Paragard IUD Risks, Breakage Concerns & Recalls

The Paragard IUD (intrauterine device) received U.S. Food and Drug Administration (FDA) approval more than 30 years ago to prevent pregnancy. 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.

The Paragard IUD is a small T-shaped device wrapped with copper wire that doctors place in the uterus to prevent pregnancy. The copper in the IUD causes an immune response in the 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. Women who cannot tolerate hormonal IUDs or don’t want to use hormones to prevent pregnancy may choose Paragard as their preferred form of birth control.

There are five IUDs available in the U.S.: Paragard, Mirena, Kyleena, Liletta and Skyla. Paragard is the only non-hormonal IUD approved in the U.S.

CooperSurgical says Paragard is effective for up to 10 years, though Planned Parenthood says it prevents pregnancy for up to 12 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.

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 the uterus may lead to additional complications, such as 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 — from pain to the need for surgery — especially if fragments of the device or bits of copper remain in the body. It’s important to note that not all people 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 April 2025, neither CooperSurgical nor the FDA has recalled Paragon 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 most recent reports from the FDA’s Adverse Events Reporting System (FAERS), there were 7,466 reports of device breakage from 2009 through 2024. It’s important to note that FAERS reports are voluntary, so the FDA cannot verify that the device caused the issues.

In May 2021, the FDA began investigating reports of Paragard breakage and 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 offers information on 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.

Manufacturer’s Response to Paragard Safety Concerns

CooperSurgical hasn’t taken corrective actions in response to concerns over Paragard’s safety. As of April 2025, we have not found any new public Paragard warnings or changes in design in response to breakage reports.

The FDA approved changes to the Paragard label in 2024, but the most current label available 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.

In addition to potential breakage concerns, there are other Paragard side effects and risks. Generally, Paragard is considered safe and effective, but it’s important to know all potential risks.

The most common side effects are changes in the intensity and length of periods. These may go away or become less severe in three to six months. If you are concerned about potential side effects, discuss them with your medical provider.

Copper Toxicity

Copper toxicity from Paragard is rare. It’s more likely to happen in women with a rare condition called Wilson 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.

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

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.

Sometimes, Paragard can migrate from its original insertion point. If the IUD has moved out of place, you may experience:

• Feeling Paragard in your vagina or near your cervix
• Irregular bleeding or bleeding after sex
• Painful sex for you or your partner
• Paragard strings missing or seeming longer than before

Contact your medical provider right away 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 inside 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.

Surgical techniques to remove IUD fragments include: