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FDA has received 47,000-plus side effects reports from Mirena users

The Food and Drug Administration has received more than 47,000 Adverse Event Reports as of September 2012 from patients who suffered side effects from the intrauterine device, according to data published by the agency. Mirena is a type of hormonal IUD that was first approved for sale by the FDA in 2000.

According to the FDA data on Mirena, more than one out of every 20 patients who reported side effects to the agency was hospitalized as a result of the injuries caused by Mirena. Some of the most serious complications that have been associated with the use of a Mirena IUD include uterine perforation, migration of the device outside the uterus, infections, adhesions, infertility, and pregnancy complications.

Numerous Mirena lawsuits have already been filed by women who suffered serious complications after using the hormonal IUD. According to the lawsuits filed against Bayer, the manufacturer of Mirena, the company failed to properly warn patients about the side effects of the birth control device, placing them at risk of serious injury from the IUD.

According to a warning letter sent by the FDA in 2009, Bayer overstated the effectiveness of Mirena while understating the risk of side effects posed by the device. The FDA cited a number of potentially serious complications that users may face, many of which may require surgical intervention in order to correct.