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As reports of IUD breakage piled up, maker changed label but many women still unaware


Ashlie Gilbert shows a piece of the broken IUD after it was removed from her body (Photo: Ashlie Gilbert)
Ashlie Gilbert shows a piece of the broken IUD after it was removed from her body (Photo: Ashlie Gilbert)
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LOS ANGELES (SBG) — As a Spotlight on America investigation first reported earlier this year, a popular form of birth control has caused serious complications for thousands of women.

We discovered more than 3,200 women have dealt with breakage of the non-hormonal Paragard IUD.

But we continued digging into issues with the product and uncovered evidence the maker knew about the problem, including changing Paragard's label as complaints piled up. Despite the change, we found many women with the device already in their bodies had no knowledge it could break upon removal.

Ashlie Gilbert joined an unfortunate sorority earlier this year, becoming one of the thousands of women who have experienced an unexpected side effect with birth control. When she was 18, Gilbert had the Paragard IUD implanted in her uterus. She was looking for a method of birth control that didn't involve hormones and told us she liked the idea that Paragardwas long-lasting and effective.

After using the device for nearly a decade, about as long as the Food and Drug Administration had approved it to remain inside the body, she saw her doctor to get it removed. That's when she says she got unexpected and shocking news.

The doctor pulled it out and she said, 'We got most of it.' And an arm was missing," Paragard user Ashlie Gilbert said. "I can't believe this is happening to me. I didn't know that could happen until right before the visit.

Gilbert said her doctor first warned her about the possibility of breakage just before she had it removed. She told Spotlight on America if she had known breakage was a possibility, she would have chosen to have the IUD removed earlier.

Spotlight on America has been digging into the issue of Paragard breakage for months.

According to the latest statistics from the FDA's adverse event reporting system, as of late July:

  • At least 3,290 women have reported Paragard breakage
  • 2,000 of those cases are listed as serious in the FDA database
  • Breakage is the fifth most common adverse reaction reported when it comes to Paragard

The maker of Paragard began reporting an increasing number of complaints it received about breakage to the FDA in 2013, with the total hitting nearly 2,500 in 2019.

That's when FDA records show the company made a change you'll only find in its fine print. That year the company updated its label, including the potential for breakage under the section called "Warnings and Precautions" saying "Breakage of an embedded Paragard during non-surgical removal has been reported".

Although the company deemed the issue of breakage serious enough to warrant a label change, Spotlight on America found it did not take action to notify women who already had the long-lasting device in their bodies. Users like Ashlie Gilbert say it's disappointing the company is not required to do so.

It's just not fair that this is common knowledge and that women still have them and don't know there’s a chance they could break and cause serious complications," said Paragard user Ashlie Gilbert.

Dr. Brian Nguyen, an OB-GYN and assistant professor at the University of Southern California told us he handles one to two cases of Paragard breakage every week, with referrals generally coming from county clinics in Los Angeles. Nguyen insists that Paragard is a very safe option for birth control and that cases of breakage are very rare.

But he told Spotlight on America:

It's a perfectly reasonable expectation for a company to inform their users of all of this, and there are ways to track who is receiving an IUD.

When it comes to making sure patients fully understand the potential risk, Dr. Nguyen also has questions. That's why he told us he's launching a research study to learn more about Paragard breakage.

"There needs to be a lot of research involved to really understand what are the causes. I think that one of the difficulties here with the IUD is that it's a long-acting method and we need to have a lot of data to really understand what is going on," he said. "There are questions. Is this related to patient factors? Is it IUD factors? Is it removal factors that may influence the breakage? We don't have those answers yet."

Nguyen also emphasized that patients should receive a card with information about the product after it is implanted. But Spotlight on America reached out to about a dozen women who had dealt with a breakage complication to see if they had received a card. The responses were mixed, from some saying they received a small card with a date for removal, while others told us they received a pamphlet with general information. Some indicated they received nothing at all from their providers.

As Nguyen's study moves forward, warnings about the potential for Paragard breakage are spreading through social media. Facebook support groups detail stories of breakage from across the country, with some women reporting the need for surgery to locate the remaining arm and even hysterectomies in some cases. An organization called IUD Alert is also compiling information and experiences from women with this complication and others.

Grace Emily Stark, a birth control researcher/writer with the organization, who also once worked at the FDA, told Spotlight on America, "They're more than just a number. And it's affected their lives pretty significantly, and in a way they never informed was possible."

As Stark pointed out, because Paragard is generally implanted at a medical office, many patients don't receive the box it came in, nor do they get a first-hand look at the label. "You go and get the device inserted, fitted and you probably don't see a lick of literature," Stark said.

The other issue, Stark told us, is that companies don't have a lot of motivation to inform past patients about new risks that may come to light. "There's not a lot of incentive to be proactive and call your patients back to the office," Stark explained. Instead, she believes there should be a requirement to launch an information campaign or even some sort of financial incentive to move doctors toward reaching out to patients to inform them of risks that may not have been previously known.

It would ultimately be up to the FDA ,at the end of the day, as the regulators of drugs and medical devices how aggressive they wanted to be with hounding a pharmaceutical company into doing the responsible thing," said Stark. "If they wanted to be responsible, absolutely there should be an information campaign.

Spotlight on America asked the FDA how companies are required to communicate label changes and whether the agency is taking new action to look at Paragard in the wake of thousands of complaints that have prompted some health advocates to push for further review.

The agency told us the label for Paragard contains all necessary information for safe and effective use and it is not currently requesting further studies of the device. It said when it approves a label change, the update is made publicly available and must be distributed with the product, although companies generally get to choose how they communicate changes to patients.

In a statement responding to our questions, the agency said,

The FDA requires that companies distribute their current product labeling with their approved drug product. When FDA approves changes to the drug labeling, the updated product and patient labeling is made publicly available and must be distributed with the approved drug product. Companies can generally choose if and how they further communicate those changes to patients, healthcare providers and other stakeholders, but companies must promptly revise promotional materials to make them consistent with certain labeling changes. When appropriate, FDA can require companies to communicate labeling changes in a specific way.

Spotlight on America also reached out to the makers of Paragard on multiple occasions, asking specific questions about its labeling changes and how it communicated newfound complications to users. The company declined our interview offer, saying, "While the company has a policy of not commenting on proposed or ongoing legal matters, CooperSurgical is deeply committed to providing safe, high-quality products to our customers in compliance with all state and federal regulatory entities. We’re proud of our history of delivering impactful solutions that improve healthcare and lead to a world of healthy women, babies and families.”

Experts repeatedly told Spotlight on America that the risks of breakage are very rare. When placed appropriately by a trained provider, they emphasized the IUD is a very safe method of birth control.

But for women like Ashlie Gilbert, who have faced complications from a broken IUD, leaving it up to the company to decide how they communicate any newly discovered risk, isn't enough. She considers herself one of the "lucky" ones. The broken piece of her Paragard IUD eventually came out on its own and she did not require surgery. But that was after facing days of agony where she faced the possibility of a hysterectomy to remove the broken piece.

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.

Gilbert says she's continued sharing her story on social media in hopes of raising awareness, so women can make informed decisions. She says she feels comforted by the growing community of women she's found online, but believes more should be done. She told us, "I think it's great that women can support one another through this, but this should not be on us."

To watch our original investigation into Paragard breakage, click the video below.

If you've had experience with Paragard IUD breakage, contact us on Twitter or email us spotlight@sbgtv.com.

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