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New research suggests that about 1.4 out of every 1,000 women implanted with Mirena IUD or other similar drug-coated intrauterine birth control devices suffers from organ perforation, and that risk appears to be increased by breastfeeding.
In a study published last month in the medical journal Contraception, German researchers evaluated data involving use of the implantable, long-acting birth control among European women.
While the overall risk is low for IUD perforation, where the devices migrates out of position and punctures the uterus or other organs, the study found that breastfeeding women face an increased risk.
The findings come amid continuing concerns about reports of sudden Mirena IUD perforations, which have resulted in thousands of product liability lawsuits filed throughout the United States against Bayer Healthcare, the manufacturer of the birth control implant.
Researchers from the ZEG- Berlin Center for Epidemiology and Health Research had more than 60,000 women from six European countries complete surveys after being implanted with either levonorgestrel-releasing intrauterine systems (LNG-IUSs), such as Mirena, or a copper IUD, such as the ParaGard, for a year.
They found that about 1.4 women per 1,000 who were implanted with drug-coated IUDs like the Mirena suffered organ perforation, compared to 1.1 women out of 1,000 implanted with copper IUDs. However, they found that breastfeeding appeared to significantly increase the risks.
“Breastfeeding at time of insertion was associated with a sixfold increase, with no differences between LNG and copper IUD users,” the researchers determined. Out of the 81 perforations noted during the study, 63 of the women had previous risk factors; primarily breastfeeding.
Another study, published simultaneously in the same journal by the same group of researchers, found that the Mirena was more effective at preventing contraception than copper IUDs. The study also linked the Mirena to a lower rate of ectopic pregnancies.
In a press release, Bayer heralded the findings, which were part of the European Active Surveillance Study for Intrauterine Devices, indicating that they confirm the safety profile for the IUD birth control.
Mirena IUD Migration and Perforation Concerns
Bayer currently faces thousands of Mirena IUD lawsuits filed in courts throughout the U.S., which allege that the birth control implant spontaneously punctured the uterus and moved out of position after it was implanted, resulting in severe and debilitating internal injuries.
In many cases involving Mirena IUD movement, women indicate that the injuries occurred years after the device was implanted. Bayer has defended the claims by arguing that the risk of Mirena migration is only seen shortly after implantation, suggesting that doctor error is to blame.
The study does not appear to address these concerns, because it only covered a 12-month period after the women surveyed were implanted.
Since 2000, more than 70,000 adverse events have been filed with the FDA involving Mirena IUD complications, including at least 5,000 cases involving women who indicated that Mirena moved out of place since 2008, and 1,322 reports where the Mirena IUD punctured the uterus.
In the federal court system, the Mirena cases are centralized as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge Cathy Seibel in the Southern District of New York to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.