MIRENA®

Why Practitioners Choose MIRENA®

Within Bayer’s levonorgestrel IUS portfolio, MIRENA® is approved for both contraception and the treatment of heavy menstrual bleeding. For OB/GYN and women’s health practices, this allows one device to address long-acting contraceptive needs and menorrhagia when the patient is an appropriate candidate. The heavy menstrual bleeding indication is supported by the prescribing information and peer-reviewed evidence on levonorgestrel-releasing intrauterine systems.[1][3] Its approved 8-year contraceptive duration (extended from 5 years following the Mirena Extension Trial) is the longest in Bayer's LNG-IUS range, compared with 5 years for KYLEENA® and 3 years for SKYLA®/JAYDESS®. Clinical data from the extension trial support efficacy and an acceptable safety profile through years 6 to 8 of use. [2]

Contact Med Supply Solutions About MIRENA®

Licensed healthcare professionals may contact the Med Supply Solutions support team for general information about MIRENA®, including product details and documentation inquiries.

What Is MIRENA® Used For?

MIRENA® is indicated for prevention of pregnancy for up to 8 years and for the treatment of heavy menstrual bleeding for up to 5 years in women who choose intrauterine contraception. It is not intended for use as emergency contraception. [1] The system contains 52mg of levonorgestrel, released gradually after placement at an initial rate of approximately 20 mcg/day, declining over time. Its contraceptive action is primarily local: thickening of cervical mucus inhibits sperm motility and function, and endometrial changes reduce the likelihood of implantation. [1] MIRENA® has an extensive clinical evidence base as a long-acting reversible contraceptive method, with data on efficacy, bleeding-pattern changes, and return to fertility after removal. [2][3]

MIRENA® Contraindications

MIRENA® is contraindicated in patients with known or suspected pregnancy; congenital or acquired uterine anomaly distorting the uterine cavity; acute pelvic inflammatory disease; history of pelvic inflammatory disease, particularly in patients at increased risk of recurrent infection; postpartum endometritis or infected abortion in the past 3 months; known or suspected uterine or cervical malignancy; and undiagnosed abnormal uterine bleeding. [1] Additional contraindications include known or suspected breast cancer or other progestin-sensitive cancer, liver disease or liver tumor, untreated acute cervicitis or vaginitis, increased susceptibility to pelvic infection, and hypersensitivity to any product component. [1] Risk counseling should address ectopic pregnancy, pelvic infection, perforation, embedment, expulsion, ovarian cysts, and bleeding-pattern changes. Patient selection should follow the prescribing information and current contraceptive eligibility guidance.

MIRENA® Safety Profile

Common adverse reactions include changes in bleeding patterns, amenorrhea, abdominal or pelvic pain, headache or migraine, vulvovaginitis, genital discharge, breast pain, ovarian cysts, acne, dysmenorrhea, and mood-related symptoms. Changes in menstrual bleeding are often a central part of patient counseling. Clinical data show that bleeding generally becomes less frequent over the first year, with some patients developing amenorrhea, and this pattern may continue with longer-term use.[1][2] Procedure-related risks that should be discussed as part of insertion counseling include pain, bleeding, vasovagal reaction, infection or sepsis, uterine or cervical perforation, embedment, and expulsion. Perforation risk may be increased when insertion occurs in lactating patients or during the postpartum period. [1] If pregnancy occurs with MIRENA® in place, ectopic pregnancy must be excluded. Intrauterine pregnancy with an IUD in situ carries risks including septic abortion, miscarriage, sepsis, premature labor, and premature delivery. [1]

Administration & Handling Notes

• Before use, inspect the sterile packaging and confirm that it is intact.
• The single-handed inserter is designed for one-time use and cannot be reloaded once MIRENA® has been released.
• Insertion and removal should be performed only by appropriately trained health care professionals using aseptic technique.

MIRENA® vs Other Intrauterine Systems

MIRENA® is most meaningfully compared with other devices a practice might consider for the same patient population.

• MIRENA® vs KYLEENA®: KYLEENA® contains 19.5mg levonorgestrel and is approved for contraception for up to 5 years. Its smaller 28×30mm frame may suit certain patients, but it does not carry the heavy menstrual bleeding indication. Where that indication is clinically relevant, MIRENA® is the appropriate device.
• MIRENA® vs SKYLA®/JAYDESS®: SKYLA®/JAYDESS® contains 13.5mg levonorgestrel and provides contraception for up to 3 years. The lower hormone dose and shorter duration may be appropriate for patients who prefer a defined shorter-term method, but neither the HMB indication nor the 8-year duration applies.
• MIRENA® vs PARAGARD®: PARAGARD® is a copper IUD providing up to 10 years of hormone-free contraception. It is an established option for patients who cannot or will not use hormonal contraception, but it is not indicated for heavy menstrual bleeding. It is commonly associated with increased menstrual flow — the opposite of MIRENA®'s effect on bleeding patterns. This distinction is central to counseling patients who present with both contraceptive needs and menstrual complaints.
• MIRENA® vs SMB® copper IUDs: SMB® copper IUDs offer hormone-free contraception for 3 to 10 years, depending on the model. As with PARAGARD®, copper IUDs are not indicated for heavy menstrual bleeding and may increase menstrual flow. They remain a clinically appropriate choice for patients in whom progestin exposure is not suitable.
• MIRENA® vs DEPO-PROVERA®: DEPO-PROVERA® is a progestin-only injectable requiring administration every 12–13 weeks. For patients who decline intrauterine placement, it is a reasonable progestin-only alternative. However, it carries an FDA Boxed Warning for bone mineral density loss with prolonged use and is associated with a delayed return to fertility after the last injection.

About MIRENA® (Bayer)

MIRENA® is manufactured by Bayer AG and was first approved in Finland in 1990, receiving FDA approval in the United States in December 2000. [1] The device consists of a 32mm polyethylene T-body with a levonorgestrel-elastomer core containing 52mg LNG, supplied sterile with a single-handed inserter for placement by trained healthcare professionals. Bayer's LNG-IUS family includes MIRENA® (52mg), KYLEENA® (19.5mg), and SKYLA®/JAYDESS® (13.5mg). MIRENA® is the only device in that range with both the contraceptive and heavy menstrual bleeding indications.

MIRENA® Regulatory Status

MIRENA® was first approved by the FDA for contraception in December 2000. Its indication for treating heavy menstrual bleeding was added in October 2009, and in 2022 the approved contraceptive duration was extended to eight years based on findings from the Mirena Extension Trial.[1][2] MIRENA® is a prescription intrauterine system marketed in more than 100 countries. Approved indications, labeling, and duration of use may differ by market.[4]

FAQs

How long does MIRENA® provide contraception?

Up to 8 years — the longest approved duration in Bayer's LNG-IUS range, supported by clinical trial data through years 6 to 8 of use. For the heavy menstrual bleeding indication, MIRENA® is approved for up to 5 years. [1][2]

Can MIRENA® be used to treat heavy menstrual bleeding?

Yes — MIRENA® is the only Bayer LNG-IUS approved for this indication. Evidence from clinical studies and the prescribing information supports its use for heavy menstrual bleeding in patients using it for intrauterine contraception. [1][3]

How does MIRENA® compare to KYLEENA® and SKYLA®?

MIRENA® contains 52mg levonorgestrel and lasts up to 8 years; KYLEENA® contains 19.5mg and lasts up to 5 years; SKYLA®/JAYDESS® contains 13.5mg and lasts up to 3 years. Only MIRENA® carries the heavy menstrual bleeding indication.

What are the main risks at insertion?

Risks associated with insertion include pain, bleeding, vasovagal reactions, infection, uterine perforation, embedment, and expulsion. Practitioners should follow the prescribing information closely and maintain aseptic technique throughout the procedure.[1]

Is MIRENA® reversible?

Yes — MIRENA® is reversible after removal, and clinical data indicate that fertility typically returns after removal. Patients should be counseled according to individual reproductive goals and clinical context. [2]

How can licensed professionals learn more about MIRENA®?

Licensed healthcare professionals may contact the Med Supply Solutions support team for general information about MIRENA®.

Citations and Resources

[1] FDA. MIRENA (levonorgestrel-releasing intrauterine system). https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021225s043lbl.pdf [2] Jensen JT, Lukkari-Lax E, Schulze A, Wahdan Y, Serrani M, Kroll R. Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial. Am J Obstet Gynecol. 2022;227(6):873.e1-873.e12. doi:10.1016/j.ajog.2022.09.007 [3] Kailasam C, Cahill D. Review of the safety, efficacy and patient acceptability of the levonorgestrel-releasing intrauterine system. Patient Prefer Adherence. 2008;2:293-302. Published 2008 Feb 2. doi:10.2147/ppa.s3464 [4] Bayer. MIRENA® HCP product information. https://www.mirenahcp.com/ For licensed healthcare professionals only. The content of this page is provided for informational purposes and does not constitute medical advice.