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Mirena is an intrauterine hormone-releasing system placed in your uterus to prevent pregnancy for up to 5 years. It can also be used to lessen menstrual bleeding loss in women who have heavy menstrual flow. Mirena is recommended for women who have had at least one child, and is a reversible means of birth control that is not required to be taken daily.
The T-shaped device is made of flexible plastic and contains the levonorgestrel (progestin), a synthetic female hormone that can suppress ovulation and which is frequently used in birth control pills. Mirena does not contain estrogen.
Mirena Hormone Releasing Device
There is only one technique and option for the Mirena device (levonorgestrel-releasing intrauterine system) as well as insertion technique listed in the Mirena patient insert and prescribing information. 1, 2
During placement of the device, patients sometimes encounter dizziness, pain or even bleeding, which may continue for up to 30 minutes after placement as well. Extended symptoms may indicate improper placement, requiring reexamination and possibly removal or a second placement attempt. Those who have a Mirena insert are encouraged to check proper positioning by feeling the removal threads, typically after each menstrual period. Consult a doctor for proper instructions.
Mirena contains 52 mg of levonorgestrel. Initially, levonorgestrel is released at a rate of approximately 20 mcg/day. This rate decreases progressively to half that value after 5 years.
Levonorgestrel and Drug Interactions
Before using Mirena, inform your doctor of any medications or dietary supplements you may be taking, such as:
- Bosentan (Tracleer)
- Carbamazepine (Tegretol)
- Felbamate (Felbatol)
- Griseofulvin (Grifulvin V, Fulvicin P/G)
- Oxcarbazepine (Trileptal)
- Phenytoin (Dilantin)
- Rifampin (Rimactane, Rifadin)
- St. John’s wort
- Topiramate (Topamax)
Mirena Device Complications
Surgical issues for placing Mirena include normal risks such as infection, pain, bleeding, fatigue, confusion, and effects of anesthesia. Other things to keep in mind:
- The presence of organisms capable of establishing PID cannot be determined by appearance, and IUD insertion may be associated with introduction of vaginal bacteria into the uterus. Administration of antibiotics may be considered, but the utility of this treatment is unknown.
- Positioning of Mirena is important to prevent expulsion and maximize efficacy. Poor positioning may lead to other serious side effects.
- Insertion may be associated with some pain and/or bleeding. Fainting, slow heart-rate, or other neurovascular episodes, especially in patients who have a predisposition to these conditions or cervical stenosis.
Common and Severe Mirena Side Effects
Contact your doctor if you experience any of the following:
- Pain, bleeding or dizziness during and after placement
- Mirena device expulsion
- Missed menstrual periods
- Bleeding and spotting between menstrual periods
- Irregular bleeding
- Cysts on the ovary
|Pelvic inflammatory disease (PID)||Common causes of PID include sexually transmitted diseases, such as chlamydia or gonorrhea, which the Mirena device does not prevent. While PID may not be accompanied by any symptoms, individuals should speak with their doctor if they experience lower abdominal pain, unexplained fever, unusual odor or vaginal discharge, pain or bleeding during sex, a burning sensation while urinating, or intermenstrual bleeding. 3|
|Serious Infections||In some cases, Mirena can induce life-endangering infections within a few days of placement. Severe pain can develop within a few hours of insertion of a Mirena device, and if left untreated, infection can quickly progress to sepsis.|
|Uterine wall attachment||A Mirena device may become attached to or embedded in the patient’s uterine wall. In such a case, it will fail to provide contraceptive protection, resulting in unexpected or undesired pregnancy. Furthermore, removal of the device may require surgery.|
|Perforation||Improper placement or a lack of experience can result in perforation of the uterus, resulting in extreme pain and other potential complications. Surgery may be required to remove the device and repair any damage. 4|
FDA and Mirena Safety Label
To date there has not been a recall on Mirena. In May and July 2008, the FDA Center for Drug Evaluation (CDER) approved safety labeling changes to be included in the updated Mirena Patient Package Insert information. These modifications included updates in the warnings, precautions, and adverse events. 5
Bayer Healthcare. Mirena Full Prescribing Information. (Revised February 2013). BayerHealthcare.com. Accessed August 29, 2014. ↩
Bayer Healthcare. Mirena Patient Insert. (Revised October 2009). Accessed August 15, 2013 ↩
Centers for Disease Control and Prevention. Pelvic Inflammatory Disease (PID) – CDC Fact Sheet. (Jan. 29, 2014). CDC.gov. Accessed Aug. 29, 2014. ↩
Erian, Mark, et al. The Wandering Mirena: Laparoscopic Retrieval. (Jan. – March 2011). Journal of the Society of Laparoendoscopic Surgeons. Accessed Aug. 29, 2014. ↩
U.S. Food and Drug Administration. Mirena (levonorgestrel-releasing intrauterine system) July 2008. (June 16, 2009). FDA.gov. Accessed Aug. 29, 2014. ↩