Insertion Steps
Step 9
Cut the threads
- Cut the threads perpendicular to the thread length, for example, with sterile curved scissors, leaving about 3 cm visible outside the cervix (Figure 9)
NOTE: Cutting threads at an angle may leave sharp ends.
Figure 9. Cutting the threads
Mirena® (levonorgestrel-releasing intrauterine system) insertion is now complete.
Important Information to Consider During or After Insertion
- Embedment of Mirena in the myometrium may occur. Embedment may decrease contraceptive effectiveness and result in pregnancy. An embedded Mirena should be removed. Embedment can result in difficult removal, and, in some cases, surgical removal may be necessary
- Perforation or penetration may occur during insertion, although the perforation may not be detected until some time later. If perforation occurs, pregnancy may result. Mirena must be located and removed; surgery may be required. Delayed detection of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation may be increased in lactating women, in women with fixed retroverted uteri, and during the postpartum period
- Partial or complete expulsion of Mirena may occur. Symptoms of the partial or complete expulsion of any IUD may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it, resulting in the loss of contraceptive protection. Partial expulsion may decrease the effectiveness of Mirena
- 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
- If you suspect that the system is not in the correct position, check insertion (for example, with 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 and/or exceptional pain or bleeding during or after insertion, appropriate and timely measures and assessments, for example ultrasound, should be performed to exclude perforation
Patient Counseling and Record Keeping
- Keep a copy of the consent form and lot number for your records
- Counsel the patient on what to expect following Mirena insertion. Give the patient the Follow-up Reminder Card that is provided with the product. Discuss expected bleeding patterns during the first 3 to 6 months after Mirena is inserted
- Prescribe analgesics, if indicated
Patient Follow-up
- Patient should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated
Step 9 / 9
Know who is appropriate for Mirena
Mirena (levonorgestrel-releasing intrauterine system) 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.
Know who is not appropriate for Mirena
Mirena is contraindicated in women with known or suspected: pregnancy; congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity; breast carcinoma; uterine or cervical neoplasia; unresolved, abnormal Pap smear; liver disease including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in past 3 months; unexplained vaginal bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); or conditions increasing susceptibility to pelvic infections.
Use with caution in patients with certain conditions
In patients with certain types of valvular or congenital heart disease and surgically constructed systemic-pulmonary shunts, Mirena increases risk of infective endocarditis and may be a source of septic emboli. Give appropriate antibiotics at insertion and removal to patients with known congenital heart disease who may have higher risk. Monitor for infections any patient on chronic corticosteroid therapy or insulin for diabetes.
Use Mirena with caution 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.
In the event of pregnancy
If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation may result in pregnancy loss. Up to half the pregnancies that occur with Mirena in place are ectopic. Tell women about the risks of ectopic pregnancy 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
Prior to 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 diseases (STDs); Mirena does not protect against STDs, including HIV. The highest risk of PID occurs shortly after insertion (usually within the first 20 days).
Expect changes in bleeding patterns
Expect spotting and irregular/heavy bleeding for 3-6 months, then shorter, lighter periods. Cycles may remain irregular and become infrequent and may 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, myometrial embedment and uterine or cervical perforation. 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 follicles.
The most common adverse reactions (>10%) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%) and ovarian cysts (12%).
Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4-12 weeks after insertion and then yearly or more often if clinically indicated.
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
For important risk and use information, please see the Full Prescribing Information.