You may be eligible to file a lawsuit if your Mirena IUD caused a brain injury, such as Pseudotumor Cerebri (PTC) or Intracranial Hypertension (IH). The most common symptoms are headaches, vision loss, and blindness.
What is the problem?
Mirena is an implantable uterine contraceptive that has been linked to many serious side effects. Although these side effects are uncommon, they do occur, and they can be debilitating or even life-threatening. Many women who have suffered from these side effects have filed lawsuits alleging that Bayer did not adequately warn about these risks.
Brain Injuries Linked to Mirena
Levonorgestrel, the hormone in Mirena, may elevate levels of cerebrospinal fluid, which puts pressure on the brain. The most common symptom of a brain injury from Mirena is a headache that worsens. Over time, it can also damage the optic nerve and cause vision problems, double-vision, papilledema, and blindness. The condition is also known as:
Mirena and the First FDA Warning Letter
On March 29, 2009, the U.S. Food and Drug Administration (FDA) sent a Warning Letter to Bayer HealthCare Pharmaceuticals regarding online advertisements for Mirena. The FDA reviewed Bayer’s sponsored links on internet search engines, such as Google.com, and found that the ads were “misleading” because they “fail to communicate any risk information.”
The FDA was also concerned that the ads failed to convey that Mirena is only recommended for women who have had at least one child, which misleadingly suggests that Mirena is appropriate for any woman.
Mirena and the Second FDA Warning Letter
On December 30, 2009, the FDA sent another warning letter to Bayer regarding an advertising program for Mirena:
“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. ”
According to the FDA, promotional materials are misleading if they imply that the product is more effective than has been demonstrated in clinical trials.
Bayer partnered with Mom Central, a social networking website, and created videos featuring a nurse answering questions from members of the Mom Central community. The video recommended Mirena as a hassle-free contraceptive that was ideal for busy moms who could be “more likely to be intimate” and “feel better about approaching the romance in our lives.” The FDA said that these claims are misleading because they imply Mirena can increase levels of intimacy, romance, and emotional satisfaction.
Mirena Side Effects
One of the most common side effects of Mirena (experienced by 12% of women during clinical trials) is ovarian cysts, which are fluid-filled sacs or pockets within the ovaries. They are generally harmless, but can cause pain and may require surgical removal if they grow too large.
Common side effects of Mirena (experienced by 5-10% of women) include acne, headaches/migraines, depressed mood, and heavy or prolonged menstrual bleeding. Less than 5% of women may experience low libido, weight gain, nervousness, unusual hair growth or loss, high blood pressure, back pain, skin irritations, vaginal discharge, and more.
Some of the most serious complications of Mirena include:
- Brain injuries
- Pseudotumor Cerebri (PTC)
- Intracranial Hypertension (IH)
- 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
- Ovarian cysts that require surgery
- And more