Bayer Healthcare, makers of the intrauterine device (IUD) called Mirena, have been faced with several product liability lawsuits concerning the implanted birth control device. Most of these lawsuits have concerned issues with an alleged side effect that leaves women with painful headaches and possibly impaired vision.
Idiopathic Intracranial Hypertension (IIH), a condition related to the level of cerebral spinal fluid (CSF) in the system has recently been associated with IUDs and other birth-control implants that secret progestin. Mirena and IIH have been linked through multiple adverse event reports to doctors and the Food and Drug Administration (FDA).
According to www.hormonesmatter.com, IIH develops when the delicate balance of CSF is disrupted in the brain. The fluid is made in and bathes the brain and is believed to be reabsorbed by the venous blood supply when in excess, keeping a homeostatic level intact.
Mirena and IIH have been connected because the IUD produces a steady supply of levonorgestrel, a progestin hormone, supposedly delivering it locally to the lining of the uterus only for up to a five-year period. It is unknown why a local hormone delivery is affecting levels of CSF in the overall system of some women.
IIH symptoms can vary between individuals greatly. The main symptoms seem to be very basic, although they don’t appear in everyone with IIH:
- Severe headaches
- Whooshing tinnitus (hearing a pulse-like whooshing sound in one or both ears)
- Visual disturbances/changes such as blurry or double vision
IIH can be caused by many things in addition to birth control and the mechanism of action isn’t necessarily known. Head trauma, stroke, cerebral blood clots and a host of medications have been related to this condition which can happen acutely or develop slowly and become chronic.
Mirena and IIH or PTC
IIH symptoms are very similar to what someone with a brain tumor might experience. Because of this, it is often referred to as pseudotumor cerebri (PTC) – which means false brain tumor in Latin. In addition to the symptoms above, other things a sufferer might notice could be:
- Dizziness
- Nausea and vomiting
- Loss of peripheral vision or literal ‘tunnel vision’
- Pain that radiates from the spine down the arms.
The Mirena IUD was approved for sale on the market by the FDA in the year 2000. It secretes a laboratory-created version of progesterone that is effective in preventing pregnancy. It is the same type of product as the Norplant, a contraceptive implant that also delivers this type of naturally-occurring steroid hormone.
Incidences of Mirena and IIH development reportedly didn’t really get scientific attention until Canadian researchers analyzed FDA data in 2015. The study found that women using Mirena reported 78% more likely to report symptoms of IIH. Risk factors in addition to the use of progestin-producing birth control methods were also identified such as obesity, being of childbearing age, Addison’s disease, Cushing disease, and hyperparathyroidism.
Women are coming forward who have suffered unnecessarily and are looking to get the compensation they deserve from the manufacturing company. If you have had implantation of the IUD Mirena and IIH symptoms have developed, consult your physician first. You may also qualify for a free initial consultation with a knowledgeable liability lawyers.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or birth control class action lawsuit is best for you. [In general, birth control lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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