Mirena IUD is a type of contraception approved by the FDA in 2000. More than 2 million American women and 15 million women worldwide currently use the popular birth control device, according to the National Law Journal. In July 2008, the FDA approved changes to Mirena’s labeling to reflect the complaints received by the federal agency. As of August 2012, the FDA received over 47,222 adverse event reports with regard to this intrauterine device.
What is Mirena?
Mirena is a flexible T-shaped plastic device that doctors insert into a woman’s uterus to provide up to five years of continuous birth control. It releases small amounts of progestin hormone to prevent pregnancy.
According to its own website, the main selling point of the IUD is convenience. Those who choose this form of contraception do not require commitment to a daily routine, nor must they make regular trips to the pharmacy. Once the device is in place, women can simply forget about it and go on with their daily lives and enjoy 99% rate of effectiveness in preventing pregnancy. Finally, Mirena is touted as a proven way “to treat heavy periods.”
Mirena side effects
RXList.com says the most common side effects of Mirena are: amenorrhea (lack of periods), inter-menstrual spotting, abdominal pain, ovarian cysts, headaches, acne and depression. The drug may also interfere with the use of insulin, warfarin and steroids. While no harmful effects on fetal development have been reported, small amounts of progestin do pass into the breast milk of nursing mothers, which will show up as steroids in the baby’s blood. The FDA cautions against use by women with a history of ectopic pregnancy or pelvic inflammation.
More serious Mirena side effects may include complications such as:
* Migration of the device
* Uterine perforation
*Pelvic inflammatory disease (PID)
*Life-threatening ectopic pregnancy
*Emergency surgical removal
Device migration is the most commonly alleged side effect of Mirena in the growing number of lawsuits that have been filed. Such complaints commonly allege that the IUD moved from the top of the uterine cavity into the uterus or outside the uterus entirely. Uterine perforation or perforation of other internal organs is often a consequence IUD migration.
Women who develop signs of serious Mirena side effects should seek medical attention. Such indications include:
*Severe cramping or pelvic pain
*Dizziness and feeling faint
*Ongoing vaginal bleeding or discharge
*Pale skin, weakness, numbness, easy bruising
*Fever and chills
*Nausea / vomiting
Mirena IUD lawsuit update
Mirena IUD lawsuits have been consolidated at both the state and federal levels. In a transfer order filed on April 8, 2013, federally filed cases were redirected for coordinated pretrial proceedings in the Southern District of New York. The order applied to more than 100 previously filed legal claims against Bayer Healthcare. At least 173 additional plaintiffs are suing Bayer in the Superior Court for Bergen County where Judge Brian R. Martinotti is presiding over consolidated claims filed in New Jersey state court.
In all Mirena lawsuits, patients report serious effects including uterine perforation and organ damage as a result of IUD migration. Infertility, surgical removal, and hysterectomy have also been alleged. For more information about these lawsuits, click here.
Plaintiffs accuse Bayer of:
*Misrepresenting the benefits of Mirena IUD
*Failing to warn patients and their doctors of the risks associated with the product
*Engaging in deceptive marketing practices
*Neglecting to provide adequate written warnings
*Breaching implied and express warranties
*Knowingly designing, manufacturing, marketing and selling a defective device
They are seeking compensation to cover medical expenses, pain and suffering, as well as punitive damages.
Lance Andrews writes for Injury Lawyer News, where he reports on the effects of dangerous drugs and medical devices as well as recalled products. A journalism graduate with a background in medical studies brings a uniquely informed point of view to his writing. He is committed to patient safety and consumer rights. You can read more of his reports on Mirena IUD here