Boston, MAThe number of reports of women suffering from Mirena side effects continues to grow, but even though the US Food and Drug Administration (FDA) receives the reports, it has not changed its stance on the safety of Mirena birth control. Side effects reportedly associated with the intrauterine device include Mirena uterine perforation, a potentially serious condition.
According to the US Food and Drug Administration (FDA) Adverse Event Reporting System, in response to a Freedom of Information request, the FDA has received thousands of cases of side effects linked to Mirena from April 2, 2008 to April 2, 2013. The report, which was obtained by WXYZ News (8/27/13) and runs more than 13,000 pages, notes that total cases may include duplicate patient reports from different sources about the same patient. Not all reports of adverse events are as serious as uterine perforation. Some, for example, involve irregular periods. But others report device dislocation, device expulsion and vaginal hemorrhage. Some reported infertility linked to their use of Mirena.
The ages of the patients in the reports range from 14 years old to more than 50 years old.
Patients who have written to Lawyers and Settlements complain about pain, severe cramping, heavy bleeding and perforation of the uterus.
Mirena is an intrauterine device, implanted in the woman’s uterus. But some women have reported side effects, including having the birth control migrate out of the uterus, possibly causing damage to other internal organs and requiring surgery to remove the device.
In 2009, Bayer received a warning letter concerning its marketing of Mirena. The letter accused Bayer of overstating the efficacy of Mirena, presenting unsubstantiated claims, minimizing the risks and including false or misleading information. According to the FDA, Bayer failed in the promotional material at issue to properly convey that a woman could “lose her baby or her fertility” if she were to become pregnant while using Mirena.
Lawsuits have been filed against Bayer, maker of the Mirena IUD birth control, alleging women suffered serious side effects as a result of using the device. So far, according to WXYZ, there are more than 220 lawsuits filed claiming women were not adequately warned about the risk of device migration.
One such lawsuit (federal case number 2:13-cv-04419-JP) was filed by a woman who says she received the device in spring 2009, and suffered device migration requiring surgery to remove the IUD. According to The Pennsylvania Record (8/1/13), the lawsuit alleges Bayer knew the Mirena IUD had a higher risk of migration than other IUDs but did not adequately disclose that risk. The plaintiff seeks compensatory damages, punitive damages, and attorney’s fees and costs.
Bayer has also faced lawsuits for some of its other birth control products, including Yasmin and Yaz. Those lawsuits allege Yasmin and Yaz - birth control pills - are linked to an increased risk of blood clots.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Mirena IUD claim at no cost or obligation.