The Mirena IUD May Increase The Risk Of Developing Pseudotumor Cerebri
Have you ever or a loved one used the Mirena IUD birth control device?
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. Your symptoms may indicate idiopathic intracranial hypertension (IIH) or pseudotumor cerebri (PTC):
- 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
NOTE: If you or a loved one has a Mirena IUD and any of these symptoms, the Mirena device should be removed immediately!
Be certain to tell your healthcare provider that you have the Mirena IUD.
- PTC is a fairly rare condition, and is often misdiagnosed or takes a long time to properly diagnose.
Is It Risky To Use The Mirena IUD?
Mirena is an intrauterine device (IUD) designed as a long-term form of birth control.
In 2000, the U.S. Food and Drug Agency (FDA) approved Mirena for manufacture and marketing by Bayer, one of the world’s largest pharmaceutical firms. The small, t-shaped Miren IUD is inserted into the uterus, where it slowly releases hormones into a woman’s system. The device is considered effective for up to five years.
The hormones released by Mirena 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.
However, the hormone levonorgestrel, one of those released by Mirena, has been linked to a greater risk of developing PTC/IIH.
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).
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.
If I Contracted PTC From The Mirena IUD, How Is The Condition Treated?
There are a variety of treatments available for PTC, depending on how a patient responds. They include:
Excess cerebrospinal fluid can be removed via regular spinal taps.
Insertion of a Shunt
A shunt is a tube-like device inserted into the body to drain excess fluid.
In more severe cases of PTC and those that do not respond to drug therapy, doctors will insert a shunt to drain fluid from the skull:
- Lumbar-peritoneal shunts (“LP shunts”) – These are tubes implanted between vertebrae in the lumbar (lower) area of your spine.
- Ventriculo-peritoneal shunts (“VP shunts”) These tubes are inserted directly into your skull, typically behind your ear.
Both types of shunts drain excess cerebrospinal fluid into the abdominal cavity where the body simply reabsorbs it. Each of these options can be painful.
As with any procedure or surgery, there is always the possibility of infection.
PTC and Papilledema
One of the complications of PTC include pressure on and swelling of the optical nerve, a condition known as papilledema.
Left untreated, this condition can result in permanent damage to the optic nerve. 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.
Studies Linking pseudotumor cerebri (PTC) to the Levonorgestrel Hormone In The Mirena IUD
Even back in the 1990s, health studies showed a link between pseudotumor cerebri (PTC) and the Levonorgestrel hormone used in the Mirena IUD.
In 1995, 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.
Other studies also link PTC with exogenous estrogen, birth control injections, and progestin-only implants.
The use of levonorgestrel alone may actually accelerate hormonal side effects.
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.
- When levonorgestrel is combined with estrogen, the estrogen increases SHBG levels, thus mitigating the hormonal side effects.
- Mirena contains levonorgestrel, but no estrogen.
The Mirena IUD Should Warn Consumers That It Can Lead To pseudotumor cerebri (PTC)
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.
In fact, many other countries do include papilledema warnings on Mirena labels.
For example, Hong Kong and South Africa both carry the warning.
Putting profits ahead of patients, Bayer has elected not to warn American doctors or patients of the risks associated with Mirena.
Mirena Lawsuits Pertaining to PTC
Several lawsuits have been filed against Bayer by women who have used Mirena and suffered from PTC.
NOTE: These PTC-related Mirena lawsuits should not be confused with the 1,000+ lawsuits against Bayer regarding alleged migration of the Mirena device.
The Personal Injury Lawsuit For PTC Injuries Alleges That The Mirena IUD’s Manufacturer Bayer AG:
- 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
If you or a loved one has been injured by using the Mirena IUD, you may be entitled to financial compensation for your losses. You need experienced attorneys on your side.
An Austin Personal Injury Law Firm That Knows What You’re Up Against
Mirena IUD and PTC Injury Lawsuits Can Be Complex to Prove
Winning a mass tort lawsuit for injuries caused by hormones like the Levonorgestrel Hormone in the Mirena IUD can involve proving that Bayer AG did not properly warn people taking it of the potential risks.
That can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.
But battling bullies is what Justinian & Associates does.
We Are Warriors For The Injured
As our record demonstrates, we have the legal knowledge, the experience, the resources, experience and trained investigators to take on adversaries of any size.
All we do is fight for injured victims. Our only goal is justice for our clients, whatever that means for them. And we do not accept defeat. Unless we get you money for your injuries, you don’t pay us a dime.
The Time to Act is Now
Your rights can be lost if you wait.
There are laws that limit how much time you have to file a lawsuit after being injured. They are known as statutes of limitation. They may apply to your lawsuit to recover for your talc injuries. The countdown may already have begun.
If you or a loved one has developed any of the above health conditions from the Mirena IUD, now is the time to seek legal assistance.
Call, text or email us for a free consultation, with no obligation. Speak to an Austin personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.