FDA Receives Over 45,000 Adverse Event Reports Related to Mirena® IUD

FDA Receives Over 45,000 Adverse Event Reports Related o Mirena® IUDOverview: According to adverseevents.com, the U.S. Food and Drug Administration (FDA) has received over 45,000 reports of injuries and complications associated with the Mirena IUD over the course of 15 years. Mirena IUD is already the subject of a handful of lawsuits alleging that the device is defective and can lead to uterine wall perforation, device migration and other serious injuries.

  • The FDA has received 45,697 reports of injuries where Mirena IUD was the primary suspect cause
  • The most common complications where Mirena was the primary suspect cause include device expulsion, device dislocation and vaginal hemorrhage
  • There are a number of lawsuits alleging that Mirena can break through the wall of the uterus and move elsewhere

Product: Mirena® intrauterine device (IUD)

Manufacturer: Bayer, Inc.

Side Effects & Complications

  • Miscarriage
  • Infertility
  • Intrauterine pregnancy
  • Streptococcal sepsis
  • Pelvic inflammatory disease
  • Perforation of cervix or uterine wall

Over 45,000 Reports of Complications Linked to Mirena

The FDA received a total of 45,966 adverse event reports associated with Mirena IUD between November 1, 1997 and June 30, 2012. According to data gathered by adverseevents.com, Mirena was the primary suspect cause in 45,697 of these reports. Among these cases, the most common complaints included device expulsion, device dislocation and vaginal hemorrhage. The average age of Mirena patients who reported adverse events was 31 years, and were treated an average of 246 days.

Mirena IUD Side Effects Lawsuits

Reports suggest that Mirena can lead to uterine perforation, where the IUD pushes through the wall of the uterus and becomes embedded elsewhere. When this occurs, users will often require surgery in order to remove the device. Parker Waichman, a national personal injury law firm, has filed a number of such lawsuits on behalf of women who allege injuries from the device. One Plaintiff was an Indiana woman who underwent operative laparoscopy in order to remove the IUD when it migrated and become lodged in her abdominal wall.

There are at least 16 Mirena personal injury lawsuits pending against Bayer in New Jersey.