Mirena Organ Perforation

Mirena is a hormone-eluting intrauterine device (IUD) that is used to prevent pregnancy. It is known to cause a number of serious side effects organ perforation after the Mirena device migrated from its position.

Mirena Organ Perforation

Quick Summary
Mirena Organ Perforation

Mirena is a T-shaped device, constructed of medication-eluting plastic which is implanted in the uterus to release birth control hormone, levonorgestrel for up to 5 years. Once placed in the uterus through a special tube device, “flaps” are released to form the T-shape which holds the IUD in place.

If the Mirena IUD moves or migrates from its seated location, it may travel into the uterus and perforate the uterine wall. In some cases, the Mirena IUD may fully penetrate or travel through the uterus into the abdominal cavity where it may perforate or penetrate other organs.

An event involving organ perforation by Mirena may result in a potentially life-threatening event.

Organ Perforation Symptoms

If Mirena becomes dislodged or migrates from its intended position, common symptoms may include pain and discomfort in the abdomen, irregular bleeding and shortening or disappearance of Mirena’s string.

In cases where the device has perforated or penetrated the uterine wall, symptoms may worsen and include:

  • Nausea and vomiting
  • Bowel changes
  • Difficulty breathing
  • Sudden or severe abdominal pain
  • Dizziness or fainting
  • Irregular heart rhythm
  • Unexplained fever
  • Severe bleeding
  • Abdominal swelling or bruising

Symptoms of device migration or organ perforation should be reported to a health care provider immediately. Changes in consciousness, severe bleeding or other serious symptoms may require emergency treatment.

Since intrauterine devices (IUDs) were reintroduced to the market in 1988 and Mirena was approved in 2000, it has grown in popularity. Over 150 million women have received the device worldwide and it has been shown to be over 99% effective at preventing pregnancy.

Unfortunately, a number of women have also developed serious side effects including many who have experienced Mirena organ perforation after the device migrated or moved from its original position.

What Is Organ Perforation?

Mirena is a T-shaped device which is constructed of a medication-eluting plastic which releases the birth control hormone, levonorgestrel over a long period of time. Mirena is implanted in the uterus by a physician and is intended to be left in place for up to 5 years. It is inserted using a special tube which allows the collapsed device to slide through the cervix and once in place, “flaps” are released to form the T-shape which holds the IUD in place.

Once seated in the uterus, if the IUD device moves or migrates from its original position, it may begin to erode the abdominal, uterine or other organ walls. It may also perforate or even penetrate organ walls, resulting in a potentially life-threatening injury.

Mirena organ perforation is most commonly seen in the uterus but once it has fully penetrated the uterus, the IUD can migrate through to other areas of the body. In addition to uterine perforation, some women have had additional organ perforation or involvement in the cervix, fallopian tubes, or abdominal organs such as the bladder or intestines.

Mirena Organ Perforation Symptoms

Though Mirena is an effective birth control method for most women, it is estimated as many as 1 in 500 insertions may result in uterine perforation when the device becomes unseated and migrates.

If the device has penetrated all the way through the uterine wall, the device may damage other reproductive organs such as the cervix, fallopian tubes, and ovaries. It may also perforate the abdominal wall, bladder, kidneys or intestines and may pose a serious risk to the patient due to hemorrhage or uncontrolled internal bleeding.

Common symptoms of Mirena device migration and organ penetration can include:

  • Dull, aching pain in the abdomen
  • Mirena’s string becomes shorter or disappears
  • Unexpected menstrual-type bleeding

More serious symptoms may be caused by a device that has perforated the uterine wall and is affecting other organs, has caused internal bleeding or has resulted in a severe infection.

  • Nausea and vomiting
  • Blood in the stool
  • Bowel movement changes
  • Difficulty breathing
  • Sudden, severe lower abdominal pain
  • Rapid heartbeat
  • Dizziness or fainting
  • Low blood pressure
  • Severe or excessive vaginal bleeding
  • Appearance of bruising in abdominal area

The longer a device migration event is left untreated, the higher the risk for additional complications. However, symptoms of organ perforation are not always easily identified as they may mimic other conditions or go unreported.

Patients should be advised to report any changes that may be related to Mirena organ perforation. Any changes in consciousness, heart rhythm or symptoms of excessive bleeding should be treated as an emergency.

Mirena Organ Perforation Treatment

Patients who are asymptomatic may notice that the Mirena device’s string has become shorter or has “disappeared”. A physical exam will be followed by X-ray procedures to locate the device and plan for removal.

If device migration has caused perforation of the uterine wall, surgery will most likely be required to remove the device, assess the injury and repair tissues if necessary. In some cases, surgery may be performed laparoscopically but severe cases will require a larger abdominal surgery.

Some patients have been required to undergo multiple surgeries to stop blood loss, remove the device and repair damaged tissues and organs. Depending on the patient’s specific condition, the patient’s fertility may be impacted as damage to the reproductive system may be permanent and prevent future pregnancies. Scar tissue development in the abdominal area may cause pain or other complications which may be debilitating.

Mirena Organ Perforation Lawsuits

Thousands of women or their families have filed lawsuits against the manufacturer of Mirena, Bayer Healthcare. The company has been accused of producing a defective device and for failure to adequately warn the public and medical profession about the dangers of Mirena.

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