Mirena Pelvic Inflammatory Disease Risk Subject of New Lawsuit

Plaintiff Angela White, a 27 year-old Tampa, Florida resident, filed a Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals, in the Southern District of Illinois on September 17. The plaintiff claims the defendant distributed Mirena without properly disclosing the various side effects of the product, including Mirena pelvic inflammatory disease risk, weight gain, acne, breast pain, the susceptibility to infections, and the possibility of miscarriage if a woman becomes pregnant.

While using Mirena, White experienced severe cramping, and developed ovarian cysts and pelvic inflammatory disease, for which she blames the defendant. She demands more than $75,000 in compensation, in addition to punitive damages and payment legal costs incurred.

Mirena IUD lawsuit claims

Mirena is an intrauterine system that is inserted by a healthcare provider during an office visit. The product is a T-shaped polyethylene frame with a steroid reservoir that releases hormones into the body. The device is placed in the uterus and is supposed to prevent pregnancy for up to five years.

The Mirena IUD lawsuit accuses defendants of overstating the efficacy of the device, while understating the potential safety concerns. It’s noted that, “Mirena’ s label does not warn about spontaneous migration of the IUS, but only states that migration may occur if the uterus is perforated during insertion.” It goes on to say the label, “describes perforation as an ‘uncommon’ event, despite the numerous women who have suffered migration and perforation post-insertion, clearly demonstrating this assertion to be false.”

The claim alleges the “defendant introduced a product into the stream of commerce which is dangerous and unsafe in that the harm of Mirena outweighs any benefit derived therefrom.”

Mirena pelvic inflammatory disease risk

The plaintiff had the Mirena inserted in 2006. She returned to her physician’s office six weeks later and was told it was properly placed. Two months later she began to experience severe cramping and pain. These symptoms continued, requiring additional medical care, treatment, and testing. On December 9, 2006, White was diagnosed with ovarian cysts and pelvic inflammatory disease. She believes her use of the IUD is to blame for developing these conditions. If White or her physician would have been properly informed of the risk of Mirena side effects, she would have been prescribed a comparable product, according to the complaint.

The plaintiff is suing the defendant on nine counts, including defective manufacturing, design defect, negligence, failure to warn, strict liability, breach of implied warranty, breach of express warranty, fraudulent misrepresentation, and fraud by concealment.

More complaints filed over Mirena injuries

More than two million women in the U.S. and 15 million worldwide have used Mirena. The device was approved by the FDA in December 2000. Following this approval, the FDA has received 70,000 + complaints about Mirena. Some complaints cite minor symptoms including acne, headaches, and back pain. Others have experienced much more serious side effects. Since 2008, 4,775 women have reported device dislocation, 3,774 complained of abdominal pain, and 1,322 say Mirena perforated their uterus.

There are currently more than 220 Mirena lawsuits pending in state and federal courts.