Mirena Recall

Published on June 21, 2013 by Laurie Villanueva

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mirena recallThe absence of a Mirena recall has not stopped thousands of women from filing lawsuits alleging injuries from the IUD against its manufacturer, Bayer Healthcare Pharmaceuticals.

According to claims, spontaneous migration of the intrauterine birth control device has the potential to cause uterine perforations, abscesses and other disturbing side effects that may require painful surgical intervention. In the worst-case scenario, a hysterectomy may be necessary to repair Mirena complications.

If you experienced infection, uterine or intestinal perforations or another complication stemming from the Mirena IUD, contact Bernstein Liebhard LLP right away to learn about your legal rights at . You may be eligible to receive compensation for medical bills, lost wages and other out-of-pocket costs related to your injury.

Despite Lack of Mirena IUD Recall, Thousands of Adverse Event Reports Filed with FDA

Between November 1997 and June 2012, the U.S. Food and Drug Administration (FDA) received an estimated 45,000 complication reports from patients who received Mirena. Of those reports, it is likely that many were serious, and could have stemmed from the spontaneous migration of the device away from its original point of insertion in a woman’s uterine wall and into other parts of her abdominal cavity. One may wonder how many women have had to undergo surgery to locate the device in order to remove it.

Approved by the FDA in 2000, the Mirena IUD is a small, t-shaped device inserted into a woman’s uterine wall by a health care provider to prevent pregnancy. The device releases a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus to prevent pregnancy, and may stay in place for up to five years.

Lawsuits filed against Bayer have been brought by women who allegedly suffered the following side effects:

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

According to Bayer, approximately 2 million women currently use Mirena as their preferred method of birth control. As intrauterine devices continue to gain popularity, this number is likely to rise—but so could the number of claims filed over the IUD. In a Multicounty Litigation currently underway in New Jersey’s Bergen County Superior Court, for example, over 60 claims are now pending after the state’s Supreme Court tasked a single judge with overseeing pretrial proceedings for similarly-filed actions against Bayer.

Federally-filed Mirena lawsuits have been centralized in a federal multidistrict litigation created in the U.S. District Court, Southern District of New York. The first status conference for this proceeding was held May 17, 2013.

In addition to a growing litigation of IUD-related lawsuits in the U.S, the fact that the FDA has already reprimanded Bayer for its marketing of the IUD may predict a future Mirena recall. In 2009, the agency sent the manufacturer a letter warning them to stop overstating the benefits of the IUD and minimizing the risk for side effects. Certain presentations during in-home marketing events were also found to be misleading by the agency, including claims that the IUD could improve a woman’s sex life and make her “look and feel great.” According to the FDA, this statement may be untrue—at least 5% of Mirena users reported decreased libido.

Dozens of Women are Filing Lawsuits in Absence of Mirena IUD Recall

If you received the Mirena IUD and experienced uterine perforations, abscesses, pain, infection or other complication as a result of the birth control device, don’t wait for the announcement of a Mirena recall. You may start the process of filing a lawsuit against Bayer by calling an attorney at Bernstein Liebhard LLP at .