FAERS Database Shows Thousands of Women Suffered Complications From the Paragard IUD
The Paragard intrauterine device (IUD) is implanted into a woman’s uterus, providing contraception. Rather than release hormones, the Paragard IUD releases copper to prevent pregnancy. The Paragard IUD has been on the market since 1988 but complications concerning the medical device have not been publicized until recently.
Adverse events associated with a drug or medical device only become known if they are reported. The United States Food and Drug Administration (FDA) has a database, called the FDA Adverse Events Reporting System (FAERS), that records voluntary reports by patients and physicians concerning complications with a drug or medical device.
Upon investigation of the FAERS database, more than 3,000 reports of Paragard IUD device breakage were identified since 2013. Because the FAERS database records voluntary reports, the total number of complications relating to device breakage may be much higher.
Nearly 2,000 instances of device breakage were considered serious injuries, with 102 of the reported instances resulting in hospitalization or life-threatening injuries. Although a few thousand reported complications may not seem sizable when considering how many women are implanted with the Paragard IUD, most patients are unaware they have a way to report complications to the FDA.
As such, the true number of Paragard IUD complications involving device breakage could be much higher. Recent lawsuits demonstrate that device breakage associated with the Paragard may be worse than previously thought.
Because of the large number of lawsuits being filed, a federal multidistrict litigation (MDL) was set up in the Northern District of Georgia. Injuries alleged in these lawsuits include, among others, surgery to remove embedded pieces of the Paragard that have broken off, infection, perforation of nearby organs (from device migration), and significant pain.
Paragard Device Breakage – What Did the Manufacturer Know?
The Paragard IUD is a contraceptive medical device that is not supposed to break when inside the body or upon removal from the body. However, reports and recent lawsuits allege the device does break. The label that accompanies the Paragard instructions or directions for use – which patients do not always see – indicates in fine print that there have been reports of device breakage, saying nothing more about the potentially dangerous safety issue.
Medical devices can be beneficial for patients, but manufacturers have a duty to not only know about potential complications but to also warn about those complications they know about or should know about. Given the Paragard label makes at least one mention of device breakage, the manufacturer has been aware (for quite some time) that a problem exists.
Yet, no additional studies or testing have addressed the safety issue. Although the FDA is aware of widespread safety concerns, the FDA has not taken any steps to require additional testing or enhanced warnings concerning Paragard and device breakage.
Contact the Paragard IUD Lawyers of Searcy Denney Today
If you or a loved one has sustained injuries following implantation of a Paragard IUD device (such as following a removal procedure), you or your loved one may qualify to receive compensation. However, because time is limited to file a claim, acting quickly is essential.
The Paragard IUD lawyers of Searcy Denney are no strangers to large mass tort litigation involving multi-billion-dollar pharmaceutical companies. With the help of our legal team, injured clients have recovered compensation for suffering severe, debilitating, and permanent injuries.
If you would like a free case evaluation concerning your potential Paragard IUD claim, contact Searcy Denney today by calling (800) 780-8607 or by completing a case inquiry form on our website.