U.S. doctors have recommended Paragard® IUDs for decades as a trusted, hormone-free birth control option. However, recent reports have raised serious safety concerns.
For decades, thousands of complaints have been filed with the Food and Drug Administration (FDA) claiming Paragard IUDs broke inside the body, often during removal. Many of these incidents resulted in hospitalizations, severe complications, and even surgery.
A broken Paragard IUD can lead to infections, organ damage, and other serious health issues. Despite these reports, Paragard remains FDA-approved and widely available as a popular hormone-free alternative to other forms of birth control.
If you or a loved one experienced complications or required surgery due to a broken Paragard IUD, you may qualify to join the Paragard IUD lawsuit.
What is Paragard?
First approved by the FDA in 1984 and available to the public since 1988, Paragard (Paragard T380A Intrauterine Copper Contraceptive) is a T-shaped, hormone-free intrauterine birth control device (IUD) designed for long-term birth control. Wrapped in thin copper on its arms and central stem, it works by releasing copper into the uterus, creating an inflammatory reaction that prevents fertilization for up to 10 years.
Paragard is the only copper IUD available in the U.S., which helped boost its popularity and its widespread use.

Reports of Paragard IUD injury
Paragard IUDs seemed like a low-maintenance, low-fuss method of contraception to many, but tens of thousands of reports of Paragard-related injuries have been voluntarily submitted to the FDA.
Many reports state the device’s arms broke during removal. Others claim breakage occurred while the IUD was still inside the uterus, often requiring surgery.
In the last decade, thousands of reported Paragard-related injuries involved device breakage, even when removed by a doctor. In some cases, ultrasounds or X-rays are required to locate missing pieces, followed by surgery to remove them.
As of 2025, there have been over 56,000 cases reported to the FDA’s Adverse Event Reporting System (FAERS), where nearly half of the cases were considered serious and 22 resulted in death. Of those 56,000 cases reported, there were:
- 14,107 reports of device expulsion
- 11,226 reports of device dislocation
- 9,283 reports of device breakage
- 7,741 reports of complications of device removal
- 6,887 reports of a “foreign body” in the reproductive tract
Reported injuries from Paragard breakage include:
- Uterine perforation
- Device dislocation
- Copper wire fragments left inside the body
- Pelvic pain
- Expulsion
- Infections
- Scarring
- Organ damage
Uterine perforation can cause infertility and lead to life-threatening conditions like hemorrhaging or sepsis.
While medical experts say complications of that nature are rare with Paragard, they happen more often with devices like Paragard than with other IUDs. According to a 2022 study, copper IUDs like Paragard had almost double the reports of breakage (9.6%) in comparison to hormonal IUDs (1.7%) approved in the U.S.
Despite thousands of reports of defective IUDs, neither Paragard’s manufacturers, CooperSurgical and Teva Pharmaceuticals, nor the FDA has issued a recall.
FDA warnings concerning Paragard
The FDA originally approved the Paragard IUD in 1984. For decades, its original manufacturer, Teva Pharmaceuticals, marketed the device without significant public safety concerns. In 2017, CooperSurgical, Inc. acquired Paragard. Shortly after, reports of serious complications began drawing national attention.
In 2021, Spotlight on America launched a three-year investigation, uncovering thousands of adverse event reports in the FDA’s database.
Their reporting also revealed that the FDA began a “safety review of broken IUDs” after the investigation started. This led to an update in 2024 to Paragard’s warning label, specifically addressing the risk of the device breaking during removal.
Concerns about misleading advertising also surfaced. In 2019, the FDA issued a warning to CooperSurgical over a TV advertisement that made false or misleading claims about Paragard’s risks.
The lack of transparency from the manufacturers, combined with the severe physical and emotional harm suffered by women nationwide, has fueled ongoing Paragard lawsuits.
What is the Paragard lawsuit?
Over Paragard’s more than 30 years on the market, thousands of women have used the IUD as a means of birth control. However, for years they were not made aware that the device could break at any point or could leave fragments inside their bodies.
Paragard IUD manufacturers, Teva Pharmaceuticals and CooperSurgical Inc., are currently facing lawsuits in all 50 states alleging they failed to warn consumers about the risk of device breakage. The claims include:
- Negligence by the companies responsible for Paragard
- Defective design and manufacturing of the IUD
- Failure to include breakage risk on the product’s warning label
If you or a loved one used the Paragard IUD and experienced the device breaking before or during removal, you may have a case.
See if you qualify for the Paragard IUD lawsuit
Paragard® is a registered trademark of CooperSurgical Inc. Their name is used here only for the purpose of identifying the products in question. Woods & Woods, LLC is not affiliated with, sponsored by, or associated with the FDA, Spotlight on America, CooperSurgical Inc., or Teva Pharmaceuticals.