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Women who used ParaGard have developed severe migraines, blindness, or other complications of Idiopathic Intracranial Hypertension (IIH). Although rare, this serious brain injury causes high pressure inside the skull and may need to be treated with surgery.

What is ParaGard?

ParaGard is an intrauterine device (IUD) that contains copper, a metal that is toxic to sperm. Once implanted in the uterus, ParaGard prevents pregnancy for up to 10 years. It is the only long-term, hormone-free copper IUD approved in the United States.

Does ParaGard Cause Idiopathic Intracranial Hypertension (IIH)?

No one knows. ParaGard was not associated with IIH during clinical trials or in recent studies. The term “idiopathic” means “a disease of unknown cause.” IIH is primarily diagnosed in obese women of childbearing age.

Researchers have many theories about what causes IIH. Birth control is listed as a risk-factor for the disease, according to the National Institute of Health (NIH). However, concern is based on hormonal contraceptives, such as exogenous estrogen or progestin-only injections. There were also more than 50 cases of IIH associated with a subcutaneous birth control implant (Norplanon) in a study published in 1995.

What is IIH?

Idiopathic Intracranial Hypertension (IIH) refers to a disease that involves elevated levels of cerebrospinal fluid. Normally, this fluid acts like a shock-absorber between the brain and the skull. When there is too much fluid, pressure inside the skull increases. Without treatment, pressure may continue increasing. The disease was formerly known as pseudotumor cerebri (PTC) because the symptoms resemble those of a growing brain tumor.

Symptoms of IIH may include:

  • Migraine headaches
  • Sensitivity to light (photophobia)
  • Changes in visual field
  • Double-vision (diplopia) or blurry vision
  • Blindness
  • Tinnitus (ringing in the ears)
  • Nausea or vomiting
  • And more

Complications

The most common complication of IIH is headache. The symptoms may be extremely painful and debilitating. Over time, headaches may grow progressively more constant and severe. Another complication is blindness, which occurs when the optic nerve is damaged. Some people also develop papilledema, which is swelling of the optic disc due to high pressure.

Surgical Treatment

Brain surgery may be necessary for people with IIH who are losing vision and are not responding to other treatments. Some patients may benefit from surgery to drain cerebrospinal fluid using a surgical tube called a shunt. Unfortunately, this procedure has a high risk of complications.