Manufactured by Bayer Healthcare Pharmaceuticals, the Mirena IUD was approved by the FDA in 2000 as a contraceptive and later as treatment for heavy bleeding after childbirth. The device is used by more than 2 million women in the U.S. and 15 million women worldwide. Although considered a safe form of birth control, the FDA has received thousands of reports from women claiming they have suffered serious complications from the device. Recent lawsuits allege that women who use the contraceptive are susceptible to the following risks:
- Perforation of the uterine or cervix wall
- Embedment in vaginal tissue
- Pelvic inflammatory disease
- Ovarian Cysts
- Migration out of the uterus which can result in infection or other injuries
Of the nearly 3 dozen lawsuits filed, the primary allegation is perforation of surrounding tissue. According to the lawsuits, Bayer Healthcare Pharmaceuticals knew or should have known about the risks and neglected to provide adequate warnings to the medical community. Plaintiffs allege that the company withheld information about the risks and made false and deceptive representations concerning the safety of the device. Although the FDA has not yet recommended a recall of the Mirena IUD, it appears likely that the manufacturer will be required to alter the warning label to include more comprehensive information about potential risks.
Click here to access the FDA’s description of the Mirena IUD, including side affects and risks.