WASHINGTON (SOA) — Two years after Spotlight on America exposed concerns about a popular birth control method in 2021, reports of breakage continue to pile up and litigation involving the device is moving forward.
The initial investigation found that the Paragard IUD had broken thousands of times, sometimes leading to serious health complications for women; both of those concerns continue to persist about the device.
Over the years Spotlight on America has been tracking this story, thousands of women have reported to the FDA's Adverse Event Reporting System, or FAERS, that their Paragard IUD broke upon removal.
For Florida woman Veronica Worley, the problem came as a total surprise. At a routine health checkup this year, she asked her nurse to check the placement of her Paragard IUD that she'd been using since 2013.
When the nurse found out the device was dislodging, she tried to remove it.
That's when it broke.
The arm of the T-shaped device had snapped off, leaving a piece in her body. Scans reveal its location in her uterus.
It was really bizarre to see this foreign piece just floating around inside my body," Worley recalled. "I worry with every cramp: It's like a ticking time bomb. Is it going to perforate something? Is it embedded?Like so many women, Worley chose Paragard because it's a non-hormonal option, unlike other methods. It was approved by the Food and Drug Administration (FDA) in 1984, and can stay in place for up to 10 years.
She said she was never warned about the possibility that the device could break.
That would've freaked me out to the point of, I would have chosen something different," Worley said.It's a familiar sentiment.
At the time of Spotlight's initial report back in 2021, our analysis of FDA data found nearly 3,200 reports of breakage.
Today, that number has nearly doubled, to more than 6,000 reports of breakage, with more than 4,800 of them deemed "serious.More than 900 reports have been submitted to the FDA in the first six months of this year alone, putting it on pace to more than double the number of reports from 2022.
But the actual number could be much higher. Reports to the FDA are voluntary, meaning the problem is likely underreported, according to Katymay Malone, a health officer with the National Women's Health Network, a non-profit advocacy organization.
But Spotlight on America found only one analysis of this issue. In 2022, a pair of doctors looked at FDA reports of breakage in all types of IUDs from 1998 to 2022.
It found there were nearly double the reports of breakage for the copper Paragard IUD versus other hormonal IUDs.
Only about 2% of problems reported about other IUDs were due to breakage. With Paragard, that number was nearly 10%, suggesting Paragard is more prone to breakage than other devices.
The study also found that Paragard breakage happened more often among women who were older and weighed more, but suggested that more research is needed.
For Katymay Malone, the gap in research starts with a lack of funding.
For now, women face dangers of serious health complications if a broken IUD is left inside their body. Malone said that could include sepsis, infection, extreme bleeding, and inability to conceive.
Spotlight on America asked the FDA if they plan to conduct any studies of Paragard, given the thousands of adverse event reports in their database.
The FDA maintains a robust postmarketing surveillance program for FDA-approved products, including Paragard. The FDA continually monitors postmarketing safety of Paragard, as we do with all approved medical products, through multiple sources of evidence," the FDA replied in a statement. "These may include adverse event reports filed with the FDA through our FAERS database, published literature, clinical studies, including re-evaluation of data from the clinical development program if warranted, and the manufacturer’s periodic safety reports."We review the information collectively to decide whether regulatory action, such as changes to the product’s drug label or other FDA communications, is warranted. Paragard remains a safe and effective intrauterine contraceptive device option for women," the FDA continued. "The currently approved drug label for Paragard contains the necessary information to ensure the safe and effective use of Paragard. This information, which is publicly available, is also intended to guide the counseling of women considering to use or continue to use Paragard."
We remain committed to informing the public in a timely manner if and when the Agency identifies new safety issues for Paragard that warrants additional FDA action, such as changes to the product’s drug label, patient information, or other FDA communications.Spotlight on America asked the agency for the "manufacturer's periodic safety reports," and were told they are not public information. Our team has filed a Freedom of Information Act request to view those reports.
Paragard's current warning label does acknowledge the possibility of breakage, saying "Paragard can break" and make removal difficult, but women we spoke to told us they were never warned about it when they discussed the device with their practitioner.
Jessica Denkmann had to undergo surgery when her IUD broke, and told us she was never told that breakage could happen. She told us she was "shocked" when it happened, and wants to to see the FDA do more to fully understand this issue and provide warnings to women.
Malone echoes that sentiment.
When asked what her message to the FDA would be, she said, "We need a response. We need to act immediately."
As research lags, the issue is making its way to court. According to leading attorneys, there are now more than 2,000 clients suing the device's maker over claims of breakage. They allege Paragard is "inherently dangerous and defective," saying the devices tended to break because they were "produced in violation of federally mandated safety regulations.The first trials on the issue are expected to start in October of 2024.
Spotlight on America reached out to attorneys representing the maker of Paragard. They did not return our request for a comment.
Back in Florida, Worley has not had the broken piece of her IUD removed. She doesn't have health insurance to afford the surgery.
She's speaking out to ensure women have the warning she wishes she had been given more than a decade ago, when she had the Paragard IUD placed.
"Any of the doctors that are even suggesting this form of birth control, they need to be telling patients that there is risk associated with it breaking," she said. "There are instances that happen like this and it could happen to them too."
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To see our original reports about Paragard, click here.
If you've been impacted by a broken Paragard device, reach out to the Spotlight on America team by emailing spotlight@sbgtv.com.
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