March 30, 2015 — Bayer HealthCare has been hit with about 3,000 lawsuits involving women who suffered spontaneous uterine perforations after using the Mirena intrauterine device (IUD).
Approximately 1,800 cases have been centralized in New Jersey, where Superior Court Judge Brian R. Martinotti recently ordered attorneys to pick 14 cases as potential candidates for the second “bellwether” trial.
Another 1,200 cases are centralized at the federal level in New York, overseen by U.S. District Judge Cathy Seibel.
As awareness of the litigation grows, more lawsuits continue to be filed around the nation. On March 18, another lawsuits (PDF) was filed in federal court in Massachusetts by Carolyn Ferrara.
Ferrara started using Mirena in 2011, but experienced “extreme pain” less than two years later. She had to undergo laparoscopic surgery in December 2013 to remove Mirena from her body. Surgeons discovered that it had migrated and perforated the back of her pelvis.
According to the lawsuit:
“Mirena’s label does not warn about spontaneous migration of the IUD, but only states migration may occur if the uterus is perforated during insertion. Mirena’s label also 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.”
Mirena is an intrauterine implant made by Bayer. It is used by about 2 million women in the United States. Although Bayer warns about uterine perforations when Mirena is being implanted, there are no warnings about spontaneous uterine perforations.
Many women accuse Bayer of downplaying risk information linking Mirena and spontaneous uterine perforations. In some cases, women were misdiagnosed for months or even years. Unfortunately, the only treatment for an IUD that has migrated outside the uterus is surgery.