Will open power morcellation of uterine tissue remain an option during hysterectomy and myomectomy?
A recent FDA hearing on the use of this technology has cast a cloud over its future. Here, two members of the AAGL Tissue Extraction Task Force discuss the evidence and emphasize the importance of preserving minimally invasive options in women’s health.
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What is your preferred surgical approach?
OBG Management: Do you perform open power morcellation in selected patients?
Dr. Wertheim: Even though I have performed morcellation with a scalpel transvaginally or through a mini-laparotomy incision for many years, I have never used open power morcellation because of the risk of leaving behind benign or malignant tissue fragments. Morcellation with a scalpel is easily learned and can be performed as quickly as power morcellation. Morcellation with a scalpel produces much larger pieces than with power morcellation. This probably markedly decreases the loss of fragments. I cannot make a definitive statement regarding cell loss, however. Until we have improved instrumentation and are better able to make a preoperative diagnosis of sarcoma, I’m going to rule out risk factors identified by the AAGL task force, do the appropriate work-up, and continue to morcellate with a scalpel, placing the specimen in a bag, if technically possible.
Dr. Reich: As I mentioned, I am a vaginal scalpel morcellator. I tried power morcellation when it first was developed but was never a fan. The same techniques used for vaginal extraction using a coring maneuver can be used abdominally through the umbilicus or a 1- or 2-cm trocar site.
What should the FDA’s next move be?
OBG Management: Care to make any predictions about the FDA’s final decision?
Dr. Wertheim: This has become a highly emotional and controversial issue with little good existing data. During the preoperative visit, this issue should be discussed with the patient using clear, lay-friendly language. Having said that, I also do not believe we should hide behind informed consent. The FDA has a responsibility to keep the public safe. If open power morcellation is allowed to continue, there will be another morcellated sarcoma or complications from retained benign tissue fragments. I doubt the FDA can live with this. I believe the risk factors identified by the AAGL task force should be ruled out, the appropriate workup done and then, if power morcellation is performed, it should be done inside a bag. In addition, I think the FDA should require that complications be reported and recorded in a registry.
Dr. Reich: I disagree. The FDA has to back off. It’s important to note that this is an American problem, as the rest of the world cannot afford power morcellators. The data are not in yet. The decision about what kind of hysterectomy is performed will be made by the “informed” patient, who undoubtedly will be very afraid to have MIS because of the surrounding negative publicity. We must do a better job of promoting the advantages of a minimally invasive approach.
OBG Management: Thank you both for your time and expertise.
Dr. Wertheim: Thank you for giving us the opportunity to express our opinions regarding this highly emotional and controversial issue.
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