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FDA Announces Update to Mirena IUD's Warning Label

On September 13, 2013, the FDA announced an update to the Mirena IUD's warning label. Specifically, the strengthened warning now states "an interim analysis from a large postmarketing safety study shows an increased risk of perforation in lactating women . ."  Prior to this change, the warning stated only that there "may be an increased risk in lactating women. ."

As of July 2013, more than 100 women filed cases against the manufacturer of the Mirena device, Bayer.  These cases have been consolidated under U.S. District Court Judge Cathy Seibel in the Southern District of New York.  In addition, nearly 175 cases have been filed in New Jersey, which have been consolidated under Judge Brian R. Martinotti in Bergen County.

Faraci Lange is currently investigating potential claims related to the migration of Mirena IUDs outside the uterus.  If you have experienced migration of a Mirena IUD and required surgery to have it removed, please contact Hadley Matarazzo at (585) 325-5150 or email her at hmatarrazo@faraci.com for a free legal consultation.