Mirena is a hormonal intrauterine device (IUD) that is used by women for birth control. Before considering the use of Mirena, it is important to understand the information provided in its FDA-approved labeling. This article will guide you through 10-15 key aspects of Mirena's labeling, ensuring that you are well-informed before making a decision.
1. Indications and Usage:
- Mirena is indicated for intrauterine contraception for up to 5 years. - It is also approved to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.
2. Contraindications:
- Mirena should not be used by women with pelvic inflammatory disease (PID), postpartum endometritis, or a current, recent, or recurrent pelvic infection. - It is contraindicated in women with a known or suspected pregnancy and in those with congenital or acquired uterine abnormalities.
3. Warnings and Precautions:
- Mirena should not be used in women at high risk for ectopic pregnancy. - The device may be expelled or displaced, leading to decreased contraceptive effectiveness.
4. Adverse Reactions:
- The most common adverse reactions include changes in menstrual bleeding patterns, amenorrhea, abdominal/pelvic pain, ovarian cysts, and headache. Consult your healthcare provider if you experience any of these.
5. Insertion and Removal Procedure:
- Mirena must be inserted and removed by trained healthcare providers, and the procedure should be performed with proper sterile technique.
6. Ectopic Pregnancy:
- Mirena does not protect against ectopic pregnancy. Inform your healthcare provider immediately if you suspect pregnancy, as ectopic pregnancy is life-threatening and can occur with Mirena use.
7. Infection Risk:
- Serious infection, including sepsis, may occur after Mirena insertion. Inform your healthcare provider if you experience fever, chills, or pelvic pain.
8. Breastfeeding Considerations:
- Mirena can be used while breastfeeding. However, small amounts of the hormone levonorgestrel may pass into breast milk. Discuss the benefits and risks with your healthcare provider.
9. Sexual Transmitted Infection (STI) Protection:
- Mirena does not protect against STIs. It is important to use barrier methods, such as condoms, to reduce the risk of contracting or spreading STIs.
10. Mirena and Weight:
- In clinical trials, less than 5% of users experienced weight gain. If you are concerned about weight changes, consult your healthcare provider for personalized advice.
11. Mirena Cost:
- The cost of Mirena may vary depending on the country. As of 2021, the approximate average cost in the United States is $800, in the United Kingdom is £300, in South Korea is ₩700,000, in Japan is ¥70,000, and in China is ¥3,000.
12. Mirena and Location:
- Mirena is available in various countries globally, including the United States, United Kingdom, South Korea, Japan, and China. It is important to consult local healthcare providers or clinics to access Mirena in your specific location.
13. Mirena Effectiveness:
- Mirena is over 99% effective at preventing pregnancy when used correctly. However, user error or device expulsion may lead to lower effectiveness. It is important to follow proper insertion and removal procedures.
14. Mirena and Age:
- Mirena can be used by women of reproductive age, including adolescents. Consult your healthcare provider to ensure it is suitable for your specific age and reproductive health.
15. Mirena and Medical Conditions:
- Women with certain medical conditions, such as liver disease or a history of breast cancer, may be advised against using Mirena. It is important to provide your healthcare provider with a complete medical history for appropriate recommendations.
Frequently Asked Questions:
- Q: Can Mirena be used for more than 5 years?
- Q: Can Mirena be used immediately after childbirth?
A: No, Mirena is only approved for use up to 5 years. Consult your healthcare provider for suitable long-term contraception options.
A: Mirena can be inserted immediately after childbirth or during the postpartum period. Discuss the timing with your healthcare provider.
References:
- Food and Drug Administration. Mirena Prescribing Information. [Link]
- American College of Obstetricians and Gynecologists. Practice Bulletin No. 152: Emergency Contraception. Obstet Gynecol. 2015;126(3):e1-e11.
- World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 5th ed. Geneva, Switzerland: WHO; 2015.
