CEDAR RAPIDS, Iowa (CN) - More than 1,500 lawsuits have been filed against Bayer Healthcare for its Mirena intrauterine device, which allegedly "migrates" after insertion, but until last week few if any of them claimed that it migrated from the uterus to the rectum.
Jennifer Martin claims in Federal Court that she went to a specialist to have an IUD inserted in July 2012, then received a positive pregnancy test in September.
The ultrasound "did not show an IUD in the uterus or pelvis," she says in the complaint. She miscarried soon after.
A month later, Martin underwent surgery to locate the IUD. Her doctor "performed an extensive search," which included the liver, spleen and stomach, with "no success," the complaint states. The doctor finally found and removed the IUD after a rectal exam.
The Courthouse News database contains more than 1,500 Mirena-related lawsuits.
According to the drugwatch.com website, there have been more than 45,000 "adverse events" reported since the U.S. FDA approved the device in 2000.
In 2009, the FDA issued a warning letter demanding that Bayer stop disseminating misleading advertising about Mirena, downplaying risks and making unsubstantiated promises, such as that Mirena would improve a woman's sex life and appearance.
Women have complained that the device perforated their uterus, migrated, caused pelvic pain, bleeding, miscarriages and infertility.
Two million women in the United States still use the device, according to the lawsuit.
Martin seeks punitive damages for defective manufacturing, defective design, failure to warn, negligence, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation and fraud by concealment.Her lead counsel is Ann Brown-Graff, with Brady, Preston & Brown, of Cedar Rapids.
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