Clinical Radiology 67 (2012) e112ee117
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Pictorial Review
Multimodality imaging of the Essure tubal occlusion device W.L. Simpson*, L. Beitia Department of Radiology, Mount Sinai Medical Center, New York, NY, USA
article in formation Article history: Received 15 May 2012 Received in revised form 3 August 2012 Accepted 9 August 2012
The Essure device is a permanent birth-control device, which is gaining popularity. The microinserts are composed of metallic elements that can be seen on radiography, computed tomography, ultrasound, and magnetic resonance imaging. Knowledge of the normal location and appearance of the Essure device will ensure appropriate patient care. The purpose of this review is to describe the Essure tubal occlusion device and illustrate its normal and abnormal appearance using various imaging methods. Ó 2012 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Introduction The Essure micro-insert (Conceptus, Mountain View, CA, USA) was first approved for use in the United States in 2002.1,2 It is a permanent birth-control device placed hysteroscopically without the need for surgery or general anaesthesia.3e5 Each micro-insert consists of a stainless steel inner coil coated with polyester fibres and an elastic nitinol outer coil (Fig 1). The ends of each coil are delineated by radio-opaque markers. The outer coil expands to anchor the device in place in the uterine fallopian tube with a few millimetres of the outer coil visualized in the cornual region of the uterine cavity at hysteroscopy. The polyester fibres coating the inner coil elicit an inflammatory healing response that occludes the tubes by tissue in-growth into the device itself.2 The literature reports a 99% effectiveness rate at 5 years.6 In addition to pregnancy, other potential complications include procedure-related infection, extrusion of the micro-insert from the tube,7 tubal perforation,8 and small bowel obstruction.9 In the United States, a hysterosalpingogram (HSG) is a Food and Drug Administration (FDA) mandated requirement 3 months after the device is placed to confirm tubal * Guarantor and correspondent: W.L. Simpson, Department of Radiology, Box 1234, Mount Sinai Medical Center, 1 Gustave L. Levy Place, New York, NY 10029, USA. Tel.: þ1 212 241 3832; fax: þ1 212 427 8137. E-mail addresses:
[email protected],
[email protected] (W.L. Simpson).
occlusion.2,10e12 In Europe and Australia the HSG is not required and is often replaced with a radiograph of the pelvis or ultrasound.13e18 Contrast-enhanced ultrasound has been proposed as an additional means to confirm tubal occlusion.19,20 However, ultrasound contrast agents are not FDA approved for this use in the United States. If the tubes are occluded, the patient can stop using other methods of birth control. If the micro-inserts are in a good position but the tubes are not occluded a repeat study in an additional 3 months is required. If the micro-inserts are not in a good position then replacement or additional birth control is necessary.2 Given that over 300,000 Essure devices have been placed over the last decade,2 radiologists will see more of these devices, not only on HSGs but on other crosssectional imaging techniques as well. We present a review of our experience with imaging of the device.
HSG The technique for the performance of HSG and the normal appearance of the uterus and tubes has been well described.21 On the scout image, the micro-inserts appear as two curvilinear metallic devices within the upper pelvis. One should be on each side of the pelvis and appear relatively symmetrical (Fig 2). The location and orientation of the micro-inserts can vary depending on the location of the interstitial portion of the fallopian tubes (Fig 3). The Essure
0009-9260/$ e see front matter Ó 2012 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.crad.2012.08.013
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Figure 1 An ex vivo image of the Essure tubal occlusion device. The stainless steel inner coil is delineated by radio-opaque markers 1 and 3. The elastic outer coil is delineated by markers 2 and 4. The insert image shows the radiographic appearance of the device after placement with the four radio-opaque markers identified.
Figure 3 A 32-year-old woman who underwent HSG to confirm tubal occlusion after Essure insertion 4 months prior. Anteroposterior image after contrast medium instillation shows a normal uterine contour. Contrast extends into the uterine tubes up to the microinserts, which are asymmetrically positioned, but does not extend beyond them consistent with successful tubal occlusion.
Figure 2 A 29-year-old woman who underwent HSG to confirm tubal occlusion after an Essure was placed 3 months prior. (a) Anteroposterior scout image demonstrates a midline balloon-tipped HSG catheter. The metallic micro-inserts are on both sides of the pelvis, parallel and symmetric. (b) Anteroposterior image after contrast medium instillation shows a normal uterine contour. Contrast opacifies the uterine cornua and abruptly ends at the micro-inserts consistent with successful tubal occlusion.
device will have this same appearance on any abdominal radiograph. After contrast material is instilled the uterine cavity should opacify normally. When the micro-inserts are in a good position and the tubes are occluded the fallopian tubes will not opacify. The contrast medium will extend into the cornual regions of the uterus. The uterine ends of the micro-inserts will be obscured by the contrast medium as they extend into the cornual aspect of the uterine cavity. The contrast medium may only extend up to the uterine end of the micro-insert in some cases (Fig 2). This can occur if the micro-inserts are placed in the uterine fallopian tube without extension into the uterine cavity or if the inflammatory response involves the cornual aspect of the uterus or uterine fallopian tube as well (Fig 3). If the micro-insert is malpositioned too fimbrially, the fallopian tubes will opacify to the point where the inflammation response occludes the tube. The tubes will opacify normally if the micro-insert does not induce the inflammatory reaction or if the micro-insert has been extruded from the tube (Fig 4). If the micro-insert is located in the fallopian tube but the tube is not occluded, the manufacturer suggests performing a repeat study in an additional 3 months.2 In the authors’ experience, micro-inserts can induce the inflammatory response given additional time with the tube being occluded on repeat imaging (Fig 5). If the micro-insert has been completely extruded from the tube into the peritoneal cavity then insertion of an additional device is necessary. Occasionally the micro-inserts can be extruded into the uterine cavity. In this case, the contrast medium in the uterus will obscure the devices and the tubes will opacify normally (Fig 6).
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Figure 4 A 29-year-old woman who underwent HSG to confirm tubal occlusion after Essure placement 5 months prior. (a) Anteroposterior scout image demonstrates a metallic clamp on the right side of the image and a balloon-tipped HSG catheter. The micro-inserts are on both sides of the pelvis but at different levels. (b) After contrast medium instillation the opacified uterus is seen en face. The right fallopian tube is occluded with contrast medium not passing beyond the micro-insert. The left tube opacifies to the ampullary portion with contrast medium surrounding the micro-insert indicating that the tube is not occluded.
Computed Tomography (CT) The Essure device can be seen at CT after placement. The micro-inserts appear as thin, curvilinear metallic structures in the uterine cornua1,13 (Fig 7). They may appear to extend outside the contour of the uterus as the fallopian tubes themselves cannot be seen on CT. If the micro-insert has been extruded from the fallopian tube it will appear as a short, curvilinear metallic foreign body most commonly in the peritoneal cavity or less likely in the uterine cavity (Fig 8).
Ultrasound As ultrasound is the most common method used to image the gynaecological organs, the Essure device will be seen incidentally on pelvic ultrasound examinations. The microinserts will appear as echogenic linear structures1,13,14,16,17 (Fig 9). The entirety of the micro-insert often is not visualized due to bowel gas surrounding the fallopian tubes. Commonly only the uterine aspect that extends into the uterine cavity is seen. There should be myometrium
Figure 5 A 31-year-old woman (same patient as in Fig 4) who was lost to follow-up after initial confirmatory HSG showed that the left fallopian tube was not occluded. She returned for repeat HSG 17 months after placement having had no intervention in the intervening period. (a) Anteroposterior scout image demonstrates a metallic clamp over the right side and a balloon-tipped HSG catheter over the sacrum. The metallic micro-inserts are on both sides of the pelvis and in similar position as in Fig 4. (b) Anteroposterior image after contrast medium instillation re-demonstrates a normal uterine contour. The right tube is again occluded as contrast medium stops at the micro-insert. The majority of the isthmic portion of the left tube opacifies. The contrast medium does not extend beyond the micro-insert now consistent with tubal occlusion at this level.
surrounding the micro-insert (Fig 9). The micro-inserts often have a curved appearance on ultrasound1 (Fig 9). If the micro-inserts are not properly positioned, they may not be seen with ultrasound. Three-dimensional (3D) ultrasound has been used to visualize more of the micro-inserts that just the uterine portion that can commonly be seen with transvaginal ultrasound.15 In addition, using this technology at least a portion of the micro-insert may be visualized if it is malpositioned in the fimbrial tube, whereas it is often completely obscured with transvaginal ultrasound.
Magnetic resonance imaging (MRI) The Essure device is MR compatible22 and can be seen on MRI as well. As the micro-inserts are metallic, they will
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Figure 6 A 37-year-old woman who underwent HSG to confirm tubal occlusion after an Essure was placed 4 months prior. (a) Anteroposterior scout image with the balloon-tipped HSG catheter in place shows the micro-inserts centrally within the pelvis and parallel but predominantly vertically oriented and somewhat in a triangular configuration. (b) Anteroposterior image after instillation of contrast medium shows the microinserts are obscured and both fallopian tubes are patent. (c) Steep oblique image demonstrates the micro-inserts to be within the uterine cavity and partially obscured by contrast medium.
Figure 7 A 39-year-old woman who underwent contrast-enhanced CT of the abdomen and pelvis to follow-up resection of a retroperitoneal leiomyosarcoma. Axial CT image through the pelvis demonstrates curvilinear metallic structures representing the micro-inserts in both uterine cornua extending into the uterine fallopian tubes.
Figure 8 A 48-year-old woman status post-right hemicolectomy who presented with vague abdominal pain. Coronal CT image through the pelvis shows the metallic micro-inserts to be malpositioned centrally within the uterine cavity and essentially overlapping (arrows).
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Figure 10 A 42-year-old woman who underwent PET/CT for restaging of lymphoma after chemotherapy. Fused axial CT and PET image shows no FDG uptake associated with the micro-insert in the right uterine cornua. The left micro-insert was not imaged at this level but was present.
the first few months after insertion during the inflammatory reaction, there may be mild PET tracer uptake. This should resolve if imaging is performed a few months later. Figure 9 A 32-year-old woman who had an Essure placed 5 months earlier and presented with pelvic pain. (a) Transverse transabdominal ultrasound image shows both micro-inserts (arrows) as curvilinear echogenic structures extending from the uterine cornuae outside the fundal contour into the fallopian tubes which are not well visualized on ultrasound. (b) Transverse transvaginal ultrasound image at the level of the uterine fundus demonstrates the right micro-insert (arrow) as a markedly echogenic linear structure surrounded by myometrium.
appear as areas of susceptibility artefact.1,22 The appearance can vary somewhat depending on the MR pulse sequence used. As on CT, the micro-inserts should be seen in the region of the uterine cornua and may extend outside the contour of the uterus itself along the course of the fallopian tubes.
Positron-emission tomography (PET) To the authors’ knowledge, the appearance of the Essure device on PET imaging has not been described. With the increasing use of PET imaging, the Essure device will be encountered more frequently on PET and PET/CT imaging. The micro-inserts will be visualized on the CT portion as previously described. The micro-inserts should not demonstrate PET tracer uptake after the initial inflammatory reaction resolves (Fig 10). If PET is performed during
Conclusion The Essure device is a permanent birth-control device placed into the uterine aspect of the fallopian tube. The micro-inserts illicit an inflammatory response that occludes the tubes, thereby preventing pregnancy. The metallic micro-inserts can be seen as curvilinear metallic densities on radiography and CT, echogenic structures on ultrasound, and as areas of susceptibility artefact on MRI. As the number of devices placed continues to increase, they will be seen more frequently on routine imaging studies. Appreciation of the normal location and appearance of the Essure device will ensure correct interpretation.
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