Women around the country are reporting numerous, often debilitating complications after being implanted with the Mirena intrauterine device (IUD). The vast majority of these women were totally unaware of Mirena’s ability to cause serious side effects until after the implant was inserted and they became extremely sick. Many others are still suffering in silence, and have no idea that Mirena is to blame.
Manufactured and marketed by Bayer Healthcare Pharmaceuticals, Inc., the Mirena IUD is a small, t-shaped contraceptive designed to be inserted directly into the uterus to prevent pregnancy for up to five years. The device releases a continuous, low dose of levonorgestrel (a third-generation synthetic progestin used in many older forms of birth control) which prevents pregnancy by thinning the lining of the uterus, thereby making it more difficult for sperm to reach and fertilize an egg. Mirena was approved by the U.S. Food & Drug Administration (FDA) in 2000, and is recommended for women who have had at least one child. In 2009, the FDA granted Mirena additional approval to treat heavy menstrual bleeding in women who prefer intrauterine contraceptives as their method of birth control. Mirena is the first IUD to be approved for this purpose.
Yet despite its widespread success and considerable effectiveness at preventing pregnancy, Mirena has recently been linked to a number of serious, potentially life-threatening side effects. The device has been reported to migrate from its original position after being implanted, perforating or embedding itself in the uterus. Mirena has also been found to migrate outside the uterine cavity, causing adhesions and scarring that can lead to infertility. Depending on the extent of the damage caused by the device, Mirena users may require a complete hysterectomy, and more serious complications may even lead to death.
Over the past several years, Mirena has been repeatedly linked to the following serious side effects:
Embedment in the uterus
Erosion of adjacent areas such as the vagina
Inflammation of the membrane that lines the abdominal cavity and internal organs (peritonitis)
Intestinal perforations or obstruction
Pelvic Inflammatory Disease
Perforation of the uterus
In December 2009, FDA officials sent Bayer a warning letter regarding the company’s marketing of Mirena. In the letter, the administration said that Bayer “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
The FDA went on to accuse Bayer of organizing live, in-home promotional events for Mirena which touted the device as having the ability to improve couples’ relationships and sex lives. Bayer representatives who held these events also reportedly went so far as to say that Mirena would help them ‘look and feel great,’ even though there was absolutely no evidence to back this claim.
Making matters worse, the FDA said it had received reports that at least 5% of Mirena recipients went on to suffer from decreased libido, a serious side effect of Mirena that almost certainly would hurt - rather than improve - a couple’s sex life. Additionally, a large number of women who were implanted with Mirena reported complications such as irregular bleeding, ovarian cysts, pack pain, weight gain, breast pain and tenderness, and severe bouts of acne. None of these side effects would help a woman look or feel ‘great,’ the FDA letter said.
In response to these issues, a large number of Mirena lawsuits have been filed in courthouses around the country on behalf of women allegedly injured by the controversial contraceptive device. All of the claims involve similar allegations that Mirena caused users to suffer severe physical injuries and substantial pain and suffering. The lawsuits further claim that Bayer has a well-documented history of overstating the benefits of Mirena, while simultaneously downplaying its potential long-term side effects.
Michael E. Schmidt is recognized as one of Americaʼs most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP, is currently accepting Mirena lawsuits in all 50 states and offers a free confidential case evaluation. To learn more about this topic and to see if you qualify to participate in a Mirena lawsuit, please visit his website: http://www.schmidtandclark.com/mirena