Mirena IUD Investigation

Stueve Siegel Hanson is investigating the prescription Mirena IUD (Intrauterine Device) related to an increased risk of uterine wall perforations and other dangerous conditions. 

Millions of American women have used the Mirena IUD as a birth control method. Since Mirena is the only hormonal IUD approved by the FDA – and because it prevents pregnancy for up to five years after insertion – Mirena has become extremely popular among women of all ages. The Mirena IUD, which is manufactured by Bayer, is inserted into the uterus through the vagina. 

The Mirena IUD is promoted as a "levonorgestrel-releasing intrauterine system". In other words, it is an IUD that releases hormones from a plastic cartridge that forms part of the "T" shaped device. The manufacturer’s promotion materials claim that:

  •  It is effective and one of the most effective birth control methods claiming 99% effectiveness.
  •  It is convenient because it can last up to 5 years.
  •  It is flexible because it can be removed.

The Mirena IUD was first approved by the FDA in 2000 for temporary pregnancy prevention. In 2009, the FDA expanded the indication to include the treatment of heavy menstrual bleeding in women who use IUDs as their method of birth control. 

According to data released by an Adverse Events Report on December 18, 2012, the FDA has disclosed receiving over 45,000 complaints involving women who suffered complications while using the Mirena IUD. The manufacturers of the Mirena IUD are now being investigated with Mirena lawsuits being filed across the country. Bayer Healthcare Pharmaceuticals are being accused of knowing the serious side effects of Mirena but withholding this information from women.

Bayer marketed it as a hassle free birth control device, misleading women about its safety, and was reprimanded by the FDA for deceptive marketing in 2009.  Women who have become infertile or suffered other serious complications after using the Mirena IUD are shocked that they could be prescribed such a dangerous IUD. 

The Mirena IUD has been reported to cause severe side effects due to the risk that the device may move from its original location.  When Mirena migrates, it may also cause the following:

  • perforation or puncture of the uterine wall (sometime after initial placement/implant);
  •  infertility;
  •  pelvic inflammatory disease; and
  • embedment 

Many women may be unaware that the device has moved out of position until damage has already been done. That is why medical professionals recommend follow up examinations shortly after implant to confirm the correct position of the Mirena IUD and women should be encouraged to check the guide strings.

When the Mirena IUD is implanted, guide strings are left protruding through the cervix and leading back to the Mirena, allowing health care professionals to easily find it and remove the IUD when it is time to come out.

The presence of the strings is one sign that the Mirena is in the correct position. If the strings cannot be found, it is possible that the Mirena has moved out of position and may have punctured the uterus or other organs.

Other signs that the Mirena has become displaced may include:

  • Severe Abdominal Pain
  • Unusual Bleeding
  • Unexplained Infection

In a number of cases, doctors have looked for the Mirena but could not find it, even with imaging scans. This is usually because they look where the Mirena should be, and it has moved so far that they cannot easily locate it.

If the Mirena IUD pierced the uterine wall, it could have traveled to anywhere in the woman’s abdominal cavity. This may result in severe damage and in many cases this results in the need for surgical removal of Mirena IUD.

As a result of the manufacturer’s failure to adequately warn about the risk of the Mirena IUD moving out of place, women and the medical community were not fully aware of this potential side effect and the importance of monitoring the placement of Mirena.  If women were provided better information about the warning signs of Mirena movement, many severe and debilitating injuries could have been avoided by detecting the problems earlier.

If you or someone you know has had a Mirena IUD and experienced complications and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.

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