The Paragard copper intrauterine device (IUD) has been linked to serious injuries and complications. Implanted in the uterus and designed to provide long-term birth control, the device may migrate and/or break inside patients, leading to health problems and difficult removal. The Food and Drug Administration (FDA) has received thousands of reports of Paragard breakage. Research also indicates that Paragard IUD may have an increased risk of expulsion and unwanted pregnancies.
Women are filing lawsuits against Teva Pharmaceuticals, claiming that the device manufacturer failed to adequately warn about Paragard side effects. If you were implanted with the Paragard IUD and suffered harm from the device, you may be eligible for legal action.
Sanders Phillips Grossman, a national leader in defective medical device litigation, is representing women injured by Paragard IUD. To discuss a potential claim, please schedule a free case review.
WHAT IS PARAGARD IUD?
Intrauterine devices are small, T-shaped devices placed in the uterus to provide long-term protection against pregnancy. Unlike other IUDs that use artificial hormones, such as Mirena, Paragard is hormone free. Instead of hormones, it uses copper. The copper produces an inflammatory reaction in the uterus that acts as a spermicide, helping to prevent fertilization.
Paragard, approved by the FDA in 1984, weighs less than one gram and is roughly the height of a sugar packet. Doctors insert the IUD through the cervical opening in a process that usually takes a few minutes. Following placement, the patient returns for a second visit about a month later to ensure Paragard is in the correct position.
According to the Paragard website, the device is over 99% effective at preventing pregnancy. The website boasts that Paragard has fewer side effects than other birth control methods, and that 90% of women report being satisfied with Paragard. But conspicuously absent from the website is any mention of the complications that have led to Paragard lawsuits.
THOUSANDS OF PARAGARD ADVERSE EVENTS REPORTED TO FDA
Since 2010, the FDA has received more than 1,600 reports of Paragard breakage. A sample of reports shows the types of adverse events typically linked to the IUD.
- Paragard was scheduled for removal after being in place for 6.5 years. When the IUD was removed, both arms were missing. Sonogram showed that the device’s arms were embedded in the woman’s myometrium (uterine tissue).
- In 2014, a hospital reported four incidents where Paragard devices fractured upon removal. Three of the four involved devices well under their expected lifespan, the report says.
- One woman had her Paragard IUD removed after 8.5 years. Upon removal, doctors found that the copper coil was missing from the long portion of the IUD.
- A woman had her Paragard IUD removed due to cramping, but when the devices came out, no arms were attached to it.
- The copper coil was noted as missing from the stem of a removed Paragard in a 2015 report.
Many women have reported needing additional surgery and suffering health complications as a result of Paragard IUD breakage. In response, some have filed lawsuits seeking compensation for their broken IUD injuries.
TYPES OF INJURIES FROM PARAGARD IUD
Based on FDA reports and lawsuit filings, the types of complications and injuries that may result from the Paragard IUD include:
- IUD embedded in the uterus
- Perforation of the uterus
- Migration of the device or part of the device, leading to organ perforation (such as the colon) and organ damage
- Device breakage requiring surgery
- Copper wire left behind in the body, causing inflammation and injury
- Ectopic pregnancy
- Loss of reproductive health
Compared to other types of IUDs, Paragard users may experience higher expulsion rates and unwanted pregnancies. This finding comes from a study published in the American Journal of Obstetrics & Gynecology. Researchers compared levonorgestrel intrauterine devices (Mirena) and Paragard and found that 10.2% of women using Paragard experienced expulsion (i.e., the device moved out of place or was expelled totally from the body), compared to 4.9% of Mirena users. And during the first year of use, 1.6% of Paragard users became pregnant, versus only 0.1% of Mirena users.
PARAGARD LAWSUITS ALLEGE INADEQUATE WARNINGS
Sanders Phillips Grossman has filed lawsuits on behalf of women injured by Paragard IUD. We’ve seen firsthand the life-changing side effects that a broken IUD can cause.
One of our clients chose to receive Paragard because it is marketed as a reversible form of birth control that would allow her to conceive in the future. But when she went to have the device removed, an arm was missing from it. She required invasive surgery to remove the Paragard’s arm, which was imbedded in her uterus. As a result, she has suffered pain, suffering, mental anguish, loss of enjoyment of life, medical costs, loss of income, and other damages.
We maintain that, based on their own testing, post-marketing complaints, and third party research, Teva Pharmaceuticals was aware Paragard can and does cause serious patient harm due to device breakage while implanted, but failed to disclose these risks.
Teva warns that Paragard may be difficult to remove because it is stuck in the uterus. The manufacturer also warns that the device may perforate the uterus. Both of these side effects could require surgery, says Teva. However, these warnings are made in the context of a whole, non-broken Paragard. Nowhere does Paragard warning information indicate that serious health risks may arise from the device breaking.
DID YOU SUFFER PARAGARD BREAKAGE INJURIES? YOU MAY HAVE A CASE.
Sanders Phillips Grossman continues to investigate Paragard IUD lawsuits on behalf of women injured by the device. If you received Paragard for birth control and suffered any of the side effects discussed on this page, you may have a claim.
Our lawyers are at the forefront of holding medical device manufacturers accountable for the harm their products cause. We’ve held leadership roles in many prominent drug and device lawsuits, including litigation against Bayer over its Mirena IUD. Our experienced trusted, and aggressive medical device attorneys have a track record of protecting victims’ rights that spans over 30 years. During that time, we’ve recovered more than $1 billion for our clients.
Learn your legal options during a no-cost, no-obligation case review. Call 1-888-729-7060 or send us a message to get started.