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New Mirena IUD Complications Lawsuits Allegations Report: Resource4thePeople Reports Important Multidistrict Litigation Hearing Scheduled
Date:6/22/2013

the huge problem of Adverse Event Reports received by the FDA that both women and health care professionals have raised concerns about the safety of the Mirena IUD both in its use as a contraceptive and to treat menstrual bleeding," said Resource4thePeople.

"Our national team of lawyers is now reviewing claims that the use of the Mirena IUD allegedly led to medical conditions including ectopic pregnancy, infertility, perforation of the uterine wall, cervix and pelvic organs, embedment of the device in the uterine wall or other organs, migration of the IUD, infertility, pelvic inflammatory disease and serious infections that may have required surgical removal of the device."

Resource4the People notes that although the device's manufacturer, Bayer Pharmaceuticals, has marketed the device as a safe, convenient alternative to birth control pills and other contraceptives the FDA raised objections to that marketing plan and reacted against the campaign.

The FDA issued a warning letter***** to Bayer officials in 2010 in which FDA regulators objected to the marketing campaign, admonished Bayer and told the company that it was downplaying the health risks of the Mirena IUD while overstating its benefits.

"The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena," the FDA said. "Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act."

In addition to the FDA's warning letter over marketing concerns, the agency also, in response to the increased number of Adverse Event Reports that it said it was receiving, directed Bayer to change the side effects warning on the Mirena IUD information labels warning patients of additional side effects.******

Among the side effects affected by this new warning label language are serious health p
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