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Paragard IUD: A Brief History of Its Benefits and Complications

Choosing a birth control method can be overwhelming for women, with well over a dozen forms available to consumers. Introduced in 1988, the Paragard IUD has emerged as a popular choice in recent years. Given that some options require you to take pills daily or change out a ring monthly, intrauterine devices (IUDs) have become one of the most common contraceptive options in the U.S. Intrauterine devices are inserted into the uterus, usually during a doctor’s visit. The process usually takes less than five minutes, and devices like Paragard are 99% effective and last for up to 10 years.

But in rare cases, the Paragard can make life excruciatingly difficult for patients — namely, falling out of the uterus, perforating the uterus, or breaking into pieces while inserted. While uncommon, issues with Paragard can cause severe pain, bleeding, and other health complications. The U.S. Food and Drug Administration (FDA) has received over 1,600 reports of Paragard breakage since 2010, and it’s almost certain that more incidents have gone unreported.  

Over 100 cases have been filed against Paragard IUD manufacturers, and they’ve been consolidated into multidistrict litigation (MDL) in the Northern District of Georgia. Multidistrict litigation dates back to the 1960s, and it is used when there are hundreds or thousands of cases across multiple courts that all involve the same problem. Ideally, MDL will save time and allow lawsuits to move through the legal system faster. 

What is causing women to choose Paragard, and why are there so many problems being reported?

Intrauterine device against a blue background

What Is Paragard?

Hormonal birth control is known for side effects like nausea, headaches, and weight gain. Because Paragard and similar intrauterine devices are hormone-free and have fewer effects, they are often favored. The risk of pregnancy is also low, with less than 1% of women becoming pregnant in the first year of use. 

Paragard is the only copper IUD available in the United States. It has a T-shaped plastic frame and is wrapped in a thin layer of copper. The Paragard IUD has been marketed under various companies in the three decades it has been on the market, including Duramed Pharmaceuticals, Teva Pharmaceuticals, and CooperSurgical and related entities.

One benefit of Paragard is that it can last up to 12 years, and it doesn’t carry severe risks like blood clots because it doesn’t have hormones. Like most IUDs, Paragard is very small, measuring about 1” wide and 1” high. IUDs are inserted with a speculum and can be painful at first. For most women, the pain subsides, and there are few side effects after IUD insertion. 

Complications Of Paragard 

Gynecologist holding an IUD birth control device before using it for patientWhile the Paragard is advertised as an effortless way to prevent pregnancy, complications can occur. If the device becomes dislodged, perforates the uterus, or breaks into pieces while inserted, the patient may need surgery, leading to medical bills, missed unemployment, and unexpected pain and suffering. 

In a recent instance, a woman in North Carolina filed a suit in the U.S. District Court for the Eastern District of North Carolina. She alleges that her doctor followed Paragard’s instructions for removal, but only part of the IUD came out, and a piece was lodged in her uterus. As a result, she was left injured with a loss of reproductive health. 

Along with the physical injury, if the Paragard is dislodged without your knowledge, it may not prevent pregnancy. While Paragard is popular among healthcare providers and patients alike, it’s essential to make yourself aware of the potential risks.