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Mirena Uterus Perforation Lawsuit


Mirena is an intrauterine device (IUD) contraceptive used by millions of women. Unfortunately, uterus perforation is a rare but serious potential complication. Perforation of the uterus may occur during insertion of the Mirena IUD. It may also occur gradually, over time, if Mirena embeds into the uterus or erodes the uterine wall. When Mirena punctures the uterus, surgery is often necessary to remove the Mirena IUD. Severe scarring can cause permanent infertility.

What is Mirena?

Mirena is an intrauterine device (IUD) which is a contraceptive used to reduce the chances of pregnancy. It was invented by Bayer HealthCare Pharmaceuticals, Inc., and it was approved by the U.S. Food and Drug Administration (FDA) in 2000.

Mirena is a T-shaped piece of flexible plastic that is implanted in a woman’s uterus. Over time, it slowly releases levonorgestrel, a type of synthetic hormone found in many birth control pills. This hormone thickens the cervical mucous, thins the lining of the uterus, and greatly reduces the chances of pregnancy. Mirena is more than 99% effective at preventing pregnancy for up to five years.

Mirena Uterus Perforation

Mirena perforation of the uterus is one of the most serious, life-threatening complications of Mirena. Emergency surgery is often necessary. However, surgery itself has a high risk of complications. Scarring from the perforation or surgery can cause irreparable harm to the uterus, increasing the risk of permanent infertility.

Perforation of the uterus can occur when Mirena is being implanted. Bayer and Health Canada estimate that this occurs in approximately one per 1,000 – 10,000 insertions. Uterus perforation is not always diagnosed when it occurs during perforation. The insertion is usually quite painful, and the health care professional may not recognize symptoms of uterus perforation.

When uterus perforation is not diagnosed right away, more serious complications can occur. Mirena can migrate from its original position, including outside the uterus. Mirena can puncture the intestines or blood vessels, which could cause life-threatening bleeding or sepsis.

Mirena can also erode into the uterus and perforate the uterus over time. This condition is very serious, but it may be asymptomatic at first.

If the uterus is perforated, Mirena may no longer protect against pregnancy. If a pregnancy occurs, there is a high risk of miscarriage or premature birth. A pregnancy with a perforated uterus could also be life-threatening for the mother.

Mirena uterus perforation is more likely to occur in women who have recently given birth, are breastfeeding, or women who have an atypical uterine shape (such as a fixed, retroverted uterus).

Symptoms of Mirena Uterus Perforation

  • Abnormal bleeding (may be continuous)
  • Abdominal pain
  • Fatigue, tiredness
  • Pelvic infection
  • Lost threads
  • Pregnancy

Mirena contains barium sulfate, which is radiopaque (meaning that it can be detected with an X-ray). A pelvic X-ray is often used to locate a “missing” Mirena IUD. Without an X-ray, a doctor might assume that the Mirena has fallen out, and fail to diagnose uterus perforation.

Other Serious Mirena Side Effects

  • Uterus perforation
  • Device migration (sometimes outside the uterus)
  • Embedment in the uterus
  • Erosion into the uterus
  • Perforation of internal organs (intestines)
  • Infection
  • Irregular bleeding
  • Scarring that can lead to infertility
  • Abscesses
  • Inflammation of the uterus (Pelvic Inflammatory Disease)
  • Infertility
  • And more

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