Safer Alternatives to Mirena IUD Would Have Avoided Vision Loss, Headaches, Other Problems: Lawsuit

According to allegations raised in a product liability lawsuit filed by a Pennsylvania woman, she may have avoided intense headaches, vision loss and other problems linked to pseudotumor cerebri (PTC), if she had been provided better warnings about the potential side effects of the Mirena IUD.

The complaint (PDF) was filed by Ericka Jones-George in the U.S. District Court for the Southern District of New York on May 2, indicating that neither she or her doctors were adequately warned about the risk that her Mirena birth control implant would cause a dangerous build up of fluid pressure on her brain.

Mirena is a T-shaped plastic device, which is implanted into the uterus to prevent pregnancy for up to five years. Also known as an intrauterine device (IUD) or intrauterine system (IUS), the polyethylene frame for Mirena contains a steroid reservoir that releases the second generation progestin levonorgestrel, which has been linked to the development of pseudotumor cerebri (PTC) in other birth control products. However, Jones-George indicates that Bayer withheld information about the risk from users of Mirena.

Jones-George was implanted with a Mirena IUD in October 2008, and states that she then began to experience intense headaches, blurry vision, vision loss, eye pressure, and tinnitus; or a ringing in the ears. In May 2009, she had the Mirena IUD removed, and was diagnosed with PTC, which is also known as idiopathic intracranial hypertension (IIH), in May 2015.

If she had been warned about the link between Mirena and PTC/IIH, Jones-Georges maintains that she would have used another method of birth control.

“There are contraceptives on the market with safer alternative designs in that they provide equal or greater efficacy and far less risk,” the lawsuit states. “There are contraceptives on the market, including the 10-year copper IUD ParaGard, with safer alternative designs in that they do not expose patients to levonorgestrel, which is known to be associated with the development of IIH/PTC.”

Jones-George’s complaint joins a growing number of similar Mirena birth control lawsuits filed nationwide by women who suffered PTC/IIH and vision loss.

All of the complaints raise similar claims that Bayer withheld information from women and the medical community about the importance of monitoring for signs of PTC/IIH with Mirena, which may have helped women avoid permanent damage to the optic nerve by detecting the problems earlier, or using an alternative to Mirena for birth control.

Given similar questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings in April 2017, centralizing all cases involving pseudotumor cerebri or intracranial hypertension complications from Mirena IUDs before one judge in the Southern District of New York.

There are currently more than 200 complaints pending before U.S. District Judge Paul A. Englemayer as part of an MDL, or multidistrict litigation. However, as Mirena injury lawyers continue to review and file claims for women nationwide, it is expected that the size and scope of the litigation will continue to grow over the coming months.