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Article Contents

Mirena IUD Lawsuits

With nearly 46,000 reported injuries resulting from the Mirena intrauterine device (IUD), patients have been turning to the court system. They have endured the serious medical complications as a result of this birth-control device and want justice.

Mirena, a T-shaped plastic device that is implanted in the uterus, is aimed at preventing pregnancy in two ways: It inhibits sperm motility and is coated with levonorgestrel, a synthetic progestin hormone that is similar to the hormone used in birth control pills. Once a medical professional inserts the Mirena in the uterus, the device can stay in place for up to five years. Manufactured by Bayer Pharmaceuticals, it is only approved for women who have already given birth. It has been used in Europe since 1991 and in the United States since 2000. In 2009, the U.S. Food and Drug Administration (FDA) approved Mirena to treat heavy menstrual bleeding. According to FDA records, a total of 45,701 adverse events, or serious side effects, have been related to Mirena usage from November 1997 to June 2012 in the United States alone.

Mirena IUD Complications

Medical professionals have found that Mirena comes with a host of complications. One of the most serious side effects is when the device moves from its normal position inside the uterus, called migration. In a 2012 study, the University of California Medical Center found that IUD migration is “a frequently encountered complication, varying from uterine expulsion to displacement into the endometrial canal to uterine perforation.” In many cases, women must undergo surgery to remove migrated devices. This can lead to permanent infertility or uterine damage.

The FDA has also noted other serious side effects:

  • Ectopic pregnancy -- Of the small percentage of pregnancies while using Mirena, about half are ectopic, or outside the uterus. This can be a life-threatening condition for the mother.
  • Pelvic inflammatory disease (PID) – According to the FDA, women with a history of PID should not use Mirena.
  • Device embedment – Mirena is known to become embedded in the uterus or cervix. It often requires surgical repair.
  • Device expulsion -- About six percent of women using Mirena experience the device spontaneously expelling from the uterus. This creates a higher risk of pregnancy and other medical complications.
  • Uterus or cervix perforation – Mirena is known to perforate nearby organs when it migrates out of the uterus. This can cause infection and internal injuries.

In addition, Mirena has been linked to uterus scarring, sepsis, infertility, intestinal damage and infections.

Already, dozens of women are pursing legal action against Bayer, accusing the manufacturer of misleading marketing, failing to reveal the device’s dangerous side effects and producing a defective product.

Mirena Class-Action Lawsuit

Even though there is no class action filed in the Mirena cases, dozens of lawsuits have been filed in New Jersey. In early January 2013, the state’s Supreme Court denied Bayer’s request to consolidate the cases. But by mid January 2013, a petition was filed with the U.S. Judicial Panel for Multidistrict Litigation (MDL) requesting all current and future Mirena cases be transferred to a federal court in Ohio. The petition says that hundreds of similar cases are likely to be filed. An MDL is considered advantageous over a class action because an MDL allows for individual trials based on individual circumstances.

Plaintiffs argue that Bayer did not properly study the device prior to releasing it to the market and that the company has done an inadequate job warning patients and doctors about the risks. The patient-safety packaging included with the device warns that it may migrate or perforate nearby organs during insertion. The document does not warn that the device may cause internal injuries months or years later.

The plaintiffs also said the company simplified the risks and over-promoted the device. Through Bayer’s scripted direct-marketing program, called Simple Style, the company tried to entice women to use Mirena by making misleading claims that the device would make them feel and look better.

Mirena Lawyers and Attorneys

To date, more than two millions women nationwide have used Mirena. Women who have experienced complications as a result of Mirena may be eligible for compensation for medical expenses, time off work and pain and suffering. Our skilled Mirena patient advocates and legal staff will help you through the process.