Mirena IUD contraceptive devices have been found to cause a rare condition known as pseudotumor cerebri (PTC), or a “false brain tumor” in a number of women implanted with the device.
This condition causes the buildup of fluid on the brain, which, in turn, leads to pressure causing intensely painful headaches, vision problems, dizziness and ringing or whooshing in the ears. In many cases, PTC is a permanent condition requiring expensive lifelong medical treatment. If the condition is not diagnosed and treated quickly, PTC can lead to serious brain surgery, placement of brain shunts (to stop fluid accumulation on the brain) and/or permanent blindness.
Further allegations state that Bayer had a history of overstating the benefits of Mirena and understating its potential complications. The makers of this device failed to properly test for adverse results, and failed to warn doctors and patients of the increased risk of PTC.
Mirena IUD Lawsuit History
FDA approved Mirena for intrauterine contraception. The device is used by ~2 million women in the US, alone.
The patient information booklet put out by the FDA warns of side effects, including PID (pelvic inflammatory disease), expulsion, and life-threatening infections.
The Department of Health and Human Services’ Division of Drug and Marketing, Advertising and Communications (DDMAC) found that claims made by Bayer’s “Simple Style Program”, which marketed to busy moms, were unsubstantiated, noting that the program failed to mention side effects.
New cases allege that the Mirena IUD can migrate and perforate the uterine wall. In New York and New Jersey, lawsuits filed federally were consolidated.
Cases involving PTC were consolidated in federal court in New York.
The federal judge in charge of the Multi-District Litigation dismisses all pending cases, as he finds the causation link between Mirena and PTC to be insufficiently supported by existing scientific studies.
Mirena cases appealed to the Second Circuit Court of Appeals. All those impacted by Mirena await the appellate process to conclude.
What are the side effects of PTC?
Side effects of PTC (pseudotumor cerebri) include, but are not limited to:
- Blurred vision
- Ringing ears
- Severe headaches or swelling of the optic nerves
What are the side effects of Mirena?
According to the FDA, Mirena has also been associated with a number of serious side effects, such as:
- Perforation of the uterine wall or cervix
- Embedment of the device in the uterine wall
- Migration of the device
Others have reported the following symptoms after using the Mirena IUD:
- Ovarian cysts
- Ectopic pregnancy
- Cervical or endometrial cancer
- Cervical or uterine perforation
- Endometritis, or inflammation of the endometrium
- Pelvic infection
- Pelvic inflammatory disease
- Significant elevation of blood pressure