Defective Medical Device
Mirena® is an IUD (intra-uterine device) made by Bayer and approved by the FDA in 2000. Mirena® is a long-term contraceptive (birth control) device that is inserted into the uterus by a doctor. Mirena® is designed to prevent pregnancy in two ways: it releases a progestin known as levonorgestrel which prevents the woman’s ovaries from releasing eggs and, if an egg still happens to be released, Mirena is designed to disrupt the joining of the sperm and egg.
Mirena® is the only hormonal IUD that has Food and Drug Administration (FDA) approval. Mirena® prevents pregnancy for up to five years after insertion.
Serious adverse side effects and potentially life-threatening complications have been reported following the implantation of this device. These complications include organ perforation, migration of the IUD to outside the uterus, expulsion of the IUD, and embedment in the uterus, among others.
Complaint records from the Food and Drug Administration, show there have been 70,072 complaints about the Mirena® IUD since 2000.
Many complaints involve serious complications. Since 2008, 4,775 women reported “device dislocation.” This may refer to the IUD becoming embedded in the uterus, moving from its initial placement at the top of the uterine cavity, or an IUD that has migrated outside the uterus, according to an FDA spokesperson.
The complaint reports also show 1,322 women have reported uterine perforations since 2008.
Other, more common side effects, include uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation, pelvic pain, and breast tenderness.
Pharmaceutical companies have a responsibility to adequately warn people of the dangers associated with their drugs or devices. Women who have or have had a Mirena® IUD and experienced complications need to to talk with an experienced medical device Lawyer of McDivitt Law Firm for a free consultation. Call us toll-free at (877) 846-4878 or click here for a free and confidential consultation.