March 30, 2015 — Over 1,200 lawsuits involving uterine perforations caused by Mirena have been centralized in a federal court in New York, and new lawsuits continue to be filed around the nation.
Another 1,800 lawsuits are centralized in a multi-county litigation (MCL) in Bergen County, New Jersey. The judge overseeing the litigation, Superior Court Judge Brian Martinotti, recently ordered parties to select 14 cases as candidates for the second “bellwether” trial.
One of the most recent lawsuits (PDF) was filed by Carolyn Ferrara in the U.S. District Court for the Western District of Massachusetts.
Ferrara had Mirena implanted in 2011. Nearly two years later, she experienced “extreme pain” and had to have laparoscopy to remove the IUD because the device migrated and perforated the anterior region of her pelvis.
According to the complaint:
“Mirena’s label does not warn about spontaneous migration of the IUS, 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.”
An estimated 2 million American women use Mirena to prevent unwanted pregnancy. The manufacturer, Bayer, warns about the risk of uterine perforations during the insertion procedure. However, they do not warn about the risk of spontaneous uterine perforation that can occur months or even years later.
As a result, many women have been misdiagnosed and required surgery to remove Mirena when it was finally located inside their abdomen. Some of the most serious side effects linked to this complication include:
- Pelvic inflammatory disease
- Organ perforation
- Perforation of the uterus
- Infertility
- Ectopic pregnancy
- Abscesses and infections
- Need for laparoscopic removal
- And more