https://13wham.com/news/spotlight-on-america/thousands-of-women-claim-a-popular-iud-broke-in-their-body-and-caused-health-complications

WASHINGTON (SBG) — Millions of women use implanted IUDs for contraception. The Food and Drug Administration has approved several brands as a safe and effective form of birth control. But one device, the Paragard IUD, is drawing thousands of complaints and dozens of lawsuits over concerns it can break, leaving women facing surgery and other complications. Now, some health advocates are calling for the FDA to step in and investigate so women can have more information about the device.

Anna Speaks told Spotlight on America that Paragard seemed like a low maintenance, low fuss method. But she says she was never warned by her health care provider that the device could potentially break.

After about five years with the device, Speaks decided to remove the IUD. While Paragard says the removal of its product should be done by a health care professional, there’s debate among experts, with some saying self-removal is safe and often the choice women make who don’t have access to care or insurance — just like Anna.

“When I realized one of the Ts had broken off, I just kind of started to freak out,” said Anna Speaks, a former Paragard user. “I was panicked. It was devastating, actually.”

Panicked, she realized the problem would now require an expensive and traumatic visit to a doctor to try to retrieve the broken piece. Eventually, surgery was required in an attempt to locate the missing fragment, which turned up on an X-ray supplied to Spotlight on America.

Our team discovered breakage like what Speaks experienced is a well-documented, yet little-publicized problem with the Paragard IUD. Spotlight on America dug through thousands of “adverse events” listed in a database known as FAERS – The FDA Adverse Events Reporting System, which tracks problems reported by individuals and health care providers.

According to the voluntary reports filed with the FDA since 2013 regarding Paragard, there have been:

• 3,186 reports of “device breakage”
• 1,910 of those events deemed “serious”
• 102 related reports of hospitalization or life-threatening complications

An exclusive Spotlight on America investigation found 3,000+ reports of Paragard breakage in an FDA database (Photo: Alex Brauer)

Those figures uncovered in our Spotlight on America investigation are attracting new attention from national leaders in women’s health. Cindy Pearson is Executive Director of the National Women’s Health Network, an organization that strives to empower women and promote equity in health care.

We shared what we found about the Paragard IUD with Pearson, who told us the complaints are just the tip of the iceberg, since they represent only those that took the time to file a report in a government system that is cumbersome and not well known to the public. The problem with voluntary reporting, Pearson says, is it’s hard to tell how often these issues happen, which specific lot numbers they may be tied to and whether the complication is related to the device or something specific about the individuals using it.

Getting the answers about the source of complications or adverse events after products hit the market can be difficult. Generally, companies are not obligated to look at the long-term effects or complications following FDA approval unless the agency instructs them to act or they voluntarily choose to conduct a study. But Pearson says with more than 3,000 Paragard breakage reports, it’s time for the FDA to take a closer look. “It’s a warning sign that deserves to be investigated,” said Pearson. “The FDA should now step in, investigate and use its authority.” Pearson says the agency could potentially require a study so that women can make an informed choice.

“That’s something that shouldn’t kill the method, it should just inform us,” said Cindy Pearson with the National Women’s Health Network. “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.”

Cindy Pearson, Executive Director of the National Women’s Health Network, says IUDs are a safe & effective birth control method but women should be informed about potential complications

The FDA told Spotlight on America it is not currently requiring any new studies of the Paragard IUD. You can read their complete response to our questions at the bottom of this article.

For now, many impacted women are banding together on social media pages to discuss their experience with Paragard. One community on Facebook has more than 8,000 members, supporting one another by sharing personal stories. Some on the site have shared experiences discussing breakage of Paragard. Pearson says those collective experiences can prove powerful, with the FDA previously taking action on another birth control device, Essure, after a grassroots campaign on social media compelled the agency to look closer at complications. Essure is no longer on the market after advocates spent years highlighting problems with the device.

As women wait to see if the FDA will take a closer look, some are taking action in court. Spotlight on America discovered at least 55 recent lawsuits filed in more than 20 states by women who claim Paragard “has a propensity to break upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility and pain.” The lawsuits were consolidated into multidistrict litigation in Georgia in December 2020 and are awaiting the next step.

Spotlight on America repeatedly tried to contact the maker of Paragard, reaching out by phone, email and even sending direct messages on social media platforms. Our requests to speak with the company were not returned.

Paragard has argued in the past that its warnings about the device are adequate, though you won’t hear any mention of breakage in the listing of potential side effects we found in commercials posted online.

When our team went through the prescribing packet for Paragard, we did find a mention of breakage in the fine print, “Breakage of an embedded Paragard during nonsurgical removal has been reported.” In a later section the company says, “Because these reactions are reported voluntarily from a population of an uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”

The prescribing information for Paragard notes that because reactions like breakage are reported voluntarily, it is not always possible to determine how often they happen (Photo: SBG)

Anna Speaks says she was unaware of the potential for breakage and never saw a product label. She is sharing her experience, hoping it will help other women make informed choices. She filed a report with the FDA and says she is working with an attorney. Speaks encourages anyone who’s experienced a complication to share their story. “I do think there’s power in that,” Speaks said. “That’s how we create better regulations and how we create more transparency with these companies and help protect women and their bodies.”

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

An X-Ray image shows a broken piece of the Paragard IUD in Anna Speaks’ uterus (Photo: Anna Speaks)

Spotlight on America reached out to the FDA to see if they are taking any action on Paragard and to get their reaction to criticism of the voluntary reporting system. The full Q&A is below:

1) Is the FDA currently doing any studies or follow-up research when it comes to adverse events involving the Paragard IUD?

Response: The FDA has been monitoring the safety of Paragard, as we do with all approved drug products, and remains committed to informing the public in a timely manner if and when the Agency identifies new safety issues that warrant FDA action. FDA is not currently requiring or requesting any studies on the Paragard intrauterine system. Also see our response to questions 3 and 4 regarding our use of the FAERS database and the strengths and limitations of FAERS.

2) Does the FDA perform any oversight of the manufacturing of the Paragard IUD – including inspections of materials, factory process, etc.?

Response: At the FDA, protecting patient and consumer health is our highest priority. For Paragard and other FDA-approved products, the FDA inspects manufacturing facilities and, when needed, takes action to enforce current good manufacturing quality standards and applicable regulations. When objectionable conditions are identified with manufacturing processes or controls, creating a risk of potentially producing an unsafe product, it’s important that the problems are quickly remedied. When needed, we exercise our regulatory authority commensurate with the assessed risk, including issuing import alerts, warning letters, and in the most serious cases, working with firms as they recall drugs, seizing drugs in commerce or enjoining manufacturers to prevent further violations. We continue to remain vigilant in our compliance and enforcement work, and we’ve taken a number of actions already this year. These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products sold in the U.S.

3) Is there a threshold for the number of complaints to the FAERS database before the FDA will re-examine a drug?

Response: There is no specific threshold for the number of reports required before FDA will reexamine a drug. The FDA is monitoring the safety of Paragard, as we do with all approved drug products, and remains committed to informing the public in a timely manner if and when the agency identifies new safety issues that warrant FDA action. The reports in the FDA Adverse Event Reporting System (FAERS) database are routinely evaluated by FDA staff to monitor the safety of products after approval. On a weekly basis, FDA reviewers monitor individual spontaneous adverse event reports from the FAERS database. These staff also routinely monitor other sources of data, such as published literature and mandatory periodic safety reports from manufacturers. This information is collectively reviewed to inform whether regulatory action, such as labeling changes or other FDA communications, are needed. Additional information on postmarketing safety is available here.

Healthcare professionals, consumers, and manufacturers submit reports to FAERS. FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses, and others) and consumers (such as patients, family members, lawyers, and others). Healthcare professionals and consumers may also report to the products’ manufacturers. If a manufacturer receives a report from a healthcare professional or consumer, they are required to send the report to FDA as specified by regulations.

While FDA relies on the FAERS database as a drug safety surveillance tool after a product is approved and marketed, there remain limitations to the data that you should consider.

• FAERS data by themselves are not an indicator of the complete safety profile of a drug.
• Duplicate and incomplete reports are in the system: There are many instances of duplicative reports and some reports do not contain all the necessary information.
• Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug caused the reaction.
• Information in reports has not been verified: Submission of a report does not mean that the information included in it has been medically confirmed.
• Rates of occurrence cannot be established with reports: The information in these reports cannot be used to estimate the incidence (occurrence rates) of the reactions reported or be used to make comparisons between products.
• Differential reporting for one product over another may occur: Reasons for this include the time the product has been on the market, publication of literature reports related to an adverse event, and publicity surrounding the product or adverse event.

4) Because the FAERS database is voluntary, critics have asserted that it does not provide a complete picture of potential adverse reactions (i.e., It does not compel medical providers to report adverse events, which would help glean specific information about the frequency of specific issues, etc.) How does the FDA respond to that criticism?

Response: While there are limitations to FAERS (see response to Question #3), there are also notable strengths. FAERS data are particularly useful for identifying new (i.e., unexpected), rare, serious adverse events that are temporally associated with a product for which the background rate of events is low. Such adverse events are often not observed in the premarketing trials because these trials are limited in the number of patients, the types of patients included, and the duration of treatment. In addition, the spontaneous adverse event reports in FAERS can further refine or characterize a known adverse event.

As also noted in our response to Question #3, in addition to FAERS, other sources of postmarketing data are utilized to monitor and assess adverse events in the post-market setting.

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