The risk of Pelvic Inflammatory Disease (PID) is one of the most serious side effects of the Mirena IUD. Although it is estimated to occur in less than 1% of women with the Mirena, complications of PID may include permanent infertility, chronic pelvic pain, and a life-threatening infection. Women may also require a hysterectomy to remove their uterus if PID occurs. Bayer is now facing lawsuits from dozens of women who have been seriously injured by the Mirena IUD.
The Mirena IUD (intra-uterine device) is an implantable contraceptive created by Bayer. It was approved in 2000 by the U.S. Food and Drug Administration (FDA) to reduce the risk of pregnancy. It is also approved to reduce heavy menstrual periods.
Mirena is a T-shaped piece of flexible plastic that is implanted in a woman’s uterus. It slowly releases levonorgestrel, a type of synthetic hormone that mimics progesterone and makes several changes to the uterus which decrease the likelihood of pregnancy. Mirena is more than 99% effective at preventing pregnancy for up to five years.
Mirena and Pelvic Inflammatory Disease (PID)
Women who use Mirena have an increased risk of Pelvic Inflammatory Disease (PID). Studies indicate this risk affects less than 1% of women who use Mirena.
Pelvic Inflammatory Disease (PID) is an infection that occurs when bacteria move beyond the vagina and cervix and infect the uterus, fallopian tubes, and reproductive organs. PID is most often caused by chlamydia and gonorrhea, which are sexually transmitted bacteria.
The risk of PID is greatest for women who have had PID in the past, have a current bacterial infection, get infections frequently, have intercourse with multiple partners, or have intercourse with one partner who has multiple partners. Even women who have none of these risk factors can get PID with Mirena. The risk is highest in the first 20 days after the device is implanted.
Complications of PID can be severe, and include death. These complications include infertility, ectopic pregnancy, chronic pain, and more. In some cases, a hysterectomy (surgical removal of the uterus) may be necessary to treat PID. The infection can be very severe and cause death.
Mirena PID Symptoms
Pelvic Inflammatory Disease (PID) may present the following symptoms:
- Pain (which may be located in the pelvis, abdomen, lower back)
- Unusual vaginal discharge
- Vaginal bleeding after sexual intercourse
- Urination that is more frequent and/or painful than usual
- Menstrual cramps that are worse than usual
- Nausea, vomiting
- And more
Women who have the Mirena IUD and experience these symptoms should seek emergency medical attention.
Mirena and FDA Warning Letter
Bayer received a warning letter from the U.S. Food and Drug Administration (FDA) in December 2009 regarding “misleading” promotional material for Mirena. According to the FDA,
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act.”
Bayer was marketing Mirena with Mom Central, a social networking website. They created several promotional videos showing members of the Mom Central community learning about Mirena from a nurse. Mirena was advertised toward “busy moms” who might feel more spontaneous about sexual intercourse. According to the FDA, this implication is misleading and broadens the approved indications for Mirena. Furthermore, studies have shown that a common side effect of Mirena is decreased libido. Mirena has also been linked to life-threatening infections, infertility, and more.
Mirena Side Effects
Dozens of lawsuits have already been filed against Bayer by women who suffered from the serious side effects of Mirena. These side effects may include:
- Migration of the device in the uterus
- Perforation of the uterus
- Perforation of the intestines
- Intestinal obstruction
- Abdominal pain
- Pelvic Inflammatory Disease (PID)
- Ectopic pregnancy
- And more