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Mirena Recall


Although a Mirena recall has not been issued, thousands of women have filed reports after experiencing uterine perforations, abscesses and other disturbing Mirena side effects associated with the IUD. According to a recent statistic from, over 45,000 reports of complications stemming from the intrauterine birth control device were filed with the U.S. Food and Drug Administration (FDA) between November 1997 and June 2012.

To learn more about how to file a Mirena lawsuit in the absence of a recall, submit the free case evaluation form on this page or call an attorney at Bernstein Liebhard LLP directly at . Claims filed against the manufacturer seek compensation for lost wages, medical expenses, pain and suffering and other damages incurred by the patient’s injuries.

Mirena IUD Recall Could be Prompted in the Future Due to Common IUD Side Effects

The Mirena IUD, which is a small, t-shaped device implanted into a woman’s uterine wall by a health care provider, releases a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus to prevent pregnancy. Once inserted, the intrauterine birth control device may stay in place for up to five years.

Approved by the FDA in 2000, the following side effects may occur in the event that the Mirena IUD should spontaneously migrate away from its original point of insertion in the uterine wall:

  • Uterine perforations
  • Infertility
  • Abscesses
  • Infection
  • Intestinal perforations or obstruction
  • Ectopic Pregnancy
  • Pelvic Inflammatory Disease

These complications, which are often only repaired through surgical intervention, have been alleged in a growing number of the IUD lawsuits. These claims have been filed by plaintiffs who claim Bayer Healthcare Pharmaceuticals failed to provide adequate warnings about the risks associated with its product, and failed to thoroughly test the IUD before marketing it to women. Complications that may stem from Mirena may result in a woman having to undergo a painful and potentially dangerous hysterectomy, which could be damaging to her fertility.

As of May 2013, court records indicated that over 60 Mirena lawsuits alleging injuries from the IUD were transferred to a Multicounty Litigation in New Jersey’s Bergen County Superior Court.

Meanwhile, federally-filed claims against Bayer have been consolidated in a multidistrict litigation (MDL) established in the U.S. District for the Southern District of New York. Cases were transferred to this location via a Transfer Order by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on April 8th, 2013. The first status conference for this proceeding took place on May 17, 2013.

Another factor potentially leading to a future Mirena recall relates to a warning letter the FDA sent to Bayer in 2009 scolding the manufacturer for overstating the efficacy of the IUD and minimizing its risk for side effects. The agency also found certain presentations during in-home events promoting the IUD to be misleading, particularly Bayer’s claims that Mirena had the potential to improve a woman’s sex life. At least 5% of women who used Mirena reported decreased libido in clinical trials, the FDA’s warning letter stated.

Regardless of No Mirena IUD Recall, Lawsuits can Still be Filed in the Absence

If you or a loved one experienced uterine perforations, abscesses, pain, infection and other complications that may have stemmed from the IUD, you don’t need to wait for a Mirena recall to be announced. Contact Bernstein Liebhard LLP today to start the process of filing a claim over Mirena at .

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