How to be sure of a complete removal of Essure® implant? A radiological study of Essure® microinserts

Purpose

Laparoscopic cornuectomy, one of the most performed surgical techniques to remove Essure® implants, is associated with a risk of fragmentation of the device. We aimed to assess the diagnostic accuracy of the intraoperative radiograph of the removed Essure® microinserts compared with intraoperative inspection of the device.

Study design

In this French retrospective cohort study including 66 patients, two experienced gynecologists and two residents evaluated the intraoperative radiograph in a blind manner. Diagnostic accuracy was calculated for each observer.

Results

The global sensitivity and specificity for intraoperative radiograph to detect a residual fragment for both senior gynecologists and residents were, respectively 87.5 % (±3.3) and 80.0 % (+/12.2). Pooled positive (PPV) and negative predictive values (NPV) for intraoperative radiograph were respectively 99.2 % (±0.5) and 21.6 % (±6.4). There was a statistically significant difference in intraoperative radiograph analysis between senior gynecologists and residents (sensitivity: 91.4 %±0.8 vs 79.6 %±1.5, p = 0.02; specificity: 100% vs 50.0 %, p < 0.0001; PPV: 100 % vs 98.0 % ±0.1, p = 0.0007; NPV: 26.8 % ±1.8 vs 7.2 % ±0.5, p = 0.009).

Sensitivity and specificity of the intraoperative inspection of the removal specimen was respectively 95.3 % and 100 % (PPV and NPV were, respectively 100 and 40 %).

There were no statistically significant differences in diagnostic accuracy between intraoperative radiographs analysis and intraoperative inspection of the device for the senior gynecologists.

Conclusions

Intraoperative radiograph of the removed Essure® implants analysis is a difficult skill needing specific training. Postoperative pelvic X-ray is still recommended in clinical practice after laparoscopic cornuectomy.