Mirena injuries can be extremely painful, and may impact the lives of victims and their families for years or more. Mirena's complications may include uterine perforation, pelvic inflammatory disease, ovarian cysts, irregular bleeding, and amenorrhea. Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility can even be put at risk.
The Mirena IUD was originally approved as an intrauterine contraceptive, and later as a treatment for heavy menstrual bleeding in women who gave birth. It works by slowly releasing the chemical progestogen levonorgestrel into the uterus. Mirena is indicated for intrauterine contraception for up to 5 years. At that point, the system should be replaced if continued contraception is desired. Mirena is only recommended for women who have had at least one child.
Bayer has marketed Mirena as a way "busy moms" can simplify their lifestyle. One of the ways it did so was through "Mirena Parties." Working with the social networking site Mom Central, Bayer had created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. The program was presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner. The script followed by the nurse practitioner at one of these Mirena Parties included phrases like "look and feel great", "simple ways to reconnect with ourselves and our partners," and "more likely to be more intimate.
According to an FDA Warning letter issued to Bayer in December 2009, the claims made in the script "clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena.
The letter went on to say that the FDA was "not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great." The agency also said the script omitted certain information regarding the risks of using Mirena, and minimized risks by utilizing the statement look and feel great." Finally, the FDA faulted the script for including a statement that Mirena “has no daily, weekly, or monthly routines to comply with," which the agency said was false.
Bayer stopped holding Mirena Parties in early 2009. But because of such misleading information presented at these events, many women who chose Mirena for its purported convenience may not have been aware of its many serious side effects.
Mirena Side Effects
Since its approval, serious Mirena side effects have included ectopic pregnancy, intrauterine pregnancy (a pregnancy in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.
- Breast Cancer
- Endometrial Cancer
- Uterine Cancer
- Ovarian Cancer
- Thyroid Cancer
- Colon Cancer
- Gastric Cancer
- Cervix Cancer
- Prostate Cancer
- Pre-Cancerous Cells
- Rectal Cancer
- Anal Cancer
- Bladder Cancer
- Birth Defects
If you or a loved one suffered from a uterine perforation, ectopic pregnancy, infection or other serious complication that might be tied to Mirena, please contact Daniel P. Kondos today. Attorneys are available by phone, e-mail, or by clicking here.