Mirena (Levonorgestrel) is an intrauterine device (IUD) that delivers low levels of the synthetic progestin hormone levonorgestrel to the user. Mirena is used as a form of contraception, but its secondary purpose is treating heavy menstrual bleeding in women who have an IUD. An estimated 8.5 percent of all women in the United States use long-term, reversible contraceptive methods like an IUD.
Mirena is manufactured by Bayer HealthCare Pharmaceuticals. The FDA approved Mirena as a contraceptive device in 2000. In 2009, it was also approved by the FDA to treat heavy menstrual bleeding for women who have an IUD.
No official recall of Mirena has been issued by the FDA or Bayer HealthCare Pharmaceuticals, however the safety of Mirena has been the source of a great deal of controversy. Bayer has long been accused of deceptive advertising practices and concealing the risks of adverse medical conditions related to the Mirena IUD.
Mirena IUD Common Side Effects & Injuries
The most serious medical condition reported by patients with a Mirena IUD is Pseudotumor Cerebri (PTC), which causes increased pressure in the skull that can lead to permanent brain damage, memory or vision loss, blindness, and other serious complications. The symptoms associated with this condition mimic those associated with a brain tumor, though no tumor is actually present.
There are many other serious adverse side effects associated with Mirena use, including:
- Ectopic pregnancy,
- Intrauterine pregnancy,
- Group A streptococcal sepsis,
- Pelvic inflammatory disease,
- Embedment of device into uterine wall,
- Perforation of uterine wall or cervix,
- Migration of device into other organs,
- Infertility, ovarian cysts, and an increased risk of breast cancer,
- Irregular uterine bleeding, and more.
|News: Popular Contraceptive Device Mirena Target of Lawsuits
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Although there has been no recall, the FDA has issued warnings in 2008 and again in 2013. These warnings included necessary product safety labelling changes. Updates to labelling included changes and additions to the contraindications, warnings, precautions, adverse reactions, and patient package inserts sections.
If you or a loved one has experienced any of the above medical conditions, or has suffered some other sort of personal injury, after receiving a Mirena IUD, it may be beneficial to consult with a personal injury attorney who handles these claims. Hiring an attorney can help preserve the value of your claim and ensure that you avoid the common mistakes that often devalue injury claims.