Mirena: Inadequate Warnings and Devastating Side Effects

June 5, 2013 | Attorney, Matthew Dolman
Mirena: Inadequate Warnings and Devastating Side Effects Since 2000 (when the drug hit U.S. markets), over ten million women have chosen Mirena IUD as their preferred form of contraception. This may be due to their catchy TV commercials or their advertisements targeting busy moms. Mirena's website describes their IUD as highly effective, convenient and reversible. But startling news about Mirena's side effects is being exposed by the media, who are now conducting their own investigations regarding the heightened risks of side effects. The Mirena Intrauterine Device (IUD) is a device manufactured by the healthcare company, Bayer. It is a T-shaped object embedded into the uterus to function as both a birth control method and treatment for heavy menstrual cycles. According to its website, the Mirena IUD works when the hormone levonorgestrel is released from the device, making the mucus in the cervix so thick that sperm can't enter into the uterus.  It is inserted by a doctor, is fairly inexpensive, and requires no upkeep. Sounds genius, doesn't it? For many using Mirena was a good idea, however, using Mirena was an unfortunate mistake for others. According to an Adverse Event Report, 47,505 women have reported Mirena IUD related injuries across the globe from 1997 to 2012. Complications may arise that are severe and devastating to the women that use Mirena, including uterine perforation. Uterine perforation is an accidental puncture of the uterus that may result from any intrauterine procedure including IUD placement and migration of the IUD device. Bayer has admitted this occurs in every 1 per 1,000-10,000 Mirena IUD users. After the IUD punctures the uterus, it may become lost in the abdominal cavity, which can lead to punctures in the intestines, bladder, and bowel. Reports of the IUD becoming lost and embedded in other organs have been recorded, as well. If the wrong organ is damaged, infertility may also occur. Symptoms of uterine perforation include nausea, vomiting, chills, vaginal bleeding, lower abdominal pain, inability to locate the IUD string, and bloating. In 2009, the Food and Drug Administration (FDA) gave warnings to Bayer after they noticed that promotional advertisements for the IUD overstated the effectiveness of the device, and minimized potential Mirena side effects. Among other things, the FDA disputed claims peddling Mirena's ability to improve a woman's sex life and help her “look and feel great.” The healthcare company has chosen not to recall their product. They also opted not to provide additional warnings on the labels, which would inform millions of women of the serious complications that may arise from using this particular IUD. One of the most severe consequences relating to the use of Mirena IUD's is an ectopic pregnancy. This is a life-threatening condition where the embryo is formed outside of the womb- typically within the fallopian tube. With seldom exceptions, ectopic pregnancies are not viable. This means the baby must be aborted. Abortion is a rather controversial and dreadful procedure for women. Ectopic pregnancies are unsafe for the mother because the risk of internal hemorrhaging, a life-threatening complication, is heightened. Current lawsuits in the federal Mirena litigation allege the IUD's label only informs the consumer of the risk of migration upon insertion of the Mirena device. Plaintiffs, however, experienced random migration that occurred long after the IUD‘s were implanted. The only solution to the problem is risky Mirena removal surgery. Over the upcoming months, judges and juries will decide whether Bayer is responsible for designing and marketing a defective drug or failing to provide sufficient warnings on potential side effects of Mirena. Some of the charges against Bayer include defective design, defective manufacturing, negligence, failure to warn, strict liability, breach of express warranty, breach of implied warranty, fraudulent concealment, and fraudulent misrepresentation. Plaintiffs are eligible in seeking a settlement for damages based on past and future medical expenses, lost wages, diminished quality of life, loss of consortium, emotional distress, and unnecessary pain and suffering. If you are a woman who is currently using the Mirena IUD, it is advisable to have it removed if you are experiencing any pain, abnormal bleeding, or any of these other serious side-effects. The described symptoms after removal don't happen to every woman and are not dangerous, as long as suicidal thoughts do not become acute. On the other hand, a migrating IUD (one that moves from its intended location) can lead to internal injuries, multiple surgeries, miscarriage, and possible sterility. (833) 606-DRUG [3784].


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has successfully fought for more than 11,000 injured clients and acted as lead counsel in more than 1,000 lawsuits. Always on the cutting edge of personal injury law, Matt is actively engaged in complex legal matters, including Suboxone, AFFF, and Ozempic lawsuits.  Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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