3 Committee considerations

3 Committee considerations

The evidence

3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 4 randomised controlled trials, 4 non-randomised comparative studies, 2 case series and 2 systematic reviews. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2 The professional experts and the committee considered the key efficacy outcomes to be: symptom relief, effective removal of fibroids and preservation of the ability to become pregnant.

3.3 The professional experts and the committee considered the key safety outcomes to be: spread of malignant and benign tissues, organ injury, bleeding, hernia and pain.

3.4 Patient commentary was sought but none was received.

Committee comments

3.5 The committee noted that the risk of developing uterine malignancy increases with age (before and after menopause).

3.6 The committee was informed that all patients should be risk assessed before the procedure for the presence of malignancy. If malignancy is considered, this should be discussed with a gynaecological multidisciplinary team.

3.7 The committee was informed that myomectomy without morcellation is also associated with a risk of disseminating previously undiagnosed malignancy.

3.8 The committee was informed that containment systems (the in‑bag technique) were increasingly used in this procedure with the aim of reducing the risk of disseminating benign or malignant cells.

3.9 The committee was informed that using containment systems adds complexity to the procedure and requires additional training. If the bag is punctured by the morcellator it would leak fibroid material and potentially injure the surrounding organs.

3.10 The committee noted that 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 encourages the use of additional labelling on laparoscopic power morcellator devices to warn of the risks of disseminating malignant and benign uterine tissue. It also advises using containment systems.

3.11 The committee noted that laparoscopic morcellation is a different procedure from hysteroscopic morcellation, on which NICE has also produced guidance.

ISBN: 978-1-4731-4241-1

  • National Institute for Health and Care Excellence (NICE)