The Essure Confirmation Test with Modified HSG

The Essure Confirmation Test with modified HSG is used to evaluate both the location of the inserts and occlusion of the fallopian tubes. Every patient must have an Essure Confirmation Test 3 months following the Essure procedure. The Essure Confirmation Test may be performed with TVU or modified HSG as determined by the TVU/HSG Confirmation Test Algorithm; however, modified HSG is always an acceptable first-line option. The patient must use alternative contraception until the Essure Confirmation Test verifies that the patient may rely on Essure® for permanent birth control. Per the TVU/HSG Confirmation Test Algorithm, modified HSG is also required after TVU if the TVU results are equivocal or unsatisfactory.

If bilateral insert location is satisfactory and bilateral fallopian tube occlusion is demonstrated, instruct your patient that she may discontinue alternative contraception and rely on Essure for birth control.

Review the content on performing the Essure Confirmation Test with modified HSG, radiograph imaging, evaluating image quality, evaluating insert location, and evaluating tubal occlusion to learn how to best perform the Essure Confirmation Test with modified HSG.

Performing the Essure Confirmation Test with Modified HSG

To evaluate insert location and tubal occlusion, Essure Confirmation Test with modified HSG images must show the relationship of the proximal end of the inner coil to the uterine cornua.

To produce adequate images, adherence to the following guideline is recommended:

1
Obtain good corneal filling so that uterine cavity silhouette is clearly seen.
2
Place fluoroscopy beam as close to A/P projection as possible.
3
Do not dilate cervix unless necessary; if dilation occurs, maintain a good cervical seal.
4
Downward traction on cervical tenaculum may be required for midpositional uteri. Remove speculum prior to fluoroscopy for best visualization of uterine anatomy
5
Take a minimum of 6 radiographs to assess insert location and tubal occlusion.

Unlike an infertility HSG, the Essure Confirmation Test with modified HSG is performed by instilling contrast media (dye) slowly and gently until the uterine cornua are distended. An increase in intrauterine pressure beyond that needed to produce corneal distention should be avoided.

Radiographic Markers

There are 4 radiographic markers on the device to evaluate insert location and tubal occlusion:

Figure 1. Proximal and distal radiographic markers.

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During the evaluation of the modified HSG films, the 4 radiopaque markers should be identified for each insert. Note that the two distal markers and the proximal marker of the inner coil are fixed in relation to one another, but the proximal marker of the outer coil may move or seem stretched because of the flexibility of the outer coil.

IMPORTANT: Bayer is providing this information to you for informational and educational purposes only. This document is not intended to be used as part of training or certification requirements for Essure, or to establish a standard of care. You are solely responsible for ensuring that you and your staff have been properly trained in all aspects of performing the Essure procedure to your patients in the office setting. For complete instructions, please refer to the Instructions for Use and the Physician Training Manual.

Radiograph Imaging

Take a minimum of 6 radiographs to assess insert location and tubal occlusion. In some cases, additional images may be necessary to evaluate insert location. This might include oblique views or lateral views.

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The Radiology Report must include:

  1. Number of inserts
  2. Location of each insert
  3. Tubal occlusion assessment for each side
  4. Description of unusual findings

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Evaluating Essure Confirmation Test with Modified HSG Films Quality

When evaluating the Essure Confirmation Test with modified HSG films, first confirm that the appropriate radiographs previously described are provided, a good A/P image of the uterine silhouette is obtained, and the uterus is completely filled in at least one view.

The Essure Confirmation Test with modified HSG will need to be immediately repeated if:

  • The appropriate sequence of radiographs was not taken
  • One or both uterine cornua were not maximally distended
  • The uterine silhouette is fundal rather than A/P
  • The image of the uterine cornua is obscured in any way
  • Insert cannot be located or position is unclear
radiographic_imaging_fig_7_head

Evaluating Insert Location

Distance from the filled uterine cornua to the proximal end of the inner coil can be measured in several ways:

1
Using the inner coil as a point of reference. The inner coil measures 30 mm in length (most commonly used method)
2
Calipers
3
Using the distal 2 markers as a measuring reference point. The distance between the 2 distal markers measures 5 mm

Note the 4 radiopaque markers and inner coil length. The inserts are symmetrical with a normal curvature. Ideal insert location is when the inner coil crosses the uterotubal junction. Note that the 2 distal markers and the proximal marker of the inner coil are fixed in relation to one another, but the proximal marker of the outer coil may move or seem stretched because of the flexibility of the outer coil.

Note: The insert may shift in response to fallopian tube movement following placement.

Satisfactory location

A satisfactory location is defined as the distal end of the inner coil being within the fallopian tube with <50% of the inner coil trailing into the uterine cavity, OR the proximal end of the inner coil being ≤30 mm into the tube from where contrast fills the uterine cornua.

Note: The normal curvature and symmetrical appearance of both inserts

Unsatisfactory location

There are 4 types of unsatisfactory location: proximal location, expulsion, distal location, and perforation or peritoneal location.

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Evaluating Tubal Occlusion

After evaluating insert location, determine whether contrast is visible beyond the insert and note any degree of proximal tubal filling, even if the tube is occluded. Satisfactory occlusion is when the tube is occluded at the cornua or contrast is seen within the tube but not past the distal end of the outer coil.

Satisfactory occlusion

After evaluating insert location, determine whether contrast is visible beyond the distal end of the outer coil or in the peritoneal cavity.

Unsatisfactory occlusion

How to manage:

If insert location is satisfactory but there is patency beyond the distal end of the outer coil or free spill of contrast into the peritoneal cavity, advise the patient not to rely on Essure®. The patient should remain on alternative contraception for 3 more months and have a repeat Essure Confirmation Test with modified HSG. If patency is again documented on the repeat Essure Confirmation Test with modified HSG, continue to advise the patient not to rely on Essure.

Evaluating Ability to Rely on Essure

  • If insert location and tubal occlusion are satisfactory, instruct the patient to discontinue alternative contraception and inform her that she can rely on Essure for contraception
  • If insert location is unsatisfactory, instruct the patient not to rely on Essure for contraception
  • If insert location is satisfactory but occlusion is unsatisfactory, instruct the patient to remain on alternative contraception. Repeat the Essure Confirmation Test with modified HSG in 3 months. If occlusion is still unsatisfactory, instruct the patient not to rely on Essure for contraception

Essure Confirmation Test with Modified HSG Checklist

Assessing patient ability to rely on Essure®:

  • If location and tubal occlusion are both rated satisfactory, instruct patient to discontinue alternative contraception
  • If location is unsatisfactory, instruct patient to not rely on the inserts for contraception
  • If location is satisfactory but occlusion is unsatisfactory, instruct patient to remain on alternative contraception. Repeat the Essure Confirmation Test with modified HSG in 3 months. If occlusion is still unsatisfactory, instruct patient to not rely on inserts for contraception

To avoid confusion with an infertility HSG, the OB/GYN and radiologist should be familiar with the Essure Confirmation Test with Modified HSG Checklist to ensure both insert location and tubal occlusion are noted in the radiology report.

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