Plaintiff Alleges Mirena IUD Perforated Her Uterus

A Texas woman has filed a Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals Inc. after the contraceptive device allegedly perforated and migrated from her uterus, requiring surgical intervention. She alleges that the injuries were caused by the intrauterine device.

According to her Mirena IUD lawsuit, Diana Olatunbosun had the Mirena IUD implanted on March 18, 2011 by Dr. Ashley Rizzutto. The Texas woman began complaining of pain and discomfort. Her doctor determined that the birth control device had perforated her uterus. On Nov. 21, 2011, she underwent a “painful surgical removal of the device.”

“Mirena has a T-shaped polyethylene frame that is 32 mm in both the horizontal and vertical directions,” the Mirena IUD lawsuit explains. “It has a steroid reservoir around the vertical stem. The reservoir consists of a white or almost white cylinder, made of a mixture of levonorgestrel and silicone, containing a total of 52 mg of levonorgestrel.”

The Mirena IUD is popular because it is supposed to work for five years before needing to be replaced — making it much more convenient than traditional birth control pills that need to be taken daily. It is especially marketed to busy moms who don’t have 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.

“More than 45,966 adverse events were reported to the FDA associated with Mirena between November 1, 1997 and June 30, 3012,” the Mirena IUD lawsuit states. “Most of the adverse events reported are associated with uterine migration and perforation of the IUD.”

Olatunbosun’s charges against Bayer include liability for a manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, fraud and misrepresentation. She is asking for compensatory damages to cover past and future damages as well as punitive and exemplary damages.

There are more than 40 Mirena IUD lawsuits currently filed against Bayer, but that number is expected to grow due to the high volume of complaints the FDA has received.

The Mirena IUD lawsuit is Diana Olatunbosun v. Bayer Healthcare Pharmaceuticals Inc., Case No. 4:13-cv-02491, in the U.S. District Court for the Southern District of Texas.

If you or someone you know has been injured by a Mirena IUD, legal options are available. Learn more and get a free legal consultation regarding a claim’s eligibility at the Mirena IUD Injury Class Action Lawsuit Settlement Investigation. Experienced legal professionals have access to medical experts to assess whether or not a Mirena IUD may be playing a role in your current pain, discomfort or other serious side effects, so act now.