The woman also claims that officials at Bayer Pharmaceuticals knew that the product posed such risks and put it on the marketplace without adequate warnings to consumers, according to the file.****
The Mirena IUD received approval from the Food and Drug Administration in 2000 as a contraceptive and was approved to treat heavy menstrual bleeding in 2009.
The device is a t-shaped IUD, which, after being placed in the uterus, is supposed to serve as a method of preventing pregnancy for as many as five years. The method of contraception is the release into the uterus of the progestin levonorgestrel to prevent the release of eggs in a woman's ovaries.
"Among the allegations in these cases is that the use of the Mirena IUD led to medical conditions including ectopic pregnancy, infertility, perforation of the uterine wall, cervix and pelvic organs, embedment of the device in the uterine wall or other organs, migration of the IUD, infertility, pelvic inflammatory disease and serious infections that may have required surgical removal of the device,” said Resource4thePeople.
Resource4the People also notes that the U.S. Food and Drug Administration raised objections to the marketing of the device as a safe, convenient alternative to birth control pills and other contraceptives.
The FDA issued a warning letter****** to Bayer officials in 2010 in which FDA regulators objected to the marketing campaign, admonished Bayer and told the company that it was downplaying the health risks of the Mirena IUD while overstating its benefits.
"The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena," the FDA said. "Thus, the p
Copyright©2012 Vocus, Inc.
All rights reserved