NOTE: Mirena® (levonorgestrel-releasing intrauterine system) should be inserted by a trained healthcare provider. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion of Mirena.
- Observe strict asepsis during insertion. The presence of organisms capable of establishing PID cannot be determined by appearance, and IUD insertion may be associated with introduction of vaginal bacteria into the uterus. Administration of antibiotics may be considered, but the utility of this treatment is unknown.
- Carefully sound the uterus prior to Mirena insertion to determine the degree of patency of the endocervical canal and the internal os, and the direction and depth of the uterine cavity. In occasional cases, severe cervical stenosis may be encountered. Do not use excessive force to overcome this resistance.
- Fundal positioning of Mirena is important to prevent expulsion and maximize efficacy. Therefore, follow the instructions for the insertion carefully.
- If the patient develops decreased pulse, perspiration, or pallor, have her remain supine until these signs resolve. Insertion may be associated with some pain and/or bleeding. Syncope, bradycardia, or other neurovascular episodes may occur during insertion of Mirena, especially in patients with a predisposition to these conditions or cervical stenosis.
Mirena is inserted with the provided inserter (Figure 1a) into the uterine cavity within 7 days of the onset of menstruation or immediately after first trimester abortion by carefully following the insertion instructions. It can be replaced by a new Mirena at any time during the menstrual cycle.
Figure 1a. Mirena and inserter
Preparation for Insertion
- Ensure that the patient understands the contents of the Patient Information Booklet and obtain consent. A consent form that includes the lot number is on the last page of the Patient Information Booklet
- Confirm that there are no contraindications to the use of Mirena
- Perform a urine pregnancy test, if indicated
- With the patient comfortably in lithotomy position, gently insert a speculum to visualize the cervix and rule out genital contraindications to the use of Mirena
- Do a bimanual exam to establish the size and position of the uterus, to detect other genital contraindications, and to exclude pregnancy
- Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution. Perform a paracervical block, if needed
- Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and apply gentle traction to align the cervical canal with the uterine cavity. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. Note that the tenaculum forceps should remain in position throughout the insertion procedure to maintain gentle traction on the cervix
- Gently insert a uterine sound to check the patency of the cervix, determine the depth of the uterine cavity, confirm its direction, and exclude the presence of any uterine anomaly. If you encounter cervical stenosis, use dilatation, not force, to overcome resistance
- The uterus should sound to a depth of 6 cm to 10 cm. Insertion of Mirena into a uterine cavity less than 6 cm in depth may increase the risk of expulsion, bleeding, pain, perforation, and possibly pregnancy
- After ascertaining that the patient is appropriate for Mirena, open the carton containing Mirena
Ensure use of sterile technique throughout the entire procedure.
Opening of the sterile package
- Open the sterile package completely (Figure 1b)
- Place sterile gloves on your hands
- Pick up the handle of the inserter containing Mirena and carefully release the threads so that they hang freely
- Place your thumb or forefinger on the slider. Make sure that the slider is in the furthest position away from you, for example, at the top of the handle toward the insertion tube (Figure 1b)
Note: Keep your thumb or forefinger on the slider until insertion is complete.
- With the centimeter scale of the insertion tube facing up, check that the arms of Mirena are in a horizontal position. If they are not, align them on a flat, sterile surface, for example, the sterile package (Figures 1b and 1c)
Figure 1b. Aligning the arms with the slider in the furthest position
Figure 1c. Checking that the arms are horizontal and aligned with respect to the scale
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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.