Bayer Under Fire For Mirena Birth Control Device
Bayer HealthCare Pharmaceuticals, Inc. is facing thousands of lawsuits by women who have used the birth control device known as Mirena. The use of Mirena has been linked with the condition pseudotumor cerebri (PTC), a debilitating brain condition that causes vision loss. As more women are diagnosed with pseudotumor cerebri, the number of lawsuits against Bayer increases.
What is Pseudotumor Cerebri?
Pseudotumor cerebri (PTC) is a serious condition resulting from an increase in the cerebrospinal fluid inside the skull that causes pressure against the brain and swelling of the optic nerve. The patient can lose his or her vision in addition to suffering symptoms that mimic a brain tumor.
Medications may be used to treat the condition; however, some patients require a shunt to be implanted in the skull to drain the excess fluid. PTC has been linked to the use of Mirena as a contraceptive method.
Symptoms of PTC include but are not limited to:
- Blurry or double vision
- Vision loss
- Dizziness and/or headaches
- Buzzing and/or ringing in the ears
- Vomiting and/or nausea
- Neck, back and/or shoulder pain
What is Mirena?
Mirena is a reversible intrauterine device (IUD) used by many women as a form of birth control. In 2009, the FDA also approved Mirena for use as a method of treating heavy menstrual bleeding. A daily dose of the hormone known as levonorgestrel is released by the IUD to prevent pregnancy; however, pseudotumor cerebri has been associated with the use of this hormone. During its 2015 annual meeting, the Association for Research in Vision and Ophthalmology (ARVO) presented an abstract entitled, “The relationship between the levonorgestrel-releasing intrauterine system and idiopathic intracranial hypertension” in which the authors cited a significant association between the use of levonorgestrel and the development of pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH).
The hormone levonorgestrel has been linked to the development of pseudotumor cerebri as far back as the 1990s when the makers of Norplant (another intrauterine device) added a warning of the possible side effect of PTC to its label and material. Bayer alleges that Mirena delivers a much lower dose of levonorgestrel; therefore, Bayer does not include a warning in its material or on its label that patients using Mirena may develop this life-altering medical condition. It is reckless and dangerous not to include a warning for an associated medical condition so that doctors prescribing Mirena and patients using Mirena can make an informed decision.
Mirena Class Action Lawsuits and Individual Lawsuits
Thousands of lawsuits have been filed against Bayer HealthCare Pharmaceuticals, Inc. and other defendants by women who have used Mirena as a contraceptive method and developed pseudotumor cerebri. Other severe medical conditions in addition to PTC have been related to the use of Mirena and are the subject of several lawsuits. Women suffering from pseudotumor cerebri may be entitled to receive reimbursement for their medical expenses and other damages related to the use of Mirena.
Have You Been Injured by a Defective Medical Device?
The defective drug attorneys of the Olinde Firm have extensive experience representing clients throughout the United States against drug companies when defective medical devices or defective drugs cause harm to patients.
Pharmaceutical litigation is a complex and complicated area of the law that requires the assistance of an experienced attorney. If you have been injured while using a medical device, contact our office for a free case evaluation.