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FDA Has 70,000 Complaints About Mirena IUD Complications


August 27, 2013 — Since 2000, the U.S. Food and Drug Administration (FDA) has received 70,072 complaints about the Mirena IUD, according to a report by 7 Action News. Most of the complaints involve non-life-threatening complications like acne, headaches, and back pain. However, nearly 5,000 women have reported “device dislocation,” which may refer to erosion, embedment, or uterine perforation.

Mirena adverse event reports since 2008:

  • 4,775 reports of device dislocation (migration, embedment, erosion, etc.)
  • 3,774 reports of abdominal pain
  • 1,322 reports of uterine perforation (may include migration outside the uterus)

Mirena is an intrauterine device (IUD) — a T-shaped birth control device that is implanted in a woman’s uterus, where it slowly releases hormones that help prevent pregnancy for up to five years. Over 2 million American women have been implanted with Mirena since it was approved in 2000.

Unfortunately, Bayer HealthCare is facing over 220 Mirena lawsuits from women who allege that Bayer failed to warn about the risk of spontaneous uterine perforations. The risk information for Mirena currently only warns about uterine perforation during the implantation procedure.

Many healthcare providers are not aware of the risk of spontaneous uterine perforations, causing patients to go undiagnosed for months or years. Physical complications can include scarring, liver laceration, nerve damage, appendectomy, hysterectomy, permanent infertility, and more.

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