Issue: Tearing of uterus and other complications
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Mirena is a small, t-shaped plastic intrauterine device (IUD) that releases a hormone into the uterus to prevent pregnancy. It is manufactured by Bayer Healthcare Pharmaceuticals.
The U.S. Food and Drug Administration (FDA) approved Mirena in 2000 as a contraceptive for women who have had at least one child. In 2009, the FDA approved Mirena to treat heavy menstrual bleeding in women who prefer intrauterine contraception as their method of birth control.
In the course of marketing Mirena, Bayer was warned by the FDA that its advertising omitted serious and frequent risks associated with Mirena, and misleadingly suggested that Mirena is safer than has been demonstrated.
Mirena Complications and Dangerous Mirena Side Effects
Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market. The most serious Mirena risks and side effects include:
- uterine perforation (the IUD tears through the cervix or the wall of the uterus),
- ectopic pregnancy (when the embryo implants outside the uterine cavity); and
- thrombosis (blood clots).
Uterine perforation is a serious injury many women have suffered. The Mirena IUD moved within their uterus, ripped through the cervix or wall of the uterus, and entered the abdominal cavity, sometimes years after the IUD was properly inserted.
The migration of Mirena outside the uterus can cause scar tissue or adhesions, infections, blockages, and perforations or other damage to other organs, as well as unwanted pregnancy. This occurrence always requires surgery to remove the IUD and in certain cases a hysterectomy (the removal of the uterus and other organs), resulting in the woman never being able to become pregnant in the future.
Women who have suffered serious Mirena complications and pain have charged that Bayer failed to disclose adequately to them and their physicians the risk of migration of the Mirena after insertion. The lawsuits also charge that the Mirena IUD poses serious side affects and is a defective and dangerous medical device. The warning label on Mirena only states that migration may occur if the uterus is perforated during the initial insertion. Bayer has not disclosed the danger of Mirena IUD tearing the uterus following its proper insertion.
When patients report symptoms associated with uterine perforation, the patients and their doctors have no reason to suspect that Mirena has torn into and perforated the uterus. As a result, there can be a delay in timely and appropriate medical care and leading to greater pain and suffering for the patient, emotional distress, the need to remove the Mirena IUD, and permanent physical injuries.
Mirena is a registered trademark of Bayer Healthcare Pharmaceuticals. The use of this trademark is solely for product identification and informational purposes. Bayer Healthcare Pharmaceuticals is not affiliated with this website, and Bayer Healthcare Pharmaceuticals has no affiliation with Lieff Cabraser Heimann & Bernstein, LLP. Nothing on this site has been authorized or approved by Bayer Healthcare Pharmaceuticals.