The Mirena Intruterine Device (IUD) is a brand of birth control manufactured by Bayer Healthcare Pharmaceuticals. It has been in use since 2000 and is a reversible method that can be used without action by the user for up to five years. The t-shaped device is inserted into the uterus by a doctor and releases synthetic hormones that make the cervix and uterus an unwelcoming environment for a fertilized egg. The hormones released by Mirena are in lower doses than those contained in birth control pills because it does not have to be digested – hormones are simply released directly into the uterus through the device. Millions of women have chosen Mirena as an effective form of birth control, which has a failure rate of only 1%. Unfortunately, many have experienced serious side effects while using the IUD. These complications range from mild discomfort and hormonal imbalances to serious issues, including ectopic pregnancies, and pelvic inflammatory disease. There are also numerous reports of Mirena perforating the cervix and uterine wall and in some cases, this perforation occurs during the insertion of the device. Unfortunately, the perforation might not be detected until later, after complications have begun. Perforation can result in adhesions, intestinal perforations and obstruction, abscesses, and migration of the device. Studies have also shown perforation is more likely when Mirena is inserted too soon after a pregnancy (including aborted pregnancies). Women are encouraged to wait at least six weeks and possibly 12 weeks after pregnancy, when their uterus has returned to “normal,” to use Mirena.
One of the most serious concerns that come as a result of perforation is that the Mirena device can migrate from its original position. The device’s t-shape includes pieces that are sharp, relative to soft organ tissues. When it shifts inside of the uterus, it can puncture the delicate tissue of the uterine wall and move into other parts of the body. At the time of Mirena removal, sometimes in emergency situations, the devices have been found in the abdominal cavity, the pelvis, and the bladder. There are even reports of Mirena traveling into blood vessels. In addition to making users squeamish, migration presents serious health dangers. It can trigger infection, become embedded in other areas of the body, and cause intense pain, bleeding, and organ damage. Surgery is sometimes needed to find and remove the device, and to repair any damage it caused. Some women are unaware their device has migrated until they go to their doctor for its removal. When it is discovered Mirena is not in place, x-rays are performed to locate it. Users must remember when the device is not in place, it is not functioning properly and it is possible to conceive.
The FDA Takes Action Regarding Mirena
The US Food and Drug Administration is fully aware of the problems with Bayer Heathcare’s birth control device. Right from the start, Mirena was under scrutiny because of the aggressive marketing campaign Bayer used to popularize the product. The FDA warned Bayer to ensure users understood the risks associated with the device and encouraged them to stop marketing the product as a glamour or beauty aid. Perforation, puncture, and migration are some of the most serious side effects associated with the device, but they are not the only ones. Mirena users are also at risk for ectopic pregnancies, bacterial infections in the ovaries, uterus, or fallopian tubes (pelvic inflammatory disease or PID), acne, nausea, vaginal discharge, breast tenderness, mood changes, weight gain, and abnormal vaginal bleeding or “spotting.” Some of these side effects are associated with other forms of hormone-driven birth control, such as the pill, but Mirena users often report the issues are more severe when using the IUD.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.