According to a new report by Spotlight for America, more than 3,000 women have reported to the FDA that the copper intrauterine device (IUD) Paragard has broken in their bodies, and nearly 2,000 of those have had serious complications as a result.
According to a local ABC news report, Anna Speaks, a woman who chose the copper IUD for its nonhormonal characteristics, “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 five years with the IUD, Speaks decided to remove the IUD, which she tried at home. “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.”
Unfortunately for Anna, after removing of her IUD, she noticed part of the IUD was missing. It was not apparent that it broke in her removal process, and later medical intervention including an X-ray was required to locate the missing piece.
According to the ABC report:
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
Anna Speaks’ experience brings attention to a little discussed issue with the IUD; because it is inserted by the doctor as opposed to being a prescription you take home, she never saw a product label including all possible risks and only had to go by what her doctor told her.
According to the ABC report,
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 have had breakage of your IUD or other adverse experience, share your story here.