Essure Confirmation Test with TVU/Modified HSG

The Essure Confirmation Test is an integral part of the Essure® permanent birth control procedure. The test must show either bilateral satisfactory insert location (when using a transvaginal ultrasound (TVU)) or both bilateral satisfactory insert location and occlusion (when using a modified hysterosalpingogram (HSG)) in the fallopian tubes before the patient can rely on Essure for contraception.

  • An Essure Confirmation Test should be performed 3 months after insert placement to evaluate insert retention and location
  • The Essure Confirmation Tests (TVU* or modified HSG) should be performed only by an experienced healthcare provider, including gynecologist, ultrasonographer, and/or radiologist who knows how to perform the appropriate Essure Confirmation Test. Training and educational materials on the Essure Confirmation Test are available through Bayer
  • The Essure Confirmation Test may be performed with TVU or modified HSG as determined by the TVU/HSG Confirmation Test Algorithm

*Healthcare providers who utilize the Essure Confirmation Test with TVU must complete training, which is administered by Bayer and documented by a certificate of completion.

Essure TVU/HSG Confirmation Test Algorithm

  • When using the TVU/HSG Confirmation Test Algorithm, TVU may be performed as a first-line confirmation test 3 months after a bilateral insert placement procedure if all of the following criteria are met:
    • Placement procedure was not difficult, including all of the following:
      • No concern at the time of placement of possible perforation due to excessive force required for insert delivery and/or a sudden loss of resistance
      • No difficulty identifying the tubal ostia during placement due to anatomical variation or technical factors such as poor distention, suboptimal lighting or endometrial debris
      • Physician is certain about placement
    • Procedure time ≤15 minutes (scope in-scope out)
    • Placement with 1-8 trailing coils
    • No unusual post-operative pain, transient or persistent, or onset at some later time post procedure, without any other identifiable cause
  • Patients on active immunosuppressive therapy (eg, systemic corticosteroids or chemotherapy) may experience delay or failure of the necessary tissue in-growth needed for tubal occlusion. For these patients, physicians must use the modified HSG as the Essure Confirmation Test. TVU should not be used for confirmation, as this test cannot confirm tubal occlusion in these patients. Clinical trials were not conducted with patients undergoing immunosuppressive therapy.
  • Trans-abdominal ultrasound cannot be substituted for TVU. If ultrasound is not indicated, patient must proceed to a modified HSG to evaluate insert location and tubal occlusion. If ultrasound evaluation is equivocal or unsatisfactory, patient must proceed to a modified HSG to evaluate insert location and tubal occlusion
  • Patient must use 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 utilized)

Remember that 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.

For additional information about Essure® and the Essure Confirmation Test, download the Essure Confirmation Test Guide.

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