Mirena is a hormonal intrauterine device (IUD) that is a form of birth control manufactured by Bayer Healthcare Pharmaceuticals, Inc. The IUD is a flexible, soft T-shaped piece of plastic that contains the hormone levonorgestrel. Mirena is a long-acting reversible contraceptive said to last up to 5 years. Mirena prevents pregnancy by releasing the hormone progestin (levonorgestrel) which prevents sperm from entering the uterus by thickening the cervical mucous. It also thins the lining of the uterus which decreases the chances that a fertilized egg will implant and grow. The device needs to be inserted and removed by a qualified medical professional and is desgnedto release 20 micrograms of the hormone levonorgestrelt he per day, eventually decreeasing the dose to 14 micrograms after 5 years.
Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of the Mirena device, including:
Most Serious Complications
• Perforation of the Uterine Wall
• Perforation of the intestine
• Obstruction of the intestine
• Erosion of the IUD into the uterus or embedment into the adjecent area
• Migration of the IUD to Outside the Uterus
• Complications that Result in Surgery to Remove Mirena IUD
Less Serious Complications
• Expulsion of the Mirena IUD
• Pelvic inflammatory disease
• Ectopic pregnancy
Perforation of the uterus is one of the most serious complications and often has to be removed or repaired surgically. If the IUD perforates the uterus it can travel into the abdominal cavity and cause potentially life-threatening complications such as intestinal obstruction, organ damage and infection/sepsis.
Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is recommended to women who have had at least one child. Mirena was also FDA-approved in 2009 to treat heavy menstrual bleeding in women who prefer intrauterine contraception as their method of birth control, the first time that the FDA has approved an intrauterine device for this purpose.
Bayer is the subject of numerous lawsuits across the United States alleging Bayer failed to adequately warn women of the risks of the Mirena IUD. Bayer has received two warning letters from the U.S. Food and Drug Administration (FDA) alleging Bayer failed to adequately relay risk information about Mirena to potential users.
In December 2009, the FDA sent Bayer a warning letter regarding a Bayer marketing program for Mirena called “Mom Central.” The direct marketing program centered on “Mirena parties” that took place in the consumer’s home or other private setting. The parties were hosted by Mirena experts who followed a script developed by Bayer, that made several misleading representations about Mirena. These Mirena experts would claim that Mirena could help a women “look and feel great” and could improve the recipient’s sex life, among other misleading statements. The FDA noted, “The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena and includes false or misleading statements regarding Mirena.”
Earlier in 2009, Bayer received a warning letter from the FDA regarding other forms of Mirena marketing misleading because they make representations about the efficacy of Mirena but failed to communicate any risk information.
Nearly two hundred lawsuits filed by women against Bayer Pharmaceuticals allege that their intrauterine device (IUD), Mirena, causes a condition known as intracranial hypertension (IH), or pseudotumor cerebri. Women all over the United States claim that Bayer was negligent in failing to warn users of the IUD of the potentially disabling side effects related to IH. Bayer has provided no warning about the possibility of Mirena causing IH, despite studies performed 20 years ago that link the hormone in their IUD to this debilitating condition.
Intracranial hypertension results from a buildup of cerebrospinal fluid around the brain that increases pressure on the skull. This pressure creates symptoms that closely mimic those of a brain tumor, which is why IH is often called pseudotumor cerebri. Increased cranial pressure causes severe headaches, vision loss, and ringing in the ears (called tinnitus). While the headaches cause immediate pain that may subside, the impact on vision is considerably more dangerous. Over time, IH can damage nerves in the eye, eventually leading to permanent blindness. While the exact cause of IH remains unclear, scientific studies point to a strong link between the primary hormone in Mirena, levonorgestrel, and IH.
Mirena releases levonorgestrel, a type of artificial progestin, into the body. Although this effectively prevents pregnancies, the hormone has caused IH for decades. Two reports published between 1995 and 1998 suggested a link between Norplant, a birth control implant that released levonorgestrel, and IH. Two years later, in 2000, British researchers concluded that intracranial hypertension “should be regarded as a condition in which the potential risks of using progestin-only methods of contraception generally outweigh the benefits.” Little was done to further investigate this connection until 2015, when Canadian pharmaceutical researchers analyzed FDA data and found that women with a Mirena IUD were 78% more likely to report suffering from IH.
Based on this compelling scientific research, Bayer should have known that using levonorgestrol in its IUD would increase a woman’s risk of developing intracranial hypertension. Shockingly, Bayer has done absolutely nothing to warn users of the potentially life-changing dangers its defective product may cause. By neglecting to adequately warn doctors and patients, Bayer’s sales increased while the health of many innocent women deteriorated. Our experienced lawyers fight for individuals harmed by defective drugs and products.
A growing number of Mirena IUD pseudotumor cerebri lawsuits are being filed against Bayer Healthcare in courts around the United States. Plaintiffs allege that Bayer Healthcare has failed to provide any warning about the Mirena IUD’s link to pseudotumor cerebri. Plaintiffs also claim that Bayer Healthcare did not adequately test the drug before putting it on the market and that had plaintiffs been warned about the risk of pseudotumor cerebri, they could have chosen an alternative method of birth control.
In April 2017, federal lawsuits involving claims of Mirena IUD induced pseudotumor cerebri, benign intracranial hypertension, and idiopathic intracranial hypertension were centralized in a multi-district litigation (“MDL”) before U.S. District Court Paul A. Engelmayer in the United States District Court for the Southern District of New York (MDL No. 2767).