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Mirena linked to Pseudotumor Cerebri

Mirena® IUD has been linked to a serious injury known as pseudotumor cerebri (PTC) or increased intracranial hypertension this according to another recent study. The study revealed that women who used a Mirena IUD had an increased odds ratio of a PTC or intracranial hypertension diagnosis of 7.7.

Pseudotumor cerebri or increased intracranial hypertension are often used interchangeably to describe a dangerous increase in the pressure of the cerebrospinal fluid.

PTC symptoms include:

  • Blurry vision
  • Floaters
  • Blackouts
  • Night vision problems
  • Dimmed vision
  • Double vision
  • Brief period of blindness, lasting only a few second and affecting one or both eyes
  • Difficulty seeing to the side
  • Other visual disturbance.

If you or a loved one have experienced any of the above symptoms while using a Mirena IUD you may have a case against the manufacturer of the device.

Currently, James Esparza is accepting clients who were diagnosed with pseudotumor cerebri (PTC) or increased intracranial hypertension while using a Mirena® IUD.

Failure to Warn – The Case Against the Manufacturer of the Mirena® IUD

The Mirena® IUD is an implanted form of birth control, which releases a hormone called levonorgestrel through a T-shaped plastic device that is placed in the uterus to prevent pregnancy for up to five years. It was approved for use in 2000. The hormone levonorgestrel is not a new hormone.  It was used in the early 1990’s in a contraceptive device called Norplant®.  Norplant® was a device that consisted of six capsules containing levonorgestrel inserted in the arm just under the skin.

As early as 1995 medical researchers wrote about the association between pseudotumor cerebri (increased intracranial pressure) and the levonogrestrel contraceptive Norplant®. The authors examined the Food & Drug MedWatch Spontaneous Reporting System from February 1991 to December 1993.  Based on the analysis of the adverse event reports, the authors speculated, but did not confirm, that Norplant may have caused 39 cases of pseudotumor cerebri in women who used the Norplant device. Interestingly, the label and the package insert for Norplant warned about the risk of pseudotumor cerebri with Norplant use.

Because of the previous association of pseudotrumor cerebri with levonorgestrel and the accompanying warning of increased intracranial hypertension by the manufacture of the Norplant system, it would seem reasonable that the manufacturer of the Mirena® IUD, Bayer, would have warned physicians and users of the device of the substantial risk of pseudotumor cerebri.  Thus, a Mirena® IUD case is a classic failure to warn case.

The James Esparza Law Firm is uniquely suited to help individuals and families who have been impacted by the Mirena® IUD as the firm has substantial experience in hormonal drug lawsuits. In fact, James Esparza handled over 600 Norplant cases in the early 1990.

Feel free to call us to discuss your situation at 1-800-745-4050.

Mirena-iud

Helpful Link:

An Estimation of the Risk of Pseudotumor Cerebri Among Users of the Levonorgestrel Intrauterine Device. read more


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