Mirena IUD Complications Reported to FDA Outnumber All Other Contraceptives: ISMP Report

In an analysis of adverse event reports linked to five popular forms of birth control, safety experts indicate that Mirena IUD complications outnumbered combined reports of problems linked to all of the other forms of birth control examined. 

In it’s January 2018 QuarterWatch report (PDF), the Institute for Safe Medication Practices (ISMP) indicates that over a two year period, there were more than 8,000 reports of serious adverse health events linked to the Mirena intrauterine device (IUD). However, the same report indicates that the Mirena was also the most effective of the forms of birth control studied.

ISMP researchers looked at adverse events reported to the FDA over a two year period ending in June 2017. The types of birth control examined included the Mirena IUD, the Paragard copper IUD, the Nexplanon birth control implant, Yaz birth control pills, and the Plan B One-Step emergency contraception pill.

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According to the findings, problems with the Mirena IUD were linked to 8,166 reports of serious adverse events. The Paragard IUD came in second, with 2,481 adverse events reported, followed by the Nexplanon with 1,747 reports, Yaz with 1,770 reports, and Plan B with 595 reports. Even if you add the reports linked to the other four birth control methods together, they still fall far short of the number of reports linked to the Mirena.

The Mirena IUD is an increasingly popular form of birth control, especially among younger women, as it does not require adherence to use of a daily pill. The implant is a T-shaped plastic device, which is placed into the uterus, releasing the progestin levonorgestrel to prevent pregnancy.

“This method had the weakest safety record by several basic measures,” the ISMP reports. “It accounted for largest number of serious injury reports, the largest number of direct reports to the FDA, and the most cases of reported psychiatric symptoms.”

ISMP’s investigators noted that there are other levonorgestrel IUDs on the market, including the Skyla, Liletta, and Kyleena. However, Mirena complications account for more than 84% of the adverse event reports, and the 8,166 incidents included in their report were for the Mirena alone.

Researchers noted that reports have been consistently high for the Mirena over a number of calendar quarters. Those risks may be so high because the Mirena combines the risk of IUD insertion, the risk of ongoing IUD contraception as well as coming with all the risks of hormonal contraception.

The report expresses concern for the fact that there is no effective national program or standard of care ensuring that removal and replacement of long-term contraception, and called for more studies to assess the extent of birth control health risks.

Mirena IUD Problems

The most frequently reported problems, both serious and non-serious, linked to the Mirena included device expulsion, device dislocation, psychiatric side effects, genital hemorrhaging, and lower abdominal pain. However, there were also hundreds of reports of uterine perforation, depression and other problems.

The findings come amid an increasing number of Mirena lawsuits filed against the manufacturer, Bayer, over claims that the Mirena causes a condition known as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH), which is a build-up of fluid pressure in the brain which can cause optical nerve damage leading to vision loss, as well as migraines and other problems.

Given similar questions of fact and law raised in lawsuits file by women 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 weeks and months.


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