I tell my patients that pretty much everybody has fibroids. Because they are so common, I need to look at the whole picture.
Dr. Wright: For the perimenopausal and postmenopausal patients we are discussing, preoperative evaluation and counseling would be similar to that for the premenopausal woman. However, given recent data, it is important to note that the prevalence ratio for a uterine malignancy increases with increasing age.2 Clinicians need to be mindful of red flags in perimenopausal and postmenopausal women.
Dr. Kho: I agree that, for each of the cases we have discussed, we need to consider more than just the presence of the fibroid. Risk stratification based on clinical factors like age, menopausal status, BMI, the indication for surgery, and response to any other therapy is extremely important and should guide decision-making regarding the surgical approach.
Although we lack reliable methods to differentiate fibroids from leiomyosarcomas, there are other malignant conditions of the uterus, as Dr. Bradley pointed out. Premalignant conditions of the uterus and cervix and endometrial adenocarcinomas occur far more frequently in the population than sarcomas, and we may be increasing risks by morcellating unsuspected cancers of any type.
At this time, whenever I am considering morcellation in any patient, I obtain pelvic imaging, endometrial biopsy, and current cervical cancer screening. If any of these studies suggest a malignant or premalignant condition, I avoid morcellation. Similarly, if a patient’s clinical history raises suspicion of a potential underlying malignant process, such as new symptoms of an enlarging myoma in a postmenopausal woman, I will try to find an alternative to morcellation.
Why we need a national surgery registry
The controversy surrounding open power morcellation was precipitated by the reporting of a single case—that of a prominent physician who had an unsuspected cancer morcellated during the course of a hysterectomy and was later upgraded to Stage 4 leiomyosarcoma as a result. But it wasn’t a gynecologic surgeon who reported the case—it was the patient herself. And we all know she was by no means the first case of an inadvertently morcellated sarcoma.
I would wager that few physicians are well versed in how to contact the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. And not many are familiar with the other specialized registries in the United States, let alone know how to report to them. Another important but often unaddressed issue: Is it hassle-free to make a report? The answer: A resounding “No.”
Who do we inform about our experiences—successful or not—in the operating room? And who pays for data collection? At present, the system is piecemeal or scattershot at best.
Sorely needed is a system for reporting that is easy to use, broad, and deep. A nationally funded system would be best. Otherwise, who is going to maintain the database? Who will filter the data? Who will ensure that the information that is entered is correct so that outcomes can be followed accurately?
For those of us employed by a hospital or other institution, it tends to be the institution itself that gathers the data—when it is gathered. But what about surgeons in private practice? How do they monitor themselves? And what about privately owned outpatient surgery centers, where patients sojourn no longer than 23 hours? Is it reasonable to expect them to add the burden and expense of data collection without a national mandate?
I know firsthand some of the skewed information that results when reporting is piecemeal or manipulated. When I was a resident, for example, in some localities, it was not uncommon for sexually transmitted diseases to go unreported when the patient had private insurance. The result: Only those in the lower socioeconomic ranks appeared to experience this problem.
Clearly, we need national standards and a national protocol. And to achieve that we need leaders strong enough to argue that the expense represents dollars well spent.
- Linda D. Bradley, MD
