Pelvic Inflammatory Disease (PID) is a bacterial infection of a woman’s uterus, fallopian tubes, and reproductive organs. The infection can be life-threatening, cause permanent infertility, or require surgery to remove the uterus (hysterectomy). It is estimated that less than 1% of women who were implanted with Mirena develop PID, but the infection can cause severe injury. Bayer is now facing dozens of lawsuits from women who were injured by the Mirena IUD.
What is Mirena?
Mirena is a type of Intra-Uterine Device, or IUD, that reduces the chances of pregnancy for up to five years. Mirena also treats heavy menstrual periods. It is a small, T-shaped piece of plastic that is inserted into a woman’s uterus, where it releases the hormone levonorgestrel (synthetic version of the reproductive hormone progesterone). Mirena reduces the risk that sperm will enter the uterus, and also reduces the risk that an egg will implant and grow in the womb.
Mirena and Pelvic Inflammatory Disease
Mirena is associated with an increased risk of Pelvic Inflammatory Disease (PID). The percentage of women who develop PID while using Mirena is less than 1%.
Pelvic Inflammatory Disease (PID) is a bacterial infection of a woman’s uterus, fallopian tubes, and reproductive organs. It is usually caused by bacteria that are sexually transmitted, such as gonorrhea and chlamydia. PID occurs when these bacteria travel beyond the vagina and cervix and into the womb.
Mirena is contraindicated for women who have had PID in the past. The risk of PID is highest in the first 20 days after IUD insertion, for women who have multiple sex partners, or an infection at the time of insertion.
Potential complications of Mirena PID include infertility, ectopic pregnancy, constant pelvic pain, and more. In severe cases, surgery may be necessary to remove the uterus (hysterectomy), and rarely, the infection can cause death.
Mirena PID Symptoms
Symptoms of Pelvic Inflammatory Disease (PID) associated with Mirena may include:
- Fever (which may come and go)
- Pain in the pelvis, abdomen, lower back
- Vaginal discharge (unusual color, texture, smell)
- Bleeding after intercourse
- Frequent, painful urination
- Increased menstrual cramping
- And more
FDA Warning Letter for Mirena
In December 2009, the U.S. Food and Drug Administration (FDA) sent Bayer a warning letter about promotional material they used for Mirena. In the warning letter, the FDA wrote:
“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 worked with the social networking website Mom Central to produce a series of promotional videos. The videos promoted Mirena as ideal for “busy moms,” because it could help them feel more spontaneous about sexual intimacy. The FDA found that these advertisements were misleading. In fact, Mirena has been linked to decreased libido and severe risks (including infections and loss of fertility), which could permanently impair sexual intimacy or well-being.
Mirena Side Effects
Bayer is facing lawsuits from dozens of women who were injured by this device. Some of the most serious Mirena side effects 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