Paragard is an intrauterine device (IUD) that uses copper instead of hormones to prevent pregnancy. It is a T-shaped device with copper wound around both arms and the central trunk, designed to be implanted for up to 10 years, and it has been on the market since 1984 with an effectiveness rate over 99 percent.
The breakage problem
Since 2010, the FDA has received more than 2,800 reports of Paragard breakage. The typical scenario: the device is missing one or both arms upon removal. Broken arms can become embedded in uterine tissue or perforate the uterus and migrate to other parts of the body, resulting in surgical removal. Despite these reports, Paragard carries no warnings related to device breakage, the closest warning relates to a whole, non-broken device becoming lodged in the uterus.
Who may have a claim
Women who had a Paragard brand IUD implanted from 2005 to the present, whose device broke at the arm upon or before removal, and where not all of the device could be removed at the first attempt, leaving a retained fragment that required or requires subsequent surgical removal, may have a claim. This includes women who have had the surgery, plan to have it, or for whom surgery is currently too dangerous due to fertility risks, often when the client is trying to become pregnant.
Cases generally do not qualify where the device was implanted more than 10 years before the removal attempt, or where the arm broke but every piece was removed non-invasively at the initial attempt without injury.
Talk to us, at no cost
If your Paragard broke during removal and a fragment was retained, Pisanchyn Law Firm offers a free, confidential case review, and we do not charge a fee unless we win. Call 1-800-444-5309. This page is part of our mass tort litigation practice.
Frequently Asked Questions
How common is Paragard breakage? The FDA has received more than 2,800 reports of breakage since 2010, typically involving one or both arms missing upon removal.
Does Paragard warn about breakage? No. The device carries no warnings related to breakage, which is central to the failure-to-warn allegations in this litigation.
What if I can’t have the fragment removed right now? Cases where surgical removal is too dangerous to attempt at this time, often due to fertility considerations, are still part of this litigation.
This page is for general informational purposes and does not constitute legal or medical advice. Reading it does not create an attorney-client relationship.
