Mirena is a type of intrauterine system (IUD) which is a small, t-shaped, device that is placed into a uterus as a form of birth control. The Mirena device releases progestin hormones called levonorgestrel into the uterus. Unlike other implantable birth control devices, Mirena lasts for as long as a patient would like for up to five years. The reason for the five year limitation is that as time goes on, the the dose of hormones decreases.
Mirena is marketed as being more than 99% effective in preventing pregnancy by thickening cervical mucus to prevent sperm from entering the uterus; inhibiting sperm from reaching or fertilizing a woman's egg; and thinning the lining of the uterus. During clinical studies it was found that Mirena the pregnancy rate was 0.7 per 100 women. Mirena is also said to help treat have menstrual cycles in women who choose intrauterine contraception due to the slow hormone release feature.
In order to use Mirena, the device must be inserted through the vagina and placed into the uterus by a trained physician. The device is usually inserted within seven days after the start of a menstrual period. After each menstrual period, patients should make sure they can continue to feel the removal strings. The device may be removed at any time by a doctor. The doctor will remove the device via the attached string. The arms of the device are flexible and bend up as the device is removed.
Mirena was approved in 2000 by the Food and Drug Administration (FDA) and is currently one of just three hormonal IUDs approved in the United States.
In 2009, the FDA expanded Mirena's existing approval as a birth control device to treat heavy menstrual bleeding in women already using an IUD.
Mirena is manufactured by the Bayer AG subdivision Bayer Pharmaceuticals. The particular division responsible for the manufacturing of drugs and medical products was formed in 2006 when Bayer purchased the pharmaceutical research company Schering AG.
Across the world Mirena is the most popular form of reversible birth control with an estimated 150 million users. Nationally, the use of Mirena continues to grow. Each Mirena device is said to cost approximately $800 which has generated over $1 billion in revenue for Bayer.
Common complications associated with Mirena include:
- Weight gain
- Mood changes
- Ovarian cysts
- Pelvic pain
- Vaginal discharge
- Abnormal bleeding
- Device migration
- Pregnancy complications
- Ectopic pregnancy
A very serious complication of Mirena is organ perforation. Organ perforation can occur when the device perforates or penetrates the organ walls. In some cases, perforation can occur after the device has caused significant erosion of the organ walls. Cases of organ perforation are mostly seen in the uterus and can cause the device to migrate to other parts of the body. Organ perforation is a medical emergency and without proper treatment, the patient may see irreversible medical effects, including infertility.
Ectopic pregnancy is another potentially serious complication associated with the Mirena device. Ectopic pregnancy is a complication of pregnancy where he embryo implants outside the uterine cavity. Ectopic pregnancies usually result in miscarriage. Bayer notes that up to half of the pregnancies that occur with Mirena are ectopic.
In 2009 the FDA issued a warning to Bayer which increased the demand from the public for a device recall to be issued. Within the warning, the FDA looked at the health risks associated with using Mirena and addressed advertising and marketing misconduct from the manufacturer. Bayer had been overstated the efficacy of Mirena while making unsubstantiated claims and misleading statements to consumers. The FDA holds strict requirements that claims regarding quality of life outcomes must be accompanied by substantial evidence.
To date, the FDA has received an estimated 45,000 adverse event reports from users.
In 2012, the first lawsuit related to claims that injury was caused by Mirena was filed against Bayer. Since that time additional lawsuits have been filed based upon claims ranging from misleading marketing, producing a defective product and failing to reveal the dangerous side effects of the device, such as spontaneous migration of the device and perforation of the uterus.
In July of 2016, a New York federal judge ruled in favor of Bayer AG against nearly 1,300 lawsuits filed by women claiming they suffered internal injury after using the Mirena birth control device. The judge said that there was no way for the lawsuits to continue after she ruled that the plaintiffs' expert witnesses would not be able to testify that the Mirena device could cause uterine perforation after insertion. The ruling was based upon the judge's opinion that the testimony would not be supported by scientific literature and would have instead been developed for the purpose of the existing litigation. Without expert testimony a jury would not be able to have a sound basis to find in favor of the plaintiffs.
Representation for Colorado Women Harmed by Mirena
If you have suffered adverse health effects as a result of a faulty medical device, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.