Thousands of lawsuits have been filed in state and federal courts against Bayer Healthcare Pharmaceuticals, manufacturer of the Mirena intrauterine device (IUD), a popular method of birth control. Bayer is alleged to have inadequately tested the product and is also alleged to have concealed information regarding the complications resulting from Mirena IUD use from both doctors and patients. Some of these risks include perforation or puncturing of the uterus and pseudotumor cerebri.
The Mirena IUD
The Mirena IUD is a small, flexible, plastic device in the shape of a “T” that is used to help control heavy menstrual bleeding and as a birth control method. A trained healthcare provider inserts the device into the uterus, where it can remain for up to five years. It works by slowly releasing a synthetic hormone called levonorgestrel into the uterus. This prevents pregnancy by causing the lining of the uterus to thin and by thickening cervical mucus to prevent sperm from entering the uterus.
Approved for use by the Food and Drug Administration (FDA) in 2000, the Mirena IUD is currently used by approximately 2 million womenthroughout the United States. Some women have experienced serious complications following the insertion of the Mirena IUD. The FDA received more than 70,000 adverse event reports between the years 2000 and 2013 regarding the side effects of the IUD. Thousands of lawsuits filed by users of the device have claimed that Bayer misled through marketing and failed to adequately warn consumers and doctors of specific complications resulting from the IUD’s usage.
The majority of the existing lawsuits allege that Bayer withheld the risk of uterine migration of the IUD after implantation. Plaintiffs allege that in the labeling of the product, Bayer only cited the risk of migration during the implantation of the IUD. Many women claim to have experienced migration of the IUD, which then led to perforation of the uterus, months or years after the healthcare provider had inserted the device. These women suffered because they were unaware of the risks of migration after insertion, and thus assumed that the device was working properly or that it had fallen out. Once the Mirena IUD had perforated the uterine wall, it could then travel into the abdominal region and possibly puncture the intestines or bladder. When the Mirena IUD perforates the uterus, surgery is required to remove the device.
Pseudotumor Cerebri (PTC)
Pseudotumor cerebri (PTC) – also referred to as idiopathic intracranial hypertension (IIH) – is an issue in a number of other lawsuits filed by users of the Mirena IUD. It happens when the pressure inside of a person’s skull increases with no known cause. The symptoms of this condition are similar to those of a brain tumor and include ear ringing that pulses in time with one’s heartbeat, nausea, vomiting, blurred vision, seeing flashes of light, headaches, and pain in the neck, shoulder, or back. PTC can cause optic nerve swelling and potentially lead to loss of vision. Treatment may involve medication to minimize the pressure or surgery, including the use of a shunt to drain excess fluid. Sometimes, symptoms may recur months or years after they were initially resolved. Some users of the Mirena IUD have experienced PTC, and while the precise cause of this condition is unknown, there is reason to believe that it could be caused by the IUD’s release of the hormone levonorgestrel.
If you or someone you care about used the Mirena IUD and suffered the side effects of pseudotumor cerebri or perforation and would like to speak with a qualified personal injury attorney, call Scott D. Hughes today at 714-423-6928. Our experienced Orange County personal injury lawyers are assertive, professional litigators who are ready to help you.
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How Does Mirena Work? Mirena, 2015.
Legal Battles over the Mirena IUD: What’s Next? Jillian Sequeira, Law Street, 20 January 2016.
Mirenda Lawsuit Filed Alleging Organ Perforation, Katarina Siegfeld, Surgical Watch, 24 March 2015.
Pseudotumor cerebri, Mayo Clinic, 1 February 2014.
Rates of Copper vs. Mirena IUD Organ Perforation Compared, Katarina Siegfeld, Injury Lawyer News, 12 February 2015.