Mirena IUD side effects include uterine perforation, amenorrhea, pelvic inflammatory disease, irregular bleeding, and severe pain and cramping. We are working with some of the leading Mirena IUD attorneys in the United States. A claim and/or Mirena IUD lawsuit can be filed on your behalf and there is no fee until you receive a reward or a Mirena IUD settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.
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As evidenced by the mounting lawsuits and studies, the Mirena IUD has now been linked to severe side effects which include:
- Uterine Perforation
- Ovarian Cysts
- Irregular Bleeding
- Pelvic Inflammatory Disease
- Severe Pain and Cramping
Manufactured and marketed by Bayer Healthcare, The U.S. Food and Drug Administration approved the Mirena IUD as a contraceptive device in 2000 after having been on the market for ten years in European nations. Later in 2009, the FDA approved the Mirena IUD to be marketed as a treatment for heavy menstrual bleeding.
Specifically, the Mirena IUD is a small, "T-shaped" device that is inserted into the uterus by a physician or health care provider and is intended to prevent pregnancy. The hormonal 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 prevent the possibility of pregnancy.
Since its introduction, Bayer Healthcare has faced pressure from lawsuits and warnings from the FDA about its continual failure to warn about the side effects caused by the Mirena IUD.
Mirena IUD Side Effects
A recent string of lawsuits and studies have raised the threat that the Mirena IUD causes the following side effects:
This occurs when the IUD itself does not stay in place wherein the shifting of the plastic device physically tears the uterine wall where it is housed. In addition to the device's shifting, the tears can also result from the improper insertion, too. 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 results from an infection in the uterus or any other of the reproductive organs. The infections are typically caused both by improper device insertion, shifting, and bacteria introduced with the Mirena IUD. Pelvic Inflammatory Disease, or PID, can lead to infertility, ectopic pregnancy (a pregnancy occurring outside the womb, such as the in the fallopian tubes), severe chronic pelvic pain, and abscess formation.
These are collections of fluid in sacs that develop within or on the surface of the ovary. These cysts can become very painful and adversely affect fertility. Additionally, tumors have been known to develop in these cysts.
This is the absence of a menstrual cycle of at least three months in woman. 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 woman using the Mirena IUD. As seen, this is typically a result of the uterine perforation (tear in the uterine wall caused by the Mirena IUD's movement) and Pelvic Inflammatory Disease that result from the Mirena IUD causing infections.
If you have suffered any of these adverse reactions to Mirena, you should contact your doctor immediately. If you think that the medical device Mirena IUD has harmed you, you should then speak with an attorney after consulting with your doctor. An experienced RI Mirena IUD doctor can help you to determine whether you have a case that could hold these pharmaceutical companies responsible for the unsafe medical device that they put on the market.
Mirena IUD Lawsuit and Settlements
Since The U.S. Food and Drug Administration approved the Mirena IUD in 2000 as a contraceptive device for woman, Bayer Healthcare has continued to face lawsuits from users claiming that the pharmaceutical giants failed to properly warn of the side effects. Recently, according to the New Jersey State Court, Bayer Healthcare Pharmaceutical has moved to centralize the 16 outstanding Mirena IUD lawsuits to Middlesex County, New Jersey. In addition to the move by Bayer to manage those lawsuits, the medical device and drug manufacturer is still facing numerous additional lawsuits regarding the Mirena IUD in both state and federal courts. All the lawsuits claim that Bayer failed to properly warn of the risks associated with its Mirena IUD.
A specific claim in the suit was brought by a woman in Indiana who claimed she suffered permanent and physical injuries and had to undergo a corrective operative laparoscopy after the Mirena IUD shifted and left her abdominal wall. (Case No. 61910-12). She alleged that the Mirena IUD label failed to warn of the potential that the device would shift after inserted. Additionally, this claim echoes the other outstanding suits against Bayer in alleging that Bayer has a history of exaggerating the Mirena IUD benefits while understating the potential side effects and complication.
This is not the first time that Bayer has come under fire for its Mirena IUD. In response to Bayer's "Simple Style Campaign," which emphasized and boasted Mirena's simplicity and ease for "busy mothers," the FDA issued a warning to Bayer for misleading consumers, 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 came down on Bayer for advertising unsubstantiated claims and failing to warn of Mirena's side effects regarding 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 harmful side effects regarding Mirena usage before recommending the device. Both the deceptive tactics employed by Bayer and its continual failure to adequately warn users are cited in the cases facing Bayer today saying that Mirena users were unaware of the serious side effects posed by the device's use.
In order to prove that you have a Mirena IUD that should be compensated for, you must prove, in addition to having been injured, that the drug did not have adequate warnings and was defective in the condition upon which it was placed on the market or that the medical device deviated from it's intended design. These lawsuits are very complex and require expert medical and legal opinion.
If you have been injured by the Mirena IUD, please contact an experienced RI Mirena IUD Injury Attorney right away. If you think that the medical device Mirena IUD has injured you, you should speak with an attorney after consulting with your doctor. An experienced RI Mirena IUD attorney can help you determine whether you have a case that could hold the medical device companies responsible for the unsafe and defective products that they put onto the market.
Mirena IUD Medical Studies
While the Mirena IUD is primarily designed to prevent pregnancies, there are cases and reports of woman becoming pregnant despite it use. Moreover, the continued use of the Mirena IUD during pregnancies can have severe side effects to the woman an infant.
In a study published in an issue of the Journal of Perinatal Medicine found that woman who become pregnant even while using an intrauterine device “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 woman 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 the Mirena IUD continues to release the hormone levonorgestral. The embryo's direct exposure to the hormones and the actually device itself could potentially 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 devices use and insertion that have led to septic abortion (a life-threatening condition to the women stemming from a uterine infection, pelvic inflammatory disease, ectopic pregnancy.
About Mirena IUD Manufacturer (Bayer Pharmaceuticals)
The Mirena IUD is manufactured by the Bayer AG subdivision Bayer Pharmaceuticals. Bayer AG is a German holding company and is one of the largest multinational corporations that focuses on medical drugs and products operating today. This particular division, which is responsible for the manufacturing of drugs and medical products, was formed in 2006 as a result of one the biggest takeovers in the healthcare industry when Bayer purchased the pharmaceutical research company, Schering AG, for $19.8 billion dollars.
In addition to the claims of those persons injured while using the Mirena IUD, in 2009, the FDA strongly condemned Bayer for it's marketing campaign for overstating and implying unproven benefits while grossly undermining the product's dangerous side effects. This "Simple Style Campaign" was also condemned by the U.S. Department for Health and Human Services and by the Canadian health regulatory agency, Health Canada.
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 it evident is Bayer's willingness to minimize, or in some cases, completely fail to disclose its products harmful side effects because the company is so large that it can afford to settle claims against when they come up.
Mirena IUD Advertising Campaign
Underlying many of the lawsuits by women injured or who have suffered the severe side effects of Mirena IUD usage is that the product’s marketing campaign misled and deceived them. Known as the “Mirena Simple Style” advertisement campaign, this marketing effort coincided with the introduction of the device in 2000. It asserted that the device was an effective and efficient birth control device for busy mothers because of its simplicity. Additionally, the ad campaign implied that the Mirena IUD promotes intimacy and the emotional satisfaction among the advertisements’ target group.
This marketing campaign has been heavily cited in claims against the manufacturer and has been the subject of sharp criticism from the medical industry and government officials and agencies. The U.S. Food and Drug Administration warned Mirena about making such broad statements that were misleading consumers without including information on the side effects or any evidence that the ad campaign’s claims were true. Additionally, the Department of Health and Human Services came out and strongly criticized the Mirena manufacturer, Bayer, regarding the “Simple Style” campaign in stating that it was deceptive because it made unsubstantiated claims and included no warnings about any of the side effects.
Since the device’s introduction to the market by Bayer, which coincided with the “Mirena Simple Style” marketing initiative, the Mirena IUD quickly gained popularity as a birth control method. However, with the rise in the device’s use, so too did the reports of injuries and severe side effects. Although the ad-campaign marketed the Mirena IUD as an efficient, safe, and smart birth control method for single mothers, reports that the device would move and cause tears in the uterus and cause pelvic inflammatory disease, ovarian cysts, amenorrhea, and general pain and cramping became a hallmark of the product. Many of the lawsuits and criticisms surrounding the Mirena IUD focus on the misleading and incomplete initial advertising campaign that caused so many women to use this device only to suffer a severe injury or side effect soon after.
PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING THE USE OF THE MIRENA IUD.
Contact the Law Offices of d'Oliveira & Associates, P.C.
If you believe that you or a one loved has been injured by the Mirena IUD, you may want to speak with a personal injury attorney regarding a potential claim. A medical device lawyer familiar with new developments in the investigation of Mirena IUD may be able to help you make important personal and legal decisions. d'Oliveira & Associates, P.C. is working some of the leading lawyers in the country who are handling these cases.
Please contact the law offices of d'Oliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.