Since the 1980s, Paragard has been prescribed as a form of birth control to those who seek a non-hormonal and more convenient alternative to the birth control pill. However, in recent years, Paragard has come under scrutiny due to a string of lawsuits that claim the device can break and become embedded in a person's organs. 

What Paragard Does

Paragard is an intrauterine device (IUD) that provides contraception for women and other people who can become pregnant. Paragard is a copper IUD that serves to prevent pregnancy for up to 10 years after insertion. It is notable as a nonhormonal IUD.

ParaGard functions by creating an inflammatory reaction in the uterus that is toxic to sperm and eggs. It is touted for its ability to prevent pregnancy with 99% effectiveness, even with no hormones.

Common side effects include bleeding between periods, cramps, severe menstrual pain, and heavy bleeding. One significant risk of ParaGard is ectopic pregnancy in the rare case of conception.

Who is Prescribed Paragard?

Paragard is available by prescription only. It can be prescribed to any premenopausal woman at any age. Healthcare providers may discourage the use of Paragard for women with uterine abnormalities, pelvic infections, or uterine or cervical cancer, among other risk factors.

New Paragard Side Effect Discovered

A significant risk of the IUD breaking apart unexpectedly can occur for women using Paragard. This can happen either in the uterus or during removal. Breakage can even occur years before Paragard's expected lifespan of 10 years is up.

When breakage occurs, sometimes the fractured pieces can remain embedded in the uterus, causing significant damage that may require invasive surgery or even a total hysterectomy. Paragard's website warns that “Paragard may attach to or go through the uterus.” It further warns of the risk of pelvic inflammatory disease, which may “require surgery or a hysterectomy.”

How the New Side Effect Came to Be Known

Broken IUDs represent an ongoing problem. Between 2010 and 2020, the FDA received over 1,600 reports of broken IUDs and other related problems. In one case series, published in 2013, a single institution reported three cases of “partially retained” Paragard IUDs over a nine-month period.

The third of these cases involved a 34-year-old woman who had a Paragard IUD inserted five years prior. Upon removal, doctors noted that an arm of the IUD had broken off, requiring the use of a paracervical block and the use of a manual vacuum aspiration device to remove the arm.

Numerous similar cases have been reported. In 2012, a patient's IUD was missing an arm after ten years of use. Also in 2012, a patient had an embedded IUD arm near the internal cervical os after six years of use. In 2013, a patient's IUD was fragmented, requiring the use of a paracervical block, alligator forceps, and ultrasound to remove the fragment.

Have you suffered an injury as the result of a Paragard side effect or due to another defective medical device? Contact your Washington, DC defective drugs and medical devices attorneys to find out if you have a case. The initial consultation is free and confidential.