FDA Received Nearly 50,000 Reports of Mirena Side Effects

Bayer AG’s Mirena, the T-shaped device that releases progestin to thicken cervical mucus and avoid pregnancy, was supposed to be revolutionary and give women five-year protection from conceiving a child. However, nearly 50,000 reports of serious Mirena side effects have already been reported to the U.S. Food & Drug Administration (FDA).

Shocking Mirena IUD Statistics

According to Adverse Events, an independent company that reports on FDA information, 47,812 adverse events related to Mirena use were reported from November 1997 to August 2012. Mirena IUD injury statistics during that time are shocking:

  • 50 deaths have been associated with the device
  • 36% of adverse events involved expulsion of the device – which can cause pregnancy
  • 10% of adverse events related to migration of the IUD
  • 8% of adverse events involved vaginal bleeding
  • 6% of adverse events required hospitalization

Although it is estimated that ten million women use Bayer AG’s Mirena IUD, neither the FDA nor the manufacturer has recalled the product to prevent women from experiencing very serious – and sometimes life-threatening – injuries, such as:

  • Abscesses
  • Ectopic pregnancy
  • Infection
  • Infertility
  • Ovarian cysts
  • Perforation of the uterus
  • Peritonitis

These Mirena side effects have resulted in hundreds of Mirena injury lawsuits filed against Bayer alleging that the company failed to warn consumers adequately about the risks associated with the device – many of which can result in the need for numerous revision surgeries.

Some Mirena Injury Lawsuits Consolidated

Some of the federal Mirena injury lawsuits have been consolidated in multidistrict litigation (MDL) in the Southern District Court of New York under U.S. District Judge Cathy Seibel, and others are pending in New Jersey state courts.

If you’ve been injured by Mirena, contact The Driscoll Firm, LLC, to discuss your situation, find out more about the ongoing litigation against Bayer and how your potential claim might be affected. You may be entitled to compensation from the company and/or its distributors for pain and suffering, medical bills and loss of income due to Mirena injuries.

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