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FDA-ApprovedIntrauterine device (IUD) — T-shaped, inserted by healthcare provider

Mirena

levonorgestrel 52mg intrauterine system · Bayer

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Key Facts

Form

Intrauterine device (IUD) — T-shaped, inserted by healthcare provider

Frequency

Replaced every 5 years (data supports up to 8 years)

Available Doses

52mg levonorgestrel (releases ~20mcg/day initially, declining over time)

FDA Approval Date

December 6, 2000

Mechanism

Progestin-releasing intrauterine system

Manufacturer

Bayer

Cost

Self-Pay

$500–$1,300 (one-time insertion cost)

Amortized cost: $100–$260/year over 5 years, making it one of the most cost-effective long-term methods. Most insurance plans cover IUDs with $0 copay under ACA. Covers both insertion and the device.

Side Effects

Side EffectRateSource
Irregular bleeding/spotting (first 3–6 months)30–40%FDA label
Amenorrhea (absence of periods by year 1)20%FDA label
Headache8%FDA label
Pelvic/abdominal pain7%FDA label
Acne5%FDA label
Ovarian cysts (benign, functional)5%FDA label
Weight gain2%FDA label

Source: Mirena FDA Prescribing Information and long-term observational studies

Weight Loss Results

Mirena Contraceptive Efficacy Study

Pearl Index: 0.1 per 100 woman-years

5 years · Treatment regimen (ITT)

5 years

Large multinational trial confirming >99.8% efficacy over 5 years, making Mirena one of the most effective reversible contraceptive methods available.

Mirena for Heavy Menstrual Bleeding

Menstrual blood loss reduction: 86% at 3 months, 97% at 12 months

12 months · Completers analysis

12 months

Controlled trial demonstrating Mirena's superiority over oral treatments for menorrhagia, leading to FDA approval for this indication.

How It Works

A healthcare provider inserts the small, T-shaped Mirena device into the uterus during an office visit. Once placed, it continuously releases levonorgestrel locally for up to 5–8 years. The local hormone action thickens cervical mucus (blocking sperm), thins the endometrial lining (reducing or eliminating periods), and may suppress ovulation in some cycles. Removal is also a simple office procedure, and fertility returns quickly.

Mechanism: Mirena releases levonorgestrel locally into the uterine cavity, creating high local concentrations with minimal systemic absorption. The local progestin effect thickens cervical mucus, suppresses endometrial growth (causing lighter or absent periods), and may partially suppress ovulation. The device also has a physical presence that contributes to contraceptive efficacy.

Who It's For

Indication

Contraception (up to 5 years) and treatment of heavy menstrual bleeding (menorrhagia)

Women seeking long-term, low-maintenance contraception with the added benefit of period reduction. FDA-approved for treating heavy menstrual bleeding. Excellent for women who want to "set and forget" their contraception for years. Safe for nulliparous women (never been pregnant). Not suitable for women with uterine abnormalities, active pelvic infection, or unexplained vaginal bleeding.

Food & Water Restrictions

✅ No Restrictions

This medication can be taken at any time of day, with or without food and water.

Comparisons

Comparison

Mirena vs Kyleena

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Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Clinical trial data referenced comes from published studies and FDA prescribing information. Side effect rates are from specific clinical trials and may not reflect real-world experience. Always consult your healthcare provider before starting, stopping, or switching any medication.