NewsInferno; April 8, 2013
In response to scores of lawsuits brought over Bayer Healthcare Pharmaceuticals, Inc.’s Mirena® intrauterine device (IUD), a mass tort is likely over allegations the device migrates after insertion, embedding in the uterus or puncturing organs.
The injuries, noted Lawyers USA Online, require surgical removal of the Mirena® and may also lead to other serious injuries and infections. Some 75 cases have been filed in New Jersey state court; 50 other cases have been filed in federal courts nationwide. Plaintiffs attorneys believe this number will continue to rise, especially given that about 2 million women use the Mirena® worldwide.
Bayer’s Mirena® IUD, a small, t-shaped plastic device attached to two strings, was approved by the U.S. Food and Drug Administration (FDA) in 2000. The hormonal IUD releases levonorgestrel when placed in the uterus to prevent pregnancy; Mirena® is both inserted and removed by a healthcare professional and may be left in the uterus for up to five years. According to the agency, the most serious side effects associated with the Mirena® IUD include:
- Perforation of the uterine wall
- Embedment of the device in the uterine wall
- Intrauterine pregnancy
- Ectopic pregnancy
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
In 2009, Bayer was reprimanded by the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) for overstating the benefits—and neglecting to mention the risks—of Mirena® in the company’s “Simple Style” program.
To read the complete article, please click here: