Mirena, a widely-used intrauterine device (IUD), has recently been linked to severe health complications including device migration, perforation of the uterus and other organs, infertility, miscarriages, internal bleeding, and death.
Free Case Evaluation: If you or a loved one has been injured by Mirena, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Mirena and we can help.
What is Mirena?
Approved by the FDA in 2000, Mirena is a t-shaped contraceptive that releases a low dose of levonorgestrel into the uterus. Like other IUDs, the levonorgestrel in Mirena protects against pregnancy by thinning the lining of the uterus, which blocks sperm from reaching and fertilizing the egg, and by thickening the cervical mucus to prevent sperm from reaching the womb. Mirena is recommended to women who have had at least 1 child, and can remain inserted for as long as 5 years. In 2009, Mirena was approved to control heavy menstrual bleeding in women who choose IUDs as their form of birth control, the first time the FDA has ever approved an IUD for this indication.
In recent years, Mirena has been linked to the following complications:
- Device migration
- Perforation of the uterus
- Embedment in the uterine lining
- 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
- Ovarian cysts
- Irregular spotting or bleeding
- Painful menstruation
- Pelvic pain
- Breast tenderness
- Streptococcal sepsis
- Ectopic Pregnancy
- Intrauterine pregnancy
- Wrongful death
Mirena FDA Warning Letter
In December 2009, the FDA issued Bayer a warning letter regarding the company’s marketing of Mirena. The agency claimed that Bayer “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
FDA accused Bayer of sponsoring live, in-home promotional events that claimed Mirena would improve couples’ sex lives, and make users ‘look and feel great,’ even though there was absolutely no evidence to support these claims.
The FDA noted that at least 5% of Mirena users reported a decrease in libido, which would definitely not help a couple’s sex life. Additionally, FDA stated that a large number of Mirena recipients had reported complications including irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne. None of these complications would help a woman look or feel ‘great,’ the FDA said.
Do I Have a Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Mirena Lawsuits. We are handling individual litigation nationwide and currently accepting new Mirena injury and death cases in all 50 states.
If you or a loved one has been injured by Mirena you should contact our law firm immediately. You may be entitled to compensation by filing a Mirena Suit and we can help.