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What is an Intrauterine Device?

An intrauterine device or IUD is a type of birth control method that has become increasingly popular amongst women in the United States because of the fact that it is advertised and perceived as a low-maintenance form of birth control.

With the IUD, a doctor inserts a small, plastic, t-shaped device through a woman’s vagina, placing into the uterus.

There are two types of IUDs, hormonal and copper.  The most popular and well-known IUD is the Mirena IUD, a hormonal form that works by:

  • physically blocking the sperm
  • thickening the cervical mucus
  • thinning the uterine lining
  • and possibly inhibiting the release of the egg

The Mirena IUD remains effective for up to 5 years after it is placed, thereby making it much more convenient for some women than taking a daily pill.

What is the Problem with the Mirena IUD?

The Mirena IUD sounds almost too good to be true:  safe, side-effect-free birth control that is effective for 5 years.  For many women, the Mirena IUD has been too good to be true, as they have suffered serious and often life-altering side effects from it.  The most common side effects include:

Device Dislocation/Migration.  The Mirena IUD may migrate out of the uterus where the doctor implanted it into other parts of the body, including the bladder, liver, and stomach.  The IUD can perforate the uterus as well as other organs, causing serious pain, infection, and the need for immediate surgery.

Infections.  A woman may suffer Pelvic Inflammatory Disease after the Mirena IUD has been placed.  She may also develop an infection if the IUD migrates out of place.  Often times symptoms of an infection are a woman’s first sign that the IUD is no longer in the uterus.  Symptoms of a serious infection include chills and fever, pain, pain during intercourse, and abnormal discharge or menstrual cycles.

Uterine Perforation.  The uterus may become perforated during the insertion process itself, or it may migrate out of place, perforating the uterus as it moves.  Perforation can be serious, causing infection or even future infertility.  Surgery may be required to remove the IUD.

Ectopic Pregnancy.  If a woman gets pregnant while on Mirena IUD, she has a high risk of developing an ectopic pregnancy.  An ectopic pregnancy occurs when the embryo implants outside of the uterus, often in the fallopian tubes.  An ectopic pregnancy is unsustainable, and can seriously endanger the health of the mother.  It can result in rupture, hemorrhage, and loss of fertility.  Mirena’s label warns that up to half of all pregnancies that occur on Mirena are ectopic.

What does the FDA say about Mirena?

The FDA approved Mirena in 2000 as a form of contraception, and in 2009 to treat heavy periods.  In 2009, the FDA sent a warning letter to Mirena manufacturer Bayer stating that in their advertisement program entitled “Mirena Simple Style Statements Program”, Bayer:

  • Made unsubstantiated claims
  • Minimized the risks of using Mirena
  • Made false/misleading presentations regarding Mirena

Beyond this, the FDA only states that all drugs and medical devices have risks, and that approved drugs, of which Mirena is one, are those whose benefits outweigh their risks.

Are Lawsuits Regarding Mirena Underway?

Lawsuits regarding Mirena are underway in New Jersey and New York, both in multidistrict litigation.

The suit that is consolidated in New Jersey alleges that Mirena caused uterine perforation, device migration, and pelvic pain.  Another suit is consolidated in the Southern District of New York and is entitled In Re: Mirena IUD Products Liability Litigation.

Multidistrict litigation allows for consolidation of common issues and evidence gathering, making the process quicker and more efficient, while still allowing each plaintiff’s case to be resolved individually.

The Attorneys at Kirkendall Dwyer LLP Are Ready to Help.

If you or a loved one have suffered serious side effects from a Mirena IUD, our attorneys are ready to answers any questions that you might have.  Many women who had the Mirena IUD implanted were never warned about the potential for serious side effects.  If you are one of these women, you deserve compensation for your pain and suffering.  Contact us today to see if you may qualify to join litigation that is underway.
Click here to learn more about IUD side effects and lawsuits at our dedicated Drug and Device website.