Bayer’s Mirena, an IUD (intrauterine device) which can be implanted for up to five years as a form of birth control and a way to control menstrual bleeding, has been linked to a number of serious side effects. The U.S. Food & Drug Administration (FDA) warned Bayer about downplaying the risks of using Mirena – and the company now finds itself defending numerous lawsuits.
How Bayer’s Mirena IUD Works
Bayer’s Mirena IUD is a small, t-shaped device that releases low doses of levonorgestrel (a synthetic progestin) directly into the uterus. This prevents pregnancy by thinning the lining of the uterus to block sperm from fertilizing the egg and by thickening the cervical mucus to prevent sperm from entering the womb. Although first approved by the FDA in 2000 as a form of birth control, Mirena was later approved to control heavy menstrual bleeding in 2009.
Mirena IUD Linked To Serious Side Effects
Mirena has been linked to a number of side effects, the most serious being the ability to puncture the uterus or become embedded in the uterine wall. This can result in infection, damage to other organs and internal scarring. In some cases, women have reported that IUDs have migrated through their intra-abdominal cavity and caused intestinal perforations, adhesions and abscesses. These side effects may require victims to undergo extensive surgical procedures or a painful revision surgery to remove the IUD altogether. Other Mirena side effects may include:
- Amenorrhea
- Breast tenderness
- Ectopic Pregnancy
- Erosion of adjacent areas such as the vagina
- Infertility
- Inflammation of the membrane lining the abdominal cavity and internal organs (Peritonitis)
- Intestinal perforations or obstruction
- Intrauterine pregnancy
- Irregular spotting or bleeding
- Miscarriages
- Ovarian cysts
- Painful menstruation
- Pelvic Inflammatory Disease
- Pelvic pain
- Streptococcal sepsis
- Vaginitis
- Wrongful death
FDA Says Bayer Misled Public About Mirena’s Risks
Numerous lawsuits have been filed against Bayer alleging that its Mirena IUD contraceptive device is defective and that the pharmaceutical giant downplayed Mirena’s risks and failed to warn users about those risks. In 2009, the FDA sent Bayer a warning letter about its questionable marketing practices such as claims that Mirena would improve couples’ sex lives and help users to “look and feel great” – neither of which could be proven. More importantly, the FDA warned Bayer that its marketing for Mirena, “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”
Mirena IUD Lawsuits
If you’ve been injured by Mirena, it’s important to understand that you may be entitled to compensation for your injuries including medical costs, lost wages, pain and suffering and more. As an attorney who has dedicated my legal practice to helping people injured by Mirena and other forms of birth control, I am committed to helping families obtain justice for injuries they suffered from dangerous and devices medical devices.