Mirena IUD Lawsuit: Intracranial Hypertension

About the Mirena IUD

Mirena is an intrauterine device (IUD) that is currently the most prescribed IUD in the US. It is estimated that over 2 million Mirena IUDs are implanted worldwide and the number is expected to continue growing. Mirena works by thickening the cervical mucus and thinning the uterine lining, making it nearly impossible for sperm to reach an unfertilized egg, or for a fertilized egg to implant in the uterus. Once Mirena is placed into the uterus, the synthetic hormone levonorgestrel is released into the uterus to provide continuous birth control for up to 5 years. Because the body is receiving synthetic hormones from the Mirena IUD, less and less natural hormones are produced each menstrual cycle. Mirena is most popular among women who have already had children and don’t want anymore children for an extended period of time. Some women also use the Mirena IUD to help treat endometriosis, polycystic ovary syndrome, heavy periods, and menstural cramping. Though highly effective, the Mirena IUD has been shown to cause numerous dangerous health complications.

Mirena IUD Side Effects

Pseudotumor Cerebri:

Psuedotumor cerebri develops when the pressure inside the cranium increases without an apparent reason. The symptoms of psuedotumor cerebri mimic those of a brain tumor, but no tumor is present. The increased pressure from psuedotumor cerebri can create swelling of the optic nerve, which if left untreated, can cause permanent vision loss. Psuedotumor cerebri is most often found in obese women of child-bearing age, but has lately been associated with Mirena use.

Papilledema:

Papilledema is an opthalmological condition where the optic disc swells due to increased intracranial pressure. This swelling damages the nerves of the eye and is secondary to psuedotumor cerebri.

Symptoms of Mirena IUD Side Effects:

There are many early warning signs of pseudotumor cerebri and papilledema. If symptoms are caught early enough, the effects might be reversible. Do not ignore the following warning signs if you are using the Mirena IUD.

  • Headaches that may originate behind your eyes
  • Hearing ringing or heartbeat noises
  • Nausea or vomiting
  • Dizziness or vertigo
  • Blurred or dimmed vision
  • Brief episodes of blindness, lasting only a few seconds and affecting one or both eyes
  • Difficulty seeing to the side
  • Double vision
  • Seeing light flashes
  • Neck, shoulder or back pain

Notify your doctor immediately if you are suffering from any of the above side effects. Permanent vision loss is possible if not treated soon enough.

Discovering and Treating Mirena IUD Side Effects:

The Mirena IUD should be removed as soon as possible is adverse side effects are suspected. Pseudotrumor cerebri is a rare diagnosis and is not initially considered by most treating physicians. Multiple test are usually required before arriving at a diagnosis of pseudotumor cerebri. Treatment for pseudotumor cerebri includes weight loss, medications, and surgery.

Test for Pseudotumor Cerebri:

  • Spinal Tap (Lumbar Puncture)
  • Eye Exams
  • Brain Imaging

Medications for Pseudotumor Cerebri:

  • Migraine Medications
  • Glaucoma Drugs
  • Diuretics

Surgeries for Pseudotumor Cerebri:

  • Spinal Fluid Shunt
  • Optic Nerve Sheath Fenestration

Failure to Warn of Mirena Side Effects:

The Mirena advertisements claim that the IUD releases a steady stream of low-dose hormones for up to five years, however several studies have shown that circulating levels of the active hormone Levonorgestrel can be very high. The levels can sometimes be equivalent to two oral tablets. Warnings of idiopathic intracranial hypertension, or psuedotumor cerebri, have been placed on Norplant, a similar long-lasting contraceptive also manufactured by Bayer. The packaging of Mirena warns that Mirena should be used with caution in patients who have “Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.” The warnings also indicate that for women who experience these symptoms, removal should be considered but is not outright advised. Lawsuits filed against Bayer claim that the manufacturer has a responsibility to more appropriately warn women and their healthcare providers of the possibilities of psuedotumor cerebri.

Scientific Articles on the Mirena IUD and Pseudotumor Cerebri

Jun 2015: Risk of Intracranial Hypertension with Intrauterine Levonorgestrel.

The study looked at Mirena adverse events reported to the FDA. The authors note that their study is the first large epidemologic study to examine the risk of Intracranial hypertension associated with the Mirena IUD. The authors conclude that the “results of our study demonstrate an increased reporting of [intracranial hypertension]…”

Sept 2014: Headache and the Pseudotumor Cerebri Syndrome.

The study discusses the presentation of pseudotumor cerebri, such as one could see as a result from the Mirena IUD. The authors note that a headache is the most common presenting symptom of pseudotumor cerebri.

May 2014: The Pseudotumor Cerebri Syndrome.

The article discusses diagnosis, evaluation, and management of patients presenting with pseudotumor cerebri. The authors note that one of the most serious side effects of pseudotumor cerebri is visual loss, which could be temporary or permanent. Our Mirena IUD lawyers have observed that if the Mirena IUD is removed soon after visual disturbances occur, that there is a high chance that the patient’s vision will return. Unfortunately, many doctors are not aware that the Mirena IUD can cause pseudotumor cerebri, and therefore do not remove the Mirena IUD soon enough to prevent permanent damage.

Jan 2014: Pseudotumor Cerebri Pathophysiology.

The authors note that “It is possible that pseudotumor cerebri dos not occur in older age patients because of the low levels of sex hormones and reduced CSF production.” The Mirena IUD releases synthetic sex hormones into the patient after implantation.

Nov 2012: Hypertension and use of an Intrauterine Levonorgestrel-Releasing Device.

The author notes that levonorgestrel-containing intrauterine devices, such as the Mirena IUD can cause elevated blood pressure. The author is surprised though that since 2007 the Mirena IUD no longer comes with a warning that it can increase blood pressure. The author also had a previous patient who experienced hypertension one month after insertion of the Mirena IUD. The Mirena was then removed and the patients blood pressure returned to normal. The author notes that even though plasma concentration of levonorgestrel is lower when using the Mirena IUD than when taking oral contraceptive pills, systemic side effects still occur. The author warns that loveonorgestrel-containing IUDs, such as the Mirena can result in side effects such as headache, acne, abnormal hair growth, and mood disturbance.

Feb 1991: Protective Effect of Intrauterine Release of Levonorgestrel on Pelvic Infection: Three Years’ Comparative Experience of Levonorgestrel and Copper-Releasing Intrauterine Devices.

The study compared levonorgestrel-containing intrauterine devices, such as Mirena, to a copper IUD. The study found that at “after 36 months, the cumulative gross rates of amenorrhea and hormonal side effects were significantly higher in the levonorgestrel-IUD users.”

Mirena IUD Lawsuit:

The Hollis Law Firm handles cases for people who have been injured by defective drugs and medical devices, such as the Mirena IUD. We work on a contingency fee basis, which means you never owe any money unless there is a recovery in your claim. All consultations with the Hollis Law Firm are completely confidential and obligation free. For a free Mirena IUD lawsuit consultation, call us today at 1-800-701-3672.

Content Created By:

C. Brett Vaughn RN, BSN, JD