Bayer Hit with Another Mirena IUD Lawsuit alleging Uterine Perforation

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A North Carolina woman filed a Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals Inc. in Pennsylvania federal court after the birth control device allegedly perforated her uterus and had to be surgically removed.

According to the lawsuit, plaintiff Kayla Harris had the Mirena IUD inserted into her uterus in December 2010 by her doctor. The device, which is designed to stay in a woman’s body for five years, began to cause her pain and discomfort. After visiting her doctor, it was determined that the intrauterine device had perforated her uterus, but that the only way it could be removed was with surgery. On Jan. 24, 2013, Harris underwent surgery to have the Mirena IUD removed.

As a result of the Mirena IUD complications, Harris may not be able to have children and has an increased risk for becoming infertile, if she isn’t already.

Bayer Cited for Misleading Mirena Ads

The Mirena IUD is a form of contraception that is made of a flexible plastic that is placed in the woman’s uterus by her doctor. It releases a synthetic progestogen called levonorgestrel that is released into the uterus and works as birth control. The Mirena IUD is effective for five years and it is designed to remain in the uterus for that amount of time. It is often advertised to busy moms who don’t have the time to remember to take a traditional birth control pill.

The Mirena IUD packaging does warn that the device may migrate outside of the uterus if the uterus is perforated during insertion, which is why doctors typically check via ultrasound after the device is inserted to be sure that perforation has not occurred. However, Bayer does not warn that the Mirena IUD may migrate spontaneously — that is, even if perforation doesn’t occur during the insertion process.

Bayer was cited in 2009 by the U.S. Food & Drug Administration (FDA) for misleading customers in their promotions of the Mirena IUD by downplaying the risks associated with the device.

“Since its approval in 2000, the most serious adverse reactions reported in patients using Mirena for any indication include: ectopic pregnancy (a pregnancy in which the fertilized egg grows outside of the uterus); intrauterine pregnancy (a pregnancy with Mirena in place); group A streptococcal sepsis; an infection called pelvic inflammatory disease; embedment of the device in the uterine wall; and perforation of the uterine wall or cervix,” the FDA warning states.

Harris is charging Bayer with strict liability for a manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, fraud and misrepresentation, consumer fraud, negligent misrepresentation, fraudulent misrepresentation, negligent infliction of emotional distress and unjust enrichment.

The Mirena IUD lawsuit is Kayla Harris v. Bayer Corporation, et al., Case No. 7:13-cv-07352-CS, in the U.S. District Court for the Eastern District of Pennsylvania.

Help for Victims of Mirena IUD Complications

If you or a loved one had a Mirena IUD inserted after January 1, 2000 or later and had to have surgery – or will be required to have surgery – to have it remove because it migrated, you may be eligible to take legal action against the manufacturer. Filing a Mirena IUD lawsuit may help you recover compensation for medical bills, pain and suffering and other damages. See if you qualify by filling out the short form at the Mirena IUD Injury Class Action Lawsuit Settlement Investigation.