ACOG Leader Defends Morcellation

Stephanie Cajigal; Hal C. Lawrence III, MD

Disclosures

January 15, 2015

Editor's Note:   When the US Food and Drug Administration (FDA) warned in November that power morcellators shouldn't be used for most women because of the risk of spreading occult cancerous tissue, surgical gynecologists were forced to reconsider the future of what was once a common procedure for uterine fibroid removal. In this interview with Medscape, Hal C. Lawrence, III, MD, executive vice president and chief executive officer of the American College of Obstetricians and Gynecologists (ACOG), explains what the industry needs to do to make the procedure safer.

Medscape: What is the most important message that gynecologic surgeons need to know about morcellation?

Hal C. Lawrence III, MD

Dr Lawrence: There are three issues I'd like to highlight. The first and the most important is that we want to make sure that OB/GYNs know which patients are not candidates for morcellation.

It's also important that they understand that there may be some patients who, based on their situation, their diagnosis, their co-diagnoses, might be good or reasonable candidates for morcellation.

The third point is that it's crucial that if physicians think they have identified a patient who will benefit, that good, thorough informed consent is provided.

Medscape: How should surgeons interpret the recent FDA announcement? Is there any information that you feel needs further clarification?

Dr Lawrence: The short answer to that question is yes.

The first bullet on the contraindications from the FDA is about how patients who are perimenopausal or menopausal are not candidates for morcellation. We need to work on defining what "perimenopausal" is because we know that young women, people in their 30s, are at much reduced risk of having a leiomyosarcoma, but all OB/GYNs have seen patients in their late 30s who are having a lot of perimenopausal-type symptoms. What does the FDA mean by "perimenopausal"? Are they trying to use an age or are they trying to use a physiologic symptom definition? I think that needs to be defined.

The other thing is that a patient who is menopausal and who develops a fibroid or has a fibroid start to grow—that is a real concern. But then there are patients who may have had a fibroid for 20 years and it hasn't changed or  it's gotten smaller. If they've had a stable fibroid for 20 years, does that mean they're not a candidate for morcellation? I don't think that's accurate either. I think there's an opportunity here for some dialogue with the FDA and hopefully some clarification.

Medscape: How should OB/GYNs proceed at this point?

Dr Lawrence: Like we proceed with any patient who's undergoing a surgical procedure. We need to identify the indications for that procedure. We need to discuss with the patient the options of different approaches and the risk and benefits of each one. ACOG has long stated that vaginal hysterectomy is the best choice, if it's feasible for that patient from a risk-and-benefits perspective. However, if a patient is thought to be at low risk for an occult leiomyosarcoma or endometrial malignancy and is trying to spare her fertility, or has multiple comorbidities, you'd want to consider morcellation. If a patient is morbidly obese or has diabetes or renal disease, you'd want to do a procedure that's going to have the lowest risk for surgical complications.

I think that going forward, two things are going to happen. One, we're going to get better with our diagnosis and screening tests to help us identify individuals who might have a leiomyosarcoma. In fact, at the recent American Association of Gynecologic Laparoscopists  meeting in Vancouver, French researchers presented a study in which they were able to identify almost five out of seven cases of leiomyosarcoma in a series of almost 3000 women undergoing hysterectomy.[1]

I also think we're going to see changes in how morcellators work. We may see surgical bags developed that facilitate the use of intra-abdominal morcellation inside of them.

I don't think we've seen the end of this discussion, and I think there's ample room here for clarification and then improved diagnosis and surgical procedures.

Medscape: Could the recent FDA warning have the unintended effect of dissuading surgeons and hospitals from using power morcellation altogether, and even for some insurance companies who may decide not to cover it? For example, in November, HCA Holdings Inc, the largest for-profit US hospital operator, said it is prohibiting the use of morcellation at its facilities. In addition, Highmark Inc. announced in August that it would halt coverage of power morcellation.

Dr Lawrence: I don't think you or I or anyone can truly predict what a hospital or insurer is going to do. I think the overriding issue here is that instead of banning this procedure, we need to do a better job of preoperatively diagnosing patients who are at risk. We need to understand and stratify risk based on age, based on presentation, based on when fibroids are diagnosed and how they are developing, and use it for patients who are at the lowest risk and not patients who are at the highest risk.

Medscape: In February 2014, The Lancet Oncology published an editorial[2] that quoted a 1-in-400 risk of morcellating an undetected tumor and called this risk "unacceptable." A few months later, the FDA concluded that the risk of morcellating an unsuspected uterine sarcoma is 1 in 352.[3] In ACOG's opinion, what would be considered an acceptable risk?

Dr Lawrence: All procedures carry risks. Our job is to minimize that risk and balance it with the benefits. And that's why I said what I said earlier about how there are some patients for whom, due to their comorbidities, the risk of their abdominal procedure may be far greater than the risk of leiomyosarcoma, and that we need to be able to balance risk versus benefits for these patients.

The other thing is that those numbers are really interesting and confusing. The Lancet said 1 in 400, the FDA said 1 in 352; ACOG actually said 1 in 500, and we all looked at the same body of literature. The issue here is to have a 95% confidence interval so you know that whatever number you say is accurate to within 95%. With the number of cases that are out there, the range for that confidence interval is between 280 and 900. So that right number is somewhere; whether it's 350, 400, 500, 750, we don't really know for sure.

Again, you have to apply any risk to that individual patient. The risk as a 33-year-old is not the same as the risk for the 47-year-old, is not the same as the risk for the 65-year-old. Also, the benefits of using morcellation in the 350- or 400-pound diabetic with renal disease are different from the risk of doing an incision in a 150-pound healthy woman. This is not a clear-cut, black-and-white issue.

Medscape: Is ACOG concerned about morcellation being banned outright?

Dr Lawrence: We have never recommended that it be banned. We have recommended the different things I've discussed today: improving preoperative diagnosis and intraoperative techniques, and, most important, stratifying patients by their individual risk when considering morcellation and making sure they are thoroughly informed of the risks and benefits.

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