Mirena (generic: levonorgestrel), an intrauterine device (IUD) indicated for the prevention of pregnancy, has recently become a subject of increasing concern. Reports suggest that these contraceptive devices exhibit an increased propensity for the development of significant injuries. Of those complications reported to regulatory officials; uterine perforation, migration, expulsion and infection were the most common. Subsequently, these complications have become the focus of increasing litigation aimed at Bayer Healthcare, the manufacturer responsible for their distribution. Recent months have witnessed the filing of approximately 16 Mirena lawsuits in a New Jersey Superior Court alone. Bayer is therefore seeking to centralize management of these cases into one large Mirena lawsuit in Middlesex County.
Mirena, now a flagship intrauterine contraceptive of Bayer Healthcare, received approval from the U.S. Food and Drug Administration (FDA) on December 6, 2000. Immediately upon its release, Mirena was indicated for intrauterine contraception for up to five years. It is also, however, indicated for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.
Levonorgestrel is in a class of medications called progestins. It works by preventing the release of an egg from the ovary or preventing fertilization of the egg by sperm (male reproductive cells). It also may work by changing the lining of the uterus (womb) to prevent development of a pregnancy.
Of significant concern, however, is an influx of adverse reports associated with the use of Mirena. Several incidents of injury acknowledge that Mirena may be responsible for the perforation of the uterus while simultaneously embedding itself within the uterine wall. This may result in the need for surgery to remove the device, and may leave women with painful and devastating side effects from internal scarring, infection or damage to other organs.
Should the device be permitted to pass through the uterine wall, women may be at risk of migration. If Mirena migrates to other parts of the body, women may be subjected to internal injuries, such as: perforation of the intestines, intestinal obstruction and abscesses. Of particular concern, however, is the risk of infection. Those severe enough may pose as a life-threatening threat to whoever contracts them.
Financial compensation may be available, through a Mirena lawsuit, for individuals who have experienced these complications. Subsequently, recent months have witnessed approximately 16 women file their own Mirena lawsuit against Bayer for problems that occurred while using the contraceptive. In anticipation of a large and growing number of cases, Bayer HealthCare Pharmaceuticals, Inc. is seeking centralized management of the Mirena lawsuits in Middlesex County.
According to court documents, the majority of the Mirena lawsuits claim that the contraceptive was responsible for the development of severe and permanent physical injuries and substantial pain and suffering. The complaints further allege that Bayer neglected to provide women with adaquate warnings of the potential complications that coincide with Mirena’s use. Accordingly, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) acknowledged several unsubstantiated claims made by Bayer in their “Simple Style Program.”
Do I Have a Mirena Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Mirena lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been injured by Mirena, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.