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Mirena Lawsuit Alleges Uterine Perforation Led to “Substantial Pain and Suffering”

A new Mirena lawsuit originally filed in Georgia has been transferred to multidistrict litigation currently underway in New York federal court. Like others whose cases are pending in the coordinated proceedings, this plaintiff alleges Mirena IUD migration led to serious complications that required the surgical removal of the device.

Mirena lawsuit adds to MDL currently underway

The plaintiff originally filed her Mirena lawsuit in U.S. District Court for the Middle District of Georgia on May 30, 2013. The case was transferred to Mirena multidistrict litigation on August 16, 2013, in U.S. District Court for the Southern District of New York. The Honorable Judge Cathy Seibel is overseeing the coordination, which was established to streamline early trial proceedings by avoiding duplicate discovery or conflicting rulings involving Mirena allegations.

The plaintiff in this case was 32 years old when she had the Mirena IUD inserted into her uterus on April 22, 2009. At the time of the insertion, the plaintiff experienced no complications and there was no reason to suspect uterine perforation during the procedure. It was not until May, 2011, that the plaintiff was informed by her physician that the device had perforated her uterus and migrated to another area of her abdominal cavity.

On June 24, 2011, the plaintiff underwent laparoscopic surgery to remove the migrated device. Since the surgery, the plaintiff alleges she has suffered “substantial pain and suffering,” as well as economic loss due to her medical bills and inability to work for a period of time. Her medical treatment and lost earning capacity are expected to continue in the future.

About the Mirena IUD

When the Mirena IUD was approved by the FDA in 2000, it was the only hormonal IUD on the U.S. market. However, reports of serious side effects with the device since that time have raised concerns about its safety for some women. The most common complication associated with the device is spontaneous IUD migration within the uterus, sometimes embedding into the uterine wall.

When this occurs, the device can perforate the uterus and migrate to another area of the abdominal cavity. Symptoms of perforation might include severe pain, nausea and heavy bleeding. The device may be difficult to locate within the abdomen, and when it is found, it often must be surgically removed.

While the product label for the device warns patients and physicians of the risk of uterine perforation, the warning indicates the perforation typically occurs at the time the device is inserted. For women like this plaintiff, the time between device insertion and discovery of the perforation was more than two years, making it difficult to associate the original procedure with the complication.

Although the FDA has not changed the warning label regarding Mirena uterine perforation, the agency did send a warning letter to Bayer in 2009 involving misleading marketing practices of the company. At the time, Bayer was marketing the Mirena IUD with a campaign known as “Mirena Simple Style Statements Program.” The FDA found this program to be misleading on a number of levels, overstating the benefits of the product while minimizing potential risks of the product.

Litigation against Bayer continues to grow

Today, some women who have been injured by the IUD have chosen to file a Mirena lawsuit against Bayer to pursue compensation for their injuries. At the time the MDL was established in New York District Court, there were eight actions pending in eight different districts that were coordinated into the proceedings. At that time, the Panel for Multidistrict Litigation had also been informed of more than 40 other related actions pending in 17 different districts.

Like this plaintiff, women filing lawsuits against Bayer claim the company failed to alert them to the potential dangers posed by the Mirena IUD. After experiencing serious and painful side effects from the IUD, these women have taken their cases to court in hopes of pursuing legal compensation for their injuries. This latest plaintiff is seeking compensatory, punitive and exemplary damages from Bayer to compensate for her pain and suffering, medical expenses and lost wages.