5 Safety
This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. Evidence on both women with a history of recurrent miscarriage and those with primary infertility has been included, because the procedure is the same for both and therefore the safety events are relevant to both conditions. For more detailed information on the evidence, see the overview.
5.1
Uterine perforation during hysteroscopic metroplasty was reported in 1% (17 out of 2,167) of women in a review of 2,528 women (37 studies) and in 1% (8 out of 923) of women in a case series of 973 women. Uterine perforation was reported in 1% (2 out of 170) of women in a case series of 170 women; this was managed by laparoscopic bipolar coagulation and both women were discharged the same day. One of these women subsequently had a pregnancy that carried to term, with delivery by caesarean section.
5.2
Uterine rupture during pregnancy or delivery was identified in 18 confirmed reports in the review of 2,528 women; in 10 of the 18 cases, uterine perforation had occurred at the time of the hysteroscopic metroplasty.
5.3
Intraoperative bleeding with 'interruption of the procedure' was reported in 1 woman in the case series of 973 women. Excessive bleeding was reported in 1% (2 out of 170) of women in the case series of 170 women; this was managed by an intrauterine balloon catheter kept in situ for 4 hours.
5.4
Cervical laceration (not further described) was reported in less than 1% (2 out of 2,167) of women in the review of 2,528 women. Difficult dilatation leading to cervical injury (not further described) was reported in 1 woman in the case series of 170 women.
5.5
Pulmonary oedema was reported in 1 woman each in the review of 2,528 women and in the case series of 973 women (no further details reported).
5.6
Uterine synechiae after hysteroscopic metroplasty were reported in 2% (4 out of 181) of women in a case series of 181 women (these synechiae were all treated surgically) and in 1 woman in the review of 2,528 women (treatment not reported). Mild adhesions were reported in 7% (11 out of 170) of women in the case series of 170 women (diagnosed by hysteroscopy). These adhesions were all treated by hysteroscopic adhesiolysis; 7 of the women subsequently became pregnant and had term deliveries.
5.7
Interstitial ectopic pregnancy after hysteroscopic metroplasty was reported in 1 woman in a case report. A laparotomy was done to resect a wedge of myometrium that was completely enclosing the gestational sac. A hysteroscopy was done 4 months later and showed only a fine linear scar at the fundus, and the uterine cavity was otherwise normal.
5.8
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). For this procedure, specialist advisers considered that the following were theoretical adverse events: incomplete resection of the septum, infection, placenta accreta and percreta, a negative effect on fertility through damage to the endometrium, and detrimental effect on uterine and endometrial blood flow.