right. Benign uterine leiomyomas are very common, and (fortunately) uterine sarcomas are fairly rare. In general, very large tumors or ones that grow quickly are more likely to be malignant, but PET scans, CAT scans, and biopsies are not accurate enough to be sure beyond a doubt that a malignancy is not present. We need better diagnosis methods to help us better assign risk.

When morcellation is done in a way that allows cells to be spilled into the peritoneal cavity, there is a small but real risk that harm can be done. Although we don’t have conclusive data, it stands to reason that the use of power morcellators, which generate the most widespread spillage of cells, have the highest risk.

In the early use of [power morcellators], I don’t think we—we being the medical profession—properly understood the risk. I would say over the last two years roughly, we have been increasingly convinced that we need to change our approach to patient management based on this risk.

MO: One of the biggest points of contention right now—at least in the public debate—is about the number of women at risk. The FDA issued a warning that 1 out of 350 women are at risk for the spread of an undetected malignancy with the use of power morcellation. Other sources say it is as low as 1 in 1,000.

You have people on one side saying it’s a death knell for many undergoing the procedure. If you extrapolate the FDA estimate, it’s 285 a year, if I am not mistaken. Then you have others saying the benefit of the procedure for the majority of the women who undergo this procedure cannot be dismissed.

What’s important for you to address, if you can, is, what is the truth here?

MB: Unfortunately, an accurate understanding of the risk is just not possible with the data we have. I agree with those figures, anywhere from 1 in 350 to 1 in 1,000, we just don’t know.

In my mind, even one woman is too many; of course we never want to see this happen.

MO: That sounds consistent with what ACOG and AAGL are saying in their reports, which were recently issued over the past two months.

They’re saying: We can’t make a global policy on this right now, and we need a lot of research because we can’t properly assess the risk, but we shouldn’t demand that morcellation stop right away. Would you say that is consistent across the board?

MB: Yes, I would. But I think we can do something immediately. At least for the power morcellator, it is my opinion that we know enough to say that it should not be used without a containment device to limit spillage of cells within the abdomen.

Even with a containment device, we can’t be certain that the procedure is safe if the tumor turns out to be a sarcoma. At our center, we require use of a containment device for cases where power morcellation of tumors is to be performed, and we are studying the issue prospectively through an IRB-approved protocol to be sure that we see the desired reduction in risk of tumor spread.

There are also a number of safe alternatives to power morcellation, and these should be used for all but the lowest risk situations.

MO: Speaking of the containment bags, is there a standard containment bag that has been approved by the FDA?

MB: No, not that I know of. We have a lot of different containment bags, because we have used them in oncology for a long time. This is because of the concern that, even without morcellation, taking out a tumor through a very small incision has a potential to seed tumor cells within the incision.

We have some level of comfort with containment devices, because their use has been applied to other diseases, particularly colon cancer, and the same risk of tumor spread does not seem to be a problem in this setting.

MO: And there is no data on that so far?

MB: No data on that. The group at Dana Farber/Brigham & Women’s has a registry trial underway, so hopefully we will have data in the future. Brigham and Women’s Hospital patients are not being treated with power morcellation unless they participate in an IRB-approved study that mandates the use of a containment device.

MO: Do you know of any other hospitals taking steps to generate data on this?

MB: Not that I know of, although now that this issue has been recognized we should see better reporting of negative outcomes, which will lead to more information.

MO: Speaking of collecting data, what do you know about the 510(k) legislation? Morcellators are 510(k) approved devices, and 510(k) doesn’t require practitioners to report adverse outcomes.

Could you tell me if a change to this legislation, requiring practitioners to report adverse outcomes, would help the cause of collecting data?

MB: I am a clinical trials researcher, and so I am strongly in favor of collecting accurate data for any device that could potentially alter a patient’s outcome.

I think that devices with this potential should have to, at a minimum, be studied for a certain period of time under a design that allows examination of adverse outcomes.

It is hard to believe we haven’t done this yet. The time has certainly come.

MO: So you are saying it is time for 510(k) to actually include this provision that requires practitioners to report adverse outcomes?

MB: Absolutely.

MO: That appears to be the thrust of the efforts on the issue right now. The IOM did a good bit back then on 510(k), but there was no catalyst for a push to change the legislation until now, right?

MB: Right. And that’s the only appropriate response. I acknowledge that this is not simple, particularly in this case. A great many women are safely treated for benign tumors with power morcellators, and a small number are harmed. As a result, we need a lot of data to understand the risk and how it might be modified. And if you don’t have reporting you can’t gather the data in a timely matter, potentially saving lives.

Would these cases have come to light more quickly if we had a reporting system from when the power morcellator was first placed in use? It seems likely.

MO: Maybe then we would have 20 years of data?

MB: Power morcellation is certainly used more often lately because minimally invasive techniques 20 years ago were not nearly as uniformly as applied as they are now, so its use has been in a significant upswing.

We do think this is a rare event. We don’t want to scare women everywhere out there who might have had a fibroid removed, and we don’t want to introduce panic that is unwarranted.

MO: There is, in the public debate, a comparison of gynecologic surgery with surgical oncology, and how gynecology is the only specialty that accepts systematic morcellation of tissues as a standard of practice.

The questions revolve around: Why do gynecologists do this when oncologists are against it?

However, I do understand that it makes sense for oncologists to not morcellate anything because you are primarily dealing with known malignancies.

MB: I think that it is very unfortunate to label a field in a negative way over an issue such as this. Instead we should emphasize more interdisciplinary education. I am very fortunate as a surgical oncologist that I was trained in an era where it was routine for general surgeons to rotate on general gynecology services, and where surgical oncology fellows worked together with gynecologic oncologists. In fact, I learned many minimally invasive surgery skills from gynecologists, who were experts in these techniques long before surgical oncologists were involved.

It is very important and worthwhile to have a call, throughout all oncology, for multidisciplinary education and consultation. We know that this improves patient care. In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.

MO: Finally, what do you think is Hooman’s contribution to this whole issue?

MB: Hooman is a really fine individual and a fine surgeon. Raising awareness of the risk of the morcellation procedure is an important and valuable contribution. His work, unfortunately resulting from personal tragedy, has galvanized all of us to be very aggressive in developing better policies so that we can avoid this horrible result in the future.