Meet Kim
Tell her it locally delivers a low dose of progestins into the uterus
Evaluate her current birth control method
- More than one-third of childbearing-complete women use less effective methods or no method at all (condoms 13%, withdrawal 5%, no birth control 18%)1-3
Mirena is one of the most effective contraceptives2,3
- 99.8% efficacy at year one
- 99.3% cumulative efficacy over 5 years
What women need to know about removal of Mirena
- The reversal of the contraceptive effect after removal of Mirena is immediate
- Patients who do not want to become pregnant should be provided a new Mirena or another type of contraception
- If a patient with regular cycles wants to start a different birth control method, remove Mirena during the first 7 days of the menstrual cycle and start the new method
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.
References:
- Centers for Disease Control and Prevention. National Center for Health Statistics. Data Access Web site.
http://www.cdc.gov/nchs/data_access/ftp_dua.htm?url_redirect=ftp://ftp.cdc.gov/pub/Health_Statistics/
NCHS/Datasets/NSFG. Accessed July 8, 2011. - Data on file. Consumer profiles. Bayer HealthCare Pharmaceuticals Inc.
- World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO project. Family Planning: a Global Handbook for Providers. Baltimore and Geneva: CCP and WHO, 2007.
