This past spring, the vaginal contraceptive ring NuvaRing followed in the footsteps of Yaz, Depo-Provera and Ortho Evra to become the next big thing in birth control lawsuits. Less than six months later, NuvaRing is losing the spotlight to the popular intrauterine device (IUD) Mirena.
At least 16 lawsuits were filed in the Superior Court of New Jersey by women suffering from perforation and similar Mirena injuries. The alleged Mirena injuries listed in the complaint are different than the side effects of NuvaRing or Yaz. The side effects of Mirena surrounding the litigation involve spontaneous migration of the IUD.
Mirena is a small T-shaped plastic device that measures 32 mm by 32 mm. A reservoir containing synthetic hormone levonorgestrel (LNG) surrounds the vertical stem of the device. The LNG is released at a rate of 20 micrograms per day and declines to a rate of 14 micrograms after 5 years, which is still within the range of clinical effectiveness. The LNG is released directly into the uterus. Most of the hormone stays inside the uterus. Only a small amount gets absorbed into the rest of the body.
Attached to a loop at the end of the device is a monofilament brown polyethylene removal thread. The thread allows physicians and patients to check and make sure the IUD is still in place. This thread also allows easy removal of the IUD.
Mirena was approved by the Food and Drug Administration (FDA) in 2000 for contraceptive use. It was later approved for the treatment of heavy menstrual bleeding in 2009. Mirena was permitted to remain in the body for up to five years.
The FDA considers Mirena a drug, as opposed to a medical device because it releases the LNG. Mirena is actually the only hormonal IUD currently on the market. More than two million women across the United States are using Mirena.
There is no daily or monthly regimen, like the pill or the ri ng, required for the device to be effective. However, it is recommended that the thread be used once a month to check its position in the uterus. An annual visit with a gynecologist is also recommended.
Unlike the NuvaRing, IUDs like Mirena can not be self inserted. Mirena must be inserted at a physician’s office and must be removed by a physician. The insertion procedure usually takes less than five minutes.
The U.S. Food and Drug Administration (FDA) received 108,884 reports of 3,124 types of adverse event reports associated with Mirena injuries. Some of the most common reactions include perforation, device expulsion, hemorrhage, pregnancy with contraceptive device and abdominal pain.
Abdominal pain and bleeding may be symptoms of a more serious problem: Mirena Migration. Other symptoms of Mirena migration include:
•pelvic pain •recurrent urinary tract infections •spotting or bleeding •blood in the urine •irritation while going to the bathroom
If the IUD migrates, it can perforate the uterus and cause damage to other abdominal organs including the bowel, liver, spleen or bladder. Often the user is not aware of her Mirena injuries until it is too late. This problem can worsen if an infection, abscess or scar tissue develops. Surgery is then required to remove the implant from the abdomen.
Mirena migration is at the heart of the Mirena lawsuits. Bayer warns that perforation of the uterus may occur during insertion. There is no mention of the risk of spontaneous migration or perforation after the insertion is successfully performed. However, perforation did occur for the plaintiffs as a result of Mirena migration.
As previously mentioned, perforation of the uterine wall or cervix may occur during insertion. While this is unfortunate, it is a warned risk that Bayer includes in Mirena’s package insert. However, if you experienced penetration or perforation after a successful insertion, you may be eligible to join in the Mirena litigation and file a Mirena lawsuit. Contact a Mirena Lawyer today for your free case evaluation.