Mirena is a popular contraceptive intrauterine device (IUD) constructed of a medication-eluting plastic which slowly releases the birth control medication, levonorgestrel over a period of up to 5 years. Though it is considered to be more than 99% effective at preventing pregnancy, Mirena may cause a number of serious side effects which are potentially life-threatening. Bayer Healthcare is already facing thousands of lawsuits by women who were injured after receiving Mirena.
The IUD did not become widely available in the U.S. until the 1950s when thermoplastics allowed for easy insertion and removal of flexible plastic. Their popularity increased in the 1960s with the introduction of the copper IUD and by 1973, an estimated 10% of women using birth control had an IUD.
Unfortunately, one of the most popular devices on the U.S. market had a serious design flaw. It had a porous monofilament string which allowed for bacteria to grown on the device, resulting in thousands of infections, hospitalizations, septic abortion events and at least 5 deaths.
The Dalkon Shield was withdrawn from the U.S. market in 1975 but sales of other IUDs in the U.S. plummeted as well. By the mid-1980s, more than 300,000 lawsuits had been filed against A.H. Robins, manufacturer of the Dalkon Shield and all other manufacturers simply quit making their devices.
Outside of the U.S. women had continued to use IUDs as a preferred contraceptive method and the first hormone-emitting device, progenitor of Mirena, was introduced to Europe in the mid-80s. Its introduction to the U.S. market in 2001 brought a renewed popularity for women who wanted longer-term birth control.
Mirena is a t-shaped device 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 but because it is contained in an implanted medical device, the risks can be severe. Many women have suffered serious and potentially life-threatening side effects after receiving Mirena and it’s manufacturer, Bayer Healthcare is facing 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. Most side effects are mild to moderate and may 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
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 pregnancies 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.
All cases are different and each must be evaluated separately by a legal expert. Women or family members of women who developed severe Mirena side effects such as device migration, organ perforation, ectopic pregnancy or pelvic inflammatory disease should seek legal advice.