Paragard IUD Risks, Breakage Concerns & Recalls

The Paragard IUD (intrauterine device) received U.S. Food and Drug Administration (FDA) approval to prevent pregnancy more than 30 years ago. However, the FDA has received thousands of reports that Paragard removal may result in the device breaking.

In response to Paragard IUD breakage reports, thousands of women have filed Paragard lawsuits claiming Teva Pharmaceuticals (the device’s original maker) designed a defective device and failed to warn the public of the breakage risk. CooperSurgical purchased Paragard from Teva in 2017 and is also a defendant in Paragard lawsuits.

As of November 2025, 3,658 cases were pending in multidistrict litigation (MDL) against the device’s manufacturers. If you experienced side effects after your IUD broke upon removal, you may be able to join the MDL. Speak with an attorney to get a case evaluation.

The Paragard IUD is a small T-shaped device wrapped with copper wire that doctors place in your uterus to prevent pregnancy. The copper in the IUD causes an immune response in your uterus, generating a toxic environment for sperm and preventing pregnancy.

How Paragard Compares To Other IUDs

Unlike other IUDs on the market, Paragard uses copper instead of hormones to prevent pregnancy. If you cannot tolerate hormonal IUDs or don’t want to use hormones to prevent pregnancy, you may choose Paragard as your preferred form of birth control.

Five IUDs are available in the United States, including Paragard, Mirena, Kyleena, Liletta and Skyla. Paragard is the only nonhormonal IUD approved in the United States. Mirena and the other IUDs use progestin hormones to stop egg production.

CooperSurgical says Paragard is effective for up to 10 years. In contrast, Mirena and Liletta are good for eight years, Kyleena works for five years and Skyla prevents pregnancy for three years.

You can also use Paragard and some other IUDs as emergency contraception if inserted within five days after having unprotected sex.

IUD Alternatives

Alternatives exist if you decide an IUD isn’t the right choice for you. Oral contraceptives, shots, patches, implants and vaginal rings take a hormonal approach and are highly effective at preventing pregnancy.

Emergency contraceptives can prevent many pregnancies if taken within 48 hours of unprotected sex. Like other hormonal birth control options, they do not protect against sexually transmitted infections.

Barrier methods such as condoms can reduce your risk of both pregnancy and sexually transmitted infections.

Your doctor can help you determine the best choice of birth control for your needs.

While Paragard is effective at preventing pregnancy, there is a risk that it can break when your doctor tries to remove it. Broken pieces of the IUD remaining in your uterus may lead to complications like pain, infection, bleeding and infertility.

What Do Studies Say About Paragard Breakage?

Studies on Paragard breakage suggest that it is more prone to break upon removal than hormonal IUDs. The following studies explain the risks.

Complications From a Broken Paragard IUD

Broken Paragard IUDs can present serious complications, including pain and the need for surgery, especially if fragments of the device or bits of copper remain in your body. It’s important to note that not everyone will experience complications.

Having an IUD break during removal can be a traumatic experience.

“After I got [the IUD] taken out and found out that the arm had broken off, I called my mom crying, really, really upset. And I found out my cousin had the same thing,” one Paragard recipient from Colorado told Drugwatch.

As of October 2025, neither CooperSurgical nor the FDA has recalled Paragard IUDs. The FDA has not issued any safety warnings regarding Paragard’s side effects.

While the FDA initiated an investigation into Paragard breakage reports and issued recommendations, CooperSurgical has yet to take action.

FDA Actions & Reports on Paragard IUD Breakage Risks

According to the FDA’s Adverse Events Reporting System (FAERS), there were 9,618 reports of device breakage from 2009 through October 29, 2025. However, FAERS reports are voluntary and don’t prove that the device caused the issues.

In May 2021, the FDA began investigating reports of Paragard breakage. It released its findings in December 2022. Based on its investigation, the FDA recommended label changes for removal instructions that could help mitigate breakage. These precautions include checking to see if Paragard is embedded in or has perforated the uterus before removal.

CooperSurgical did not provide the FDA with a risk analysis that addresses what could cause breakages. As a result, the FDA concluded that it couldn’t determine how to best mitigate device breakage risks.

In response to the FDA’s original requests, CooperSurgical said it did not have “information regarding all testing that occurred during the product design phase or all testing that may have been requested by the Agency” before the device’s original approval. It also said there was “no significant increase in the number of reports of breakage events.”

CooperSurgical blamed the FDA’s perceived increase in breakage events on “stimulated reporting” driven by the increasing number of Paragard lawsuits. The FDA disagreed with CooperSurgical’s evaluation of the numbers, citing “significant increases” over several years, but didn’t force CooperSurgical to investigate further.

Manufacturer’s Response to Paragard Safety Concerns

CooperSurgical hasn’t taken corrective actions in response to concerns over Paragard’s safety. As of October 2025, there are no new public Paragard warnings or design changes in response to breakage reports.

The FDA approved changes to the Paragard label in 2024, but the most current label on the Paragard website shows that it was last updated in February 2020. CooperSurgical and Teva didn’t reveal any details regarding how they are handling Paragard lawsuits in their 2024 annual reports.

Paragard is considered safe and effective, but it’s important to know all potential risks aside from breakage concerns. The device may cause pain, heavy periods, spotting and anemia.

In rare cases, ectopic pregnancy, uterus perforation, infection, device expulsion or uterine wall embedment may occur. These can lead to a serious medical emergency or death.

“Perforation from an IUD like Paragard is rare but can damage organs if undetected,” Sazan Sylejmani, owner and pharmacy manager of Westmont Pharmacy in Westmont, Illinois, told Drugwatch. “Patients should be informed of risks like infection and organ damage.”

A 2023 study conducted by researchers at the Center for Global Infectious Disease Research at Seattle Children’s Research Institute showed that copper IUDs like Paragard disrupted normal vaginal bacterial balance. The same study also uncovered significant increases in inflammatory markers in vaginal tissue with IUDs compared to other hormonal contraceptives.

Common Paragard Side Effects

Most Paragard side effects are mild and do not affect contraceptive performance. The most common side effects are pain and changes in the intensity and length of periods.

These side effects may stop or become less severe three to six months after insertion, but they contribute to a significant number of patients requesting IUD removal.

Latest Paragard Side Effects Information

As of October 29, 2025, device expulsion or dislocation was the most common Paragard side effect reported to the FDA. Device breakage and insertion complications were also commonly reported. Of the over 56,000 reported adverse effects, about 45% were serious.

Serious Paragard Side Effects

Device expulsion, ectopic pregnancies, infection and uterus perforation are all possible with a Paragard IUD. These serious but rare side effects can cause severe health risks and possibly death.

Research shows that the risks of perforation, which is when the device pierces through your uterus, and the risk of expulsion are very low. According to a 2023 study published in Obstetrics and Gynecology, the risk of expulsion within the first five years of using Paragard is nearly 5%, and the risk of perforation is 0.6%.

Device Expulsion

Device expulsion is more likely to happen if the IUD is inserted within the first six weeks following childbirth.

“The copper in Paragard can cause inflammation, leading to expulsion in up to 5% of women. This risk is highest in the first year,” Sylejmani said.

Copper Toxicity

Copper toxicity from Paragard is rare. It’s more likely to occur in women with a rare condition called Wilson’s disease, which causes copper buildup in the body. If you have this condition, talk to your doctor before using Paragard.

Symptoms of copper toxicity include vomiting (with possible blood), diarrhea, headaches, dark stools and abdominal pain.

Ectopic Pregnancies

Ectopic pregnancy in the Paragard clinical trials (which did not include women with a prior history of ectopic pregnancy) was around 0.06%. Women who conceive while on Paragard are more likely to develop an ectopic pregnancy.

In an ectopic pregnancy, the fertilized egg implants in areas other than your uterus, like the fallopian tubes, cervix or ovaries. These pregnancies have high rates of miscarriage and can cause maternal health complications. Some ectopic pregnancies can cause the fallopian tubes to rupture, which may lead to internal bleeding, infections or death.

Symptoms of an ectopic pregnancy include nausea, vomiting, cramps, pain on one side of your abdomen, pain in your shoulder or neck, dizziness and weakness. Contact your doctor immediately if you experience these symptoms while using Paragard, especially if you suspect you’re pregnant.

Pelvic Inflammatory Disease

There is a correlation between patients with IUDs and increased rates of pelvic inflammatory disease (PID). This is most pronounced during the first three weeks after insertion. In clinical trials with Paragard, the incidence of PID that led to the removal of Paragard was approximately 0.1%.

PID is inflammation of your genital tract and is usually contracted through sexual intercourse. However, procedures that potentially introduce bacteria to your uterus, such as IUD insertions, can also cause PID.

Patients with an IUD who develop PID do not always need it removed. However, if treatment is ineffective and your symptoms do not resolve, your doctor may decide removal is necessary.

MRI Compatibility

Paragard is magnetic resonance (MR) conditional. This means that patients with Paragard inserted can have Magnetic Resonance Imaging (MRI) scans under certain conditions.

To ensure a safe and effective scan, patients should inform their doctors if they are using Paragard or any other copper IUD before receiving an MRI scan. Current data suggest specific test parameters can increase safety and limit image artifacts.

Tell your doctor if you experience Paragard complications. Some Paragard side effects are serious and require immediate attention.

“Early symptom recognition and regular doctor visits are key,” Sylejmani said. “The greatest risk is within the first few months of insertion.”

Because Paragard can perforate, embed in or be expelled from your uterus, you should check its placement at least once per month. If you cannot feel the two threads, they change length or you feel any part of the IUD besides the threads, contact your doctor for a comprehensive exam.

If the device has dislocated, your doctor will likely try to remove it. You and your doctor should discuss the risks and benefits of removal before deciding whether or not to remove the device.

How To Tell if Your Paragard IUD Is Broken or Misplaced

When Paragard breaks, it’s usually during removal. You’ll know because the IUD will be missing pieces when doctors remove it. Medical professionals should check if the IUD is intact after removal.

Contact your doctor immediately if you experience any of these symptoms. They can verify whether the device is out of place.

What Are the Options if Your Paragard IUD Breaks?

If your Paragard IUD breaks upon removal and a piece remains in your body, your doctor will discuss surgical and nonsurgical options with you.

If your provider can locate the IUD fragment with an ultrasound, they may be able to remove it without surgery, depending on its location. This involves using forceps, hooks or clamps guided by the ultrasound to reach and remove the fragment.

How To Manage Post-Insertion Side Effects

Post-insertion side effects, including cramping, dizziness and discomfort, tend to last for a few minutes. Tell your doctor if you experience these symptoms for an extended period.

Other side effects tend to be mild and many subside over the first few months after insertion. Taking NSAIDs can be an effective way to manage back pain, cramping and period discomfort.

Report any severe side effects to your doctor immediately. Some could be signs of serious complications that could lead to infection, permanent scarring of the uterus or death.