But now there seems to be yet another concern. According to various lawsuits that have been filed, the active ingredient in the Mirena intrauterine contraceptive system (IUS), levonorgestrel, is associated with the onset of pseudotumor cerebri, or so it is alleged. Pseudotumor cerebri can reportedly lead to a buildup of fluid in the skull, potentially leading to blindness.
These Mirena side effects are in addition to other reported adverse reactions, which include ectopic pregnancy, intrauterine pregnancy, Group A strep infection, inflammation of the pelvis and other side effects.
Mirena uterine perforation can occur when the device, inserted vaginally through the cervix, migrates away from the original point of insertion and can travel throughout the abdomen following perforation of the uterine wall. This can result in organ damage and severe pain. Many patients have required a surgical procedure to have a wayward Mirena IUD removed.
This latest wrinkle, the development of pseudotumor cerebri, is just the latest concern to surface in recent months about a device that has proven popular due to its feature of “set it, and forget it.” Mirena has been a boon to women who wish to avoid unwanted pregnancies but react badly to traditional birth control products taken orally, or for those women who tend to be forgetful and have trouble remembering to take their daily pill. Dermal contraceptive patches can administer contraception for upwards of a month, v. the Mirena product that can and is expected to last up to five years before the spent device requires harvesting and replacement.
The Mirena device, which is prohibitively more expensive than traditional birth control products, is destined to be available to more women through expected changes in the so-called Obamacare program. Cost, for those unable to afford to pay, may no longer be a barrier.
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What’s more, this more recent concern over pseudotumor cerebri has spawned lawsuits, given an allegation that Mirena manufacturer Bayer failed to adequately notate the potential for pseudotumor cerebri and the risk for related health issues on product labeling. According to reports, the US Judicial Panel on Multidistrict Litigation is being lobbied to consolidate nine Mirena personal injury lawsuits in Federal Court in the Middle District of Tennessee.
The case is No. 63 document 1-1, In re: Mirena IUS Levonorgestrel-Related Products Liability Litigation, before the Judicial Panel of Multidistrict Litigation, filed May 27, 2014.