Florida Mirena IUD Attorneys
Mirena is an intrauterine device, or IUD, that is inserted into the uterus for the purpose of long-term contraception. After being inserted, Mirena releases hormones to prevent pregnancy. The device can stay in place for up to five years. In recent years, many users of Mirena have reported dangerous side effects. Users of Mirena may be entitled to compensation if use of the device has caused injuries or conditions.
Mirena FDA Complaints
Mirena was approved by the FDA in 2000. Since its approval, the FDA has received thousands of complaints regarding Mirena. The most common complaint is in relation to IUD expulsion. If the IUD is expelled from its optimal position at the top of the uterus, users may experience discomfort, pain, and cramping. IUD expulsion also makes users susceptible to pregnancy. In addition to expulsion complaints, there have been a number of side effects associated with Mirena IUD.
Mirena IUD Side Effects
Users of Mirena have experienced serious side effects in some cases, including ectopic pregnancy, pelvic inflammatory disease, and sepsis. In some cases, the device has become embedded in the uterine wall or perforated the cervix or uterus. Embedding and perforation complications may be allowed to become more severe, because symptoms are often limited. Mirena IUD users may also experience less severe side effects such as pelvic pain, unusually heavy menstruation, recurring headaches, and spotting.
Possible Side Effects
Mirena IUD has also been associated with an increased risk of developing serious conditions such as:
- Cervical cancer
- Breast cancer
- Thyroid cancer
- Bladder cancer
- Prostate cancer
- Colon cancer
In July 2008, the FDA made changes to the labeling of Mirena IUD. The labeling for Mirena is now required to warn users of potential side effects and factors that may increase the risk of injuries and conditions associated with the use of Mirena IUD. Patients with high blood pressure or cancer, patients that have had a stroke, and patients that experience frequent headaches or migraines are cautioned against using Mirena.
False Mirena IUD Advertising
In December 2009, the FDA issued a letter to Bayer, the manufacturers of Mirena IUD. In the letter, the FDA warned that certain claims made by Bayer overstated the usefulness of Mirena IUD. In advertisements, Mirena IUD had been marketed as a way that busy moms could simply life because the device required no daily, monthly, or weekly routines. Advertisements also claimed that Mirena could make women “look and feel great” and that women using Mirena were “more likely to be intimate.” The FDA regarded these claims as false and misleading.
Bayer Negligence Claims
In addition to engaging in misleading advertising, Bayer has been accused of negligence for releasing a defective device and failing to adequately warn users and health care providers of side effects. In some cases, Bayer failed to warn physicians of the side effects, while in other cases Bayer described serious side effects as uncommon. Claims further indict Bayer for concealing side effects and willfully endangering users of the device.
Lawsuits against Bayer
There are currently many lawsuits against Bayer in regards to Mirena IUD. In New Jersey, the decision was made to centralize Mirena IUD litigation due to the increasing number of claims with similar allegations. Similar centralization techniques have been used in other states to increase the efficiency of processing the large number of complaints.
Mirena IUD Attorneys
Mirena IUD users that have sustained injuries or developed conditions after using the device are encouraged to find an attorney with experience in pursuing legal action against drug companies. Drug companies often use the defense that users were forewarned of side effects in advance. Experienced attorneys can help victims provide evidence that warnings were insufficient or incomplete and that the risks versus benefits were not clearly communicated. Victims may be awarded compensation for medical costs, lost wages, and pain and suffering. Punitive damages may also be assessed against Bayer for deceptive advertising.
“About Mirena.” Mirena. Bayer HealthCare Pharmaceuticals, 1 Aug. 2014. Web. 24 Oct. 2014. <http://www.mirena-us.com/>
Erian, Mark. “The Wandering Mirena: Laparoscopic Retrieval.” Journal of the Society of Laparoendoscopic Surgeons 15.1 (2011): 127-30. National Center for Biotechnology Information. U.S. National Library of Medicine. Web. 24 Oct. 2014. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134688/>
“Mirena (levonorgestrel-releasing Intrauterine System) July 2008.” U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 19 June 2009. Web. 24 Oct. 2014. <http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121936.htm>