No Mirena recall has ever been announced, despite the number of lawsuits and adverse event reports tied to the IUD. In fact, the Mirena IUD is growing in popularity. However, as the number of Mirena IUD lawsuits continue to mount, it is likely that calls for a recall will increase.
Mirena Adverse Event Reports
As of June 30, 2012, the U.S. Food & Drug Administration (FDA) had received 45,700 reports of adverse events where Mirena was identified as the primary suspect drug causing the event. Of those, 2,500 Mirena complications resulted in hospitalization, while 350 were deemed life-threatening, and 426 resulted in disability.
Device migration or dislocation was the second most common Mirena complication reported to the FDA. When the Mirena IUD migrates from its proper location, serious injuries can occur, including:
- Organ Damage
- Perforated Uterus
- Intestinal obstruction or perforation
- Pelvic Inflammatory Disease
- Ectopic Pregnancy
These Mirena complications can endanger a woman’s fertility, as well as her life. In many instances, victims must undergo surgery, and even emergency medical treatment, to correct Mirena injuries.
Mirena FDA Warning Letter
While there has been no recall of the Mirena IUD, Bayer Healthcare Pharmaceuticals did receive an FDA Warning Letter in 2009, after the agency determined one of its marketing programs for the IUD was misleading. The letter cited information contained in scripted talks delivered by nurses at so-called “Mirena Parties” that were held in consumers’ homes. The parties were organized through the social networking site, Mom Central. Among other things, women attending were told using Mirena could improve their sex lives and help them “look and feel great.”
Among other things, the FDA warning letter stated that the agency was not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. In fact, the FDA pointed out that some Mirena users experience a decrease in libido and other minor side effects, such as headaches and nausea, which could negatively impact their sex lives. The FDA also said the script minimized the risks associated with the Mirena IUD.
Harmed by Mirena? Consider filing a Mirena IUD Lawsuit.
Even though there hasn’t been a recall, victims of serious Mirena complications, including spontaneous device migration and uterine perforations may be entitled to compensation for their medical bills, lost wages, pain and suffering, and other damages. If you suffered a Mirena injury, be sure to seek medical attention immediately. Keep track of your doctor’s appointments, any hospitalizations, and time absent from work due to your injury or treatment. You should also obtain a copy of your medical records from your physician, as they will be important evidence in your Mirena lawsuit.
The attorneys at Bernstein Liebhard LLP offer free lawsuit evaluations to victims of Mirena complications. For more information about a Mirena recall, or to learn more about filing a Mirena IUD lawsuit please contact us today, at 1-888-364-6688 or submit the free case evaluation form on this page.