Mirena Ectopic Pregnancy

Mirena is a hormone-emitting intrauterine device (IUD) intended to prevent pregnancy. In some cases, however, it is not effective and can result in an ectopic pregnancy outside of the uterus, that is potentially life-threatening.

Quick Summary
Mirena Ectopic Pregnancy

Hormonal IUD birth control device, Mirena is said to be more than 99% effective at preventing pregnancy with a failure rate of 0.2% per year, however clinical studies have shown that half of those pregnancies may be classified as ectopic pregnancies that occur outside of the uterus.  Patients who have a history of ectopic pregnancy, tubal surgery or pelvic infection have a higher risk of ectopic pregnancy when using Mirena.

Pregnancy which occurs during IUD use warrants medical treatment with removal of the IUD.  Ectopic pregnancy symptoms may occur suddenly, be severe and life-threatening and should be treated as a medical emergency.

Ectopic Pregnancy Symptoms

Ectopic pregnancy is a pregnancy which occurs outside of the uterus.  It most commonly occurs in the fallopian tubes and has been called “tubal pregnancy” but may also occur on the cervix, abdomen or vaginal wall.

As cells of the embryo divide and grow larger, ectopic pregnancy may cause sudden or severe pain.

Symptoms of ectopic pregnancy may include:

  • Pain or inflammation abdomen or back
  • Pain during urination
  • Vaginal bleeding
  • Abdominal swelling or pressure
  • Dizziness or fainting

If the ectopic pregnancy has ruptured a fallopian tube or other tissues, pain may be severe or spread to other areas.  Ectopic pregnancy symptoms should be treated as an emergency.

Mirena Ectopic Pregnancy

Mirena is a contraceptive intrauterine device (IUD), manufactured by Bayer Healthcare. It is a small, T-shaped device constructed out of a hormone-eluting plastic. After being inserted in the uterus, it releases the medication levonorgestrel into the uterine cavity, over a period of years.

The device is intended to prevent pregnancy for up to 5 years and can be used for women who have heavy menstrual bleeding who desire intrauterine contraception.  Though IUDs have traditionally been recommended for women with children, Mirena can also be used by women who have not been pregnant.  

While Mirena may be up to 99% effective, it may cause serious side effects and has also resulted in the occurrence of ectopic pregnancy in some women.

What is Ectopic Pregnancy?

In normal pregnancy, an egg which has been released from the ovaries and that has been fertilized travels through the fallopian tubes to the uterus and implants in the uterine wall as an embryo.

Also sometimes called “tubal pregnancy”, ectopic pregnancy occurs when the embryo implants outside the uterine cavity, most commonly in the fallopian tubes but sometimes in the cervix, ovaries or abdomen. Ectopic pregnancy is not considered viable and may pose a serious risk to the mother due to threat of hemorrhage.

Mirena Ectopic Pregnancy Symptoms

Mirena works by emitting hormone in the uterus, making the uterus and cervix inhospitable to a fertilized egg.  The hormone levels that are emitted from the device are lower than those in oral contraceptives or other hormonal birth control methods and may not protect against pregnancy if the IUD may shift or migrate from its position in the uterus.  If pregnancy occurs, an ectopic pregnancy is possible. 

Ectopic pregnancy occurs when an embryo implants outside of the uterus. Most commonly, implantation occurs in the fallopian tubes and as cellular division occurs, the tube or other tissues may rupture and bleed. Internal bleeding caused by tissue rupture can result in severe pain and may become life-threatening if not controlled.

Signs and symptoms of ectopic pregnancy include:

  • Pain or inflammation in lower abdomen
  • Pain during urination
  • Vaginal bleeding

Ectopic pregnancy can mimic the symptoms of other conditions such as:

  • Appendicitis
  • Gastrointestinal disorders
  • Urinary system complications
  • Pelvic inflammatory disease

Ruptured Ectopic Pregnancy

If an ectopic pregnancy is not discovered quickly, the rapid cell division of the growing embryo may cause the fallopian tube to rupture. This may cause excessive internal bleeding or hemorrhage which can be life-threatening for the mother.

Symptoms of ruptured ectopic pregnancy may include:

  • Sudden and severe pain in abdomen
  • Swelling of abdomen
  • Back, shoulder or pelvic pain
  • Pressure of rectum
  • Dizziness or fainting
  • Symptoms of low blood pressure

Hemorrhage associated with ruptured ectopic pregnancy may lead to life-threatening blood loss. symptoms of ruptured ectopic pregnancy should be treated as a medical emergency. In the western world, death due to ectopic pregnancy is rare but it may result in infertility as surgery is usually required to remove the affected fallopian tube and other involved tissues.

Resolving Mirena Ectopic Pregnancy

A ruptured ectopic pregnancy is treated as a medical emergency due to risk of life-threatening hemorrhage or blood loss. Surgery will be performed to control internal bleeding and may include removal of the fallopian tubes and other involved tissue, resulting in termination of the pregnancy.

If ectopic pregnancy is discovered prior to rupture, removal of the device and termination of the pregnancy will be recommended. Termination may be performed through laparoscopy and a medication known as methotrexate may be used to assist in dissolution of the pregnancy. In some cases, removal of the fallopian tube may also be required even when rupture has not occurred. This may have an impact future fertility.

Mirena lawsuits

Since its return to the U.S. market in 2000, The IUD has grown in popularity, now accounting for over 10% of birth control products given by physicians. Mirena has been used in 150 million women worldwide and is highly effective in most cases but may pose a serious risk in some women. Thousands of lawsuits been filed against Bayer Healthcare, manufacturer of Mirena.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.