6 Committee comments
6.1 The Committee noted that another procedure, laparoscopic power morcellation, for the treatment of fibroids is the subject of a safety communication from the US Food and Drug Administration (FDA). In this communication, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids because concerns have been raised about the risk of spreading unrecognised malignant tumours. In light of this, the Committee sought opinion from a number of specialists. Specialist advisers were asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so) and they commented that:
Laparoscopic morcellation is a different procedure from hysteroscopic morcellation, and has a different risk profile. Laparoscopic morcellation involves inserting a morcellator device through a small incision in the patient's abdomen, and the morcellation of fibroid tissue takes place within the peritoneal cavity. In hysteroscopic morcellation, the morcellator device is inserted into the uterus through the vagina, and the fibroid tissue is morcellated within the uterus.
Theoretically, in women with patent fallopian tubes, hysteroscopic morcellation of unrecognised malignant tissue could result in the spread of malignant cells to the peritoneal cavity. Advisers considered that this would be very unlikely and highlighted that, to date, it has not been reported in the peer‑reviewed research literature. There is no evidence that the risk is different than for any other transcervical procedure used to remove tissue from the uterus.
The FDA has stated that the guidance it has issued on laparoscopic power morcellators does not apply to hysteroscopic morcellators, which have a different principle of operation. The FDA guidance states that, 'when used in accordance with current indications and instructions for use, hysteroscopic morcellators do not pose the same risk as [laparoscopic power morcellators] because any sarcomatous tissue present does not enter the peritoneal cavity.'
6.2 Noting the concern about possible unrecognised malignancy within fibroids, the Committee understood that the use of any type of morcellation procedure is contraindicated when malignancy is suspected. The Committee also noted that leiomyosarcoma is very rare in premenopausal women.
6.3 Specialist advisers noted that, in their opinion, hysteroscopic morcellation is most useful for small or pedunculated leiomyomas.
6.4 The Committee noted that available publications contained little information about symptom relief, quality of life or fertility outcomes. This reinforced their consideration that the evidence on efficacy was limited.