In early September, Ohio woman Sara Marie Wessel filed a product liability suit against the makers of Mirena, alleging that it caused papilledema and pseudotumor cerebri (PTC). The case was filed in the U.S. District Court for the District of New Jersey.
Mirena is an intrauterine device (IUD) implanted to effect long-term birth control by releasing the progestin levonorgestrel. The birth control is designed to be effective for five years.
The suit alleges that Mirena was the triggering event for symptoms Wessel began experiencing shortly after the product was implanted, including severe headaches and blurry vision. These were caused by fluid pressure building up around her brain. Mirena is manufactured by Bayer.
Mirena IUD lawsuit: allegations
The focus of the suit is Bayer’s alleged failure to warn women and the medical community about these possible side effects.
The suit’s time line indicates that Wessel received a Mirena IUD in July 2012 and the symptoms began very shortly thereafter. The fluid build-up around the brain is known as PTC or idiopathic intracranial hypertension (IIH). It is often associated with swelling of the optic disc, termed papilledema, which stems from rising intracranial pressure.
The lawsuit notes “there is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure. Because of this, treatment of PTC or IIH is focused on halting visual loss that has already occurred. Although PTC or IIH is considered reversible in some patients, it may take years before normal pressure is maintained. it also may be irreversible in some cases.”
Did Bayer warn patients about Mirena IUD risks?
Although it was known that levonorgestrel exposure in birth control products had been associated with pseudotumor cerebri, Bayer gave no warnings about the Mirena IUD implant. It also gave no warnings or recommendations that physicians should monitor patients for signs of vision problems, sudden headaches, or other problems indicating fluid build-up around the brain.
Information that papilledema was a possible side effect of a Mirena implant was given to women in several other countries, such as South Africa and Hong Kong.
A number of similar lawsuits have been filed across the U.S. by women alleging that long-term damage to the plaintiffs could have been avoided had Bayer provided warnings about the risk of papilledema.
Last year, the rising number of Federal Mirena PTC cases led to a request filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to put the cases before a single judge. The filing was rejected.
Mirena IUDs have also been reported to cause perforations in the uterus or other severe injuries to the internal organs caused by the IUD moving out of position.
Are you eligible to file a Mirena injury lawsuit?
Are you contemplating filing a lawsuit against the makers and distributors of Mirena? The national product liability lawyers at Bonsignore have special expertise in litigating cases against pharmaceutical and medical device companies over defective and dangerous products. We are currently offering free case reviews to patients with symptoms caused by Mirena IUDs. We will review your case at no charge and then discuss the legal recourse available.
Mirena IUD injury resources
- FDA, Mirena (levonorgestrel-releasing intrauterine system) http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm119274.htm
- Department of Health and Human Services, Mirena® (levonorgestrel-releasing intrauterine system), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM197229.pdf