Ultrasound assessment of the Essure contraceptive devices: is three-dimensional ultrasound really needed?

Abstract

Study objective: To evaluate the feasibility of 3-dimensional ultrasound (3DUS) for sonographic localization of Essure microinserts, comparing it with 2-dimensional ultrasound (2DUS) insofar as time to visualize the inserts and accuracy in determining their localization.

Design: Prospective study (Canadian Task Force classification II-2).

Setting: University clinic.

Patients: Twenty-seven consecutive women undergoing hysteroscopic Essure device placement.

Interventions: Essure microinserts were inserted in the outpatient hysteroscopy clinic following the manufacturer's recommendations, leaving from 3 to 8 loops of the inserts in the uterine cavity. In all patients, 2DUS and 3DUS were performed 3 months after the procedure. 2DUS was performed first; the device(s) were located, and their position was recorded. Then 3DUS scans were acquired, trying when possible to have both devices at least at a 45-degree angle with the insonation beam for optimal rendering on 3DUS. The OmniView method with volume contrast imaging was used to show the relationships of the microinserts within the uterine cavity when possible. To define the position of the Essure device in relation to the uterus and the salpinges, we used the classification developed by Legendre and colleagues. After sonographic evaluation all women underwent hysterosalpingography to assess the success of sterilization.

Measurements and main results: Hysteroscopic insertion was successful in all patients, with 2 Essure devices placed in 25 patients and 1 device in 2 patients (due to previous salpingectomy performed because of ectopic pregnancy), for a total of 52 devices. One spontaneous late (within 3 months) expulsion of the device occurred; the device had migrated almost completely into the uterine cavity. At 3-month follow-up, all 51 correctly placed devices were easily observed at 2DUS (mean [SD] duration of the procedure, 2.25 [0.8] minutes). At 3DUS in 51 cases, the device was in perfect position (1+2+3) in 21 (41.2%), in position 2+3 in 14 (27.4%), and in position +3 in 16 (31.4%). Both microinserts were observed on 3DUS reconstructed images in 31 of 35 (88.6%) 1+2+3 and 2+3 cases. However, in the 16 cases in which the devices were in position +3 (salpinx only), a single 3D sweep failed to demonstrate both devices in 10 of 16 cases (62.5%), due to substantially different angles of orientation of the inserts. This was because if 1 of the 2 devices was placed at a <30-degree angle with the insonation beam, its identification along the uterine wall was questionable because of concurrent hyperechogenicity of the bowel loops and poor visualization. Time for performance of 3DUS was 14.4 [4.8] minutes. Hysterosalpingography was performed in all patients, and confirmed tubal occlusion in all but 1 case.

Conclusions: On the basis of a limited number of patients, 2DUS is more time-efficient and equivalent to 3DUS in locating Essure contraceptive microinserts. These results should be considered when planning sonographic follow-up of patients with Essure devices.

Keywords: Essure microinserts; Hysteroscopy; Three-dimensional ultrasound; Two-dimensional ultrasound.