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Mirena IUD and Infertility

According to the Centers for Disease Control and Prevention (CDC), about 10 percent of women in the U.S. between the ages of 15 and 44 have difficulty getting pregnant or staying pregnant. That’s about 6.1 million women who may be suffering from infertility.

Several health conditions can contribute to a woman’s inability to conceive, but these typically have nothing to do with birth control devices. In recent years, however, many women have linked the popular Mirena IUD to problems with conception and in more dire cases, Mirena infertility.

Risk factors for infertility

Factors that can increase a woman’s risk of infertility include:

  • Smoking, drugs, and heavy alcohol use
  • Sexually transmitted diseases and infections
  • Health problems that affect hormones, like polycystic ovarian syndrome and primary ovarian insufficiency
  • Overactive or underactive thyroid gland
  • Blocked fallopian tubes
  • Other conditions including endometriosis and pelvic inflammatory disease (PID)
  • Being overweight or underweight or having an eating disorder
  • Older than 35
  • Use of the Mirena IUD — if it leads to PID or ectopic pregnancy

Mirena infertilityMedical studies on Mirena infertility

Whether or not an IUD like the Mirena can actually cause infertility has been the subject of debate for years. A study published in 2007, for example, looked at just over 200 women divided into two groups. A total of 109 removed their IUD as part of their plans to conceive a child, and 96 became pregnant or planned pregnancy after a complicated IUD use. The researchers concluded that there was no evidence that prior use of an IUD increased risk for impaired fertility, regardless of the reason for removal.

An earlier study published in the American Journal of Obstetrics & Gynecology examined 245 infertile patients—176 had used an IUD and 69 had not. All were tested for signs of pelvic inflammatory disease, which can lead to infertility. Researchers concluded that those who suffered from PID had developed the inflammation not from the IUD, but from chlamydia infections.

A third study published in 2000 looked at IUDs and upper-genital tract infections in relation to infertility. Again, researchers concluded that women using the IUDs had no increased risk of infertility.

Earlier studies, including two published in 1985 and 1992 in the New England Journal of Medicine, reported that the use of certain IUDs could lead to infertility in those women who had never been pregnant before using one, but this research involved older IUDs that were used before the Mirena was launched in 2000.

So far, we don’t have concrete evidence that links Mirena problems directly to infertility. But, the device may increase this risk indirectly. Even the FDA and manufacturer Bayer have indicated that women who are implanted with Mirena may suffer from PID or ectopic pregnancy, both of which can increase the chances of infertility.

Mirena problems associated with infertility

According to the current Bayer labeling on the Mirena IUD, patients must be aware of two potential Mirena side effects that can lead to  infertility.

  • Pelvic Inflammatory Disease (PID): The Mirena label reads, “All women who choose Mirena must be informed prior to insertion about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility…” Earlier in the labeling literature, it reads, “Use of IUDs has been associated with an increased risk of PID. The highest risk of PID occurs shortly after insertion….A decision to use Mirena must include consideration of the risks of PID.”
  • Ectopic pregnancy: The label cautions that ectopic pregnancy has been associated with the Mirena and states, “Ectopic pregnancy can cause internal bleeding, infertility, and even death.” The label also notes that PID can cause ectopic pregnancy, and states, “Up to half of pregnancies that occur with Mirena in place are ectopic.”

Pelvic inflammatory disease is an infection of the uterus, fallopian tubes, and other reproductive organs. It usually occurs when bacteria move up from the woman’s vagina or cervix into the reproductive organs. Sexually transmitted infections like gonorrhea and chlamydia can cause PID, as can other types of bacteria. If the Mirena attracts some of these bacteria during insertion, it can later transfer them to the reproductive area. If the infection moves into the fallopian tubes, it can cause scarring, which can then block or interrupt the normal movement of eggs into the uterus.

Ectopic pregnancy is a pregnancy that occurs outside the uterus, and is life-threatening to the mother. A fetus cannot survive this type of pregnancy. Typically, ectopic pregnancy occurs in one of the fallopian tubes, but it can also occur in the abdominal cavity, ovary, or cervix. Ectopic pregnancies can result in women using Mirena because the IUD blocks normal uterine pregnancy, so those that do result are ectopic.

Symptoms of conditions that may cause infertility

Women may not have any warning signs of Mirena infertility right away.

Symptoms of ectopic pregnancy usually present as the following:

  • Abdominal pain
  • Late or missed period
  • Vaginal bleeding
  • Pregnancy symptoms
  • Dizziness and fainting
  • Shoulder pain
  • Weakness
  • Heart racing

Signs of pelvic inflammatory disease (PID) may include:

  • Fever and chills
  • Pain or tenderness in the pelvis or abdomen
  • Vaginal discharge with abnormal color, texture, or smell
  • Bleeding after intercourse
  • Fatigue
  • Frequent or painful urination
  • Lack of appetite
  • Nausea, with or without vomiting
  • Pain during intercourse
  • Lower back pain

Symptoms of infertility vary among women; some of the more common signs may be:

  • Abnormal or irregular periods, or painful periods
  • Signs of hormonal changes, like increased acne, changes in sex drive or desire, loss of hair or thinning hair, or dark hair growth on the lips, chest, and chin
  • Inability to get pregnant after 12 months of unprotected intercourse

Treatment for Mirena infertility may employ various medications, surgical intervention, intrauterine insemination, or other options like in vitro fertilization. Treatment depends on the circumstances, and the extent of damage done to the fallopian tubes, uterus, and other organs.

Plaintiffs allege Mirena IUD caused infertility

In January 2013, a Minnesota woman filed a lawsuit against Bayer, alleging that the Mirena IUD had caused her to suffer severe complications, including uterine perforation and an ectopic pregnancy, which can cause Mirena infertility.

A Canadian plaintiff reported that she had the Mirena implanted in 2008, but then experienced heavy bleeding. It was later discovered that the Mirena IUD had perforated her uterus and become lodged in place. Her doctor removed it, but six months later, an MRI showed fluid in the fallopian tube, a result of injury or infection. Both her tubes were blocked, and she also had PID, resulting in infertility.

The current Mirena label does indicate that the intrauterine device can cause perforation, but suggests such problems only occur during insertion, whereas many women have reported perforation and migration months or years afterward—leading to complications that can result in infertility. Women who have suffered these and other serious problems may be eligible to file a Mirena lawsuit against Bayer in an effort to recover damages.