What You Should Know About Paragard IUD Side Effects and Recall Info?

Legally Reviewed and Edited by: Terry Cochran

Paragard Copper IUD is a popular long-term non-hormonal contraceptive that has been used by women in the US since 1988. In addition to the known Paragard IUD side effects, women are now filing lawsuits alleging serious injuries and long-term complications when using and during the removal of Paragard IUD. Although the FDA has not issued a recall for the IUD, it approved an updated warning label in 2019 incorporating additional information on the risk of breakage during removal of the IUD.

What Is the Paragard Copper IUD?

The Paragard IUD is a small, T-shaped contraceptive device wrapped in copper wire. Unlike hormonal IUDs, Paragard works by creating a localized inflammatory response in the uterus. Copper in the IUD produces ions that create a toxic environment for sperm. This prevents sperm from reaching the ovum and also prevents the implantation of fertilized eggs.

Paragad is the only non-hormonal IUD in the US. It is marketed as being over 99% effective, preventing pregnancies for up to 10 years. For years, the copper IUD has been the go-to choice for women looking for a convenient birth control method that:

• Does not affect hormones
• Doesn’t require constant monitoring to remain effective (set-it-and-forget-it)
• Does not affect fertility (reversible birth control)

Teva Pharmaceuticals manufactured the IUD until 2017, when CooperSurgical acquired the company.

Known Health Risks and Side Effects Linked to Paragard IUD Use

The manufacturer acknowledges several common Paragard IUD side effects, including heavier and longer periods (affecting up to 60% of users), spotting between periods, cramping, and pelvic pain. However, the severe copper IUD risks reported in thousands of lawsuits exceed these side effects.

According to FDA data from a long-term study (1998-2022), at least 9.6% of users experienced IUD breakage during removal, the primary issue in current litigation. When the device breaks, the T-shaped arms can become lodged in the uterine tissue, requiring additional procedures to retrieve fragments.

Device migration presents additional dangers when broken pieces move throughout the body, embedding in organs. Some women have developed copper toxicity, pelvic inflammatory disease, or required hysterectomies due to migrating IUD fragments.

Despite these risks and side effects of using the IUD, a Paragard IUD recall has yet to be issued. In 2019, however, the FDA mandated an update in Paragard’s labelling to include warnings about the risk of breakage during removal.

Injured by a Paragard IUD? Steps You Should Take Immediately

If you’ve suffered injuries from a Paragard IUD, seek immediate medical attention for severe pain, heavy bleeding, fever, or other concerning symptoms. Request thorough documentation of all findings, including imaging studies showing any breakage or migration of the IUD.

Should surgical removal of device fragments become necessary, ask that these materials be preserved as evidence. Obtain complete copies of all medical records of your IUD insertion, complications, and removal procedures. These records establish the timeline connecting the device to your injuries.

Maintain detailed records of all medical bills, lost wages, and how these complications have affected your quality of life. This comprehensive documentation helps quantify economic and non-economic damages if you pursue legal action.

You should also contact an attorney immediately if you notice these concerning symptoms to help you gather the relevant evidence for your copper IUD toxicity lawsuit. In addition to gathering evidence, your attorney will help you navigate the Paragard IUD lawsuit process, negotiate with the defendants, and calculate your damages.

How to Establish Fault in a Paragard IUD Injury Case

The current litigation against Teva Pharmaceuticals, CooperSurgical, and other defendants centers on three primary legal theories: defective products, insufficient warnings, and negligence by the manufacturer.

Defective design claims allege the IUD’s T-shaped design with rigid plastic arms makes it prone to breaking, particularly after extended use. Court documents suggest the manufacturers knew the raw plastic didn’t meet minimum flexibility requirements.

Failure to warn allegations assert that manufacturers were aware of breakage risks based on their clinical trials, adverse event reports, and internal analyses, yet failed to adequately warn patients and doctors until forced to by the FDA in 2019. Negligence claims argue that the manufacturers failed to test the device properly and concealed known risks.

To establish fault, attorneys must demonstrate that the device contained a defect making it unreasonably dangerous, that this defect directly caused your specific injury, that you used the product as intended, and that the manufacturer knew or should have known about these risks.

Types of Compensation You May Be Eligible for in a Paragard Lawsuit

Women who have suffered from serious Paragard complications may seek various forms of compensation. Medical expenses typically form the foundation of claims, covering past and anticipated future costs.

Lost income compensates for wages lost during recovery and reduced earning capacity if complications cause long-term disability. Pain and suffering damages address physical discomfort and emotional distress. In cases leading to infertility, additional compensation may recognize this profound loss and the psychological effect it has.

The Paragard lawsuit is still in the early stages of the proceedings. However, the growing number of plaintiffs and the scheduled bellwether trials may speed up the process towards a possible settlement.

Since this case is being litigated as a Multidistrict Litigation, the potential settlement may be distributed through a tiered system depending on the severity of the injuries sustained.

Working with a Paragard IUD lawyer in Michigan can improve your chances of a better outcome. Your attorney will evaluate your case to determine eligibility, help you join the MDL suit, and fight for fair compensation on your behalf.

Since this process may take years to resolve, entrusting your case to an experienced products liability attorney will also free up your time.

Need Legal Support? Contact Our Paragard IUD Lawsuit Lawyer in Michigan

If you were injured after using Paragard IUD, contact the product liability attorneys at Cochran, Kroll & Associates, P.C., today. We can determine if you are among the people who can file a Paragard IUD lawsuit and represent your case. We’ll assist you during the entire process, from the initial consultation to representation in court.

Our contingency fee basis means we only get paid if we win your case, so there is no financial risk to you to get started. Call our law firm today at 1-866-MICH-LAW and schedule your no-obligation, free case evaluation.

Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.