The Mirena Intrauterine Device (IUD) was approved by the Food and Drug Administration (FDA) in 2000 for use as a contraceptive and in 2009 “to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention”. Mirena was not the first IUD on the market, but Mirena offered the promise of additional protection by delivering a slow release of hormones into the system of users. Since approval, women have reported numerous problems. Learn why.
Did you use Mirena? Do you believe you have been injured? Problems with the popular IUD such as migration, perforation, vaginal hemorrhage and surgery have been reported in Mirena cases as possible complications. If you have concerns please fill out our contact form to the right or call our toll-free number. All calls are confidential. You can request to speak with a female representative.
Mirena lawsuit: FAQ
- How much does it cost to get a case evaluation? The initial consultation is free.
- How much does it cost to file a Mirena litigation case? You will not be asked for any upfront payments. Cases are taken on a fee contingent basis.
- How do I know if I have a Mirena case? During a free case evaluation, you will be asked several questions and offered answers. Medical records must be reviewed. A Mirena lawyer can assist you with this process.
- Am I entitled to money for my pain and suffering? Medical device cases are complex. Many factors can affect the outcome including the resources available to your Mirena attorney. Please feel free to discuss all concerns.
What are the potential Mirena side effects?
- Migration: (Source: RadioGraphics) “migration of the IUD from its normal position in the uterine fundus is a frequently encountered complication”
- Expulsion: (Source: RadioGraphics) “Expulsion or intrauterine displacement of the IUD leads to decreased contraceptive efficacy
- Perforation: (Source: RadioGraphics) “Complete uterine perforation, in which the IUD is partially or completely within the peritoneal cavity, requires surgical management, and timely and direct communication with the clinician is essential in such cases. Careful evaluation for intraabdominal complications is also important, since they may warrant urgent or emergent surgical intervention.”
What is Mirena?
Mirena manufactured by Bayer Pharmaceuticals, was initially approved in 2000 as a contraceptive device. It is a small (3cm in length) medical device made of soft plastic that is inserted through the cervix into the uterus (womb). It is intended to be a long term method of contraception and is marketed to last about 5 years.
Intrauterine devices (T-shaped devices inserted into the uterus) have been around for decades and were originally made of copper. Mirena is referred to by the manufacturer as an Intrauterine System rather than a Intrauterine device. The typical copper IUD is just that, an IUD whereas Mirena includes a hormonal reservoir in the neck of the device that provides for a slow release of low dose hormones (estrogen and progestin) into the woman’s body to among other things, assist in the prevention of pregnancy. It was marketed to women as a long term, effective, low risk contraceptive that later (2009) was approved to control heavy periods.
FDA statements about Mirena
Various allegations have been made against Bayer Pharmaceuticals in Mirena cases. The range of allegations made against the manufacturer, vary from false marketing claims to failure to warn about possible side effects potentially associated with the device.
A letter sent from the Department of Health and Human Devices – Food and Drug Administration (FDA) to Bayer Pharmaceuticals makes the following statements regarding marketing claims as well as potential risks associated with the device.
“Overstatement of Efficacy/Unsubstantiated Claims” (as quoted by the FDA)
“Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.”
The letter describes certain promotional materials used by Bayer to market Mirena then offers the reasons why the material might be misleading. According to the FDA the statements are misleading because, say’s the FDA:
Statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes, such as those described above, must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review. We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libidoas a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy.
FDA on Mirena side effects:
The same letter sent to Bayer concerns Mirena side effects that may possibly be relevant to Mirena litigation. There are time limits for Mirena litigation. Those time limits are based on several factors and may include FDA dates of FDA alerts and warnings as well as State and Federal regulations. In a letter addressed to Bayer Pharmaceuticals from the FDA the following precautions were noted:
- “The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea. Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility”
Have you used Mirena? Do you worry that you have been injured?
Women face special challenges regarding their personal healthcare. Sometimes you need help. If you have a medical problem you need the advice of a healthcare professional. If you believe you have been injured by a medical device such as Mirena, you may need legal counsel. Do you prefer a female representative? It is easy to make that request. Please fill out our contact form our call our convenient toll-free number. Case evaluations are free and confidential.