A woman in the United States has issued legal proceedings against 2 companies Bayer Corporation and Berlex Laboratories claiming that she has been left permanently disabled due to defects with the Mirena Intra-Uterine Device (IUD).
The companies are responsible for the distribution and manufacturing of the Mirena IUD. The lawsuit claims that when the Plaintiff was to have the Mirena surgically removed, it had moved from where it was supposed to be and that it had injured her. The Mirena is a contraceptive device and more than 15 million women in the US have received the device during a surgery since it was first approved in 2000.
The woman claims that she was implanted with the device in March 2009 and that about 18 months later she was to have a surgery to have it removed but that when an ultrasound was performed to locate the device it was not where it was implanted near the uterus. The device had migrated to the left abdominal wall and required a laparascopy to remove it 6 days after the original surgery.
The Plaintiff claimed that the manufacturer of the device did not specifically warn her that the device could migrate. The only reference to device migration made in warning labels and safety information indicated that the side effect was possible when the uterus was perforated during the surgery to implant it.
Currently 2 million women in the US use the Contraceptive Device. It delivers the synthetic progestin, levonorgestrel directly to the uterus. It is implanted a week before menstruation and can stay in the body for up to 5 years. The Device is supposed to thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy. In addition to potential migration of the device, the Mirena device has also been linked to several other serious side effects such as pelvic inflammatory disease, ovarian cysts, irregular bleeding and a condition known as Amenorrhea.
It is claimed that the device can also cause weight gain, acne and breast tenderness. To get the device fitted in Ireland can cost up to €500 to include the cost of the implantation itself. It has been implanted into thousands of women in Ireland.