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Approved by the FDA in 2000, Mirena is an intrauterine device (IUD) primarily used as birth control and secondarily as treatment for heavy menstrual bleeding. Since 2009, the IUD has gotten attention for its harmful side effects and subsequent lawsuits.
After being added, a Mirena IUD is expected to stay in place for five years. During that time, it releases levonorgestrel, a synthetic form of hormone progestin, preventing pregnancy and reducing heavy bleeding in the process. The hormone is the same as the substance found in certain oral contraceptives.
Since the IUD’s introduction, a fair handful of patients experienced severe side effects, including the following:
- Device expulsion, which has since counted for 45 percent of all complaints to the FDA.
- Pain, which amounts to 25 percent of the total.
- Bleeding, which makes up 21 percent of the complaints
- Pregnancy. Making up five percent of all complaints, this encompasses ectopic pregnancy, miscarriage, or intrauterine pregnancy.
- Uterine or Cervical Perforation, which accounts for three percent.
- Group A streptococcal sepsis
- Pelvic inflammation disease, and subsequent infertility
- Device embedded in the uterine wall
- Breast tenderness
- Painful menstruation
- Vaginal erosion
- Ovarian cysts
Six percent of all IUD recipients have reportedly undergone hospitalization or surgery, either to get the device removed or to treat an associated condition.
Warnings began in 2009, when the FDA sent two letters to manufacturer Bayer, citing overstated effectiveness, minimizing risks, and failure to warn about side effects.
Part of the tactics the FDA targeted were the device’s marketing, such as gearing the IUD toward “busy” women needing “increased” libido and hosting “Mirena Parties.” For the latter, held through social networking site Mom Central, a representative and nurse practitioner met with a group of women essentially to sell them on the IUD. The practice stopped in 2009.
Following the two letters, Bayer and Health Canada put out a statement, saying that intrauterine perforation is rare but increases with pregnancy, during lactation, or with atypical anatomy.
With 600 pending lawsuits as of the end of 2013, all cases have been consolidated into the New Jersey Superior Court in Middlesex County. Plaintiffs with legal representation allege permanent injuries, pain and suffering, lost wages and earnings, a need for laparoscopic surgery to remove the IUD, and economic losses stemming from medical expenses.
Currently, 2 million use an IUD, and 7.5 percent of all women taking birth control have them. If you hadn’t been informed of the risks prior to having an IUD implanted, were subject to deceptive marketing practices, or experienced any of the device’s side effects, have Trantolo & Trantolo’s lawyers assess and represent your Mirena claim.