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Analysis of FDA records reveals 60,000 Mirena side effects reports over four year period

A recent analysis of Adverse Event Reports (AERs) received by the Food and Drug Administration has revealed that the health agency received nearly 60,000 complaints about the hormonal intrauterine device Mirena over a four year period. The data—made public though a request made under the Freedom of Information Act—covered all reports of adverse events linked to Mirena that were filed with the agency between April 2008 and April 2012.

Many of the side effects reported by Mirena users were extremely serious, posing a risk of permanent complications if not properly treated. The FDA data revealed more than 1,300 cases of uterine perforation among Mirena users, in which the IUD became loose, causing damage to the uterine wall. In some cases, women who experience perforation of the uterus caused by Mirena may be left permanently incapable of having children as a result of their internal injuries.

Other serious complications from Mirena that have been reported to the FDA include migration of the IUD outside the uterus, adhesions, excessive bleeding, severe abdominal pain, and complications requiring surgery. Women who become pregnant while using a Mirena IUD may also be at risk of complications affecting their own health or that of their child, including ectopic pregnancy, miscarriage, premature delivery, septic abortion, or permanent infertility.

Women who have suffered side effects from Mirena have filed numerous lawsuits against Bayer, the manufacturer of the IUD. These Mirena lawsuits have alleged that Bayer failed to properly warn patients about the health risks of Mirena while simultaneously overstating the effectiveness of the IUD.