Drug Safety Developments

Mirena IUD Associated with Harmful Neurological Side Effect

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

What is Mirena?

Mirena is an intrauterine device manufactured by Bayer Healthcare Pharmaceuticals that is used to prevent pregnancy in women of child-bearing age.  It is also indicated to treat heavy menstrual bleeding (HMB). 

It functions by releasing a synthetic hormone called levonorgestrel, and is 99% effective at preventing pregnancy for up to five years.

 

What are the possible side effects?

Perhaps the most dangerous side effect of the Mirena IUD is pseudotumor cerebri (PTC), also referred to as idiopathic intracranial hypertension (IIH).

This neurological side effect develops when an increased amount of cerebrospinal fluid (CSF) accumulates in one's skull.  This then causes increased pressure on the brain, which can lead to swollen optic nerves.

If PTC / IIH is not diagnosed in a timely manner, permanent vision loss and even blindness can result.

The symptoms of PTC / IIH include the following:

• Severe migraines or migraine-like headaches with blurred vision
• Temporary blindness, blind spots, or other visual deficiencies
• Diplopia: double vision
• Papilledema: optic disc swelling due to increased intracranial pressure
• Tinnitus: “whooshing” or ringing in the ear

 

How are these neurological conditions diagnosed?

Unfortunately, many doctors -- and even specialists -- find it difficult to diagnose PTC / IIH, especially since the side effects mimic those of a tumor in the brain.

When patients present with symptoms of PTC / IIH they often first undergo an MRI, CT scan, and/or other diagnostic radiology tests to rule out an actual tumor or blood clot in the brain.  

To confirm the diagnosis of PTC / IIH, a lumbar puncture, or spinal tap, is often performed.

 

Have any Mirena lawsuits been filed?

Many lawsuits concerning the Mirena IUD were previously filed in regard to damages caused by migration of the device, perforation of the uterus, and embedment within the uterus.

More recently, lawsuits concerning PTC / IIH have been filed and consolidated into a Mirena federal court multidistrict litigation (MDL) in the Southern District of New York. 

If you or someone you know have been diagnosed with PTC / IIH, or have experienced any of the aforementioned symptoms of PTC / IIH, we encourage you to complete a Free Case Evaluation.  You may also visit our website for more information.

We will continue to monitor the medical literature for more information on the association of the Mirena IUD with PTC / IIH.  In addition, we will also watch for developments in the Mirena federal court MDL.

 

 

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Lawsuits over Bayer birth-control device to be concentrated in Bergen County

Quoted from http://www.northjersey.com/news/Lawsuits_over_Bayer_birth-control_device_to_be_concentrated_in_Bergen_County.html

Lawsuits over Bayer birth-control device to be concentrated in Bergen County

Thursday May 30, 2013, 4:26 PM
BY KIBRET MARKOS STAFF WRITER

More than 60 lawsuits against Bayer Healthcare Pharmaceuticals over a birth-control device will be tried in Hackensack under a state Supreme Court order to centralize the claims in Bergen County.

The Wayne-based Bayer is the manufacturer of the device known as Mirena, a plastic implant to prevent pregnancy for up to five years. More than two million women in the United States are users of Mirena, according to court filings.

Thousands of users have said they experienced problems with the device, which is implanted into the uterus during a doctor’s visit. Lawsuits have been filed by users in nearly two dozen states, claiming they suffered injuries from using Mirena. The lawsuits claim Bayer marketed an unsafe product and failed to provide warnings about the health risks that come with using Mirena, which includes the perforation of the uterus.

[Article continues at original source]

Bayer Sued Over Alleged Hidden Risks of Mirena Contraceptive

Quoted from http://www.bloomberg.com/news/2013-01-28/bayer-sued-over-alleged-hidden-risks-of-mirena-contraceptive-1-.html

Bayer Sued Over Alleged Hidden Risks of Mirena Contraceptive

By Sophia Pearson - Jan 28, 2013 4:08 PM ET

Bayer AG (BAYN) was sued over claims the German drugmaker failed to provide disclosures and warnings regarding the health risks associated with its popular contraceptive Mirena.

The label for Mirena, an intrauterine device that prevents pregnancy for as long as five years, doesn’t warn that it can can become embedded in the body or cause an ectopic pregnancy, Pennsylvania resident Tricia Prendergast said in a complaint filed in federal court in Philadelphia. Prendergast required surgery to remove the device after complications, according to her complaint....

Mirena, approved by the Food and Drug Administration in December 2000, is made of flexible plastic designed for insertion in the uterus, where it releases a synthetic progestogen that inhibits pregnancy, according to the complaint. More than 15 million women worldwide use the product, including more than 2 million in the U.S., Prendergast said in the complaint.

[Article continues at original source]