Over 47,000 Mirena Adverse Events Reported to FDA

More than 47,000 adverse event reports regarding the Mirena IUD have been submitted to the FDA, according to recently-released data. Most reports relate to migration or expulsion of the device, as well as more serious Mirena side effects such as perforation of the uterus and infection.

The data was collated by a company called Adverse Events, Inc., which trawls FDA information from a range of sources, including physicians, healthcare workers and consumers. The adverse event reports were collected between November 1997 and August 2012.

The Mirena IUD was initially marketed as a safe, easily removable form of long-term contraception. Designed to give women five-year protection from unwanted pregnancies, the T-shaped device also releases progestin, thickening the cervical mucus and diminishing the mobility of sperm.

In recent years there have been growing concerns surrounding the risk of serious Mirena side effects, with numerous women filing lawsuits against the manufacturer, Bayer. Complainants allege the company failed to adequately warn consumers of the risk of complications that in many cases – including perforation of the uterus – require multiple revision surgeries to correct.

Of the 47,218 adverse event reports submitted to the FDA, around 36% involved expulsion of the device (an event that frequently goes unnoticed, leaving women open to unwanted pregnancies). Some 10% of the reports related to migration of the IUD, and 8% to vaginal bleeding. Mirena side effects required hospitalization in around 6% of cases, and Adverse Events, Inc. have implicated the device in at least 50 deaths.

More than ten million women use Mirena IUD

The scale of the problem may be even greater than the figures suggest, with 10 million women having been implanted with the Mirena IUD since 2000. At least 50 lawsuits have been filed in federal court, and legal experts expect that number to rise significantly.

Mirena side effects reported by plaintiffs include:

• perforation of the uterus
• infection
• ectopic pregnancy
• abcesses
• peritonitis
• infertility
• ovarian cysts

Mirena lawsuits consolidated

Lawyers representing some of the women who have suffered Mirena side effects met last month to discuss moving forward with the recently-announced multidistrict litigation (MDL) proceeding against Bayer. The cases have been centralized in the Southern District of New York in order to reduce duplication of evidence and avoid conflicting pretrial rulings.

At least two of the lawsuits are reportedly at an advanced stage of dicovery, with most of the evidence in. The presiding judge has indicated that Bayer should make the facts of those cases available for wider use in the ongoing MDL.

For their part, Bayer has consistently opposed the MDL, claiming their defense would be prejudiced by negative press if there was any delay in the start date of the first hearings. The company has also argued that publicity surrounding the MDL would encourage women to file frivolous lawsuits.

In addition to the federal complaints, there are approximately 110 lawsuits pending in New Jersey state court, and other cases in states across the country. Legal action against Bayer is also underway in Canada, with one plaintiff requesting class action status for her Mirena side effects lawsuit.