WASHINGTON — It's been three years since Spotlight on America started investigating reports of breakage and complications from a popular birth control device. Our reports have focused on the Paragard copper IUD, the only non-hormonal IUD approved for use in the United States.

Now, for the first time, the U.S. Food and Drug Administration is revealing it conducted a "safety review of IUD breakage" that began after our first report in 2021. We've learned that review concluded with new language in the Prescribing Information for Paragard, but a lack of transparency on behalf of the company and the FDA has made it difficult to get information on behalf of the public.

During our years investigating Paragard breakage, more than a dozen women have told Spotlight about their experiences with the IUD breaking inside of them during removal.

Their words about the experience: "scary," "traumatizing," "terrifying."

Veronica Worley's Paragard IUD broke, and for more than a year now, the broken piece has remained inside her, because she didn't have the health insurance for surgery to remove it.

It's like a ticking time bomb," she told Spotlight on America. "Is it going to perforate something?

Jennifer Davis went through a 4-month ordeal with a broken Paragard IUD that ended with a hysterectomy.

Ashlie Gilbert was facing a hysterectomy before her IUD ultimately expelled itself.

I had a month to sit with the fact that I may never have children," Paragard user Ashlie Gilbert told us. "And that wasn't something I planned on getting taken away from me.

Tracy Patterson was frightened and worried about possible complications when her Paragard broke inside her and the broken piece could not be found. She says she was frustrated when her doctor dismissed her concerns, ultimately fighting to get them to do an X-ray to find where the missing piece had lodged inside her. Wanting to share her story to help other women, she started a conversation on Reddit, which now has more than 100 comments from women.

Jessica Denkmann had to undergo surgery to remove the broken piece inside her and was upset that it put her at "unnecessary risk."

And this is just to name a few.

There are now more than 7,000 adverse events reports in the FDA's database detailing Paragard breakage. The majority of those reports are deemed "serious" and required hospitalization.

While experts say it's still a rare complication with Paragard, it happens more frequently with Paragard than other IUDs. According to a 2022 analysis, Paragard had nearly double the reports of breakage compared to other IUDs approved in the U.S.Only about 2% of problems reported about other IUDs were due to breakage. With Paragard, that number was nearly 10%.

As far back as 2021, women's health advocates have told Spotlight on America that the FDA should do more to examine the issue.

Cindy Pearson, then Executive Director of the Women's Health Network in 2021, told us more information was needed.

"It's a warning sign that deserves to be investigated," said Pearson. "The FDA should now step in, investigate and use its authority. That's something that shouldn't kill the method, it should just inform us."

In 2023, Katymay Malone, a health officer with the National Women's Health Network, echoed the sentiment.

"We definitely need more information, more research, and we need to be listening to women," she told Spotlight on America.

Throughout our three-year investigation, we have asked the FDA if it is conducting any reviews and what it's doing to address concerns about breakage. The agency repeatedly told us that Paragard is considered "safe and effective," and that it "remains committed to informing the public in a timely manner" if issues arise that warrant action. Spotlight on America has obtained documents revealing safety concerns raised after FDA inspections of the Paragard manufacturing facility in Buffalo, New York.

It never disclosed that it had initiated a safety review until now.

In an email this month, the FDA revealed for the first time, it conducted a "safety review" of IUD breakage after we started asking questions in 2021.

Just recently completed, it led to regulatory action, with the FDA approving a change to Paragard's warning label, providing new information on what to do if the device cannot be removed easily.

"“If removal cannot be accomplished by gentle pulling, consider checking Paragard location and assess for embedment and perforation (with imaging, if necessary).”

The new language was approved by the FDA in June, but we discovered it took two months for Paragard's web site to reflect the change. This is the second label change for Paragard in five years. In 2019, the language was updated to include disclosure of the risk of breakage.

Still, the women we spoke to told us they were never warned by their doctors.

Dr. Mitchell Creinin is an OB-GYN and complex family planning specialist based in California, who often treats patients with broken Paragard devices. He told Spotlight on America that breakage is still rare, but he believes women should be warned.

"I think clinicians overall probably are not talking about it as commonly as is necessary." Dr. Creinin said. "It's important for them to know."

Knowing all the facts can help women make an informed choice.

According to the FDA, the latest label change is "intended to guide the counseling" of women on the use of Paragard, but Dr. Creinin told us he has yet to receive any notification of the new language from Paragard's maker.

We asked the agency how long Paragard has to notify clinicians about the change. It told us the company is not required to provide a notification. We asked CooperSurgical, Paragard's maker, if it plans to send out notifications, and we received no response. CooperSurgical has not returned our multiple requests for a comment and interview.

Women who have suffered from broken IUDs want to see more warnings and more transparency.

"Tell people that this could break, this could cause major surgery," Jennifer Davis told us. "This could affect the rest of your life."

Thousands of women are now suing Paragard's maker over breakage. No word on when initial trials could begin.

For now, we're working on getting more information about exactly what the FDA uncovered about IUD breakage during its 3-year safety review. The agency told us its report is not public information. We filed a public records request and requested a return within 10 days. The FDA denied our request for an expedited review. We plan to continue pushing for answers.

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If you've been affected by a broken Paragard IUD, reach out to the Spotlight on America team at [email protected].