5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 The majority of the following events were reported in a published review of the Food and Drug Administration (FDA) manufacturer and user facility device experience (MAUDE) database. The review estimated that approximately 180,000 hysteroscopic procedures had been done during the study period, with an overall reported adverse event rate of less than 0.1%.

5.2 Bowel damage was reported in 12 patients treated by hysteroscopic morcellation in the review of the FDA MAUDE database: 2 patients had temporary colostomies and were admitted to intensive care units.

5.3 Fluid overload needing treatment by intubation and admission to an intensive care unit was reported in 11 patients in the review of the FDA MAUDE database. Uncomplicated fluid overload that resolved spontaneously or with conservative treatment was reported in 19 patients in the same review.

5.4 Hysteroscopic morcellation was not completed in 1 patient because of imminent fluid overload, in a randomised controlled trial of 60 patients treated by hysteroscopic morcellation or conventional hysteroscopic resection.

5.5 Conversion of the procedure to hysterectomy was reported in 6 patients in the review of the FDA MAUDE database: 3 were because of excessive blood loss, 2 were at the patient's request after the diagnoses of uterine perforation and a failed endometrial ablation, and 1 was due to device failure (also reported in section 5.7).

5.6 Uterine perforation that needed no additional surgery or treatment was reported in 28 patients in the review of the FDA MAUDE database.

5.7 Device failure (including metal shavings and broken pieces of device visualised in the uterine cavity), poor visualisation, failure of outflow, or a defective device that could not be activated were reported in 25 patients in the review of the FDA MAUDE database. In 1 reported case, the blade fell into the uterine cavity and could not be retrieved. A hysterectomy was done and the patient recovered well postoperatively.

5.8 Pelvic infection was reported in 4 patients in the review of the FDA MAUDE database.

5.9 Postoperative bleeding that could be controlled with non‑invasive measures was reported in 6 patients in the review of the FDA MAUDE database.

5.10 One patient with multiple comorbidities died after the procedure from 'pulmonary embolism and comorbidities'. A second patient, who was an elderly woman described as 'not well', was readmitted the day after her procedure and died shortly after. An exact cause of death was not reported.

5.11 In addition to safety outcomes reported in the literature, specialist advisers are 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). Information from specialist advisers is provided in section 6, in the context of comments from the Committee.

  • National Institute for Health and Care Excellence (NICE)