Timing of Insertion

Tools for Insertion

Preparation for insertion

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Exclude pregnancy and confirm that there are no other contraindications to the use of Kyleena.

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Ensure that the patient understands the contents of the Patient Information Booklet and obtain the signed patient informed consent located on the last page of the Patient Information Booklet.

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With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus.

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Gently insert a speculum to visualize the cervix.

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Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.

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Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and gently apply traction to stabilize and align the cervical canal with the uterine cavity. Perform a paracervical block if needed. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. The tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.

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Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity in centimeters, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block.

Insertion Procedure

Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for Kyleena. Ensure use of aseptic technique throughout the entire procedure.

Step 1–Opening of the package

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Open the package (Figure 1). The contents of the package are sterile.

Figure 1. Opening the Kyleena Package

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Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package.

Step 2–Load Kyleena into the insertion tube

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Push the slider forward as far as possible in the direction of the arrow, thereby moving the insertion tube over the Kyleena T-body to load Kyleena into the insertion tube (Figure 2). The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.

Figure 2. Move slider all the way to the forward position to load Kyleena

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Maintain forward pressure with your thumb or forefinger on the slider. DO NOT move the slider downward at this time as this may prematurely release the threads of Kyleena. Once the slider is moved below the mark, Kyleena cannot be re-loaded.

Step 3–Setting the Flange

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Holding the slider in this forward position, set the upper edge of the flange to correspond to the uterine depth (in centimeters) measured during sounding (Figure 3).

Figure 3. Setting the flange

Step 4–Kyleena is now ready to be inserted

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Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5–2 cm from the cervix and then pause (Figure 4).

Figure 4. Advancing insertion tube until flange is 1.5 to 2 cm from the cervix

Do not force the inserter. If necessary, dilate the cervical canal.

Step 5–Open the arms

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While holding the inserter steady, move the slider down to the mark to release the arms of Kyleena (Figure 5). Wait 10 seconds for the horizontal arms to open completely.

Figure 5. Move the slider back to the mark to release and open the arms

Step 6–Advance to fundal position

Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. If you encounter fundal resistance do not continue to advance. Kyleena is now in the fundal position (Figure 6). Fundal positioning of Kyleena is important to prevent expulsion.

Figure 6. Move Kyleena into the fundal position

Step 7–Release Kyleena and withdraw the inserter

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Holding the entire inserter firmly in place, release Kyleena by moving the slider all the way down (Figure 7).

Figure 7. Move the slider all the way down to release Kyleena from the insertion tube

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Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.

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Using a sharp, curved scissor, cut the threads perpendicular, leaving about 3 cm visible outside of the cervix [cutting threads at an angle may leave sharp ends (Figure 8)]. Do not apply tension or pull on the threads when cutting to prevent displacing Kyleena.

Figure 8. Cutting the threads

Kyleena insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records.

Important information to consider during or after insertion

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If you suspect that Kyleena is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Kyleena if it is not positioned completely within the uterus. Do not reinsert a removed Kyleena.

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If there is clinical concern, exceptional pain or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation.

Timing of Removal

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Kyleena should not remain in the uterus after 5 years.

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If pregnancy is not desired, the removal should be carried out during the first 7 days of the menstrual cycle, provided the woman is experiencing regular menses. If removal will occur at other times during the cycle or the woman does not experience regular menses, she is at risk of pregnancy: start a new contraceptive method a week prior to removal for these women. [See Dosage and Administration (2.4).]

Tools for Removal

Removal Procedure

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Remove Kyleena by applying gentle traction on the threads with forceps (Figure 9).

Figure 9. Removal of Kyleena

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If the threads are not visible, determine location of Kyleena by ultrasound [see Warnings and Precautions (5.10)].

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If Kyleena is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Kyleena, examine the system to ensure that it is intact.

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Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions.