Essure Permanent Birth Control Device: Radiological followup results at our center Poster No.: C-0212 Congress: ECR 2013 Type: Scientific Exhibit Authors: R. Díaz Aguilera, A. M. Higuera Higuera, V. Palomo Gallego, C. S. Linares Gonzalez, M. T. Jaén Reyes, I. Rivera Salas; Andújar. Jaén/ES Keywords: DOI: Abdomen, Genital / Reproductive system female, Radiografía simple, Hysterosalpingography 10.1594/ecr2013/C-0212 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. www.myesr.org Page 1 of 13
Purpose The Essure permanent birth control device is a relatively recent method of permanent female birth control that is increasingly being used. This procedure is replacing the classic tubal ligation technique because it is a minimally invasive method, performed in an outpatient setting that does not require general anesthesia, and permits a more rapid recovery time of patients with faster return to work and normal activities. The device placement is achieved via catheterization with an operative hysteroscope. The microinsert is attached to a guidewire used for placement and is extended into the proximal portion of the fallopian tube where the device is deployed. Once here, the microinsert stimulates a benign fibrotic reaction that progressively occludes the tube. The device consists of two coils: an outer coil and an inner coil (Fig. 1 on page 2). The inner coil is coated with polyethylene fibers that generate the benign fibrotic reaction that occludes the tube. The outer coil surrounds the inner coil like a spring and, once deployed in the tubal lumen, it expands to anchor in the tubal mucosa. Each device presents four radiodense markers (Fig. 2 on page 3), corresponding to proximal and distal outer coil and proximal and distal inner coil. The aim of our study is to analyze the results of the radiological follow-up of patients treated with Essure permanent birth control device at our institution. Images for this section: Page 2 of 13
Fig. 1: This image shows Essure device, which consists of two coils, an outer coil and an inner coil. Note the four distinct markers located in the proximal and distal portions of inner coil (green arrows) and in the proximal and distal portions of outer coil (orange arrows). Page 3 of 13
Fig. 2: Radiograph of Essure device. Note the four radiodense markers corresponding to proximal and distal portions of inner coil (green arrows) and proximal and distal portions of outer coil (orange arrows). Page 4 of 13
Methods and Materials We retrospectively reviewed all patients treated with Essure permanent birth control device at our institution from January 2006 to May 2011. For each patient we collected the findings of the radiological examinations performed as follow-up. The majority of these exams were carried out three months after microinserts placement and they consisted of single radiograph of the pelvis anteroposterior view, hysterosalpingography (HSG) or both. On X-ray of the pelvis we assessed the following items: - microinserts number - microinserts integrity - microinserts position - microinserts separation On Hysterosalpingography we assessed the following items: -microinserts position. We classified the position into three grades according to the grading system developed by the device s manufacturer: Grade 1 (unsatisfactory): It corresponds to expulsion of the device into the uterine cavity or proximal position of the device with more than 50% of the length of the inner coil trailing into the uterine cavity. Grade 2 (satisfactory): It is defined by a microinsert that crosses the uterotubal junction with less than 50% of the length of the inner coil trailing into the uterine cavity or when the proximal end of the inner coil is within 30 mm of the proximal fallopian tube measured from the contrast-filled uterine cornua. Grade 3 (unsatisfactory): It corresponds to a device that is too distal in the tube, with the proximal end of the inner coil more than 30 mm from the contrast-filled cornua or when the device is expelled into the peritoneal cavity. -microinserts function. We classified the function into three categories: Page 5 of 13
1. Bilateral tubal occlusion 2. Unilateral tubal occlusion 3. Bilateral tubal patency Results A total of 225 patients were treated at our institution between January 2006 and May 2011. Two patients had unilateral microinsert placement (due to previous tubal occlusion secondary to scarring from prior pelvic inflammatory disease). Three months after the procedure, 140 patients underwent single radiograph of the pelvis, 74 patients underwent HSG, and 19 underwent both imaging methods as radiological follow-up. In 22 patients, the x-ray of the pelvis showed suspected positional abnormalities or unsatisfactory devices position. Seventy-four patients, treated with a total of 146 microinsert devices (two had unilateral Essure placement), underwent HSG. The position and function of these devices were as follows (Table 1 on page 7; Fig. 3 on page 7, Fig. 4 on page 8, Fig. 5 on page 9, Fig. 6 on page 10, and Fig. 7 on page 11): - A total of 112 microinsert devices were in position grade 2 (satisfactory) and they occluded the tubes. - A total of 21 microinsert devices were in position grade 2 (satisfactory) but they did not produce occlusion of the tubes. - Three microinsert devices were in position grade 1 (unsatisfactory): two occluded the tubes and one not. - Ten microinsert devices were in position grade 3 (unsatisfactory): five occluded the tubes and five not. Page 6 of 13
Fifty-six (75%) out of 74 patients showed Essure in grade 2 position (satisfactory) with bilateral tubal occlusion. There was one reported pregnancy among the patients during the follow-up period. Images for this section: Table 1 Page 7 of 13
Fig. 3: Case 1. Hysterosalpingography images obtained three months after microinsert placement showing normal positioning of Essure devices. No contrast medium is seen extending beyond the cornua. Page 8 of 13
Fig. 4: Case 2. A) Hysterosalpingography images obtained three months after Essure placement showing satisfactory position of devices. After contrast agent injection, the contrast medium is seen within both tubes and peritoneal cavity indicating bilateral tubal patency. Page 9 of 13
Fig. 5: Case 2. B) Hysterosalpingography obtained three months after the previous one showing tubal occlusion bilaterally. Note that now contrast agent is not seen within tubes indicating further interval fibrosis. Page 10 of 13
Fig. 6: Case 3. A) Hysterosalpingography images. Abnormal position of right microinsert; the device has been expelled into the peritoneal cavity. There is opacification of the right Fallopian tube and free spillage of contrast medium into peritoneal cavity. Note that left microinsert is in satisfactory position with tubal occlusion. Page 11 of 13
Fig. 7: Case 3. B) A new device was placed in the right tube. HSG performed three months after the procedure showing normal position of the new right microinsert with ipsilateral tubal occlusion. Page 12 of 13
Conclusion Single radiograph of the pelvis may be useful during follow-up after Essure permanent birth control device placement. Nevertheless, this imaging technique is only able to detect positional abnormalities. Hysterosalpingography is the only imaging test that can assess both microinserts position and function and it must be performed in case of suspected device malfunction. References 1. Khati NJ, Parghi CR, Brindle KA. Multimodality imaging of the essure permanent birth control device: emphasis on commonly overlooked abnormalities. AJR Am J Roentgenol. 2011 May;196(5):W648-58. Review. 2. Wittmer MH, Famuyide AO, Creedon DJ, Hartman RP. Hysterosalpingography for assessing efficacy of Essure microinsert permanent birth control device. AJR Am J Roentgenol. 2006 Oct;187(4):955-8. 3. Wittmer MH, Brown DL, Hartman RP, Famuyide AO, Kawashima A, King BF. Sonography, CT, and MRI appearance of the Essure microinsert permanent birth control device. AJR Am J Roentgenol. 2006 Oct;187(4):959-64. Personal Information Page 13 of 13