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The FDA has received more than 47,000 reports of injuries and complications associated with the Mirena intrauterine device (IUD), according to a private company that analyzes adverse event reports submitted to federal health regulators.
Most of the Mirena IUD problems reported to the FDA involved the birth control device being expelled from women’s bodies, migrating to different locations or causing vaginal hemorrhaging, according to the analysis.
The tens of thousands of reports of Mirena adverse event reports were received by the FDA between November 1997 and late August 2012, according to a information provided by Adverse Events, Inc. (AEI), a company that combs through and streamlines reports of problems and side effects reported to the FDA by health care professionals, consumers and others.
The Mirena IUD is a birth control device that is implanted in the uterus to prevent pregnancy for up to five years. It is designed to be easily removable and is promoted as a way to free woman from worrying about birth control. Placement is designed to prevent pregnancy by keeping the sperm from the egg, and the device also releases levonorgestrel, a progestin designed to keep a woman’s ovaries from releasing eggs for fertilization.
In recent years, concerns have grown about the risk of problems with the Mirena IUD where it may perforate the uterus and migrate out of position. A growing number of women throughout the United States are now pursuing a Mirena injury lawsuit against Bayer, alleging that the manufacturer failed to adequately warn about the risk of women experiencing these complications, which could cause infections, damage to internal organs and often results in the need for surgery to remove the IUD.
According to AEI, there have been at least 47,218 adverse event reports submitted to the FDA involving Mirena IUD. Of the problems reported, about 36% involved Mirena expulsion, another 10% of the reports involved Mirena migration inside the body, and 8% reported vaginal bleeding.
About 6% of the reports involved woman being hospitalized as a result of the Mirena problems, and the AEI report identified more than 50 deaths that may have been associated with Mirena adverse event reports.
An estimated 10 million women have had a Mirena implanted inside of them since 2000 according to some reports. As of early last month, at least 50 lawsuits over IUD problems had been filed throughout the federal court system, and many Mirena lawyers investigating potential claims have indicated that it is likely that thousands of cases will be filed in the coming months.