Mirena and Pseudotumor Cerebri
Have you ever or a loved one used the Mirena IUD birth control device? Have you or a loved one developed pseudotumor cerebri (Soo-doe-too-mur SER-uh-bry) (PTC) also known as idiopathic intracranial hypertension (IIH)?
Mirena is an intrauterine device (IUD) designed as a long-term form of birth control. The small, t-shaped device is inserted into the uterus and is considered effective for up to five years. The Mirena device is manufactured by Bayer, one of the world’s largest pharmaceutical firms and was approved by the FDA in 2000. Mirena functions by the slow release of hormones into a woman’s system. These hormones are known to reduce the chance of pregnancy by thickening the cervical mucus to prevent sperm from entering the uterus. They also thin the lining of the uterus, which blocks sperm from fertilizing the egg. The hormone levonorgestrel, one of those released by Mirena, has been linked to a greater risk of developing PTC/IIH.
Mirena IUD, image courtesy of Mirena.com.
What is PTC?
Pseudotumor cerebri is a medical condition involving an increase in the pressure inside the skull (intracranial pressure); it is a serious neurological condition. Cerebrospinal fluid builds up in the skull causing symptoms that closely resemble those of a growing brain tumor. PTC can be incredibly painful and even result in permanent injuries, such as blindness (due to swelling of the optic nerve).
If you or a loved one has the Mirena IUD and are suffering from any of the following symptoms, it is vital that you seek medical attention immediately.
PTC symptoms may include:
- Moderate to severe headaches often originating behind your eyes and worsening with eye movement
- Severe migraines
- Ringing in your ears that pulses in time with your heartbeat (pulsatile tinnitus)
- Nausea, vomiting or dizziness
- Blurred or dimmed vision
- Brief episodes of blindness, lasting only a few seconds and affecting one or both eyes (visual obscurations)
- Difficulty seeing to the side
- Double vision (diplopia)
- Seeing light flashes (photopsia)
- Neck, shoulder or back pain
If you or a loved one has a Mirena IUD and any of these symptoms, the Mirena device should be removed immediately!
One thing to be aware of when you visit your doctor is that PTC is a fairly rare condition and is often misdiagnosed or takes a long time to properly diagnose. Therefore, it is crucial that you tell your doctor you have the Mirena IUD.
How is PTC Diagnosed?
Unfortunately, the only sure way to diagnose PTC is via a spinal tap (lumbar puncture), which is a procedure involving the insertion of a needle between two vertebrae in your lower spine. The doctor will draw a sample of the cerebrospinal fluid to determine the level of intracranial pressure. It is an unpleasant procedure. In certain cases of PTC, an eye exam could reveal optic nerve swelling.
Can PTC Be Treated?
Yes. There are drugs that slow down the production of cerebrospinal fluid, which will help reduce the pressure. If the drugs don’t work, the only options left for treatment include further medical procedures and even surgery. If your vision has not been compromised, your doctor is likely going to start treatment with drugs. The overall goal of any PTC treatment is the reduction of intracranial pressure, which will stop optic nerve swelling and prevent blindness.
One method is the removal of excess cerebrospinal fluid via regular spinal taps. Another method involves the surgical insertion of a shunt (a tube-like device) in order to drain the extra fluid from the skull. Both of these options can be painful and, as with any procedure or surgery, there is always the possibility of infection.
There are two types of shunts used in treating more severe cases of PTC, as well as those that do not respond to drug therapy. One is inserted into your lower back and the other is inserted directly into your skull.
Lumbar-peritoneal shunts or “LP shunts” are tubes implanted between vertebrae in the lumbar (lower) area of your spine.
Ventriculo-peritoneal shunts or “VP shunts” are tubes inserted through your skull, typically behind your ear.
Both types of shunts drain excess cerebrospinal fluid into the abdominal cavity where the body simply reabsorbs it.
As mentioned earlier, one of the complications of PTC include pressure on and swelling of the optical nerve, a condition known as papilledema. Left untreated, the damage that is caused to the optic nerve is permanent. No treatment exists that can reverse or undo such damage. This is one of the reasons it is vital that you or your loved one seek medical assistance immediately if you experience PTC symptoms, especially those involving vision.
The link between levonorgestrel and PTC has been known for some time. However, Mirena’s warning label doesn’t say a word about PTC and its symptoms, at least not in the U.S. Many other places, such as Hong Kong and South Africa, include papilledema warnings on Mirena labels. Putting profits ahead of patients, Bayer has elected not to warn American doctors or patients of the risks associated with Mirena.
There are studies dating back to the 1990s showing the link between birth control, specifically levonorgestrel, and PTC. One such study, published in 1995 by the New England Journal of Medicine, highlighted 56 cases of PTC and papilledema connected to both birth control pills and implants that contained the hormone levonorgestrel. Certain other studies also link PTC with exogenous estrogen, birth control injections, and progestin-only implants.
These studies found that levonorgestrel binds with other hormone receptors, thus increasing the risks of hormonal side effects, such as PTC. Levonorgestrel, a type of progestin, used alone (as it is in Mirena) also causes a significant decrease in sex hormone binding globulin (SHBG). SHBG works in the body to manage hormonal side effects. This includes the prevention of PTC. The use of levonorgestrel alone may actually accelerate hormonal side effects. When levonorgestrel is combined with estrogen, the estrogen increases SHBG levels, thus mitigating the hormonal side effects.
Mirena contains levonorgestrel, but no estrogen.
Mirena Lawsuits Pertaining to PTC
Several lawsuits have been filed against Bayer by women who have used Mirena and suffered from PTC. These are not to be confused with the 1,000+ lawsuits against Bayer regarding migration of the Mirena device.
The complaint again Bayer over Mirena and PTC alleges that the company:
- Knew or should have known of the increased PTC risks
- Didn’t warn doctor and patients about Mirena’s dangerous, potentially permanent, side effects like blindness and brain injuries
- Manufactured, marketed and sold a known defective device
- Used deceptive marketing practices
Don’t Wait! The Time is now to Seek Legal Assistance!
If you or a loved one have been suffered PTC in connection with the Mirena IUD, now is the time to seek legal assistance. The Statute of Limitations, the time period during which you can file a lawsuit, may already be running. If you wait too long, you will be forever barred from seeking the justice you deserve. Contact the experienced attorneys at Justinian and Associates now for a free case consultation. We are experienced in dealing with dangerous medical device suits and we will fight for you.