The Essure Confirmation Test with Transvaginal Ultrasound (TVU)

TVU Eligibility Checklist for the Essure Confirmation Test

Immediately after Essure® bilateral placement, complete the optional TVU Eligibility checklist shown below and on page 7 of the Essure Confirmation Test Guide. This checklist was created to help healthcare professionals determine whether the patient is eligible for the Essure Confirmation Test with TVU (see Essure TVU/HSG Confirmation Test Algorithm). The Essure Confirmation Test should be performed at 3 months post-placement.

TVU Eligibility

*Refer to the TVU/HSG Confirmation Test Algorithm criteria to determine whether the patient is a candidate for an Essure Confirmation Test using TVU.

  • Counsel the patient to remain on alternative contraception until a satisfactory Essure Confirmation Test is documented
  • Discuss the 2 methods used in the Essure Confirmation Test (TVU and modified HSG)
  • Inform patients of the differences between the methods, including benefits and risks including possible increased risk of pregnancy if TVU is the only confirmation method used

Remember to include a procedural note in the patient's chart indicating whether she is an appropriate candidate for the Essure Confirmation Test with TVU, or if she must proceed directly to a modified HSG. A modified HSG is always an acceptable first-line option for the Essure Confirmation Test. If TVU is performed and the results are equivocal or unsatisfactory, the patient cannot rely on Essure for birth control and a modified HSG is required to evaluate insert location and tubal occlusion. The patient must also be instructed not to discontinue her alternative contraception.

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Proceeding with the Essure Confirmation Test with TVU

Before proceeding with the Essure Confirmation Test with TVU at 3 months, confirm that the patient meets the criteria for the option of an Essure Confirmation Test with TVU (see Essure TVU/HSG Confirmation Test Algorithm). If TVU is not indicated, a modified HSG is required to evaluate insert location and tubal occlusion.

Performing the Essure Confirmation Test with TVU

As the treating physician, it is your responsibility to confirm the results from the Essure Confirmation Test with TVU report. Based on the clinical trial protocol, the Essure Confirmation Test with TVU has 3 components: orientation, identification, and location. A minimum of 3 required images (TVU scout image, image of left insert, image of right insert) must be obtained and retained for documentation of the Essure Confirmation Test with TVU. It is also useful to obtain real-time video, including the 3 required images, if technically possible.

Use the chart shown below and on pages 8-10 of the Essure Confirmation Test Guide to perform and record placement results.

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Classification of TVU Locations

How to manage the TVU evaluations with satisfactory or optimal locations of both inserts:

The patient may be told to discontinue her alternative contraception and rely on Essure for birth control. The Essure Confirmation Test with TVU does not assess tubal occlusion. Satisfactory and optimal placement, as assessed by TVU, has been demonstrated in clinical studies to be an effective measure of the patient's ability to rely when utilizing the TVU/HSG Confirmation Test Algorithm.

Unsatisfactory location

The insert location is unsatisfactory if a portion of each insert cannot be visualized in the cornua in the transverse or oblique transverse view in one scout image. There are 5 types of unsatisfactory placement locations: distal, proximal, perforation, expulsion, and unclassified.

Distal

Distal placement is suspected if the proximal end of the insert is not located in the myometrium in the cornua and not crossing or in contact with the SUTJ.

Figure 6

Transverse focused view

Proximal

Proximal placement is suspected if >50% or the majority of the insert is visualized in the uterine cavity or if the linear axis of the insert(s) is visualized in the midline sagittal view.

Figure 7

Transverse focused view

Midline sagittal view

Perforation

Perforation is suspected if the linear axis of one or both inserts are parallel to the endometrial stripe in the sagittal view or if the linear axis of an insert is visualized crossing the myometrium in the midline sagittal view.

Figure 8

Midline sagittal view

Expulsion

Expulsion is suspected if one or both inserts are not identified in the cornua in a transverse view in a single scout image.

Figure 9

Transverse fundal view

Unclassified

If the linear axis of an insert cannot be identified, suggesting it is coiled, bent, or elongated, insert location is considered unsatisfactory. If the surrounding soft tissue cannot be clearly defined, position is considered unsatisfactory.

Figure 10

Oblique transverse view

Transverse view

How to manage the TVU evaluations with satisfactory or optimal locations of both inserts:

If the TVU evaluation is equivocal or unsatisfactory, the patient must proceed to a modified HSG to evaluate insert location and tubal occlusion. The patient must also be told to continue her alternative contraception and that she cannot rely on Essure until a satisfactory Essure Confirmation Test is documented.

If TVU is performed and the results are equivocal or unsatisfactory, the patient cannot rely on Essure for birth control and must remain on alternative contraception, and a modified HSG is required to evaluate insert location and tubal occlusion.

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Next: Learn about the Essure Confirmation Test with Modified HSG