Mirena IUD side effects include perforated uterus, pelvic inflammatory disease, ovarian cysts, bleeding, etc. Our firm is working with some very experienced Mirena IUD attorneys who can file a lawsuit on your behalf and charge no fee until you receive a settlement or award. Give us a call toll free anytime or visit us online for your free legal consultation.
Mirena lawsuits and studies are on the rise given the device’s link to a number of severe side effects. Manufactured and marketed by Bayer Healthcare, the U.S. Food and Drug Administration approved the Mirena IUD as a contraceptive in 2000. Later in 2009, the FDA approved its marketing as a treatment for heavy menstrual bleeding. The Mirena IUD is a small, T-shaped device that is inserted into the uterus by a physician or health care provider in order to prevent pregnancy. The device is coated with a certain level of “levonorgestral,” a type of progestogen, which effectively regulates the release of more levonorgestral. This hormonal regulation is designed to eliminate the risk of pregnancy. Since its introduction, Bayer Healthcare has faced the threat of a Mirena IUD lawsuit by many people and warnings from the FDA about its continual failure to adequately warn patients about the side effects caused by the Mirena IUD.
Mirena IUD Side Effects
This occurs when the IUD does not stay in place, and its shifting ends up physically tearing the uterine wall where it is housed. In addition to the device’s shifting, the tears can also result from improper insertion of the device. These shifts not only tear the uterine wall and leave those areas susceptible to infection, but also render the device ineffective as a contraceptive.
Pelvic Inflammatory Disease
This condition results from an infection in the uterus or any of the other reproductive organs. Infections are typically caused by improper device insertion, shifting, and introduction of bacteria by the Mirena IUD. Pelvic Inflammatory Disease (PID) can lead to infertility, ectopic pregnancy (a pregnancy occurring outside the womb, such as in the fallopian tubes), severe chronic pelvic pain, and abscess formation.
These cysts are fluid-filled sacs that develop within or on the surface of the ovary. They can become very painful and lead to infertility or advance into tumors.
Amenorrhea occurs when a woman does not go through her menstrual cycle for at least three months. Classified as either primary (cycles never begin) or secondary (regular cycles cease), the Mirena IUD has been increasingly linked to causing secondary amenorrhea.
Pain and Cramping have been reported in a significant number of women using the Mirena IUD. This is typically a result of the uterine perforation and PID that result from the device.
Mirena IUD Side Effects
Bayer Healthcare has continually faced lawsuits alleging a failure to warn of the risks associated with use of the Mirena IUD. One such claim was brought by an Indiana woman who claimed she suffered permanent and physical injuries and had to undergo a corrective operative laparoscopy after the Mirena IUD shifted inside of her. (Case No. 61910-12). She alleged the device’s label failed to warn of potential shifting after insertion. Her claim echoes others against Bayer that allege the company has a history of overstating Mirena IUD benefits while understating potential side effects.
This is not the first time the company has come under fire for the Mirena IUD, however. In response to Bayer’s “Simple Style Campaign,” which emphasized and boasted Mirena’s simplicity and ease of use for “busy mothers,” the FDA issued a warning to Bayer for misleading consumers; specifically, failing to include information about the side effects, and lying about Mirena’s routine uses. DDMAC, the Division of Drug Marketing, Advertising, and Communication, of the U.S. Department of Health and Human Services also reprimanded Bayer for advertising unsubstantiated claims and failing to warn of side effects in the ad campaign. Further, in response to a growing number of Mirena IUD users experiencing uterine perforation, Health Canada, the Canadian regulatory agency, urged doctors to consider the device’s harmful side effects before recommending its use. Both the deceptive tactics employed by Bayer and its continual failure to adequately warn users of the product’s side effects are cited in cases against the company.
The recent consolidation of Mirena IUD lawsuits and the strong warnings from the FDA that Bayer received for its deceptive marketing campaign of the Mirena IUD closely mirrors the problems regarding another Bayer birth control product: Yasmin. After consolidating over 1,900 separate claims against Bayer for failure to disclose about the risk of blood clots, the healthcare manufacturing giant agreed to settle for more than $402 million. Moreover, it has been reported that Bayer had set aside at least $610 million just for potential settlements regarding Yaz/Yasmin.
While it is yet to be determined if the Mirena lawsuits will rise to the level of the Yasmin claims and settlement, what is evident is Bayer’s willingness to understate its products’ harmful side effects because the company is so large that it can afford to settle these types of claim as they arise.
Elements of a Mirena Lawsuit
In order to show that you have a compensable Mirena claim, you must prove, in addition to having been injured, that the drug lacked adequate warnings and was defective in the condition upon which it was placed on the market, or that the medical device deviated from its intended design. These lawsuits can be extremely complex and may often require both medical and legal expert opinions.
Mirena IUD Medical Studies
While the Mirena IUD is primarily designed to prevent pregnancy, there are cases and reports of women becoming pregnant in spite of its use. Moreover, the continued use of the Mirena IUD during pregnancies can have severe side effects to the woman and her infant.
In a study published in the Journal of Perinatal Medicine, findings indicated that women who leave intrauterine devices in during their pregnancy “are at a very high risk for adverse outcomes,” including potentially life-threatening complications such as ectopic or tubal pregnancies. The study reported that 56 percent of those women who became pregnant despite the use of an IUD had a miscarriage. Moreover, the study found that woman using products like the Mirena IUD were three times more likely to suffer from a placental abruption. The fetus is potentially also at risk when users of the Mirena IUD become pregnant because of the device’s continued release of levonorgestral. The embryo’s direct exposure to this hormones and also the device itself could result in severe side effects to the developing fetus because, as Contracept.org states, “[the] mechanisms of the IUD are not completely understood.”
Severe cases have been reported where users of the Mirena IUD have been infected by germs resulting from the device’s use and insertion that have led to septic abortion (a life-threatening condition to the woman stemming from a uterine infection), pelvic inflammatory disease, and ectopic pregnancy.
Contact the Law Offices of d’Oliveira & Associates
If you or a one loved has suffered severe injury or side effects as a result of using the Mirena IUD, you may want to speak with a personal injury attorney regarding a potential claim. A Mirena lawyer familiar with new developments in the investigation of this product may be able to help you make important legal and personal decisions. d’Oliveira & Associates is working closely with attorneys across the country who handle these types of cases and would be happy to assist you with yours.
Call d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for your free legal consultation.