Wading Through the FDA’s Mirena Reports

Washington, DCAs with many other drugs, Mirena side effects run the gamut from mild to severe. And also similar to many other drugs, the Mirena birth control side effects that are severe are reportedly life threatening. But as a news report shows - and as Mirena side effects lawsuits allege - there is some concern among women and critics that the risk of side effects does not outweigh the benefits.

The report is 13,434 pages (although some reports could be duplicates about the same patient but from a different source) and was obtained by WXYZ News (8/27/13) in response to a Freedom of Information Act request. To be fair, not all of the adverse reactions are serious or life threatening. Like all drugs and medical devices, Mirena comes with a risk of non-serious side effects. Some of the side effects mentioned in relation to Mirena include rash, amenorrhoea (absence of menstruation) and acne.

But other reports include adverse events such as “device expulsion,” in which the Mirena intrauterine device becomes dislodged from the place it was implanted, vaginal haemorrhage, abdominal pain and uterine perforation, in which the device perforates the woman’s uterus. These are all serious or potentially serious side effects. And according to WXYZ News, more than 1,300 women have complained about Mirena uterine perforation since 2008. Women who have suffered side effects have required hospitalization and, in some cases, surgery to repair the damage done, including a reported hysterectomy.

Some women have even reported ectopic pregnancy linked to their use of the Mirena device, while others linked infertility to the IUD. These side effects might be acceptable to some women if there were no other alternatives, or if they had been warned about the risks. But lawsuits filed against Bayer, maker of Mirena, allege the company did not adequately disclose that Mirena had a greater risk of migration than other IUD products.

Not all medical professionals believe there is a problem with the Mirena IUD. They, and the FDA, contend that the risk of birth defects is outweighed by the benefits.

Mirena is a hormonal birth control that is implanted into the woman’s uterus. Approximately two million women are estimated to be using Mirena. A case management conference (In re: Mirena Litigation; Case No. 297) was reportedly scheduled for September 25, 2013, with a multidistrict litigation conference scheduled for the next day.