Paragard IUD lawsuits are accumulating across the country.
Thousands of women have reported adverse events and complications related to the use of the Paragard IUD, a copper intrauterine device prescribed to prevent pregnancy.
Women represented by defective product attorneys have alleged that design flaws, manufacturing defects, failure to warn, and negligence on the part of Paragard’s manufacturers and distributors has led to broken IUDs, which have resulted in serious health complications such as pain, infection, infertility, and the need for revision surgery.
As of December 2020, multiple lawsuits have been consolidated into a multi-district litigation (MDL) in Georgia. No trials have yet been scheduled. If you have been harmed by a broken Paragard IUD that required surgery or other Paragard removal complications, you may qualify for financial compensation through a Paragard IUD lawsuit.
If you believe you are one of the thousands of women affected by a faulty Paragard IUD, the time to act is now. The statute of limitations in some states to pursue a personal injury or wrongful death case is just one or two years from the date of injury. You can contact our Paragard lawsuit attorneys today for a free, no obligation consultation regarding your case.
What Is Paragard?
The Paragard IUD is a form of birth control that works by disrupting the process of conception. The T-shaped copper device is placed inside the uterus and produces an inflammatory reaction which acts as a non-hormonal spermicide, inhibiting the union of a sperm cell with an egg cell.
The Paragard IUD is the only copper intrauterine device approved for use in the United States. Paragard is also 100% hormone free and has been approved by the Food and Drug Administration (FDA) for use up to 10 years.
Each device is made in the USA and consists of a T-shaped polyethylene frame wound with copper wire. Two monofilament threads hang down from the device to aid in simple removal of the IUD in a doctor’s office.
How Long Has Paragard Been on the Market?
The FDA first approved Paragard for use in 1984. Initially, it was only available to women who had never suffered pelvic inflammatory disease, had had at least one child, and were in a stable monogamous relationship. In September of 2005, those parameters expanded when the FDA approved the use of copper IUDs by those as young as 16 years old.
Who Manufactures and Sells Paragard IUDs?
Teva Pharmaceuticals, a global pharmaceutical company, was responsible for the manufacture and sale of Paragard IUDs until 2017, when the brand was sold to CooperSurgical, a subsidiary of Cooper Medical. CooperSurgical subsequently acquired the global rights and business of the Paragard IUD, including a manufacturing facility in Buffalo, New York.
What Are Side Effects and Complications of Paragard?
Most reported Paragard side effects are mild to moderate and are temporary (or resolve when the device is removed). These side effects may include cramping, bleeding between periods, and heavy periods. Some women’s bodies may also “reject” or expel the IUD. In addition, upon removal some women may experience light bleeding or cramping. These side effects are common and not usually a cause for immediate concern.
However, in a small number of cases, the IUD can cause serious problems, either upon insertion or during removal. Paragard removal complications are especially concerning, since they can lead to life-threatening conditions.
Commonly-Reported Adverse Reactions to Paragard IUD
As of March 2021, the FDA Adverse Events Reporting System (FAERS) has received at least 40,604 reports of adverse reactions to Paragard, 16,645 of which were classed as serious cases. In addition, at least 15 deaths have been linked to the IUD. Some of the most commonly-reported adverse reactions include:
- Device expulsion (11,042 cases)
- Device dislocation (9,220 cases)
- Uterine disorder (4,117 cases)
- Device breakage* (3,217 cases)
- Complication of device insertion (2,667 cases)
- Vaginal hemorrhage (2,639 cases)
- Menometrorrhagia (abnormal uterine bleeding) (2,102 cases)
- Embedded device (1,837 cases)
- Complication of device removal (1,487 cases)
Women who suffered health complications related to copper IUDs manufactured by Teva or CooperSurgical may be entitled to compensation in a potential ParaGard IUD lawsuit.
*Current Paragard litigation is primarily focused on women who endured complications related to IUD breakage and removal.
Possible Complications of a Broken Paragard IUD
Many complications have been reported that stem from a broken device. These include, but are not limited to:
- Uterus or cervix perforation
- Inflammation or allergic reaction to IUD pieces left behind
- IUD migration or missing IUD pieces
- Pieces of IUD embedded in organs
- Pelvic inflammatory disease
- Severe pain
In order to remove broken Paragard IUD fragments, some women may have to undergo surgical procedures such as hysteroscopy, laparoscopy, laparotomy, and in severe cases, hysterectomy.
Has Paragard Been Recalled?
Although Paragard is a non-hormonal IUD, it still remains classed and approved as a drug rather than a medical device by the FDA. Despite thousands of reported adverse reactions, Paragard has not been recalled or taken off the market by the FDA, Teva Pharmaceuticals, or CooperSurgical due to device breakage. Two batches of the device were recalled in 2014 due to questions about their sterility, but no other recalls have been made.
Who Is Responsible for Paragard IUD Complications?
As manufacturers and sellers of the Paragard IUD, both Teva Pharmaceuticals and CooperSurgical may be held liable for Paragard breakage and other associated complications. From a design perspective, it can be argued that the T-shaped IUD was poorly designed and that both Teva and Cooper should have foreseen a risk of breakage.
It is also possible that a successful Paragard IUD lawsuit may hinge on a manufacturing defect. While the design of the IUD may have been acceptable, if the item was poorly constructed or constructed using brittle materials, Teva or Cooper may still be held legally responsible for complications arising from broken devices.
Liability may also be established based on the company’s improper labelling and failure to warn doctors and consumers about the risk of breakage. While other possible side effects were disclosed on the Paragard IUD’s disclaimer, many argue that there was inadequate information provided to physicians about how to avoid IUD breakage during removal.
Do You Qualify for a Paragard IUD Lawsuit?
Women who were implanted with the Paragard IUD and subsequently experienced serious complications due to a broken device may be eligible to file a Paragard IUD lawsuit to recover financial compensation related to medical bills, lost wages, pain and suffering, and other damages.
Our experienced legal team is standing by to offer possible victims of defective Paragard IUDs free, no obligation consultations to help determine if they may be eligible to file a personal injury lawsuit. To request your complimentary case review, contact us 24/7 by calling 844-977-1900. Those who do not qualify for a Paragard lawsuit may still be eligible for compensation if their injuries stemmed from medical malpractice.
Still have questions? Connect with a representative standing by via LiveChat for answers. You can also submit your case details for review by filling out this simple form. Rest assured that there is no fee unless we obtain a recovery on your behalf.