ClassAction.org is reporting that women who filed lawsuits against Bayer regarding its Mirena intrauterine device (IUD) allege that the manufacturer made false and misleading statements through its direct-to-consumer marketing campaign known as “Mirena parties.” According to the plaintiffs, many women chose Mirena for its supposed convenience, which was touted at these parties, and as a result, were put at risk for serious complications including infections, ovarian cysts and hemorrhages. In 2009, the FDA ordered Bayer to end this marketing campaign, finding that the statements made during these “parties” lacked scientific evidence, were misleading and did not fully disclose Mirena’s side effects.
During “Mirena parties,” a nurse practitioner and a representative from a social media website working with Bayer would allegedly read from a script that marketed the contraceptive to “busy moms.” The script states that Mirena will make women “look and feel great” and will help “increase intimacy” for busy couples. In addition, at the “parties,” women were told that Mirena was convenient because the contraceptive required “no daily, weekly or monthly routine.”
The FDA in 2009 sent Bayer a warning letter regarding these “parties,” claiming that the presentations made “false and misleading” statements about Mirena. After reviewing the script from these parties, the FDA determined that Bayer had not provided any scientific evidence to support many of its claims about Mirena, including that it would help improve the way women look and feel. With regard to Bayer’s claim that Mirena would help “increase intimacy,” the FDA pointed out that women in clinical studies reported adverse side effects including weight gain, ovarian cysts and acne that could potentially have an adverse effect on intimacy. Furthermore, the script stated that Mirena was different from other contraceptives because it did not require a maintenance routine; however, the FDA said that this statement was false, because women are required to monitor the device on a monthly basis to ensure that it is working to prevent unwanted pregnancies.
Although the “Mirena parties” did provide women with warnings about some adverse side effects including pelvic inflammatory disease and ovarian cysts, the FDA concluded that these warnings were inadequate. The FDA also found that these warnings did not inform women that Mirena may cause miscarriages and fertility problems. In addition, the device may put women at an increased risk for having an ectopic pregnancy (pregnancy that occurs outside of the womb), according to the agency.
Due to the misleading claims made at these parties, many women may not have been aware of the serious side effects associated with Mirena. According to lawsuits, the device can migrate from its original position in the uterus and embed itself within body tissue, which can cause further complications such as organ perforation and hemorrhages.
If you were injured after being fitted with the Mirena IUD, you may be able to seek compensation for your injuries through a lawsuit. For more information on your potential legal rights, visit http://www.classaction.org/mirena today and fill out our free case review form.
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