A Mirena IUD lawsuit against Bayer Healthcare Pharmaceuticals was filed by a South Carolina woman who alleges she required surgery, hospitalization and physical therapy after using the birth control device and suffering a perforated uterus.

The Mirena intrauterine device was developed as a long-term birth control alternative to pills and as such was supposed to last for about five years. However, the plaintiff alleges that less than a year after the initial insertion and after follow-up appointments to verify that the Mirena IUD had been inserted properly, it had spontaneously migrated.

As a result, she had to undergo surgery to remove the Mirena IUD because of “extreme lower torso pain… extensive medical therapy, continuing treatment and medical monitoring.” The Mirena IUD lawsuit alleges the woman would have used an alternative device or contraceptive rather than the Mirena IUD had she known of the risks before her first appointment.

Instead, the Mirena IUD migration lawsuit argues that Bayer made a practice of over-promoting the benefits of the device without giving equal time to the possibility of uterine perforation and other Mirena complications. The U.S. Food and Drug Administration stepped in and requested corrective advertising after the company released allegedly misleading commercials. However, the agency-approved medical device information packet does not contain information about spontaneous migration, Mirena IUD lawsuits note.

Company officials argue that these events should not occur if the device is properly inserted. However, tens of thousands of adverse event reports submitted to the FDA have caused some plaintiffs to argue that Bayer could have done more to advise women and doctors of the possibility of Mirena complications.

The Mirena IUD lawsuit is Lalakesheica Wittrell v. Bayer Healthcare Pharmaceuticals Inc., et al., Case No. 14-cv-2102 in the U.S. District Court of South Carolina.