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Consumer SitePrescribing Information

Important Safety Information About MIRENA®

Mirena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Mirena. Continue reading below

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Home / Insertion & Removal

Insertion Steps & Removal Instructions

  • Intro
  • Step 1
  • Step 2
  • Step 3
  • Step 4
  • Step 5
  • Step 6
  • Step 7
  • Step 8
  • Removal

Learn about the updated insertion process with the Bayer Inserter

It's important to follow these insertion instructions exactly as described in order to ensure proper insertion and avoid premature release of Mirena® from the inserter. Remember: once Mirena is released, it cannot be reloaded.

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

Preparatory Steps

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

Gently insert a speculum to visualize the cervix.

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

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. This tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.

Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter any difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block. The uterus should sound to a depth of 6 to 10 cm. Insertion of Mirena into a uterine cavity less than 6 cm by sounding may increase the incidence of expulsion, bleeding, pain, perforation, and possibly pregnancy.

Tools for Insertion

Preparation

  • Gloves
  • Speculum
  • Sterile uterine sound
  • Sterile tenaculum
  • Antiseptic solution, applicator

Procedure

  • Sterile gloves
  • Mirena with inserter in sealed package
  • Instruments and anesthesia for paracervical block, if anticipated
  • Consider having an unopened backup Mirena available
  • Sterile, sharp curved scissors

STEP 1: Open The Package

  • The contents of the package are sterile
  • Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package

STEP 2: Load Mirena into the
insertion tube

  • Push the slider forward as far as possible in the direction of the arrow, thereby moving the Mirena T-body into the insertion tube. The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube

IMPORTANT

  • 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 Mirena. Once the slider is moved below the mark, Mirena cannot be reloaded

STEP 3: Set the flange

  • 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

STEP 4: Mirena is now ready
to be inserted

  • Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5 to 2 cm from the cervix and then pause

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

STEP 5: Open the arms

  • While holding the inserter steady, move the slider
    down to the mark
    to release the arms of Mirena

STEP 6: Advance to the 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. Mirena is now in the fundal position. Fundal positioning of Mirena is important to prevent expulsion

STEP 7: Release Mirena and
withdraw the inserter

  • Holding the entire inserter firmly in place, release Mirena by moving the slider all the way down
  • Continue to hold the slider all the way down while slowly and gently withdrawing the inserter from the uterus

Cutting the threads

  • 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). To prevent displacing Mirena, do not apply tension or pull on the threads when cutting

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

Important information to consider during or after insertion

  • If you suspect that Mirena is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Mirena if it is not positioned completely within the uterus. A removed Mirena must not be reinserted
  • If there is clinical concern, exceptional pain, or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound
  • Evaluate patients 4 to 6 weeks after insertion and then yearly or more often if clinically indicated

Removal of Mirena

Timing of Removal

  • Mirena should not remain in the uterus after 5 years
  • If pregnancy is not desired, the removal should be carried out during menstruation, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle, consider starting a new contraceptive method a week prior to removal. If removal occurs at other times during the cycle and the woman has had intercourse in the week prior to removal, she is at risk of pregnancy

Tools for Removal

Preparation

- Sterile gloves

- Sterile speculum

Procedure

- Sterile forceps

Removal Procedure

  • Remove Mirena by applying gentle traction on the threads with forceps
  • If the threads are not visible, determine location of Mirena by ultrasound. If Mirena 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 Mirena, the system should be examined to ensure that it is intact the cervical canal. After removal of Mirena, the system should be examined to ensure that it is intact

  • Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope or a seizure in an epileptic patient)

Continuation of Contraception After Removal

  • If pregnancy is not desired and if a woman wishes to continue using Mirena, a new system can be inserted immediately after removal any time during the cycle
  • If a patient with regular cycles wants to start a different birth control method, time removal and initiation of new method to ensure continuous contraception. Either remove Mirena during the first 7 days of the menstrual cycle and start the new method, or start the new method at least 7 days prior to removing Mirena if removal is to occur at other times during the cycle
  • If a patient with irregular cycles or amenorrhea wants to start a different birth control method, start the new method at least 7 days before removal

Indications for Mirena (levonorgestrel-releasing intrauterine system) 52 mg

Mirena is indicated for intrauterine contraception for up to 5 years. Mirena is also indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena is recommended for women who have had a child. Mirena should be replaced after 5 years if continued use is desired.

IMPORTANT SAFETY INFORMATION ABOUT MIRENA

Who is not appropriate for Mirena

Mirena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Mirena.

Clinical considerations for use and removal

Use Mirena with caution after careful assessment in patients with: coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing Mirena if these or the following arise during use: uterine or cervical malignancy or jaundice. If Mirena is displaced (e.g., expelled or perforated the uterus), remove it.

Pregnancy related risks with Mirena

If pregnancy should occur with Mirena in place, remove Mirena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with Mirena. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

Educate her about PID

IUDs have been associated with an increased risk of PID most likely due to organisms being introduced into the uterus during insertion. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted infections (STIs); Mirena does not protect against STIs, including HIV. Upper genital infections including PID occurred more frequently within the first year. In a clinical trial with other IUDs and a clinical trial with an IUD similar to Mirena, the highest rate occurred within the first month after insertion.

Expect changes in bleeding patterns

Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUDs like Mirena are expulsion, sepsis, and perforation. Perforation may reduce contraceptive efficacy. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.

Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.

The most common adverse reactions (≥5% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%), ovarian cysts (12%), headache/migraine (7.7%), acne (7.2%), depressed/altered mood (6.4%), menorrhagia (6.3%), breast tenderness/pain (4.9%), vaginal discharge (4.9%) and IUD expulsion (4.9%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion and then yearly or more often if clinically indicated.


For important information about Mirena, please see the full Prescribing Information.



For the proper insertion and removal instructions,
choose which Mirena® product you are using.

NDC 50419-421-01
NDC 50419-423-01

PLEASE READ!

This video features the insertion instructions for the original inserter for
Mirena ® (levonorgestrel-releasing intrauterine system) 52 mg (NDC# 50419-421-01)

To view the updated Prescribing Information for the Bayer Inserter for Mirena (NDC# 50419-423-01)

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