Are there any outstanding warnings by the FDA regarding Mirena?

Yes. Although the Mirena IUD was approved by the FDA in 2000 for use in women seeking an alternative method of contraception.

  • In 2008, the FDA issued changes to the warning label to include warnings regarding perforation, embedment, intrauterine pregnancies, expulsions, breast cancer and ovarian cysts.
  • In 2009, the FDA issued a warning letter to Bayer pertaining to their lack of evidence amid claims that Mirena did not provide consumers with the quality of life the manufacturer had promised in their marketing materials. The FDA claimed that their ads were irrelevant, issued false claims and led consumers astray by distracting background music and photos.
  • In 2012, the FDA reportedly received over 45,000 complaints between its introduction and June 2012. Women most commonly reported device dislocation, device expulsion and excessive vaginal bleeding.
  • In 2013, the FDA increased the number of complications to over 70,000.

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