Mirena Side Effects
Hormone-eluting IUD Mirena may cause a number of mild to moderate side effects, most of which will go away with time. Bleeding is the most common side effect of Mirena and may include irregular bleeding, spotting, bleeding which is heavier or lighter than expected, lack of menstruation. In most cases, bleeding irregularities are temporary, and users may develop lighter menstruation or stop menstruating over time.
In addition to bleeding, common side effects of Mirena associated with levonorgestrel hormone include:
- Feeling bloated
- Mood changes, depression or anxiety
- Vaginal discharge
- Breast tenderness
If bleeding is excessive, sudden or is accompanied by other symptoms, it should be reported to a health professional.
Because it is a medical device which is implanted in the uterus, Mirena may cause serious side effects or complications, particularly when it becomes dislodged or migrates from its intended location.
Complications of Mirena may include:
- Organ perforation may occur when Mirena becomes dislodged and migrates away from its location in the uterus. It may perforate or penetrate the uterus or may travel through the uterus to the abdominal cavity.
- Ectopic Pregnancy may occur if Mirena migrates and no longer releases hormone into the uterus. About half of pregnancies that occur with Mirena may be ectopic pregnancy outside of the uterus.
- Pelvic Inflammatory Disease may occur when the uterus becomes infected due to Mirena implantation. The risk for infection is highest during the first weeks of implantation and when Mirena has been implanted in a person with an existing vaginal or pelvic infection
Mirena Side Effects
Mirena is a t-shaped contraceptive intrauterine device (IUD) constructed of medication-eluting plastic that contains levonorgestrel, a birth control hormone. The medication is slowly released from the device over a period of at least 5 years when it is intended to be removed and replaced. Mirena is reported to be more than 99% effective at preventing pregnancy and has been used in over 150 million women worldwide.
Like all medications, the hormone in Mirena may cause side effects, mainly caused by localized hormonal action when medication is released in the uterus. In some cases however, because the hormone is contained in an implanted medical device, complications can be severe. Many women have suffered serious and potentially life-threatening side effects after receiving Mirena and its manufacturer, Bayer Healthcare has faced thousands of lawsuits over Mirena side effects.
Common Mirena Side Effects
The most common side effects of Mirena are caused by the hormone, levonorgestrel, which is released from the device into the uterus. As the hormone levels produced by the device are lower than other forms of hormonal contraceptives, most side effects are mild to moderate and will go away after a period of time.
Most new Mirena users experience some changes in their menstrual cycle with irregular bleeding and spotting. Many will experience lighter periods and 1-in-5 users will stop having a menstrual period at all within the first year.
Other mild to moderate side effects of Mirena are also related to the hormone, levonorgestrel and include:
- Headaches or migraines
- Acne development
- Weight increase
- Feeling bloated
- Mood changes or depression
- Vaginal discharge
- Tenderness or pain in the breasts
- Pelvic pain during periods
- Non-cancerous cysts in the ovary
In more serious cases, Mirena side effects and complications including severe bleeding may be serious or life-threatening.
Mirena Perforation and Migration
Mirena is intended to be implanted in the uterus and left in place for a period of 5 years but in some patients, the device becomes unseated and “migrates” to another area, where it may cause serious damage including organ perforation.
Most commonly, when Mirena migration occurs, the device travels further into the uterus where it may erode and may cause perforation of the uterine wall. If the device travels through the uterine wall, it may result in perforation of reproductive organs like the cervix, ovaries or fallopian tubes or may damage abdominal organs such as the bladder, intestines or kidney.
Mirena migration and organ perforation will generally require surgery to remove the device, control bleeding and repair or reconstruct damaged tissues. If the reproductive organs have been significantly affected, future fertility may be limited. Patients with organ perforation have also developed scar tissue and chronic pain which is not easily treated.
Mirena and Pelvic Inflammatory Disease
Mirena also increases the risk for pelvic inflammatory disease (PID), a severe bacterial infection which affects the uterus and other reproductive organs. The risk is highest during the first 20 days after placement and patients who have an existing vaginal infection at the time of Mirena placement are more likely to get PID.
If PID is not treated, it may cause severe and permanent damage and may result in loss of fertility. PID may also increase the risk of ectopic pregnancy, a life-threatening occurrence. Untreated PID can result in growth of painful scar tissue which necessitates surgical treatment and, in some cases, requires a total hysterectomy to remove all reproductive organs. Many PID patients continue to have severe pelvic pain long after the infection is resolved.
Symptoms of pelvic inflammatory disease include:
- Nausea and vomiting
- High fever or chills
- Pain during urination
- Pain during intercourse
- Yellowish or greenish vaginal discharge
- Tenderness or dull pain in the stomach or abdomen
Symptoms of PID should be treated right away to minimize permanent damage.
Mirena Side Effects and Pregnancy
While Mirena is considered to be more than 99% effective, some women can still become pregnant during use. In many cases, termination of the pregnancy will be recommended but women who become pregnant while using Mirena may also experience spontaneous or even septic abortion.
Spontaneous abortion occurs suddenly without precipitation but in some cases, not all of the endometrial tissue is shed from the uterus. Endometrial or fetal issue that is left behind may become infected, and if not treated, can result in a life-threatening occurrence of sepsis. Pregnancy symptoms should be reported to a health care professional and symptoms of spontaneous abortion or symptoms of infection should be treated immediately.
Mirena Ectopic Pregnancy
Mirena clinical studies indicate that the device has a pregnancy failure rate of 0.8% over a 5-year period and estimates show that half of these will be ectopic pregnancy. In normal pregnancy, once the egg is fertilized, it travels to the uterus and attaches itself to the uterine wall. Ectopic pregnancy occurs when the fertilized egg attaches outside of the uterus. Most commonly, ectopic pregnancy occurs in the fallopian tube and may be called a “tubal” pregnancy, but it may also occur in other areas like the cervix, ovaries, intestines or another abdominal organ.
Ectopic pregnancies are not considered viable and most often require surgical removal. If discovered early enough, surgical termination may be performed through laparoscopy, but emergency cases will usually require abdominal surgery.
If surgical removal is not performed, the dividing cells of the embryo will grow too large and may rupture the fallopian tube. This may result in severe hemorrhage which can be life threatening. A patient who has had one ectopic pregnancy may be at increased risk for future ectopic pregnancy. Some patients experience early symptoms of ectopic pregnancy of abdominal pain, inflammation and general pregnancy symptoms but others are asymptomatic until tissue is ruptured.
Symptoms of ectopic pregnancy that may indicate rupture or hemorrhage include:
- Sudden, sharp abdominal pain
- Unexpected vaginal bleeding
- Dizziness or fainting
- Nausea and vomiting
- Pressure on rectum
- Low blood pressure
- Rapid heart rate
- Abdominal swelling
Any pregnancy symptoms that occur while using Mirena should be reported to a medical professional. Signs or symptoms of ruptured ectopic pregnancy or bleeding should be treated as a medical emergency.
Mirena Side Effects Lawsuit
Thousands of women who were injured or developed severe side effects after receiving Mirena have filed lawsuits against the IUD’s manufacturer, Bayer Healthcare. The lawsuits claim that Bayer is responsible for manufacturing a dangerous and defective device and did not adequately warn the medical community and the public about the risks of Mirena. The plaintiffs are seeking compensation for their injuries to cover medical costs, lost wages, pain and suffering and in some cases, loss of future fertility.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.