ParaGard IUD

ParaGard (Copper IUD) is a long-term, reversible and hormone-free method of birth control that’s more than 99% effective at preventing pregnancy. However, a growing number of reports suggest ParaGard side effects may include device migration and breakage, infections, and even ectopic pregnancies.

ParaGard IUD: Background

ParaGard is an intrauterine device (IUD) that consists of copper wires coiled around a T-shaped plastic frame. Once inserted into the uterus, ParaGard triggers an inflammatory reaction that’s toxic to both sperm and egg, thus preventing pregnancy. However, prior theories that the copper IUD damages fertilized embryos or prevents implantation are not supported by current evidence

ParaGard begins working as soon as the IUD is placed in the uterus and does not require a woman to use a back-up method of birth control. As a result, the copper IUD can be used as an emergency contraceptive and is considered an alternative to Plan B. However, unlike Plan B emergency birth control pills, the effectiveness of ParaGard is not dependent on a woman’s weight.

ParaGard is Different from Other IUDs

ParaGard is marketed by Teva Pharmaceuticals and was approved by the U.S. Food & Drug Administration (FDA) in 1984. Sales of the copper IUD began in 1988.

ParaGard is just one of several IUDs approved for use in the United States. But unlike other IUDs currently on the market — Mirena, Skyla, Liletta and Kyleena — ParaGard does not emit hormones to prevent pregnancy.

While the copper IUD can remain in a woman’s body for up to 10 years, Mirena and Kyleena must be removed after five years. Skyla and Liletta can only remain in place for three years.

More Younger Women are Using IUDs, Including ParaGard

IUDs have been available in the United States for decades. However, a safety controversy involving the Dalkon Shield resulted in the removal of all but one from the market in the 1980s.

The use of IUDs in the United States has been increasing steadily since the early 2000s. ParaGard and other IUD products are generally more popular with younger women who may not be familiar with the safety controversy that erupted decades ago over the Dalkon Shield.

Both the American College of Obstetricians and Gynecologists (ACOG)21 and the American Academy of Pediatrics (AAP) now recommend IUDs for all women. Because the Affordable Care Act requires most private insurance plans to cover the copper IUD and at least one hormonal IUD at no cost to policy holders, Obamacare has also contributed to their increasing popularity among young women.

ParaGard IUD Side Effects

The ParaGard Copper IUD should not be used by women who:

  • Suffer from large fibroids or other uterine abnormalities that would interfere with the placement or retention of ParaGard
  • Have pelvic inflammatory disease or another pelvic infection
  • Have uterine or cervical cancer
  • Experience unexplained vaginal bleeding
  • Are allergic to any component of ParaGard
  • Have a disorder that causes too much copper to accumulate in your liver, brain and other vital organs (Wilson’s disease)

The most common side effects associated with ParaGard include:

  • Bleeding between periods
  • Cramps
  • Severe menstrual pain and heavy bleeding

ParaGard can also be expelled from the uterus, often without the woman even realizing this has occurred. Those most at risk for ParaGard expulsion include women  who:

  • Have never been pregnant
  • Experience heavy or prolonged periods
  • Suffer from severe menstrual pain
  • Have previously expelled an IUD
  • Are younger than age 25
  • Had the IUD inserted immediately after childbirth

ParaGard Lawsuits Allege IUD Caused Serious Side Effects

Several women have filed ParaGard lawsuits alleging the copper IUD was defectively designed and can cause potentially serious complications, including:

  • Breakage of the IUD arms
  • Device migration
  • Device embedment
  • Uterine perforations
  • Ectopic pregnancy

In 2015, a study published in the Open Journal of Clinical & Medical Case Reports followed a gynecological practice in Chicago for a period of 3 years. Seven patients experienced ParaGard breakage during that time, and all underwent hysteroscopic removal of the IUD. However, doctors were ultimately unable to remove the IUD’s arm from one of those women.

While Paragard breakage remains rare, the authors of the study suggested this complication is likely underreported.

Reports indicate that some women have also suffered uterine perforations during or shortly after ParaGard insertion. Complications associated with IUD perforation include infection, scarring, and damage to other nearby organs. Uterine perforations generally result in the need for corrective surgery.

While less than 1% of women with ParaGard will become pregnant while using the device, a pregnancy that occurs with the copper IUD in place is more likely to be ectopic. An ectopic pregnancy occurs outside the uterus, usually in a fallopian tube, and is always a medical emergency. If not addressed immediately, an ectopic pregnancy will cause dangerous internal bleeding, scarring, infertility, and even death.

  1. (2019) “Highlights of Prescribing Information”
  2. Kaiser Family Foundation (N.D.) “Intrauterine Devices (IUD): Access for Women in the United States”
  3. Mayo Clinic (N.D.) “ParaGard (Copper IUD)”
  4. Bloomberg Law (2018) “Teva Must Face Suit Over Broken IUD”
Last Modified: February 6, 2020

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