Paragard IUD Side Effects

Paragard is a hormone-free intrauterine device (IUD) made of polyethylene and barium sulfate wrapped with copper. Paragard is inserted by a doctor or healthcare provider into the uterus. Once placed, the IUD can prevent pregnancy for up to 10 years. Paragard creates an inflammatory reaction in the uterus that prevents eggs from being fertilized or implanted.

Paragard is a T-shaped device with a monofilament thread attached to one end for easy removal. The arms are meant to bend or flex slightly as the device is removed. As long as the device stays intact, most side effects are minor and will ease or go away entirely within three to six months.

More serious side effects can develop if the device breaks, is implanted too deeply or moves out of position. But the Paragard manufacturer didn’t include all of these side effects in the warning label. This neglect exposed many users to serious and potentially life-threatening risks without their or their doctors’ knowledge.

All medications and medical devices have potential side effects and safety concerns listed on their product labels. When the drug or device makes it to market, the manufacturer is responsible for monitoring the experiences consumers have with the product. If doctors or patients report any new adverse side effects or safety concerns, the manufacturer must report those concerns to the U.S. Food and Drug Administration (FDA).

The FDA collects reports of adverse events for drugs and medical devices. Ideally, if the manufacturer receives multiple reports of adverse events post-market, they update the product label to include new warnings. They must also notify doctors so they can tell their patients about the risks.

Common, listed side effects

Some of Paragard’s common side effects when the device was presented to the public included:

• Anemia (low red blood cell count)
• Backache
• Pain and cramping
• Painful or irregular periods
• Pain during sex
• Spotting between periods
• Vaginal irritation or discharge

These symptoms were most common in the month after placement and subsided within a few weeks.

Serious, listed side effects

Serious but still common side effects listed on the label include getting pregnant while the implant was still in place. These issues could include:

• Ectopic pregnancy: Pregnancy with the IUD in place can result in an ectopic pregnancy. This is a pregnancy where the embryo implants outside the uterus, often in the fallopian tube or in the abdominal wall. An ectopic pregnancy is a life-threatening condition and the embryo is never viable.
• Risks with intrauterine pregnancy: A normal pregnancy with the IUD places the woman at risk for septic abortion (abortion with systemic infection) or later miscarriage. The IUD can’t easily be removed once an embryo has implanted in the uterine wall.
• Group A streptococcal sepsis: Group A strep (GAS) is the bacteria associated with toxic shock syndrome and necrotizing fasciitis. If the insertion of the IUD has not been sterile, GAS infection is possible and can spread rapidly.
• Pelvic inflammatory disease (PID): Also associated with unsterile insertion of the IUD, PID may result in serious tubal damage, need for surgical intervention (hysterectomy), sepsis or death.
• Embedment or perforation: Paragard has been reported to become partially embedded in the wall of the uterus during insertion, or even penetrate completely through the uterus. If not diagnosed immediately, it can lead to further injuries or result in pregnancy. Surgery may be required for removal. 

Patients using Paragard should tell their doctor right away if they think they might be pregnant. They should also report unusual bleeding, spotting or heavy periods. They should also tell their doctor about any fever, chills, vaginal pain, long-lasting pain, discharge or abdominal pain.

Many women have experienced their Paragard IUD breaking during or after insertion or on removal. The arms of the IUD are supposed to bend backward as the device is removed. Frequently, the broken IUD pieces can only be removed surgically. In some cases, this may impact a future woman’s ability to conceive.

Paragard has gotten numerous reports of IUD breakages requiring surgical intervention. Despite those reports CooperSurgical, Paragard’s manufacturer, did not update its labels and adequately warn users of the potential adverse side effects.

The side effects related to breakage are similar to those of known side effects already listed, including:

• Ectopic pregnancy: If the IUD was removed because the user intended to get pregnant, it is essential that all pieces are accounted for. Ectopic pregnancy is described here as both a listed and unlisted side effect because it is not linked to breakage on the label. Breakage increases the chances of ectopic pregnancy and the package insert states that “Ectopic pregnancy may require surgery and may result in loss of fertility.”
• Intrauterine pregnancy: A normal pregnancy with Paragard in place is high risk. A pregnancy with an unrecognized piece of a broken IUD in the uterus may also pose risks.
• Embedment or perforation: Whether Paragard perforates the uterus during insertion or after breakage occurs, surgery is often necessary for removal.

When a Paragard IUD breaks, removing the pieces often requires surgery, usually through a laparoscopy, a laparotomy or a hysterectomy. These surgeries are invasive and come with their own risks. For example, women who have hysterectomies won’t be able to have children following the procedure.

Doctors must know these potential risks and side effects so they can help their patients weigh the pros and cons of their birth control options. If companies don’t provide doctors with a list of all possible side effects, doctors are as much in the dark as the patients.

Unexpected Paragard IUD side effects lead to lawsuits

These unrecognized and/or previously unlisted side effects have led to many users developing serious health issues. Costs of surgery, treatment and recovery from unexpected IUD fragment removal has led to numerous lawsuits against the Paragard manufacturers.

These lawsuits have been consolidated into an MDL pending in the U.S. District Court for the Northern District of Georgia. Motley Rice attorney Fidelma Fitzpatrick was court-appointed to the Paragard MDL Plaintiffs’ Executive Committee (PEC). Kristen Hermiz was court-appointed to the Plaintiffs’ Steering Committee (PSC).

As of mid-2024, over 2,700 actions were pending in the consolidated case.

The Paragard IUD has many side effects. Most are not serious unless they continue for several months. These are some of the most frequently asked questions about Paragard IUD side effects.

The attorneys at Motley Rice have extensive experience representing plaintiffs alleging they’ve been harmed by defective devices. Our recent cases include:

• Appointed to the Plaintiffs’ Steering Committee (PSC) for the Depo-Provera MDL
• Acting as court-appointed lead counsel for coordinated cases involving permanent birth control device Essure®
• Acting as court-appointed co-lead counsel for the Mirena® IUD MDL
• Serving on the Plaintiffs’ Steering Committee (PSC) for NuvaRing® MDL

In addition to being a member of the Plaintiffs’ Executive Committee (PEC) of the Paragard MDL, medical attorney Fidelma Fitzpatrick served as court-appointed lead counsel of the PEC for more than 32,000 Essure® cases coordinated in California state court.

Read more on our birth control litigation experience.