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29 Women File Mirena Injury Lawsuit in California

On July 18, 29 women filed a Mirena injury lawsuit against manufacturer Bayer Healthcare Pharmaceuticals, Inc. The case is currently proceeding in the Superior Court of California, San Francisco.

According to the complaint, the plaintiffs all suffered serious injuries after being implanted with the Mirena intrauterine device (IUD). All of the women had to go through Mirena IUD surgical removal.

Plaintiffs endured Mirena IUD surgical removal

The court documents detail the cases of all the plaintiffs, who had the Mirena IUD implanted sometime between 2004 and 2012, and then subsequently had to have it removed. Many suffered Mirena migration, a condition in which the device moves from its original position in the uterus out into other areas of the body, including the abdomen. One of the plaintiffs had the device inserted in December 2008, and learned in August 2011 that she was pregnant and had ovarian cysts. She had to go through a hysterectomy.

The plaintiffs together claim that the defendant knew that the Mirena was defective, and could spontaneously migrate to other parts of the body. Yet Bayer still provides no warnings about this potential side effect, and says only that migration may occur if the uterus is perforated during insertion. Mirena’s label also describes perforation as an “uncommon” event, despite the numerous women who have suffered migration and perforation post-insertion.

FDA receives numerous reports of problems

The FDA approved the Mirena in 2000 as a birth control option for women. A T-shaped plastic device, it gradually releases synthetic progestrogen into the uterus to prevent pregnancy. Bayer also states that the Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival.

As of July 2013, the FDA had received over 70,000 reports of problems related to the Mirena. Side effects may include bleeding, perforation of other organs, abscesses, ectopic pregnancy, infections, pain, and more. Many of these conditions require Mirena IUD surgical removal, which is typically performed with a laparoscopic procedure.

When the Mirena has migrated to another position in the body, surgery to get it out can be more complicated. The doctor has to first discover where the Mirena has gone, which requires tests like ultrasound imaging, X-rays, and fiber optic instruments. In some cases, it takes a number of tests to discover the location of the device.

Mirena injury lawsuit brings claims of negligence

The plaintiffs in this Mirena injury lawsuit bring claims of defective manufacturing, design defect, negligence, failure to warn, strict liability, and breach of warranties. They state that the defendants concealed the dangers and health risks of the Mirena IUD from the plaintiffs, physicians, pharmacists, and other medical providers, the FDA and the public at large. They seek general, compensatory, statutory, and punitive damages.

Federal Mirena lawsuits have been centralized as multidistrict litigation in the Southern District of New York. State cases have also been consolidated in New Jersey.