Brigette Honaker  |  March 2, 2022

Category: Medical Devices

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young woman with pain from IUD

Since 2013, more than 3,000 people have allegedly had their Paragard IUDs break. However, the birth control device long lacked any warning about this possibility.

The Paragard IUD is a unique intrauterine device which does not use hormones to stop conception. Instead, the copper wiring on the device causes a local inflammation response which is toxic to sperm and eggs. As a result, pregnancy is prevented. Paragard is owned by CooperSurgical.

Users can keep their Paragard IUD in for up to 10 years in order to prevent conception. This is several years longer than many other IUD options, which typically last between 3 and 5 years, or in the case of the Mirena IUD, 7 years. The device can even be used as a form of emergency contraception. When the maximum time period is up or the patient decides they want it removed, the Paragard can be removed and fertility is restored almost immediately.

Unfortunately, there are reportedly distinct risks associated with the Paragard. In addition to side effects such as severe menstrual pain and heavy bleeding, the copper IUD may be associated with device breakage.

Since 2013, there have been 3,217 reports of Paragard “device breakage” submitted to the FDA Adverse Events Reporting System (FAERS) database. Of these FDA reports, nearly 2,000 were deemed “serious,” and 102 cases involved either hospitalization or life-threatening complications.

Health advocates have argued that, after receiving this many complaints, the FDA and manufacturer should warn doctors and patients alike about the risk for breakage with the Paragard IUD, as they warn with other birth control devices.

“That’s something that shouldn’t kill the method, it should just inform us,” Cindy Pearson with the National Women’s Health Network told 13 WHAM, an ABC affiliate. “If there’s no way to figure out what makes it more likely to break but we’re able to determine it breaks 1 in 25,000 times, then that’s a risk many women would still be willing to take, but we need to know.”

In 2019, Paragard’s maker added the potential for breakage to the device’s “Warnings and Precautions.” The warning reads: “Breakage of an embedded Paragard during non-surgical removal has been reported.”

However, due to a lack of warning about this risk for years, countless IUD users may be shocked when their Paragard IUDs break before or during removal. Many may still be unaware about this risk.

Magnum-m2a-hip-revision-surgeryIn some cases, this breakage could lead to complications. If a Paragard IUD breaks in the body, the broken pieces of the device could be lodged in the lining of the uterus, perforate the uterus, or migrate and damage other pelvic organs. This could lead to infections, pain, cramping, bleeding, and other problems.

Although IUD removal is an in-office procedure, the device may break upon removal. IUD pieces left in the uterus and resulting complications may require invasive surgery to correct.

Filing a Paragard IUD Lawsuit

A growing number of people are coming forward with litigation, claiming that their Paragard IUD has caused serious complications and injuries.

If your Paragard IUD broke when removed, you may be able to take legal action. If CooperSurgical failed to warn about the risk for breakage, the company could be held liable for injuries and resulting expenses.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Join a Free Birth Injury Lawsuit Investigation

If you suffered from serious ParaGard IUD removal complications, you may qualify to join this ParaGard lawsuit investigation.

Fill out the form on this page now to see if you qualify or click the link below to learn more!

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