Product News and Recalls

IUD users report “horrific” injuries

According to a report on WEWS-TV out of Cleveland, patients who filed lawsuits over the Mirena intrauterine device are reporting a range of “horrific” injuries.

The report includes an interview with a woman who continues to suffer pain on the left side of her body, which he doctor said is due to nerve damage and will never go away. That woman needed surgery after the IUD became detached, perforated her uterine wall and was found floating around in her abdomen.

Investigators with WEWS found more than 70,000 complaints about Mirena IUD devices filed with the U.S. Food and Drug Administration since 2000.

Since 2008, 4,775 of those reports concerned “device dislocation,” which may refer to the IUD becoming embedded in the uterus, moving from its initial placement at the top of the uterine cavity, or an IUD that has migrated outside the uterus. And since 2008, 1,322 women have reported uterine perforations.

At least 100 lawsuits have been filed in New Jersey against Bayer Healthcare Pharmaceuticals, and an additional 50 have been filed in federal court.

According to the report, one plaintiff claims the IUD lacerated her liver. Another had an appendectomy, hysterectomy and stomach tissue removed after her IUD became embedded in her uterus. Another claims the Mirena IUD migrated into her rib cage.

WEWS said the plaintiffs claim Bayer failed to properly warn physicians and patients about the risks.

Patients should consult their doctors if they have any health complaints from a Mirena IUD device. A consultation with a Mirena lawyer is also important if surgery was required from Mirena.