About 65% of women in the U.S. – roughly 47 million – use contraception to prevent pregnancy. One in 10 women chooses LARC or long-acting reversible contraceptives. Among LARC options, intrauterine devices (IUDs) are common, given their convenience and low maintenance levels. But there are risks associated with IUDs that patients may not know. Paragard, the only copper IUD available in the U.S., faces thousands of lawsuits from people who allege the device has injured them.
Introduced in 1987, the Paragard IUD is non-hormonal and wrapped in copper, making it ideal for women who don’t want to have the side effects associated with hormonal birth control. Paragard is inserted into the uterus by a doctor in a medical office. It is effective for up to a decade. Because it’s about the size of a quarter, it’s often non-intrusive, and the pain after insertion doesn’t last for long. Some may experience heavier menstrual cycles while using Paragard, and people allergic to copper are advised not to use it.
Paragard is touted as a good, low-cost solution, and it’s not surprising that it is a top choice for OB-GYNs and patients. In rare instances, though, Paragard can cause injuries and even be dangerous. Thousands of women have filed lawsuits against Paragard manufacturers, claiming they didn’t adequately warn consumers about the potential dangers of the Paragard IUD.
Most Paragard users will not experience serious complications, but those who do may see detrimental impacts on their mental and physical health. Some frequent problems with Paragard include:
- Uterine perforation: In some cases, an IUD can tear the uterus, which can lead to severe issues. Some potential side effects include abdominal pain, heavy bleeding, and nausea.
- Expulsion from the uterus: IUD expulsion is what it sounds like — an IUD falls out of the uterus and sometimes falls out of the body entirely. In this case, you wouldn’t be protected from pregnancy and may even have a fever due to infection.
- Ectopic pregnancy: In an ectopic pregnancy, a fertilized egg attaches outside of the uterus. If you get pregnant while using an IUD, the risk of ectopic pregnancy is higher. While prescription medication can treat an ectopic pregnancy, some cases will require surgery and might become life-threatening.
- Pelvic inflammatory disease (PID): PID is an infection of a woman’s reproductive organs, and sexually transmitted diseases like chlamydia can cause it. Paragard IUD insertion can also increase the chances of PID.
- Menstrual problems: Hormonal IUDs can shorten or lighten a menstrual cycle, but the Paragard IUD may make it heavier and last longer. Inflammation from the copper can increase cramping and abdominal pain as well.
Lawsuits Against Paragard
In 2019, the U.S. Food and Drug Administration (FDA) sent a warning letter to the manufacturers of Paragard, saying that the product’s advertisements didn’t adequately alert patients to possible risks. Here’s an excerpt from its statement:
“The TV ad includes the statement as onscreen superimposed text (SUPER), ‘Don’t use Paragard if you have certain cancers[,]’ the TV ad fails to include any of the other contraindications for the product, such as acute pelvic inflammatory disease, or current behavior suggesting a high risk of pelvic inflammatory disease.”
Women who have experienced Paragard IUD complications may have recourse to pursue legal action. At the end of 2020, dozens of lawsuits against Paragard were consolidated into multidistrict litigation (MDL) and transferred to the same court. MDL is often used after product liability suits, and it’s designed to make processing the cases more efficient. One judge manages the legal process, which helps rulings stay consistent. While the cases are now being consolidated, women who have suffered Paragard IUD injuries still have time to consider a lawsuit if they haven’t already.