History of the Mirena IUD
The U.S. Food and Drug Administration (FDA) approved Bayer’s Mirena IUD as an implantable birth control device in 2000, and in 2009, the agency expanded Mirena’s approval to include treating heavy menstrual bleeding in women already using an intrauterine device. Although Bayer claims that device migration is a rare occurrence with Mirena use, a study published by the Department of Radiology at the Ronald Reagan UCLA Medical Center indicates that migration of Mirena to other parts of the body is actually a “frequently encountered complication.” In fact, there have been more than 45,000 adverse event reports submitted to the FDA in connection with the Mirena IUD, including device migration, device expulsion and vaginal hemorrhage.
Mirena IUD Complications
- Pseudotumor Cerebri (Intracranial Hypertension)
- Migration of the device to other parts of the body
- Intrauterine pregnancy
- Ectopic pregnancy
- Embedment of the device in the uterine wall
- Perforation of the uterus, cervix or other organs
- Chronic abdominal pain
- Damage to internal organs
- Spontaneous expulsion of the device from the body
- Pelvic inflammatory disease
What is the Mirena IUD?
Mirena IUD is a T-shaped birth control device made from polyethylene plastic that is implanted into the uterus and designed to slowly release the progestin hormone levonorgestrel directly into the uterus over a long period time. Mirena is marketed as 99% effective in preventing pregnancy for up to five years, at which point the device must be replaced, and while the exact way in which the implant works remains unknown, Mirena may work by altering the wall of the uterus, thickening the mucus on the cervical wall to prevent sperm from entering the uterus, and inhibiting the survival of sperm. After five years, Mirena is removed from the uterus and another IUD can be implanted if the woman wants to continue to prevent pregnancy.
Why Are Lawsuits Being Filed?
Past lawsuits claim:
- Bayer Pharmaceuticals designed a defective and unreasonably dangerous product.
- The manufacturer failed to warn the public about the potential risks associated with Mirena IUD.
- Bayer knew about the potential side effects of Mirena, yet released the defective product anyway.
- Bayer willfully endangered the safety of women using the birth control device.
- The manufacturer engaged in misleading advertising.
- Bayer misrepresented the benefits of Mirena, and downplayed its side effects.
- Bayer understated Mirena IUD complications, calling them “uncommon.”
Mirena IUD Lawsuit Information
Women who have experience serious side effects while using Mirena IUD have filed product liability lawsuits against Bayer Pharmaceuticals, claiming that the device manufacturing company failed to properly warn the public about the potential for Mirena to cause debilitating medical problems in women. In one case, a woman brought a complaint against Bayer after her Mirena IUD implant perforated her uterus and traveled into her abdominal cavity. She required surgery to remove the device, and became pregnant soon after the implant was retrieved from near her liver. Unfortunately, she subsequently experienced vaginal bleeding and a miscarriage, and may now be infertile as a result of her alleged Mirena side effects.
As more and more consumers become aware of the potential for Mirena IUD to cause devastating side effects in users, additional product liability complaints are expected to be brought against the medical device maker in the coming months and years. If you believe you have been harmed by alleged side effects of Mirena IUD, contact a knowledgeable product liability lawyer as soon as possible to discuss your possible compensation options.