The intra-uterine device produced and marketed under the brand name Mirena by Bayer Pharmaceutical Company received approval by the FDA in 2000. I was designed to be inserted vaginally by a physician into the uterus as a contraceptive device. Hormones released by the IUD would cause a thickening of mucous on the walls of the uterus to prevent the traveling of sperm, thus decreasing its chance of survival. The simplicity and reliability of the device as a means to prevent pregnancy in women who had already given birth made it extremely popular. Since getting the nod from the FDA, thousands of reports of adverse effects from users have surfaced. These reports varied greatly in severity from headaches and abdominal pain to migration of the device causing uterine perforation and damage to other internal organs. In cases of migration one or more surgeries were required to remove the IUD. Other reported adverse effects have been potentially fatal ectopic pregnancy and pelvic inflammatory disease.
Lawsuits Are Piling Up Nationwide
Thousands of women who have suffered from the adverse effects have filed lawsuits seeking compensation from Bayer Pharmaceuticals for the medical bills along with pain and suffering. So great are the numbers in federal courts that many of the cases have been consolidated into multi-district litigation in two regions with sample cases selected to test the waters and encourage out of court settlements. The intention is to get an idea of jury’s reaction to these cases and reduce the potential of a traffic jam in the courts. Most of the suits filed allege that Bayer was aware of the potential for harm and did not adequately warn the users and their physicians. In addition, Bayer stated that the “Simple Style” marketing program which claimed to make the user “look and feel great” disregarded the increased chances of miscarriage occurring, should the user become pregnant along with the possibility of infection.
Today, suits are filed across the country in federal and state courts on behalf of thousands of women, by experienced defective drug attorneys making the following claims including, but not limited to:
- Failure to provide warnings regarding the detrimental effects of Mirena that include spontaneous migration occurring anywhere from a few weeks up to the Mirena usage limit of five years after insertion.
- Deceptive and misleading advertisement
- Hiding the adverse side effects of the product
- Production and promotion of a product that was known as being defective
- Falsely and deceptively claiming benefits
The Risks of Side Effects
Any woman who has had the Mirena IUD inserted is at a risk of suffering a wide range of adverse side effects, some of which are painful, physically damaging and require surgery. In some cases there is even a chance of infertility. Any signs like abnormal bleeding, abdominal pain or discomfort should be reported to a physician immediately. Ignoring these signs could lead to uterine perforation, infection or damage to the liver, bowels or spleen.
Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765
(833) 606-DRUG