A woman whose Mirena intrauterine device (IUD) allegedly moved out of place and perforated her uterus has filed a Mirena IUD lawsuit against Bayer Pharmaceuticals, accusing the pharmaceutical giant of a litany of charges, including defective manufacturing, design defect, negligence, failure to warn, product liability, breach of warranty, and fraud.

Plaintiff Casey S. of Pippa Passes, Fla. is seeking both compensatory and punitive damages in her Mirena IUD lawsuit. 

Casey maintains that her doctor in Whiteburg, Ky. inserted the Mirena in early April 2010. Less than two months later, the birth control device allegedly moved — or migrated — and embedded in her uterine wall, perforating through her uterus.

On May 27, 2010, Casey underwent surgery to remove the device. She continues to suffer pain and discomfort as a result, according to her Mirena lawsuit, which was filed in the Southern District of New York, where there are some 600 Mirena lawsuits centralized in a multidistrict litigation, or MDL.

All of the plaintiffs in those Mirena IUD lawsuits include women who purportedly suffered internal injuries after the Mirena moved out of place, puncturing the uterus and migrating to other areas of the body, causing internal injuries, infections and leaving women unprotected against unwanted pregnancy.

The plaintiffs accuse Bayer of failing to change its packaging despite numerous reports of “embedment of and perforation through the uterine lining and/or migration of the IUD through the uterine lining after the period of insertion.”

The U.S. Food and Drug Administration (FDA) issued a warning about the device, but Bayer has continued to manufacture, advertise, and sell the Mirena IUD.

The Mirena IUD, a T-shaped polyethylene frame that contains a steroid reservoir that releases levonorgestrel, a prescription medication used as a contraceptive, is inserted by a healthcare provider during an office visit.

The FDA approved it for use as a long-term contraceptive device in December 2000 and today, more than 2 million women in the United States, and more than 15 million women worldwide, use Mirena.

According to Casey’s Mirena IUD lawsuit, Mirena’s label does not warn about spontaneous migration. It states only that migration may occur if the uterus is perforated during insertion of the device. Migration of the device is characterized on the label as an “uncommon event despite the numerous women who have suffered migration and perforation post insertion, clearly demonstrating this assertion to be false.”

Bayer has overstated the efficacy of Mirena while understating its potential safety concerns, the Mirena lawsuit alleges.

Casey contends that Bayer knew that Mirena was ”dangerous and ineffective; concealed the dangers and health risks from Plaintiff , physicians, pharmacists, other medical providers, the FDA, and the public at large; made misrepresentations to Plaintiff, her physicians, pharmacists, hospitals and medical providers and the public in general as previously stated herein as to the safety and efficacy of Mirena; and with full knowledge the health risks associated with Mirena and without adequate warnings of the same, manufactured, designed, formulated, tested, packaged, labeled, produced, created, made, constructed, assembled, marketed, advertised, distributed and sold Mirena for routine use.”