Drug Lawsuit Home

The Mirena Drug Lawsuit

The Mirena intrauterine device (IUD) is a birth control device containing levonorgestrel. It is inserted in the uterus, allowing for a gradual release of the hormone to reduce the chance of pregnancy for up to five years. Although Mirena is very popular, with millions of women using it each year, the FDA has received thousands of reports from women who have had trouble with the device, including uterus perforation, embedment into the uterine wall, and pelvic inflammation.

Articles related to Mirena

Tags related to Mirena

What is Mirena?

Mirena is small, flexible, t-shaped, plastic, intrauterine contraceptive device which is secured in the uterus by a trained healthcare profession. After insertion of the device, the hormone levonorgestrel is released (progestin birth control hormone). This hormone changes the lining in the woman’s uterus and cervix, decreasing the likelihood that the male’s sperm will reach the uterus or that an egg, which has been fertilized, will connect to the uterine wall. The device can effectively lower the risk of pregnancy for up to five years.

What is Mirena used for?

Mirena is an intrauterine contraception device specifically used to reduce the risk of pregnancy in women. It can also be used by women who have heavy menstrual bleeding.

  • Reduces the risk of pregnancy
  • May reduce the severity of cramps
  • May relieve endometriosis
  • Reduces heavy menstrual bleeding by an average of 90% after the first few months of use
  • May reduce risk of endometrial hyperplasia
  • May reduce the risk of endometrial cancer

Mirena Usage and Statistics

Mirena is a very popular, long-term, contraceptive device. Manufactured by Bayer Pharmaceuticals, it is estimated that more than fifteen million women in the world use it, including more than two million women in the United States. Approved for use in 2000, it is one of only two intrauterine devices currently in use. In 2009 Mirena was also approved for heavy menstrual bleeding by the Federal Drug Administration (FDA). Mirena has become popular because women can have safe birth control without the hassle of taking a pill each day. Given that the failure of oral contraception can be as high as 30% because women may not consistently take their medication, Mirena is seen as a viable option for many women with a 99% efficiency rating of controlling pregnancy for up to five years. The Mirena IUD device is quickly becoming one of the most popular forms of birth control worldwide. Not only is it easy to use, it is relatively inexpensive costing an estimated $800. Bayer Pharmaceuticals especially recommends the device for women who have already had a child. Unfortunately, like all medications and most medical devices, the Mirena IUD is not without risks. In fact, there have been reports that the device may relocate within the body and move to the abdomen or uterine wall. Other women report they have experienced severe health issues such as perforation of the uterus, pelvic inflammatory disease, and ectopic pregnancy from the use of this product.

How Mirena Works

An IUD is an intrauterine device placed in the uterus to prevent pregnancy. The popularity of the IUD is growing due to its effectiveness, ease of use, and low cost. There are two different types of IUDs available: hormonal (Mirena and Skyla) or copper (ParaGuard). Mirena is not an abortifacient. Rather than destroying the egg after fertilization, it interferes with the sperm’s ability to fertilize the egg and creates barriers so the sperm cannot reach the egg. To accomplish this task, Mirena releases a synthetic hormone, progestogen, constantly in small amounts over a period of five years.

Side Effects of Mirena

  • Missed periods
  • Heavy bleeding after insertion
  • Pelvic pain
  • Abdominal pain
  • Pain in the back
  • Headaches
  • Migraines
  • Nervousness
  • Weight gain
  • Dizziness
  • Nausea
  • Vomiting
  • Bloating
  • Breast tenderness
  • Changes in hair growth
  • Depression
  • Moodiness
  • Lack of interest in sex
  • Skin rashes
  • Itching
  • Puffy hands, ankles and feet

Mirena Medical Studies

Recent medical studies indicate that IUDs are not abortifacients, and they can be highly effective and long-lasting pregnancy reduction solutions. Medical experts also contend that IUDs can be safely used by most women, and given new recent advancements, fewer women have had to have them removed due to pain or bleeding. Despite numerous studies, however, there still seems to be some controversy about whether or not IUD use is connected to an increased risk of pelvic inflammatory disease (PID), ectopic pregnancy, or subsequent infertility. Questions also remain about whether the inserter’s skill affects performance, whether there should be a push to remove IUDs in women as they age, and whether older, less effective IUD devices should be replaced with newer, more effective models.

Mirena Black Box Warnings

  • The Black Box Warning is a warning the FDA requires on certain medications. These warnings may be required either on the packaging or the patient instruction sheet if the FDA has decided the public needs to be made aware of serious or life-threatening risks associated with the drug. The Black Box Warning is the most stringent warning required by the FDA. In addition to the warnings listed below, the FDA recommends removal if a woman has endometritis, pelvic infection, is nursing or has another drug interaction.
  • Ectopic pregnancy
  • Sepsis
  • Perforation
  • Ovarian Cysts
  • Breast Cancer
  • Increased risk of pelvic infections

Articles related to Mirena

Tags related to Mirena